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НУРОТОН ЗЕРО СИРОП 100мг 5мл 100г

НУРОТОН ЗЕРО СИРОП 100мг 5мл 100г

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Instruction
on medical use of medicine
Nuroton Zero

International non-proprietary name: Ibuprofen
Dosage form: suspension for intake
Description of dosage form: suspension of white or almost white color with orange smell. Stratification of the suspension is allowed, which is eliminated by shaking.
Composition
active substance: 5 ml of the suspension contains 100 mg of ibuprofen as an active substance.
auxiliary substances: macrogolglycerin hydroxystearate, xanthan gum, glycerol, sodium benzoate (E 211), sodium dihydrogen phosphate dihydrate, sodium hydroxide, diluted phosphoric acid, lemon acid monohydrate, saccharin sodium, maltitol liquid, flavoring Orange PX1488, purified water.
Pharmaco-therapeutic group
Non-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid.
ATC Code M01AE01
Pharmacological Action
Pharmacodynamic properties
Ibuprofen is a derivative of propionic acid. It has antipyretic, analgesic, anti-inflammatory effect. The mechanism of action of ibuprofen is conditioned, first of all, by the suppression of biosynthesis of prostaglandins (PG) by reducing the activity of cyclooxygenase (COX), an enzyme regulating the conversion of arachidonic acid into prostaglandins, prostacyclin and thromboxane.
In this case, the formation of prostaglandins decreases as a result of irreversible inhibition of the cyclooxygenase pathway of arachidonic acid metabolism. The decrease in the concentration of prostaglandins at the site of inflammation is accompanied by a decrease in the formation of bradykinin, endogenous pyrogens, other biologically active substances, oxygen radicals and NO. All this leads to a decrease in the activity of the inflammatory process (anti-inflammatory effect of ibuprofen) and is accompanied by a decrease in painful reception (analgesic effect). A decrease in the concentration of prostaglandins in the cerebrospinal fluid leads to a normalization of body temperature (antipyretic effect).
Pharmacokinetic properties
After oral administration, more than 80% of ibuprofen is absorbed from the digestive tract.
90% of the drug is absorbed and binds to blood plasma proteins (mainly with albumins). The period of reaching the maximum concentration in blood plasma when taking it on an empty stomach is 45 minutes, when taken after meals - 1,5-2,5 hours; in synovial fluid - 2-3 hours, where higher concentrations are created than in blood plasma. The drug is not accumulated in the body. Ibuprofen is metabolized mainly in the liver. It is subject to presystemic and post-systemic metabolism. After absorption about 60% of the pharmacologically inactive form of ibuprofen is slowly transformed into an active form. 60-90% of the drug is excreted by the kidneys in the form of metabolites and products of their compounds with glucuronic acid. To a lesser extent not more than 1% is released with bile and in an unchanged state. After taking a single dose, the drug is completely excreted within 24 hours.
No special studies of pharmacokinetics have been conducted at children.
The literature data confirm that the absorption, metabolism and excretion of ibuprofen at children occurs in the same way as at adults.

Indications for use
NUROTON® ZERO is recommended for use in the following cases:
• Increased body temperature of different genesis in case of:
- colds;
- acute respiratory viral infections;
- influenza;
- angina (pharyngitis);
- child infections accompanied by increase of body temperature;
- post-vaccinal reactions.
• Pain syndrome of various origins of mild and moderate intensity in case of:
- ear pain with inflammation of the middle ear;
- toothache, painful teething;
- headache, migraine;
- pain in muscles, joints;
- injuries of the musculoskeletal apparatus.
Method of Administration and Dosage:
Always take this medicine exactly as Your doctor has appointed to You. Consult Your doctor or pharmacist, if You are unsure about anything.
For oral use.
The drug is intended for short-term use only.
5 ml of the suspension contain 100 mg of ibuprofen.
Before use, shake it until a uniform suspension is obtained.
The drug is taken after meals with liquid.
A measuring cup with the scale attached to the package allows you to accurately dose the drug.
1. Open, if available, the individual packaging of the set, which includes a dosing syringe and an insert, or only a dosing syringe. Remove the cap from the vial. Insert, if necessary, the insert into the neck of the vial so that it is firmly fixed. Insert the dosing syringe into the hole of the insert (the diagram is shown below).

2. Turn the vial with the syringe over and pull the syringe plunger until the plunger tip reaches the mark corresponding to the required volume of the drug (the diagram is shown below). If the required volume of the drug exceeds the maximum volume of the syringe (5 ml), then see point 4.

3. Turn the vial with the syringe to its initial vertical position. Make sure that the syringe plunger has not moved and that the plunger tip is still at the desired mark. Pull the syringe out of the hole in the insert (the insert should remain fixed in the neck of the vial). Close the vial with a cover.
4. The patient should be in a vertical position (except for younger patients, see points 7-10). Slowly push down on the plunger of the syringe, gradually releasing the drug. Sharp pressure on the piston is not allowed. When releasing the drug, it is necessary to direct the opening of the syringe towards the inside of the cheek.
5. If the required volume of the drug exceeds the maximum volume of the syringe (5 ml), then the above points should be repeated so that the total volume of the injected suspension should correspond to the required dose.
5.Disassemble the syringe and rinse it in clean drinking water. Wait for the natural drying of the barrel and piston of the syringe.
6. Keep the vial and dosing syringe out of the reach of children.
The use of the drug at children (up to 3 years), including infants (up to 1 year)
7. After the fulfillment of the abovementioned steps 1-3, place the baby in the feeding position (see figure below).

8. Insert the tip of the syringe into the child's mouth and slowly release the contents towards the inside of the cheek.
9. It is necessary to maintain pauses during the administration of the drug in order to allow the child to gradually swallow the drug.
10. After the child has taken the drug, give him a small amount of water to drink so that the residual amount of the suspension in the oral cavity is swallowed.
11. Follow steps 5-6.
Dosing regime
The likelihood of development of unwilling reactions can be minimized by using the smallest effective dose for the shortest period of time necessary to eliminate the symptoms.
The dose is determined depending on the age and body weight of a child.
It is prescribed at a dose of 20 mg / kg / day; this daily dose should be divided into several doses, and a single dose can be from 5 to 10 mg / kg of the child's body weight,
It is not recommended for use at children weighing less than 5 kg.
The drug is prescribed in a single dose according to the following scheme:
Age Body weight Single dose Administration order
100mg/5ml
3-6 months >5 kg 2,5 ml 3 times/day, see also subsection "Other Instructions" under the table
6-12 months 7-9 kg 2,5 ml up to 3-4 times/day
1-3 years 10-15 kg 5,0 ml up to 3 times/day
4-6 лет 16-20 kg 7,5 ml up to 3 times/day
6-9 years 21-30 kg 10,0 ml up to 3 times/day
9-12 years 31-40 kg 15,0 ml up to 3 times/day
Children above 12 and adults More than 40 kg 15,0-20,0 ml up to 3 times/day

