Grippoton Sachet N10

 

Leaflet-insert: information for the consumer

Grippoton® Sachet, powder for oral solution

paracetamol + pheniramine maleate + ascorbic acid

 

Please read this leaflet-insert carefully before You start taking this medicine because it contains important information for You.

·         Always use the medicine exactly as described in this leaflet-insert or as directed by Your doctor or pharmacist.

·         Keep this leaflet-insert. You may need to read it again.

·         If you have any further questions, please turn to Your doctor or pharmacist.

·          If You experience any unwilling reactions, contact Your doctor. This recommendation is spread to any possible adverse reactions, including those not listed in section 4 of the leaflet-insert.

·         If after 5 days after the start of the drug the condition does not improve or worsens, You should consult a doctor.

Contents of the leaflet-insert

1. What Grippoton® Sachet is and what it is used for.

2. What You need to know before using the drug Grippoton® Sachet

3. How to use Grippoton® Sachet.

4. Possible unwilling reactions

5. Storage of the drug Grippoton® Sachet

6. Contents of the package and other information

1. What Grippoton® Sachet is and what it is used for

Grippoton® Sachet is a combined drug that has anti-allergic, bronchodilator, anti-inflammatory, antipyretic, analgesic, antioxidant effects, accompanied by the decrease of nasal discharge, lacrimation, sneezing and restoration of nasal breathing. At normal body temperature, the antipyretic effect is not manifested. The action of the drug is conditioned by the effects of its constituent components.

Grippoton® Sachet is used for the symptomatic treatment of colds, flu-like conditions in adults and children aged 15 and older, accompanied by:

- headache and/or fever;

- sneezing;

- clear discharge from the nose and lacrimation.

If after 5 days after the start of the usage of drug there is no improvement or You feel worse, You should consult a doctor.

2. What you need to know before you use the drug  Grippoton® Sachet

Do not use Grippoton® Sachet in the following cases:

·         if you are hypersensitive to the components of the drug;

·          if you have severe liver and/or kidney dysfunction;

·         if you have glaucoma;

·         if you have urinary retention associated with disorders of prostate function;

·         if you have phenylketonuria;

·         if you have a gastric and duodenal ulcer in the acute stage;

·         if you have a severe form of diabetes;

·         if you have fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltose deficiency;

·         in case of alcoholism;

·         at children age under 15;

·         if you are pregnant or breastfeeding.

 

Warning and Precautions 

Consult Your doctor or pharmacist before you start using the drug Grippoton® Sachet.

Do not exceed the recommended dose or do not take the drug for more than 5 days in a row.

The patient should consult a doctor in the following cases:

-if the symptoms are not improved for 5 days;

- if the symptoms are accompanied by fever that lasts for more than 3 days;

- if the symptoms include sore throat that lasts more than 3 days accompanied by fever, headache, efflorescence, nausea or vomiting.

- if you have kidney disease;

- if you have liver failure.

For adults weighing more than 50 kg, the total dose of paracetamol should not exceed 4 g per day.

Other Drugs and Drug Grippoton® Sachet

Inform Your doctor or pharmacist if you are taking, have recently taken or may start taking any other medicines.

Combinations that should be taken into account

Morphine derivatives (painkillers, antitussives, and substitution drugs), antipsychotics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (for example, meprobamate), hypnotics, sedatives, antidepressants (amitriptyline, doxepin, mianzerin, mirtazapine, trimipramine), H1 receptor blockers with sedative action, centrally acting antihypertensive drugs, baclofen and thalidomide have a depressant effect on the central nervous system.

Atropine-acting drugs (imipramine antidepressants, atropine-like H1-receptor blockers, anticholinergic antiparkinsonian drugs, antispasmodic atropines, disopyramide, phenothiazine antipsychotics and clozapine) increase the risk of side effects such as urinary retention, constipation and dry mouth.

Drug Grippoton® Sachet with food, drinks and alcohol

          Avoid taking alcoholic beverages and medicines containing alcohol during treatment with Grippoton® Sachet. Alcohol enhances the sedative effect of pheniramine, which is part of the drug. The weakening of attention can be dangerous when driving vehicles and working with mechanisms.

 

         Administration during pregnancy and lactation.

