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AZIREX tab 500mg N3

AZIREX tab 500mg N3

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Macrolide Composition: each tablet contains 500 mg of azithromycin. Indications for use: Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, otitis media); - infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, pneumonia ); - infections of the skin and soft tissues (acne of moderate severity, erysipelas, impetigo, secondarily infectious dermatoses); - the initial stage of Lyme disease (borreliosis); - urinary tract infections caused by Chlamydiatrachomatis (urethritis, cervicitis). Dosage and administration: 1 time per day.

Description products

Լeaflet: information for the consumer
Azirex®, film-coated tablets, 500 mg
azithromycin

Read this package leaflet completely before you start using the medicine because it contains important information for
you.
• Keep the leaflet. You may need to read it again.
• If you have any further questions, please contact your doctor.
• The drug has been prescribed specifically for you. Do not pass it on to other people. It can harm them even if their
symptoms are the same as yours.
Contents of the leaflet
1. What Azirex® is and what it is used for
2. What you need to know before you use Azirex®
3. How to use Azirex®
4. Possible adverse reactions
5. Storage of Azirex® medicinal product
6. Contents of the package and other information
1. What Azirex® is and what it is used for
Azirex contains the active ingredient azithromycin, which belongs to a group of antibiotics called macrolides.
Azirex® is indicated for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the
drug:
- infections of the upper respiratory tract (tonsillitis, pharyngitis, sinusitis);
- infections of the lower respiratory tract (bronchitis, community-acquired bacterial pneumonia, including pneumonia
caused by atypical pathogens);
- infections of the middle ear (acute otitis media);
- skin and soft tissue infections: moderate acne (acne vulgaris), erythema migrans annulare (the initial stage of Lyme
disease), erysipelas, impetigo, secondary pyoderma;
- sexually transmitted infections caused by Chlamydia trachomatis (uncomplicated urethritis, cervicitis).
2. What you need to know before you use Azirex®
Do not use Azirex® in the following cases:
- you are hypersensitive to azithromycin, erythromycin, other macrolide and ketolide antibiotics and / or to any auxiliary
component of the drug listed in section 6;
- the drug should not be used simultaneously with ergotamine derivatives.
Special instructions and precautions for use
Talk to your doctor before using Azirex®.
Talk to your doctor before using Azirex® in the following cases:
- in diseases of the kidneys;
- with cardiovascular diseases;
- if you have liver disease (your doctor may need to monitor your liver function or stop treatment);
- with myasthenia gravis (a disease in which there is weakness of certain muscles);
- if you are taking ergotamine derivatives (medicines used to treat migraine), as they should not be taken with
azithromycin.
Tell your doctor immediately if you experience palpitations or irregular heartbeat, or if you experience dizziness, fainting,
or muscle weakness while using Azirex®.
Tell your doctor if you experience diarrhea (loose stools) while using Azirex® or after treatment ends.
When using azithromycin, serious skin reactions may occur. At the first sign of a skin rash, damage to the mucous
membranes or any other symptoms of hypersensitivity, stop using the drug immediately and contact your doctor.
Other medicines and Azirex®
Tell your doctor if you are currently taking, have recently taken or may be taking any other medicines, including those
obtained without a prescription, before taking Azirex®.
Some medicines can interact with Azirex. Make sure your healthcare provider knows you are taking the following
medicines:
- ergotamine derivatives (see subsection "Special instructions and precautions for use");
- warfarin or other drugs to prevent blood clots;
- cyclosporine (drug to prevent graft rejection);
- antacids (drugs used for heartburn);
- digoxin (medication for the treatment of heart failure);
- colchicine (drug used to treat gout);
- terfenadine (an antiallergic drug).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor
before using this medicine.
If during the use of Azirex® you suspect or determine that you are pregnant, consult your doctor about the possibility of
continuing treatment with this drug.
Pregnancy
Do not use Azirex® unless it has been prescribed to you by your doctor.
Breast-feeding
Do not use Azirex® unless it has been prescribed to you by your doctor. Do not use Azirex® unless it has been prescribed
to you by your doctor. If your doctor has prescribed Azirex® to you, you must stop breastfeeding. Feeding can be resumed
2 days after discontinuation of Azirex®.