Usage in case of post-vaccinal reactions:
2.5 ml of drug NUROTON ® ZERO 100 mg / 5 ml (which corresponds to 50 mg of ibuprofen) once. If necessary, repeated usage of 2.5 ml (50 mg of ibuprofen) after 6 hours. It is not allowed to use more than 5 ml of the drug within 24 hours. If the increased body temperature does not decrease, a doctor's consultation is necessary.
Other indications
The medicine can be repeated every 6-8 hours (if needed), keeping the period of no less than 4 hours between the next doses.
Do not double the dose if you missed taking the drug! If the next dose is missed, the drug should be taken, if necessary, as soon as you remembered about the omission, under the condition that at least 4 hours have passed since the taking of the previous dose.
The use of the drug to children under 3 months is contraindicated.
The use of the drug by babies from 3- 6 months is possible only after consultation with the doctor. If the symptoms persist for 24 hours or worsen at babies aged 3-6 months it is necessary to consult the doctor again.
If the use of the drug at children over 6 months is needed for more than 3 days, or if the symptoms of the disease worsen despite the ongoing treatment, you should consult a doctor.
Do not exceed the recommended dose.
NUROTON® ZERO is used for no more than 3 days as an antipyretic and no more than 5 days as an anesthetic.
If symptoms persist or condition worsens, consult a doctor.
Side effects:
Like other medicines, Nuroton® ZERO can cause unwilling effects, although not everybody gets them.
Conditions to pay special attention to (most serious unwilling reactions) are the following:
̶ Immediate allergic reactions
Immediate hypersensitivity reactions may occur when using the drug in rare cases. These reactions occur suddenly, in the very near future (several seconds, minutes) after the use of the drug and can increase rapidly.
The following may appear:
• Anaphylaxis, Quincke's edema or severe shock
Manifestations: one or more of the following symptoms may occur simultaneously - swelling of the larynx, glottis, face, lips, pharynx and / or tongue, which can lead to difficulty of breathing as a result of impaired respiratory tract, difficulty of swallowing or worsening of the ability to speak; often with a simultaneous drop in blood pressure;
• hypersensitivity reactions from the respiratory tract.
Manifestations: Asthma symptoms may occur, worsening of symptoms of pre-existing asthma, bronchospasm, shortness of breath.
If you noticed the occurrence of any of the listed symptoms or other symptoms that, in your opinion, indicate the development of an allergic reaction, you should immediately stop using the drug and immediately turn for medical support.
Severe skin reactions
These reactions can develop during the use or after the end of the use of the drug:
• urticaria.
Manifestations: itchy red rash, accompanied by inflammation of the skin;
• Stevens-Johnson syndrome and toxic epidermal necrolysis (the latter is a more severe form, during which extensive skin peeling occurs, capturing up to 30 percent or more of the body surface).
Manifestations: widespread rash in the form of red spots, blisters, painful ulcers, accompanied by peeling and exfoliation of the skin and mucous membranes; the mucous membranes of the oral cavity, nose, eyes, genitals, any parts of the skin are affected; before the appearance of changes in the skin and mucous membranes, there may be an increase in body temperature, chills, sore throat, headache;
• Acute generalized exenthematous pustulosis.
Manifestations: red scaly widespread rash protruding above the surface of the skin, blisters located mainly on skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment;
• erythema multiforme;
Manifestations: the appearance of spots in the form of small targets (the dark part in the center is surrounded by a paler zone, a dark ring forms along the contour of the pale zone); other types of spots, vesicles, skin changes similar to blisters may also form; skin lesions may be accompanied by fever and increase of body temperature and increased fatigue, as well as damage of the mucous membranes (eyes, genitals, oral cavity);
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
Manifestations: flu-like symptoms with rash, fever (increase of body temperature), swollen lymph nodes, and changes in blood indices (including the increase of the quantity of eosinophils and the level of liver enzymes).
If you noticed the development of the given symptoms or other symptoms that, in your opinion, indicate the development of a severe skin reaction, you should immediately stop using the drug and consult a doctor immediately, as some of the listed skin reactions can be life-threatening.
Other allergic reactions
Other allergic reactions that may develop during and after the end of the use of the drug are the following:
• other types of skin rash.
You should stop taking the drug immediately and consult a doctor immediately.
The frequency of occurrence of side effects is estimated according to the following scheme: very often (more than 1 person out of 10); often (less than 1 person out of 10); infrequently (less than 1 person out of 100); rarely (less than 1 person out of 1000); very rarely (less than 1 person out of 10,000); frequency is not established (cannot be estimated on the basis of the available data).
Infections and infestations
Very rarely: an exacerbation of the inflammatory process caused by an infection (for example, the development of necrotizing fasciitis), in exceptional cases, severe infectious complications from the skin and soft tissues with chicken pox may occur.
From the gastrointestinal tract:
Infrequently: abdominal pain, nausea, dyspepsia;
Rarely: diarrhea, vomiting, flatulence, constipation;
Very rarely: melena, vomiting with blood, ulcerative stomatitis, gastritis, exacerbation of colitis and Crohn's disease, esophagitis, pancreatitis, the formation of intestinal strictures; the ulceration of the mucous membrane of the stomach and / or duodenum, in some cases complicated by perforation and bleeding, sometimes fatal, especially at the elderly people.
From the liver:
Very rarely: a disorder of the liver, liver damage (especially in case of prolonged use), acute hepatitis.
From the nervous system:
Infrequently: headache.
Rarely: dizziness, agitation, insomnia, irritability, fatigue. Very rarely: aseptic meningitis (more often at patients with autoimmune diseases, for example at patients with with systemic lupus erythematosus, mixed connective tissue disease), which is manifested by such symptoms as stiff neck muscles, headache, nausea, vomiting, fever, and loss of orientation.
From the sense organs:
Infrequent: visual disturbances (blurred vision or diplopia), dry and irritated eyes, conjunctival and eyelids edema (allergic genesis).
From the hearing organ
Rarely: hearing loss, ringing in ears or tinnitus
From the blood and lymphatic system
Very rarely: anemia hemopoiesis disorders (including hemolytic, aplastic), leukopenia, thrombocytopenia, thrombocytopenic purpura, pancytopenia, agranulocytosis (the first signs of which are fever, sore throat, superficial mouth sores, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising)
From the heart
Very rare: development or worsening of heart failure, tachycardia. The long-term use of ibuprofen (especially at high doses of 2400 mg per day) may be associated with a slight increase of the risk of arterial thrombosis and pathology caused by arterial thrombosis (myocardial infarction, stroke).
From the vessels
Very rarely: the increase of blood pressure, development of edema. The long-term use of ibuprofen (especially at high doses of 2400 mg per day) may be associated with a slight increase of the risk of arterial thrombosis and pathology caused by arterial thrombosis (myocardial infarction, stroke).
From the kidneys and urinary tract
Very rarely: nephrotic syndrome (edema), acute kidney failure, papillary necrosis, polyuria, increased serum urea concentrations, interstitial nephritis.
From the skin and subcutaneous tissues
Very rarely: alopecia.
If any side effects occur, stop taking the medicine and consult your doctor.
Contraindications
Inform your doctor about any health problems or allergies you have or have had before you start taking this medicine.
- popular hypersensitivity to ibuprofen or to other components of the drug;
- Hypersensitivity reactions to aspirin or other NSAIDs in the anamnesis (for example, bronchial asthma, allergic rhinitis, angioedema, urticaria);
- recurrent peptic ulcer or peptic ulcer, including history (two or more separate episodes of confirmed ulcer or bleeding), peptic ulcer that first appeared.
-the availability in anamnesis of gastrointestinal bleeding or perforations connected with the previous NSAID therapy;
- the severe liver, kidney or heart failure (NYHA IV);
-the last trimester of pregnancy;
- Disorders of blood clotting (including hemophilia, prolonged bleeding time, propensity to bleeding, hemorrhagic diathesis);
- Children's age up to 3 months.