          If You are pregnant, likely to become pregnant or planning to become pregnant, or if You are breastfeeding, You should consult Your doctor before taking this medicine.

         If during the use of the drug You suppose or determine that You are pregnant, consult Your doctor about the possibility of continuing treatment with this drug.

        The drug is contraindicated in the period of pregnancy and lactation for independent use, and consultation with a doctor is necessary.  

Effects on the ability to drive and use machines

During the treatment driving and using compound machines requiring high concentration of attention and high speed of psychomotor reactions is not recommended. Feniramine due to its   anticholinergic properties may cause drowsiness, dizziness, blurred vision and psychomotor disorder in some patients, which may greatly influence the ability to drive and use machines.  The simultaneous use of sedative drugs, tranquilizers or alcohol may result in the increase of drowsiness.

Excipients

1 packet of Grippoton® Sachet contains aspartame E951, which is a source of phenylalanine and may be harmful to people with phenylketonuria.

1 packet of Grippoton® Sachet contains E102 tartrazine, which can cause allergic reactions.

1 packet of Grippoton® Sachet contains white crystalline sugar. If You have an intolerance to some sugars, contact Your doctor before taking this drug.

3. How to use Grippoton® Sachet

Always use the medicine exactly as directed in this leaflet-insert or as advised by Your doctor or pharmacist. If You have any doubts, ask Your doctor or pharmacist for advice.

Dosing regime

The drug is prescribed for adults and children from 15 and older by 1 packet 2-3 times a day.

An interval of at least four hours should be observed between doses.

If you have kidney failure,  the interval between doses of the drug should be at least 8 hours.

The duration of the drug use is not more than 5 days.

 

Mode of administration

Before use, the contents of the package should be dissolved in 100 ml of freshly boiled and cooled drinking water. Ready solution should be used intake.

If you missed the usae of Grippoton® Sachet, do not use a double dose to make up for the missed dose.

If you have taken more quantity of Grippoton® Sachet than you should.

If you took more quantity of Grippoton® Sachet than you should, or if you accidentally swallowed the solution, stop taking the drug and contact your doctor or the nearest emergency unit/hospital. If possible, take the package with the given drug and/or the given leaflet-insert with you

Overdosage with paracetamol:

There is a risk of damage of liver in adults in case of taking 10 and more g of  paracetamol. Taking 5 and more g of paracetamol may lead to the risk of damage of liver if patient has the following risk factors:

- a patient undergoes long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone,  rifampicin, tutsan and other drugs inducing liver enzyms;

- a patient takes ethanol routinely above recommenced quantities;

- a patient is exhausted  (HIV infection, mucoviscidosis, hunger).

Symptoms: nausea, vomiting, anorexia, abdominal pains in the first day. Hepatic failure may manifest itself from 12 to 48 hours after taking the drug. In case of severe poisoning, hepatic failure may progressively worsen until encephalopathy, bleeding, hypoglycemia, brain edema and death. Acute renal failure accompanied by acute necrosis, lumbago, hematuria and proteinuria may occur even if there is no serious liver damage.

Treatment: in case of the appearance of poisoning symptoms consult your doctor immediately.

Overdose by pheniramine

Overdosage may result in convulsion, impairment in consciousness, change in behavior,  dystonic reactions, cardiovascular collapse, bradycardia (slow heart rate), drowsiness, visual impairment,  depression, atropine psychosis (psychosis with impaired consciousness).

The overdose by ascorbic acid can lead to a significant increase in the level of oxalates in the blood and urine, as well as provoke the deposition of calcium oxalate at patients with a predisposition to nephrolithiasis, tubulointerstitial nephropathy (damage of the kidney tubules) and acute kidney failure as a result of crystallization of calcium oxalate.

If you have any additional questions about the use of the medicine, turn to your doctor or pharmacist.

Possible unwilling reactions

Like all the medicines, Grippoton® Sachet can cause unwilling reactions, although not everyone gets them.