Driving vehicles and working with mechanisms
When driving vehicles and working with mechanical equipment, it is necessary to take into account the possibility of
adverse reactions such as dizziness, drowsiness and visual impairment.
3. How to use Azirex®
Always use this drug exactly as described in this leaflet or as advised by your doctor. If in doubt, consult your doctor.
Tablets should be taken 1 time per day, regardless of the meal, without chewing.
Adults, including elderly patients, and children weighing more than 45 kg
For infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of migrating annular
erythema): 500 mg 1 time per day for 3 days, the total dose is 1500 mg.
In uncomplicated forms of acne vulgaris: 500 mg once a day for the first 3 days, then 500 mg once a week for 9 weeks,
the course dose is 6 g. In the second week, the dose is taken 7 days after the previous dose.
With migrating annular erythema: 1 g on the first day and 500 mg daily 1 time per day from the second to the fifth day.
For sexually transmitted infections (urethritis / cervicitis): 1 g once.
Children weighing less than 45 kg
Children weighing less than 45 kg should not take Azirex® 500 mg.
Special patient groups
Patients with impaired renal and hepatic function
The doctor may adjust the dose of the drug.
Elderly patients
In elderly patients, the same dose is used as in adults.
If you have taken more Azirex than you should
If you or your child has taken more than you should, call your doctor or go to the nearest emergency room/hospital. If
possible, take the container of this drug and/or this package leaflet with you.
Symptoms of a possible overdose may include reversible hearing loss, nausea, vomiting, or diarrhea.
Treatment of overdose includes the administration of activated charcoal and general symptomatic and life-sustaining
therapeutic measures.
If you forget to take Azirex®
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of the drug, contact your doctor.
4. Possible adverse reactions
Like other medicines, Azirex can cause side effects, although not everyone gets them.
Some symptoms that occur infrequently (in less than 1 in 100 people), rarely (in less than 1 in 1000 people), or with an
unknown frequency [frequency unknown, but a reaction is likely (cannot be determined from the available data)] require
immediate medical attention.
If you develop any of the following adverse reactions, stop using the drug immediately and contact your doctor:
- angioedema. Possible manifestations: swelling of the larynx, glottis, face, lips, pharynx and / or tongue, which can lead
to difficulty breathing due to a deterioration in airway patency, difficulty swallowing or deterioration in the ability to
speak;
- Anaphylactic shock is a severe allergic reaction. Possible manifestations: a sharp decrease in blood pressure, a fast and
weak pulse;
- serious skin reactions:
• acute generalized exanthematous pustulosis - widespread red skin rash with small vesicles containing pus;
• Stevens-Johnson syndrome and toxic epidermal necrolysis (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).
before the appearance of changes in the skin and mucous membranes, there may be an increase in body temperature,
chills, sore throat, headache;
• DRESS syndrome - drug reaction syndrome with eosinophilia and systemic manifestations [hypersensitivity reaction
with skin rash, fever, swollen lymph nodes, an increase in the number of one type of white blood cells (eosinophilia) and
inflammation of the internal organs (liver, lungs, heart, kidneys and colon intestines)];
• erythema multiforme. Possible manifestations: skin rash, which is characterized by 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 and other skin changes may also form;
- fast or irregular heartbeat;
- low blood pressure.
Azithromycin may have adverse effects on the liver. Adverse reactions from the liver may include: abnormal liver
function, hepatitis (inflammation of the liver), including fulminant hepatitis (fulminant hepatitis), liver failure, sometimes
fatal, liver necrosis (death of liver cells), cholestatic jaundice (impaired outflow and bile stasis).
Signs of liver dysfunction include:
- pronounced weakness;
- loss of appetite;
- nausea, vomiting;
- yellow staining of the eyelids or sclera of the eyes (yellowness).
With the development of any of the above conditions, you should stop using the drug and immediately consult a doctor.
Other possible adverse reactions
Very common side effects (may affect up to 1 in 10 people):
- diarrhea, abdominal pain, nausea, flatulence.
Common adverse reactions (may affect up to 1 in 10 people):