Overdose, measures to help in case of overdose
You should immediately turn to medical support in case of accidental or intentional ingestion of a large amount of the drug, or if an overdose of the drug is suspected.
At children symptoms may be manifested with oral doses of more than 400 mg / kg. At adults, the dependence of symptoms on the dose is expressed weaker. The half-life of ibuprofen in case of overdose is 1.5-3 hours.
Symptoms: nausea, vomiting, epigastric pain, retardation, tinnitus, headache, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, hypotension, convulsions, liver dysfunction, acute renal failure, bradycardia, tachycardia. Patients with bronchial asthma may have an exacerbation of the disease.
Treatment: you should immediately turn for medical support in case of an overdose. It is likely that symptomatic therapy will be needed, which is aimed at maintaining the patency of the respiratory tracts, monitoring of cardiac activity and vital activity before the normalization of the indices. Within one hour after taking a toxic dose of the drug, it is possible to rinse the stomach and take activated charcoal. In the case of an asthmatic attack, bronchodilators are indicated.

Interaction with other drugs and other types of interaction
Inform your doctor if you are taking, have recently taken or plan to take any other medicines before you have been prescribed Nuroton® ZERO.
Acetylsalicylic acid
The simultaneous use of ibuprofen and acetylsalicylic acid is not recommended in connection with the possible increase of the development of undesirable phenomena.
According to the results of laboratory studies, it is supposed that ibuprofen, when used concomitantly with the low doses of acetylsalicylic acid, can competitively inhibit platelet aggregation. Although the admissibility of extrapolation of these data to clinical practice remains uncertain, one cannot exclude the possible effect of regular long-term administration of ibuprofen on reducing the cardioprotective effect of low doses of acetylsalicylic acid. The effect of episodic use of ibuprofen on the cardioprotective properties of acetylsalicylic acid seems unlikely.
Other NSAIDs, including selective inhibitors of cyclooxygenase-2: the simultaneous administration of two or more NSAIDs should be avoided, as the risk of adverse drug effects may increase.
Anticoagulants. NSAIDs may increase the effects of anticoagulants such as warfarin (see section "Special Instructions and Precautions").
Diuretics, ACE inhibitors, beta-adrenoblockers and angiotensin II receptor antagonists. Ibuprofen may reduce the effect of diuretics and other antihypertensive drugs. At some patients with kidney dysfunction, the co-administration of ACE inhibitors, beta-blockers or angiotensin II receptor antagonists and ibuprofen can lead to further worsening of renal function. Thus, the combination of the indicated drugs should be carried out with caution, especially in the elderly.
The simultaneous use of ibuprofen and potassium-sparing diuretics can bring to hyperkalemia.
Digoxin, phenytoin, lithium, methotrexate. The simultaneous use of ibuprofen with digoxin, phenytoin, methotrexate or lithium preparations may increase the concentration of these drugs in the blood. In addition, NSAIDs may worsen heart failure and reduce glomerular filtration rate (GFR) when heart failure is treated with cardiac glycosides.
Cyclosporine. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of the development of its hepatotoxic effects, as well as increases the risk of developing nephrotoxicity.
Tacrolimus. In case of simultaneous administration the risk of nephrotoxicity increases. Corticosteroids. Ibuprofen increases the risk of gastrointestinal bleeding.
Mifepristone. NSAIDs should not be taken within 8-12 days after taking mifepristone because, like all NSAIDs, ibuprofen may bring to reduction of the effect of mifepristone.
Antidiabetic drugs. When combined, ibuprofen increases the hypoglycemic effect of oral antidiabetics (sulfonylureas) and insulin.
Zidovudine. There is a possibility of an increased risk of hemarthrosis and hematomas in HIV-positive people with hemophilia who are taking zidovudine and ibuprofen simultaneously.
Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants). They increase the production of hydroxylated active metabolites, increasing the risk of development of severe hepatotoxic reactions.
Antiaids and cholestyramine. They reduce the absorption of ibuprofen. With concomitant administration the medicines should be administered at an interval of several hours.
Cefamandol, cefoperazone, Iefotetan, valproic acid, plikamycin. They increase the frequency of development of hypoprothrombinemia.
Quinolone antibiotics. The simultaneous use with ibuprofen may increase the risk of development of convulsions.
Captopril. Ibuprofen inhibits sodium excretion (captopril effect).
Probenoid and sulfinpyrazone. Medicines containing probenecid and sulfinpyrazone may delay the release of ibuprofen.
Ritonavir. It can increase the plasma concentrations of ibuprofen.
Aminoglycosides. Ibuprofen can reduce the excretion of aminoglycosides.
Myelotoxic agents. They enhance the manifestation of hematotoxicity of the drug.
Caffeine. It strengthens the analgesic effect of ibuprofen.