Most serious unwilling reactions

Some unwilling reactions that occur very rarely (less than at 1 out of 10,000 people) require immediate medical support. If you noticed any of the following symptoms, stop using the medicine and contact your doctor immediately:

• anaphylactic reactions. Possible manifestations: the rapid appearance of itchy, raised rashes above the skin (urticaria); other types of rash, redness or blanching of the skin; spasm of the bronchi, leading to difficulty of breathing; a sharp decrease in blood pressure, a fast and weak pulse; stomach pain, nausea, vomiting, or diarrhea; dizziness, fainting, or lightheadedness.
• anaphylactic shock (severe allergic reaction). Possible manifestations: a sharp decrease in blood pressure, a fast and weak pulse.
• skin hypersensitivity reactions, including skin rash, angioedema (swelling of the larynx, glottis, face, lips, pharynx, and/or tongue, which can lead to difficulty of breathing due to worsening of airwayof  patency, difficulty swallowing, or impairment of the ability to speak), and Steven-Johnson syndrome (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 observed an increase in body temperature, chills, sore throat, headache).

 

Other possible unwilling reactions

Related to paracetamol

The frequency of these reactions is not defined, but usually they occur rarely:

- thrombocytopenia (a decrease in the number of blood cells that help stop bleeding may be manifested by reddening of the skin or turning the skin purple);

- bronchospasm in patients susceptible to aspirin and other NSAIDs (difficulty of breathing, may be accompanied by shortness of breath, wheezing breathing)

- liver dysfunction.

 

Related to pheniramine

Neurovegetative effects:

- sedative effects or drowsiness, especially at the beginning of treatment;

- the dryness of mucous tunic, constipation, accommodation disorders, mydriasis, tachycardia, the risk of retention of urine; 

- orthostatic hypotension (the process of a sharp drop in pressure);

- imbalance,  dizziness, depression, weakening of memory or concentration, which often occurs in the elderly people;  weakening of memory or concentration, which is common in the elderly people;

- impaired coordination of movements, shiver;

- mental confusion, hallucinations;

- more rarely - effects on type of excitation: agitation (motor restlessness, often occurring with strong emotional arousal, accompanied by feelings of anxiety and fear), nervousness, insomnia.

 

The reactions of high sensitivity (rarely):

- erythrema (skin reddness), itch, eczema (skin lesions in the form of rashes, vesicles, accompanied by itching, the appearance of peeling), urticaria (the rapid appearance of itchy, raised rashes above the skin);

- edema.

Hematological effects:

- leucocytopenia, neutropenia (in some cases, critical decrease in the number of blood cells that help protect the body from the development of infections);

- hemolytic anemia (the decrease of the number of red blood cells due to their destruction).

Reporting about unwilling reactions

It is important to report about suspected unwilling reactions after registration of a drug in order to ensure continuous monitoring of the benefit/risk ratio of the drug. In case of the appearance of unwilling reactions listed in the given leaflet-insert, as well as those not mentioned in it, or in case of ineffectiveness of the drug, it is necessary, first of all, to inform Your doctor immediately about it.

 

Storage of the drug Grippoton® Sachet

Shelf life is 2 years. Shelf le ife is indicated on the package.

The drug should not be used after the date indicated on the package.

To store in a place protected from moisture at a temperature of no higher than 25^oC.

To keep out of the reach of children.

Package contents and other information

Grippoton® Sachet contains paracetamol in combination with drugs (excluding psychotropic drugs).

1 package of powder contains active ingredients: 325 mg of paracetamol, 25 mg of pheniramine maleate, 220 mg of ascorbic acid.

Excipients: anhydrous citric acid, aspartame E 951, lemon oil, tartrazine E 102, white crystalline sugar.

The appearance of the drug Grippoton® Sachet and the contents of the package

Powder for the preparation of solution for oral administration.

The powder of almost white color with a specific smell of lemon. When the contents of the package are dissolved in 100 ml of freshly boiled and cooled water, a transparent or slightly opalescent solution from light yellow to yellow with a specific lemon smell is obtained.

By 3.0 g each in heat-sealed bags made of laminated packaging foil (bouffel). By 10 bags with a leaflet-insert for consumers are placed in a pack of cardboard.

Holder of Registration Certification

«Giga Farm» LLC, the Republic of Armenia, t. Gyumri,  Gogunts str. 3/5.

Tel. +37494000264, +79896335759. E-mail: gig.am@mail.ru.

«Grippoton^®  Sachet»  is  a trademark of the "Giga Farm" LLC

 

Manufacturer:

the “Pharmtechnology” LLC,

the Republic of Belarus,

220024, t. Minsk,  Korzhenevsky str., 22.