- headache, paresthesia (a feeling of tingling, tingling or numbness), dysgeusia (violation of taste sensations);
- blurred vision, deafness;
- vomiting, indigestion;
- pain in the joints;
- fatigue;
- a decrease in the number of lymphocytes, an increase in the number of eosinophils in the blood, a decrease in the content
of bicarbonates in the blood serum.
Uncommon adverse reactions (may affect up to 1 in 100 people):
- candidiasis, oral candidiasis (infections caused by the fungus Candida), vaginal infection, pneumonia, pharyngitis, fungal
infections, bacterial infections, gastroenteritis (inflammatory disease of the gastrointestinal tract), respiratory distress
(respiratory failure with shortness of breath, rapid and shallow breathing);
- decrease in the number of leukocytes, decrease in the number of neutrophils in the blood;
- loss of appetite;
- neurosis, insomnia;
- hypesthesia (decreased sensitivity of hands and feet, numbness), dizziness, drowsiness, insomnia;
- hearing impairment, tinnitus;
 palpitations, hot flashes;
- shortness of breath, nosebleeds;
- gastritis, constipation, impaired swallowing, dry mouth, stomatitis, belching, increased salivation;
- rash, itching, dermatitis (inflammation of the skin), dry skin, increased sweating, urticaria (rapid appearance of itchy,
raised rashes above the skin);
 muscle pain, osteoarthritis (inflammation of the joint), pain in the back, neck;
- metrorrhagia (uterine bleeding not associated with menstruation), impaired testicular function;
 urination disorders, pain in the kidney area;
- chest pain, swelling, weakness, persistent feeling of fatigue, fever;
- hearing impairment, tinnitus;
- palpitations, hot flashes;
- shortness of breath, nosebleeds;
- gastritis, constipation, impaired swallowing, dry mouth, stomatitis, belching, increased salivation;
- rash, itching, dermatitis (inflammation of the skin), dry skin, increased sweating, urticaria (rapid appearance of itchy,
raised rashes above the skin);
- muscle pain, osteoarthritis (inflammation of the joint), pain in the back, neck;
- metrorrhagia (uterine bleeding not associated with menstruation), impaired testicular function;
- urination disorders, pain in the kidney area;
- chest pain, swelling, weakness, persistent feeling of fatigue, fever;
- an increase in the level of liver enzymes (AST, ALT), an increase in bilirubin, an increase in the level of creatinine, urea
in the blood serum, changes in the amount of potassium in the blood serum, an increase in the number of basophils,
monocytes, neutrophils, platelets in the blood, an increase in alkaline phosphatase, chlorides, ions hydrogen, glucose,
changes in sodium concentration, decrease in hematocrit.
Rare adverse reactions (may affect up to 1 in 1,000 people):
- anxiety;
- vertigo (sensation of movement of surrounding objects around you or rotation in space);
- fotochuvstvitel'nost' (povyshennaya chuvstvitel'nost' kozhi k solnechnomu svetu, vozmozhnyye priznaki:
vozniknoveniye solnechnykh ozhogov s zudom, otekom i poyavleniyem puzyrey).
Chastota neizvestna (nevozmozhno opredelit' chastotu na osnovanii imeyushchikhsya dannykh):
- psevdomembranoznyy kolit (ostroye vospalitel'noye zabolevaniye kishechnika, proyavlyayushcheyesya
tyazheloy diareyey);
- snizheniye kolichestva trombotsitov v krovi, gemoliticheskaya anemiya (snizheniye kolichestva eritrotsitov v
krovi vsledstviye ikh razrusheniya);
- photosensitivity (increased sensitivity of the skin to sunlight, possible symptoms: sunburn with itching, swelling and
blistering).
Frequency not known (cannot determine frequency from available data):
- pseudomembranous colitis (acute inflammatory bowel disease, manifested by severe diarrhea);
- decrease in the number of platelets in the blood, hemolytic anemia (decrease in the number of red blood cells in the
blood due to their destruction);
aggressiveness, anxiety, hallucinations, delirium (confusion);
- fainting, convulsions (involuntary muscle contractions), motor excitation, severe muscle weakness, loss of smell,
impaired odor perception, loss of taste sensitivity;
- pancreatitis (inflammation of the pancreas), discolored tongue;
- acute renal dysfunction, interstitial nephritis (non-infectious inflammation of the kidneys).
Reporting adverse reactions
It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure
continuous monitoring of the benefit/risk ratio of the medicinal product. In the event of adverse reactions listed in this
package insert, as well as those not mentioned in it, or in case of ineffectiveness of the medicinal product, it is necessary,
first of all, to inform the attending physician immediately.
5. Storage of Azirex® medicinal product
Store in a place protected from moisture at a temperature not exceeding 25 °C.
Keep out of the reach of children.
Shelf life: 4 years.
Do not use after the expiry date stated on the packaging.