SPECIAL INDICATIONS AND PRECAUTIONS
• The severity of unwanted effects can be reduced by taking the minimum effective dose required to control symptoms for the shortest period of time.
• In elderly people, the frequency of adverse reactions caused by NSAIDs is increasing. Especially gastrointestinal bleeding and perforation, which can be fatal for the given category of partients. The use of the drug at this category of patients requires caution and medical supervision.
• The development of bronchospasm is possible at the patients with bronchial asthma or allergic diseases or with such conditions in anamnesis when taking ibuprofen.
• In the presence of systemic lupus erythematosus (SLE) and mixed connective tissue diseases, when taking ibuprofen, the risk of aseptic meningitis is increased.
• Ibuprofen-based preparations should be used with caution by patients with impaired kidney function, as these disorders may be aggravated by the use of ibuprofen. There is a risk of development of impaired kidney functions at children with dehydration.
• In case of liver dysfunction NUROTON® ZERO is used with caution.
• When treating with ibuprofen patients in an anamnesis of hypertension and / or heart failure should be cautious because of the risk of fluid retention, increased blood pressure and edema associated with treatment with NSAIDs.
• There is a possibility that agents suppressing cyclooxygenase and the synthesis of prostaglandins can disrupt the work of female reproductive function by affecting ovulation, which is reversible after the withdrawal of treatment.
• At the patients having in anamnesis gastrointestinal diseases (ulcerative colitis, Crohn's disease), NSAIDs should be used with caution, as the exacerbation of these conditions is possible.
• In case of the treatment with all NSAIDs bleeding from the gastrointestinal tract, the formation of ulcers or their perforation are possible up to a lethal outcome (regardless of the duration of treatment). In this case, warning symptoms or the anamnesis of serious phenomenon from the part of the gastrointestinal tract may be absent. With an increase in the dose of NSAIDs, the risk of bleeding from the gastrointestinal tract, the formation of ulcers or perforation increases in patients with ulcer anamnesis, especially in case of the complications of the ulcer with bleeding or perforation at the elderly people as well. These patients should begin treatment from the lowest dose.
In case of the presence of data on the toxic effects of NSAIDs on the gastrointestinal tract in the anamnesis of the patient, it is necessary to inform the attending physician about all the unusual symptoms in the abdominal area (especially about bleeding from the gastrointestinal tract), it is quite important that the elderly people should pay more attention to this at the early stages of treatment.
The patients, concomitantly taking drugs that may increase the risk of ulceration and bleeding, such as oral corticosteroids, anticoagulants (warfarin, etc.), selective serotonin reuptake inhibitors, and antiplatelet agents (aspirin, etc.), should be more cautious.
In case of development of bleeding from the gastrointestinal tract or the formation of peptic ulcer, the patients taking ibuprofen should discontinue the treatment.
Severe skin reactions. On the background of treatment with NSAID serious skin reactions are possible in very rare cases, in some cases with a fatal outcome, including cases of development of exfoliative dermatitis (extensive inflammation and redness of the skin, accompanied by the formation of blisters or peeling of the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (wide-spread rash in the form of red spots, blisters, painful ulcers, accompanied by peeling and exfoliation of the skin and mucous membranes. The mucous membranes of the mouth, nose, eyes, genitals, any areas of the skin are affected. Before the appearance of changes on the skin and mucous membranes, an increase in body temperature, chills, sore throat, headache may be observed. The latter is a more severe form, in which there is an extensive exfoliation of the skin, capturing up to 30 percent or more of the body surface).
The risk of development of such reactions is more characteristic for the initiation of a course of treatment, in particular, during the first month of therapy.
Acute generalized exanthematous pustulosis (red, scaly widespread rash protruding above the surface of the skin, blisters located mainly on the skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment) has also been reported in case of the use of ibuprofen-containing drugs.
If signs and symptoms of serious skin reactions appear, such as skin rash, mucosal lesions, blisters or any other signs of allergy, the drug should be stopped immediately and a you should consult a doctor.
• The results of clinical trials suppose the presence of possible relationship between the administration of ibuprofen, especially at high doses (≥ 2,400 mg per day), with a slight increased risk of the development of thrombotic phenomena and pathologies associated with thrombosis (for example, myocardial infarction and stroke). Epidemiological studies do not suppose a relationship between taking low doses of ibuprofen (≤1200 mg / day) and an increased risk of development of arterial thrombotic phenomena.
• Patients with uncontrolled hypertension, congestive heart failure on NYHA class II-III classification, coronary heart disease, peripheral arterial diseases and / or cerebrovascular diseases should be prescribed ibuprofen only after a thorough assessment of the benefit-risk ratio, while avoiding the use of high doses of ibuprofen (2400 mg / day).
• Long-term therapy with ibuprofen, especially with high doses (≥ 2,400 mg / day), at the patients with risk factors for cardiovascular complications (for example, hypertension, hyperlipidemia, diabetes, smoking) is possible in case of emergency and only after consultation with a doctor.
• Due to the fact that the syrup maltitol is included in the composition of the drug it is not recommended for the patients with fructose intolerance to take this drug.
• Excipients. The composition of the drug includes liquid maltitol. Inform your doctor if you have been diagnosed with an intolerance to some sugars before the medicine was prescribed to you.
5 ml of the drug contains 20.0 mg of sodium benzoate (E211)
Masking the infection
NSAIDs may mask the symptoms and signs of infections, such as fever and pain. Therefore, it is possible that Nuroton Zero may delay the appropriate treatment of the infection, which may lead to an increased risk of complication. This has been observed in pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If Nuroton Zero is used for fever or pain relief due to infection, infection monitoring is recommended. Under non-hospital conditions, the patient should consult a doctor if symptoms persist or worsen.

Use during pregnancy and lactation
If You are pregnant or breastfeeding, if You do not exclude the possibility of pregnancy at the given moment or if You are planning a pregnancy, please consult Your doctor before starting the use of the drug.
If during the use of Nuroton® ZERO You suppose or determine that You are pregnant, consult Your doctor about an alternative treatment. The continued use of Nuroton® ZERO during pregnancy may harm Your baby.
The use of ibuprofen should be avoided during the first 6 months of pregnancy.
During the third trimester of pregnancy, the use of ibuprofen is contraindicated because of the risk of premature closure of the arterial duct of the fetus with possible persistent pulmonary hypertension. The beginning of childbirth may be delayed, the duration of childbirth may be increased, and the risk of bleeding both in the mother and in the child may be increased as well.
In small amounts ibuprofen can be excreted with breast milk, therefore it is recommended to stop breastfeeding for the period of treatment.
Effect on ability to drive and other machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible when taking NSAIDs.
There aren’t any cases of the effect of ibuprofen in the form of a suspension at a dosage of 100 mg / 5 ml on the ability to drive vehicles and mechanisms when using the drug at the recommended doses and for the recommended period of time.
Form of release and packaging
By 100 gr of suspension in plastic bottles, placed together with a dosing cup and instruction for use in cardboard packs. Each vial, together with a 5.0 ml dosing syringe with an orange or white plunger, an insert for a dosing syringe and instructions for medical use, is placed in a cardboard pack. The insert for the dosing syringe can be inserted into the neck of the vial or enclosed in a pack complete with a dosing syringe. A dosing syringe or a dosing syringe set and an insert for a dosing syringe are placed in a cardboard box in a transparent or white protective individual package, or without packaging.
STORAGE CONDITIONS:
Store at a temperature not exceeding 25º C, protected from light & moisture
Keep out of the reach of children.
Shelf- life
2 years. The date of expiry is indicated on the package
Do not use it after the expiry date indicated on the package.
Shelf-life after opening is 6 months.
Legal status for supply
Without prescription
Manufactured by order of the “Giga Farm” LLC, the Republic of Armenia, t. Gyumri, Gogunts str. 3/5, tel.: +37494000264, +79896335759, e-mail gig.am@mail.ru
Organization receiving claims:
“Giga Farm” LLC, The Republic of Armenia, t. Gyumri, Gogunts str.3/5.
Tel: +37477 67 61 83. E-mail: pharmacovigilance@gigafarm.ru.
Registration certificate holder:
“Giga Farm” LLC, Republic of Armenia.
“NUROTON” is a trademark of “Giga Farm” LLC. Manufacturer: “Pharmtechnology” Ltd, the Republic of Belarus, 220024, c. Minsk, Korzhenevskogo street, 22
Видео

Instruction

on medical use of medicine

Nuroton Zero

International non-proprietary name: Ibuprofen

Dosage form: suspension for intake

Description of dosage form: suspension of white or almost white color with orange smell. Stratification of the suspension is allowed, which is eliminated by shaking.