6. Contents of the package and other information
Compound
Active ingredient: azithromycin.
Each film-coated tablet contains 500.0 mg of azithromycin (as azithromycin dihydrate).
Excipients: corn starch, hypromellose, pregelatinized starch, sodium lauryl sulfate, magnesium stearate, microcrystalline
cellulose, anhydrous calcium hydrogen phosphate.
Shell composition: hypromellose, titanium dioxide (E171), talc, indigo carmine (E132), macrogol 400.
Appearance of the Azirex® medicinal product and the contents of the package
Film-coated tablets.
Blue biconvex film-coated tablets.
3 tablets in a blister pack made of polyvinyl chloride film and flexible packaging based on aluminum foil. Each blister
pack, together with the leaflet, is placed in a pack of cardboard.
Terms of dispensing from pharmacies
By prescription.
Marketing Authorization Holder
Giga Farm LLC, Republic of Armenia, Gyumri, st. Gogunts 3/5.
Tel. +37494000264. E-mail: gig.am@mail.ru.
AZIREX® is a trademark of Giga Farm LLC
Manufacturer
Pharmtechnology LLC
Republic of Belarus
220024, Minsk, st. Korzhenevsky, 22.

Լeaflet: information for the consumer

Azirex®, film-coated tablets, 500 mg

azithromycin

Read this package leaflet completely before you start using the medicine because it contains important information for

you.

• Keep the leaflet. You may need to read it again.

• If you have any further questions, please contact your doctor.

• The drug has been prescribed specifically for you. Do not pass it on to other people. It can harm them even if their

symptoms are the same as yours.

Contents of the leaflet

1. What Azirex® is and what it is used for

2. What you need to know before you use Azirex®

3. How to use Azirex®

4. Possible adverse reactions

5. Storage of Azirex® medicinal product

6. Contents of the package and other information

1. What Azirex® is and what it is used for

Azirex contains the active ingredient azithromycin, which belongs to a group of antibiotics called macrolides.

Azirex® is indicated for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the

drug:

- infections of the upper respiratory tract (tonsillitis, pharyngitis, sinusitis);

- infections of the lower respiratory tract (bronchitis, community-acquired bacterial pneumonia, including pneumonia

caused by atypical pathogens);

- infections of the middle ear (acute otitis media);

- skin and soft tissue infections: moderate acne (acne vulgaris), erythema migrans annulare (the initial stage of Lyme

disease), erysipelas, impetigo, secondary pyoderma;

- sexually transmitted infections caused by Chlamydia trachomatis (uncomplicated urethritis, cervicitis).

2. What you need to know before you use Azirex®

Do not use Azirex® in the following cases:

- you are hypersensitive to azithromycin, erythromycin, other macrolide and ketolide antibiotics and / or to any auxiliary

component of the drug listed in section 6;

- the drug should not be used simultaneously with ergotamine derivatives.

Special instructions and precautions for use

Talk to your doctor before using Azirex®.

Talk to your doctor before using Azirex® in the following cases:

- in diseases of the kidneys;

- with cardiovascular diseases;

- if you have liver disease (your doctor may need to monitor your liver function or stop treatment);

- with myasthenia gravis (a disease in which there is weakness of certain muscles);

- if you are taking ergotamine derivatives (medicines used to treat migraine), as they should not be taken with

azithromycin.

Tell your doctor immediately if you experience palpitations or irregular heartbeat, or if you experience dizziness, fainting,

or muscle weakness while using Azirex®.

Tell your doctor if you experience diarrhea (loose stools) while using Azirex® or after treatment ends.

When using azithromycin, serious skin reactions may occur. At the first sign of a skin rash, damage to the mucous

membranes or any other symptoms of hypersensitivity, stop using the drug immediately and contact your doctor.

Other medicines and Azirex®

Tell your doctor if you are currently taking, have recently taken or may be taking any other medicines, including those

obtained without a prescription, before taking Azirex®.

Some medicines can interact with Azirex. Make sure your healthcare provider knows you are taking the following

medicines:

- ergotamine derivatives (see subsection "Special instructions and precautions for use");

- warfarin or other drugs to prevent blood clots;

- cyclosporine (drug to prevent graft rejection);

- antacids (drugs used for heartburn);

- digoxin (medication for the treatment of heart failure);

- colchicine (drug used to treat gout);

- terfenadine (an antiallergic drug).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor

before using this medicine.

If during the use of Azirex® you suspect or determine that you are pregnant, consult your doctor about the possibility of

continuing treatment with this drug.

Pregnancy

Do not use Azirex® unless it has been prescribed to you by your doctor.

Breast-feeding

Do not use Azirex® unless it has been prescribed to you by your doctor. Do not use Azirex® unless it has been prescribed

to you by your doctor. If your doctor has prescribed Azirex® to you, you must stop breastfeeding. Feeding can be resumed

2 days after discontinuation of Azirex®.

Driving vehicles and working with mechanisms

When driving vehicles and working with mechanical equipment, it is necessary to take into account the possibility of

adverse reactions such as dizziness, drowsiness and visual impairment.

3. How to use Azirex®

Always use this drug exactly as described in this leaflet or as advised by your doctor. If in doubt, consult your doctor.

Tablets should be taken 1 time per day, regardless of the meal, without chewing.

Adults, including elderly patients, and children weighing more than 45 kg

For infections of the upper and lower respiratory tract, skin and soft tissues (with the exception of migrating annular

erythema): 500 mg 1 time per day for 3 days, the total dose is 1500 mg.

In uncomplicated forms of acne vulgaris: 500 mg once a day for the first 3 days, then 500 mg once a week for 9 weeks,

the course dose is 6 g. In the second week, the dose is taken 7 days after the previous dose.

With migrating annular erythema: 1 g on the first day and 500 mg daily 1 time per day from the second to the fifth day.

For sexually transmitted infections (urethritis / cervicitis): 1 g once.

Children weighing less than 45 kg

Children weighing less than 45 kg should not take Azirex® 500 mg.

Special patient groups

Patients with impaired renal and hepatic function

The doctor may adjust the dose of the drug.

Elderly patients

In elderly patients, the same dose is used as in adults.

If you have taken more Azirex than you should

If you or your child has taken more than you should, call your doctor or go to the nearest emergency room/hospital. If

possible, take the container of this drug and/or this package leaflet with you.

Symptoms of a possible overdose may include reversible hearing loss, nausea, vomiting, or diarrhea.

Treatment of overdose includes the administration of activated charcoal and general symptomatic and life-sustaining

therapeutic measures.

If you forget to take Azirex®

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of the drug, contact your doctor.

4. Possible adverse reactions

Like other medicines, Azirex can cause side effects, although not everyone gets them.

Some symptoms that occur infrequently (in less than 1 in 100 people), rarely (in less than 1 in 1000 people), or with an

unknown frequency [frequency unknown, but a reaction is likely (cannot be determined from the available data)] require

immediate medical attention.