Composition

active substance: 5 ml of the suspension contains 100 mg of ibuprofen as an active substance.

auxiliary substances: macrogolglycerin hydroxystearate, xanthan gum, glycerol, sodium benzoate (E 211), sodium dihydrogen phosphate dihydrate, sodium hydroxide, diluted phosphoric acid, lemon acid monohydrate, saccharin sodium, maltitol liquid, flavoring Orange PX1488, purified water.

Pharmaco-therapeutic group

Non-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid.

ATC Code M01AE01

Pharmacological Action

Pharmacodynamic properties

Ibuprofen is a derivative of propionic acid. It has antipyretic, analgesic, anti-inflammatory effect. The mechanism of action of ibuprofen is conditioned, first of all, by the suppression of biosynthesis of prostaglandins (PG) by reducing the activity of cyclooxygenase (COX), an enzyme regulating the conversion of arachidonic acid into prostaglandins, prostacyclin and thromboxane.

In this case, the formation of prostaglandins decreases as a result of irreversible inhibition of the cyclooxygenase pathway of arachidonic acid metabolism. The decrease in the concentration of prostaglandins at the site of inflammation is accompanied by a decrease in the formation of bradykinin, endogenous pyrogens, other biologically active substances, oxygen radicals and NO. All this leads to a decrease in the activity of the inflammatory process (anti-inflammatory effect of ibuprofen) and is accompanied by a decrease in painful reception (analgesic effect). A decrease in the concentration of prostaglandins in the cerebrospinal fluid leads to a normalization of body temperature (antipyretic effect).

Pharmacokinetic properties

After oral administration, more than 80% of ibuprofen is absorbed from the digestive tract.

90% of the drug is absorbed and binds to blood plasma proteins (mainly with albumins). The period of reaching the maximum concentration in blood plasma when taking it on an empty stomach is 45 minutes, when taken after meals - 1,5-2,5 hours; in synovial fluid - 2-3 hours, where higher concentrations are created than in blood plasma. The drug is not accumulated in the body. Ibuprofen is metabolized mainly in the liver. It is subject to presystemic and post-systemic metabolism. After absorption about 60% of the pharmacologically inactive form of ibuprofen is slowly transformed into an active form. 60-90% of the drug is excreted by the kidneys in the form of metabolites and products of their compounds with glucuronic acid. To a lesser extent not more than 1% is released with bile and in an unchanged state. After taking a single dose, the drug is completely excreted within 24 hours.

No special studies of pharmacokinetics have been conducted at children.

The literature data confirm that the absorption, metabolism and excretion of ibuprofen at children occurs in the same way as at adults.

Indications for use

NUROTON® ZERO is recommended for use in the following cases:

• Increased body temperature of different genesis in case of:

- colds;

- acute respiratory viral infections;

- influenza;

- angina (pharyngitis);

- child infections accompanied by increase of body temperature;

- post-vaccinal reactions.

• Pain syndrome of various origins of mild and moderate intensity in case of:

- ear pain with inflammation of the middle ear;

- toothache, painful teething;

- headache, migraine;

- pain in muscles, joints;

- injuries of the musculoskeletal apparatus.

Method of Administration and Dosage:

Always take this medicine exactly as Your doctor has appointed to You. Consult Your doctor or pharmacist, if You are unsure about anything.

For oral use.

The drug is intended for short-term use only.

5 ml of the suspension contain 100 mg of ibuprofen.

Before use, shake it until a uniform suspension is obtained.

The drug is taken after meals with liquid.

A measuring cup with the scale attached to the package allows you to accurately dose the drug.

1. Open, if available, the individual packaging of the set, which includes a dosing syringe and an insert, or only a dosing syringe. Remove the cap from the vial. Insert, if necessary, the insert into the neck of the vial so that it is firmly fixed. Insert the dosing syringe into the hole of the insert (the diagram is shown below).

2. Turn the vial with the syringe over and pull the syringe plunger until the plunger tip reaches the mark corresponding to the required volume of the drug (the diagram is shown below). If the required volume of the drug exceeds the maximum volume of the syringe (5 ml), then see point 4.

3. Turn the vial with the syringe to its initial vertical position. Make sure that the syringe plunger has not moved and that the plunger tip is still at the desired mark. Pull the syringe out of the hole in the insert (the insert should remain fixed in the neck of the vial). Close the vial with a cover.

4. The patient should be in a vertical position (except for younger patients, see points 7-10). Slowly push down on the plunger of the syringe, gradually releasing the drug. Sharp pressure on the piston is not allowed. When releasing the drug, it is necessary to direct the opening of the syringe towards the inside of the cheek.

5. If the required volume of the drug exceeds the maximum volume of the syringe (5 ml), then the above points should be repeated so that the total volume of the injected suspension should correspond to the required dose.

5.Disassemble the syringe and rinse it in clean drinking water. Wait for the natural drying of the barrel and piston of the syringe.

6. Keep the vial and dosing syringe out of the reach of children.

The use of the drug at children (up to 3 years), including infants (up to 1 year)

7. After the fulfillment of the abovementioned steps 1-3, place the baby in the feeding position (see figure below).

8. Insert the tip of the syringe into the child's mouth and slowly release the contents towards the inside of the cheek.

9. It is necessary to maintain pauses during the administration of the drug in order to allow the child to gradually swallow the drug.

10. After the child has taken the drug, give him a small amount of water to drink so that the residual amount of the suspension in the oral cavity is swallowed.

11. Follow steps 5-6.

Dosing regime

The likelihood of development of unwilling reactions can be minimized by using the smallest effective dose for the shortest period of time necessary to eliminate the symptoms.

The dose is determined depending on the age and body weight of a child.

It is prescribed at a dose of 20 mg / kg / day; this daily dose should be divided into several doses, and a single dose can be from 5 to 10 mg / kg of the child's body weight,

It is not recommended for use at children weighing less than 5 kg.

The drug is prescribed in a single dose according to the following scheme:

Age Body weight Single dose Administration order

100mg/5ml

3-6 months >5 kg 2,5 ml 3 times/day, see also subsection "Other Instructions" under the table

6-12 months 7-9 kg 2,5 ml up to 3-4 times/day

1-3 years 10-15 kg 5,0 ml up to 3 times/day

4-6 лет 16-20 kg 7,5 ml up to 3 times/day

6-9 years 21-30 kg 10,0 ml up to 3 times/day

9-12 years 31-40 kg 15,0 ml up to 3 times/day

Children above 12 and adults More than 40 kg 15,0-20,0 ml up to 3 times/day

Usage in case of post-vaccinal reactions:

2.5 ml of drug NUROTON ® ZERO 100 mg / 5 ml (which corresponds to 50 mg of ibuprofen) once. If necessary, repeated usage of 2.5 ml (50 mg of ibuprofen) after 6 hours. It is not allowed to use more than 5 ml of the drug within 24 hours. If the increased body temperature does not decrease, a doctor's consultation is necessary.

Other indications

The medicine can be repeated every 6-8 hours (if needed), keeping the period of no less than 4 hours between the next doses.

Do not double the dose if you missed taking the drug! If the next dose is missed, the drug should be taken, if necessary, as soon as you remembered about the omission, under the condition that at least 4 hours have passed since the taking of the previous dose.

The use of the drug to children under 3 months is contraindicated.

The use of the drug by babies from 3- 6 months is possible only after consultation with the doctor. If the symptoms persist for 24 hours or worsen at babies aged 3-6 months it is necessary to consult the doctor again.

If the use of the drug at children over 6 months is needed for more than 3 days, or if the symptoms of the disease worsen despite the ongoing treatment, you should consult a doctor.

Do not exceed the recommended dose.

NUROTON® ZERO is used for no more than 3 days as an antipyretic and no more than 5 days as an anesthetic.

If symptoms persist or condition worsens, consult a doctor.

Side effects:

Like other medicines, Nuroton® ZERO can cause unwilling effects, although not everybody gets them.

Conditions to pay special attention to (most serious unwilling reactions) are the following:

̶ Immediate allergic reactions

Immediate hypersensitivity reactions may occur when using the drug in rare cases. These reactions occur suddenly, in the very near future (several seconds, minutes) after the use of the drug and can increase rapidly.

The following may appear:

• Anaphylaxis, Quincke's edema or severe shock

Manifestations: one or more of the following symptoms may occur simultaneously - swelling of the larynx, glottis, face, lips, pharynx and / or tongue, which can lead to difficulty of breathing as a result of impaired respiratory tract, difficulty of swallowing or worsening of the ability to speak; often with a simultaneous drop in blood pressure;

• hypersensitivity reactions from the respiratory tract.

Manifestations: Asthma symptoms may occur, worsening of symptoms of pre-existing asthma, bronchospasm, shortness of breath.

If you noticed the occurrence of any of the listed symptoms or other symptoms that, in your opinion, indicate the development of an allergic reaction, you should immediately stop using the drug and immediately turn for medical support.

Severe skin reactions

These reactions can develop during the use or after the end of the use of the drug:

• urticaria.

Manifestations: itchy red rash, accompanied by inflammation of the skin;

• Stevens-Johnson syndrome and toxic epidermal necrolysis (the latter is a more severe form, during which extensive skin peeling occurs, capturing up to 30 percent or more of the body surface).

Manifestations: widespread rash in the form of red spots, blisters, painful ulcers, accompanied by peeling and exfoliation of the skin and mucous membranes; the mucous membranes of the oral cavity, nose, eyes, genitals, any parts of the skin are affected; before the appearance of changes in the skin and mucous membranes, there may be an increase in body temperature, chills, sore throat, headache;

• Acute generalized exenthematous pustulosis.

Manifestations: red scaly widespread rash protruding above the surface of the skin, blisters located mainly on skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment;

• erythema multiforme;

Manifestations: the appearance of spots in the form of small targets (the dark part in the center is surrounded by a paler zone, a dark ring forms along the contour of the pale zone); other types of spots, vesicles, skin changes similar to blisters may also form; skin lesions may be accompanied by fever and increase of body temperature and increased fatigue, as well as damage of the mucous membranes (eyes, genitals, oral cavity);

• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Manifestations: flu-like symptoms with rash, fever (increase of body temperature), swollen lymph nodes, and changes in blood indices (including the increase of the quantity of eosinophils and the level of liver enzymes).

If you noticed the development of the given symptoms or other symptoms that, in your opinion, indicate the development of a severe skin reaction, you should immediately stop using the drug and consult a doctor immediately, as some of the listed skin reactions can be life-threatening.

Other allergic reactions

Other allergic reactions that may develop during and after the end of the use of the drug are the following:

• other types of skin rash.

You should stop taking the drug immediately and consult a doctor immediately.

The frequency of occurrence of side effects is estimated according to the following scheme: very often (more than 1 person out of 10); often (less than 1 person out of 10); infrequently (less than 1 person out of 100); rarely (less than 1 person out of 1000); very rarely (less than 1 person out of 10,000); frequency is not established (cannot be estimated on the basis of the available data).

Infections and infestations

Very rarely: an exacerbation of the inflammatory process caused by an infection (for example, the development of necrotizing fasciitis), in exceptional cases, severe infectious complications from the skin and soft tissues with chicken pox may occur.

From the gastrointestinal tract:

Infrequently: abdominal pain, nausea, dyspepsia;

Rarely: diarrhea, vomiting, flatulence, constipation;

Very rarely: melena, vomiting with blood, ulcerative stomatitis, gastritis, exacerbation of colitis and Crohn's disease, esophagitis, pancreatitis, the formation of intestinal strictures; the ulceration of the mucous membrane of the stomach and / or duodenum, in some cases complicated by perforation and bleeding, sometimes fatal, especially at the elderly people.

From the liver:

Very rarely: a disorder of the liver, liver damage (especially in case of prolonged use), acute hepatitis.

From the nervous system:

Infrequently: headache.

Rarely: dizziness, agitation, insomnia, irritability, fatigue. Very rarely: aseptic meningitis (more often at patients with autoimmune diseases, for example at patients with with systemic lupus erythematosus, mixed connective tissue disease), which is manifested by such symptoms as stiff neck muscles, headache, nausea, vomiting, fever, and loss of orientation.

From the sense organs:

Infrequent: visual disturbances (blurred vision or diplopia), dry and irritated eyes, conjunctival and eyelids edema (allergic genesis).

From the hearing organ

Rarely: hearing loss, ringing in ears or tinnitus

From the blood and lymphatic system

Very rarely: anemia hemopoiesis disorders (including hemolytic, aplastic), leukopenia, thrombocytopenia, thrombocytopenic purpura, pancytopenia, agranulocytosis (the first signs of which are fever, sore throat, superficial mouth sores, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising)

From the heart

Very rare: development or worsening of heart failure, tachycardia. The long-term use of ibuprofen (especially at high doses of 2400 mg per day) may be associated with a slight increase of the risk of arterial thrombosis and pathology caused by arterial thrombosis (myocardial infarction, stroke).

From the vessels

Very rarely: the increase of blood pressure, development of edema. The long-term use of ibuprofen (especially at high doses of 2400 mg per day) may be associated with a slight increase of the risk of arterial thrombosis and pathology caused by arterial thrombosis (myocardial infarction, stroke).

From the kidneys and urinary tract

Very rarely: nephrotic syndrome (edema), acute kidney failure, papillary necrosis, polyuria, increased serum urea concentrations, interstitial nephritis.

From the skin and subcutaneous tissues

Very rarely: alopecia.

If any side effects occur, stop taking the medicine and consult your doctor.

Contraindications

Inform your doctor about any health problems or allergies you have or have had before you start taking this medicine.