If you develop any of the following adverse reactions, stop using the drug immediately and contact your doctor:

- angioedema. Possible manifestations: swelling of the larynx, glottis, face, lips, pharynx and / or tongue, which can lead

to difficulty breathing due to a deterioration in airway patency, difficulty swallowing or deterioration in the ability to

speak;

- Anaphylactic shock is a severe allergic reaction. Possible manifestations: a sharp decrease in blood pressure, a fast and

weak pulse;

- serious skin reactions:

• acute generalized exanthematous pustulosis - widespread red skin rash with small vesicles containing pus;

• Stevens-Johnson syndrome and toxic epidermal necrolysis (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).

before the appearance of changes in the skin and mucous membranes, there may be an increase in body temperature,

chills, sore throat, headache;

• DRESS syndrome - drug reaction syndrome with eosinophilia and systemic manifestations [hypersensitivity reaction

with skin rash, fever, swollen lymph nodes, an increase in the number of one type of white blood cells (eosinophilia) and

inflammation of the internal organs (liver, lungs, heart, kidneys and colon intestines)];

• erythema multiforme. Possible manifestations: skin rash, which is characterized by 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 and other skin changes may also form;

- fast or irregular heartbeat;

- low blood pressure.

Azithromycin may have adverse effects on the liver. Adverse reactions from the liver may include: abnormal liver

function, hepatitis (inflammation of the liver), including fulminant hepatitis (fulminant hepatitis), liver failure, sometimes

fatal, liver necrosis (death of liver cells), cholestatic jaundice (impaired outflow and bile stasis).

Signs of liver dysfunction include:

- pronounced weakness;

- loss of appetite;

- nausea, vomiting;

- yellow staining of the eyelids or sclera of the eyes (yellowness).

With the development of any of the above conditions, you should stop using the drug and immediately consult a doctor.

Other possible adverse reactions

Very common side effects (may affect up to 1 in 10 people):

- diarrhea, abdominal pain, nausea, flatulence.

Common adverse reactions (may affect up to 1 in 10 people):

- headache, paresthesia (a feeling of tingling, tingling or numbness), dysgeusia (violation of taste sensations);

- blurred vision, deafness;

- vomiting, indigestion;

- pain in the joints;

- fatigue;

- a decrease in the number of lymphocytes, an increase in the number of eosinophils in the blood, a decrease in the content

of bicarbonates in the blood serum.

Uncommon adverse reactions (may affect up to 1 in 100 people):

- candidiasis, oral candidiasis (infections caused by the fungus Candida), vaginal infection, pneumonia, pharyngitis, fungal

infections, bacterial infections, gastroenteritis (inflammatory disease of the gastrointestinal tract), respiratory distress

(respiratory failure with shortness of breath, rapid and shallow breathing);

- decrease in the number of leukocytes, decrease in the number of neutrophils in the blood;

- loss of appetite;

- neurosis, insomnia;

- hypesthesia (decreased sensitivity of hands and feet, numbness), dizziness, drowsiness, insomnia;

- hearing impairment, tinnitus;

 palpitations, hot flashes;

- shortness of breath, nosebleeds;

- gastritis, constipation, impaired swallowing, dry mouth, stomatitis, belching, increased salivation;

- rash, itching, dermatitis (inflammation of the skin), dry skin, increased sweating, urticaria (rapid appearance of itchy,

raised rashes above the skin);

 muscle pain, osteoarthritis (inflammation of the joint), pain in the back, neck;

- metrorrhagia (uterine bleeding not associated with menstruation), impaired testicular function;

 urination disorders, pain in the kidney area;

- chest pain, swelling, weakness, persistent feeling of fatigue, fever;

- hearing impairment, tinnitus;

- palpitations, hot flashes;

- shortness of breath, nosebleeds;

- gastritis, constipation, impaired swallowing, dry mouth, stomatitis, belching, increased salivation;

- rash, itching, dermatitis (inflammation of the skin), dry skin, increased sweating, urticaria (rapid appearance of itchy,

raised rashes above the skin);