- popular hypersensitivity to ibuprofen or to other components of the drug;

- Hypersensitivity reactions to aspirin or other NSAIDs in the anamnesis (for example, bronchial asthma, allergic rhinitis, angioedema, urticaria);

- recurrent peptic ulcer or peptic ulcer, including history (two or more separate episodes of confirmed ulcer or bleeding), peptic ulcer that first appeared.

-the availability in anamnesis of gastrointestinal bleeding or perforations connected with the previous NSAID therapy;

- the severe liver, kidney or heart failure (NYHA IV);

-the last trimester of pregnancy;

- Disorders of blood clotting (including hemophilia, prolonged bleeding time, propensity to bleeding, hemorrhagic diathesis);

- Children's age up to 3 months.

Overdose, measures to help in case of overdose

You should immediately turn to medical support in case of accidental or intentional ingestion of a large amount of the drug, or if an overdose of the drug is suspected.

At children symptoms may be manifested with oral doses of more than 400 mg / kg. At adults, the dependence of symptoms on the dose is expressed weaker. The half-life of ibuprofen in case of overdose is 1.5-3 hours.

Symptoms: nausea, vomiting, epigastric pain, retardation, tinnitus, headache, depression, drowsiness, metabolic acidosis, coma, hemorrhagic diathesis, hypotension, convulsions, liver dysfunction, acute renal failure, bradycardia, tachycardia. Patients with bronchial asthma may have an exacerbation of the disease.

Treatment: you should immediately turn for medical support in case of an overdose. It is likely that symptomatic therapy will be needed, which is aimed at maintaining the patency of the respiratory tracts, monitoring of cardiac activity and vital activity before the normalization of the indices. Within one hour after taking a toxic dose of the drug, it is possible to rinse the stomach and take activated charcoal. In the case of an asthmatic attack, bronchodilators are indicated.

Interaction with other drugs and other types of interaction

Inform your doctor if you are taking, have recently taken or plan to take any other medicines before you have been prescribed Nuroton® ZERO.

Acetylsalicylic acid

The simultaneous use of ibuprofen and acetylsalicylic acid is not recommended in connection with the possible increase of the development of undesirable phenomena.

According to the results of laboratory studies, it is supposed that ibuprofen, when used concomitantly with the low doses of acetylsalicylic acid, can competitively inhibit platelet aggregation. Although the admissibility of extrapolation of these data to clinical practice remains uncertain, one cannot exclude the possible effect of regular long-term administration of ibuprofen on reducing the cardioprotective effect of low doses of acetylsalicylic acid. The effect of episodic use of ibuprofen on the cardioprotective properties of acetylsalicylic acid seems unlikely.

Other NSAIDs, including selective inhibitors of cyclooxygenase-2: the simultaneous administration of two or more NSAIDs should be avoided, as the risk of adverse drug effects may increase.

Anticoagulants. NSAIDs may increase the effects of anticoagulants such as warfarin (see section "Special Instructions and Precautions").

Diuretics, ACE inhibitors, beta-adrenoblockers and angiotensin II receptor antagonists. Ibuprofen may reduce the effect of diuretics and other antihypertensive drugs. At some patients with kidney dysfunction, the co-administration of ACE inhibitors, beta-blockers or angiotensin II receptor antagonists and ibuprofen can lead to further worsening of renal function. Thus, the combination of the indicated drugs should be carried out with caution, especially in the elderly.

The simultaneous use of ibuprofen and potassium-sparing diuretics can bring to hyperkalemia.

Digoxin, phenytoin, lithium, methotrexate. The simultaneous use of ibuprofen with digoxin, phenytoin, methotrexate or lithium preparations may increase the concentration of these drugs in the blood. In addition, NSAIDs may worsen heart failure and reduce glomerular filtration rate (GFR) when heart failure is treated with cardiac glycosides.

Cyclosporine. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of the development of its hepatotoxic effects, as well as increases the risk of developing nephrotoxicity.

Tacrolimus. In case of simultaneous administration the risk of nephrotoxicity increases. Corticosteroids. Ibuprofen increases the risk of gastrointestinal bleeding.

Mifepristone. NSAIDs should not be taken within 8-12 days after taking mifepristone because, like all NSAIDs, ibuprofen may bring to reduction of the effect of mifepristone.

Antidiabetic drugs. When combined, ibuprofen increases the hypoglycemic effect of oral antidiabetics (sulfonylureas) and insulin.

Zidovudine. There is a possibility of an increased risk of hemarthrosis and hematomas in HIV-positive people with hemophilia who are taking zidovudine and ibuprofen simultaneously.

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants). They increase the production of hydroxylated active metabolites, increasing the risk of development of severe hepatotoxic reactions.

Antiaids and cholestyramine. They reduce the absorption of ibuprofen. With concomitant administration the medicines should be administered at an interval of several hours.

Cefamandol, cefoperazone, Iefotetan, valproic acid, plikamycin. They increase the frequency of development of hypoprothrombinemia.

Quinolone antibiotics. The simultaneous use with ibuprofen may increase the risk of development of convulsions.

Captopril. Ibuprofen inhibits sodium excretion (captopril effect).

Probenoid and sulfinpyrazone. Medicines containing probenecid and sulfinpyrazone may delay the release of ibuprofen.

Ritonavir. It can increase the plasma concentrations of ibuprofen.

Aminoglycosides. Ibuprofen can reduce the excretion of aminoglycosides.

Myelotoxic agents. They enhance the manifestation of hematotoxicity of the drug.

Caffeine. It strengthens the analgesic effect of ibuprofen.

SPECIAL INDICATIONS AND PRECAUTIONS

• The severity of unwanted effects can be reduced by taking the minimum effective dose required to control symptoms for the shortest period of time.

• In elderly people, the frequency of adverse reactions caused by NSAIDs is increasing. Especially gastrointestinal bleeding and perforation, which can be fatal for the given category of partients. The use of the drug at this category of patients requires caution and medical supervision.

• The development of bronchospasm is possible at the patients with bronchial asthma or allergic diseases or with such conditions in anamnesis when taking ibuprofen.

• In the presence of systemic lupus erythematosus (SLE) and mixed connective tissue diseases, when taking ibuprofen, the risk of aseptic meningitis is increased.

• Ibuprofen-based preparations should be used with caution by patients with impaired kidney function, as these disorders may be aggravated by the use of ibuprofen. There is a risk of development of impaired kidney functions at children with dehydration.

• In case of liver dysfunction NUROTON® ZERO is used with caution.

• When treating with ibuprofen patients in an anamnesis of hypertension and / or heart failure should be cautious because of the risk of fluid retention, increased blood pressure and edema associated with treatment with NSAIDs.

• There is a possibility that agents suppressing cyclooxygenase and the synthesis of prostaglandins can disrupt the work of female reproductive function by affecting ovulation, which is reversible after the withdrawal of treatment.

• At the patients having in anamnesis gastrointestinal diseases (ulcerative colitis, Crohn's disease), NSAIDs should be used with caution, as the exacerbation of these conditions is possible.