- muscle pain, osteoarthritis (inflammation of the joint), pain in the back, neck;

- metrorrhagia (uterine bleeding not associated with menstruation), impaired testicular function;

- urination disorders, pain in the kidney area;

- chest pain, swelling, weakness, persistent feeling of fatigue, fever;

- an increase in the level of liver enzymes (AST, ALT), an increase in bilirubin, an increase in the level of creatinine, urea

in the blood serum, changes in the amount of potassium in the blood serum, an increase in the number of basophils,

monocytes, neutrophils, platelets in the blood, an increase in alkaline phosphatase, chlorides, ions hydrogen, glucose,

changes in sodium concentration, decrease in hematocrit.

Rare adverse reactions (may affect up to 1 in 1,000 people):

- anxiety;

- vertigo (sensation of movement of surrounding objects around you or rotation in space);

- fotochuvstvitel'nost' (povyshennaya chuvstvitel'nost' kozhi k solnechnomu svetu, vozmozhnyye priznaki:

vozniknoveniye solnechnykh ozhogov s zudom, otekom i poyavleniyem puzyrey).

Chastota neizvestna (nevozmozhno opredelit' chastotu na osnovanii imeyushchikhsya dannykh):

- psevdomembranoznyy kolit (ostroye vospalitel'noye zabolevaniye kishechnika, proyavlyayushcheyesya

tyazheloy diareyey);

- snizheniye kolichestva trombotsitov v krovi, gemoliticheskaya anemiya (snizheniye kolichestva eritrotsitov v

krovi vsledstviye ikh razrusheniya);

- photosensitivity (increased sensitivity of the skin to sunlight, possible symptoms: sunburn with itching, swelling and

blistering).

Frequency not known (cannot determine frequency from available data):

- pseudomembranous colitis (acute inflammatory bowel disease, manifested by severe diarrhea);

- decrease in the number of platelets in the blood, hemolytic anemia (decrease in the number of red blood cells in the

blood due to their destruction);

aggressiveness, anxiety, hallucinations, delirium (confusion);

- fainting, convulsions (involuntary muscle contractions), motor excitation, severe muscle weakness, loss of smell,

impaired odor perception, loss of taste sensitivity;

- pancreatitis (inflammation of the pancreas), discolored tongue;

- acute renal dysfunction, interstitial nephritis (non-infectious inflammation of the kidneys).

Reporting adverse reactions

It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure

continuous monitoring of the benefit/risk ratio of the medicinal product. In the event of adverse reactions listed in this

package insert, as well as those not mentioned in it, or in case of ineffectiveness of the medicinal product, it is necessary,

first of all, to inform the attending physician immediately.

5. Storage of Azirex® medicinal product

Store in a place protected from moisture at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life: 4 years.

Do not use after the expiry date stated on the packaging.

6. Contents of the package and other information

Compound

Active ingredient: azithromycin.

Each film-coated tablet contains 500.0 mg of azithromycin (as azithromycin dihydrate).

Excipients: corn starch, hypromellose, pregelatinized starch, sodium lauryl sulfate, magnesium stearate, microcrystalline

cellulose, anhydrous calcium hydrogen phosphate.

Shell composition: hypromellose, titanium dioxide (E171), talc, indigo carmine (E132), macrogol 400.

Appearance of the Azirex® medicinal product and the contents of the package

Film-coated tablets.

Blue biconvex film-coated tablets.

3 tablets in a blister pack made of polyvinyl chloride film and flexible packaging based on aluminum foil. Each blister

pack, together with the leaflet, is placed in a pack of cardboard.

Terms of dispensing from pharmacies

By prescription.

Marketing Authorization Holder

Giga Farm LLC, Republic of Armenia, Gyumri, st. Gogunts 3/5.

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

AZIREX® is a trademark of Giga Farm LLC

Manufacturer

Pharmtechnology LLC

Republic of Belarus

220024, Minsk, st. Korzhenevsky, 22.

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AZIREX tab 500mg N3

SHort description

AZIREX tab 500mg N3

SHort description

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