• In case of the treatment with all NSAIDs bleeding from the gastrointestinal tract, the formation of ulcers or their perforation are possible up to a lethal outcome (regardless of the duration of treatment). In this case, warning symptoms or the anamnesis of serious phenomenon from the part of the gastrointestinal tract may be absent. With an increase in the dose of NSAIDs, the risk of bleeding from the gastrointestinal tract, the formation of ulcers or perforation increases in patients with ulcer anamnesis, especially in case of the complications of the ulcer with bleeding or perforation at the elderly people as well. These patients should begin treatment from the lowest dose.

In case of the presence of data on the toxic effects of NSAIDs on the gastrointestinal tract in the anamnesis of the patient, it is necessary to inform the attending physician about all the unusual symptoms in the abdominal area (especially about bleeding from the gastrointestinal tract), it is quite important that the elderly people should pay more attention to this at the early stages of treatment.

The patients, concomitantly taking drugs that may increase the risk of ulceration and bleeding, such as oral corticosteroids, anticoagulants (warfarin, etc.), selective serotonin reuptake inhibitors, and antiplatelet agents (aspirin, etc.), should be more cautious.

In case of development of bleeding from the gastrointestinal tract or the formation of peptic ulcer, the patients taking ibuprofen should discontinue the treatment.

Severe skin reactions. On the background of treatment with NSAID serious skin reactions are possible in very rare cases, in some cases with a fatal outcome, including cases of development of exfoliative dermatitis (extensive inflammation and redness of the skin, accompanied by the formation of blisters or peeling of the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (wide-spread rash in the form of red spots, blisters, painful ulcers, accompanied by peeling and exfoliation of the skin and mucous membranes. The mucous membranes of the mouth, nose, eyes, genitals, any areas of the skin are affected. Before the appearance of changes on the skin and mucous membranes, an increase in body temperature, chills, sore throat, headache may be observed. The latter is a more severe form, in which there is an extensive exfoliation of the skin, capturing up to 30 percent or more of the body surface).

The risk of development of such reactions is more characteristic for the initiation of a course of treatment, in particular, during the first month of therapy.

Acute generalized exanthematous pustulosis (red, scaly widespread rash protruding above the surface of the skin, blisters located mainly on the skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment) has also been reported in case of the use of ibuprofen-containing drugs.

If signs and symptoms of serious skin reactions appear, such as skin rash, mucosal lesions, blisters or any other signs of allergy, the drug should be stopped immediately and a you should consult a doctor.

• The results of clinical trials suppose the presence of possible relationship between the administration of ibuprofen, especially at high doses (≥ 2,400 mg per day), with a slight increased risk of the development of thrombotic phenomena and pathologies associated with thrombosis (for example, myocardial infarction and stroke). Epidemiological studies do not suppose a relationship between taking low doses of ibuprofen (≤1200 mg / day) and an increased risk of development of arterial thrombotic phenomena.

• Patients with uncontrolled hypertension, congestive heart failure on NYHA class II-III classification, coronary heart disease, peripheral arterial diseases and / or cerebrovascular diseases should be prescribed ibuprofen only after a thorough assessment of the benefit-risk ratio, while avoiding the use of high doses of ibuprofen (2400 mg / day).

• Long-term therapy with ibuprofen, especially with high doses (≥ 2,400 mg / day), at the patients with risk factors for cardiovascular complications (for example, hypertension, hyperlipidemia, diabetes, smoking) is possible in case of emergency and only after consultation with a doctor.

• Due to the fact that the syrup maltitol is included in the composition of the drug it is not recommended for the patients with fructose intolerance to take this drug.

• Excipients. The composition of the drug includes liquid maltitol. Inform your doctor if you have been diagnosed with an intolerance to some sugars before the medicine was prescribed to you.

5 ml of the drug contains 20.0 mg of sodium benzoate (E211)

Masking the infection

NSAIDs may mask the symptoms and signs of infections, such as fever and pain. Therefore, it is possible that Nuroton Zero may delay the appropriate treatment of the infection, which may lead to an increased risk of complication. This has been observed in pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If Nuroton Zero is used for fever or pain relief due to infection, infection monitoring is recommended. Under non-hospital conditions, the patient should consult a doctor if symptoms persist or worsen.

Use during pregnancy and lactation

If You are pregnant or breastfeeding, if You do not exclude the possibility of pregnancy at the given moment or if You are planning a pregnancy, please consult Your doctor before starting the use of the drug.

If during the use of Nuroton® ZERO You suppose or determine that You are pregnant, consult Your doctor about an alternative treatment. The continued use of Nuroton® ZERO during pregnancy may harm Your baby.

The use of ibuprofen should be avoided during the first 6 months of pregnancy.

During the third trimester of pregnancy, the use of ibuprofen is contraindicated because of the risk of premature closure of the arterial duct of the fetus with possible persistent pulmonary hypertension. The beginning of childbirth may be delayed, the duration of childbirth may be increased, and the risk of bleeding both in the mother and in the child may be increased as well.

In small amounts ibuprofen can be excreted with breast milk, therefore it is recommended to stop breastfeeding for the period of treatment.

Effect on ability to drive and other machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible when taking NSAIDs.

There aren’t any cases of the effect of ibuprofen in the form of a suspension at a dosage of 100 mg / 5 ml on the ability to drive vehicles and mechanisms when using the drug at the recommended doses and for the recommended period of time.

Form of release and packaging

By 100 gr of suspension in plastic bottles, placed together with a dosing cup and instruction for use in cardboard packs. Each vial, together with a 5.0 ml dosing syringe with an orange or white plunger, an insert for a dosing syringe and instructions for medical use, is placed in a cardboard pack. The insert for the dosing syringe can be inserted into the neck of the vial or enclosed in a pack complete with a dosing syringe. A dosing syringe or a dosing syringe set and an insert for a dosing syringe are placed in a cardboard box in a transparent or white protective individual package, or without packaging.

STORAGE CONDITIONS:

Store at a temperature not exceeding 25º C, protected from light & moisture

Keep out of the reach of children.

Shelf- life

2 years. The date of expiry is indicated on the package

Do not use it after the expiry date indicated on the package.

Shelf-life after opening is 6 months.

Legal status for supply

Without prescription

Manufactured by order of the “Giga Farm” LLC, the Republic of Armenia, t. Gyumri, Gogunts str. 3/5, tel.: +37494000264, +79896335759, e-mail gig.am@mail.ru

Organization receiving claims:

“Giga Farm” LLC, The Republic of Armenia, t. Gyumri, Gogunts str.3/5.

Tel: +37477 67 61 83. E-mail: pharmacovigilance@gigafarm.ru.

Registration certificate holder:

“Giga Farm” LLC, Republic of Armenia.

“NUROTON” is a trademark of “Giga Farm” LLC. Manufacturer: “Pharmtechnology” Ltd, the Republic of Belarus, 220024, c. Minsk, Korzhenevskogo street, 22

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