Azitromycin 500 mg. 3 capsules

1. What Azithromycin is and what it is used for

Azithromycin contains the macrolide antibiotic azithromycin. It is active against a large number of causative agents of some common human diseases.

It is used to treat infections caused by bacteria sensitive to azithromycin and other microorganisms, such as:

infections of the upper respiratory tract: inflammation of the throat and tonsils, sinuses, middle ear;

lower respiratory tract infections: bronchitis, some types of pneumonia;

skin and soft tissue infections: - moderate form of acne, erythema chronica migrans (first stage of the so-called Lyme disease), scarlet fever (erysipelas), bacterial skin infections (impetigo, secondary pyoderma);

sexually transmitted diseases caused by a microorganism called chlamydia.

2. What you need to know before you take Azithromycin ADR

Do not take Azithromycin ADR

if you are allergic to azithromycin or any of the other ingredients of this medicine (listed in section 6);

if you are allergic to erythromycin or other macrolide and ketolide antibiotics;

if you are currently taking drugs containing ergotamine derivatives, due to the theoretical possibility of the appearance of ergotism (blueing of the limbs, limping).

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin ADR.

It is necessary to inform your doctor if:

you have or have had liver disease in the past.

Your doctor will decide whether it is necessary to monitor the condition of the liver or to stop treatment with this medicine.

you have had diarrhea while taking antibiotics.

If you develop diarrhea or loose stools during or after treatment with this medicine, contact your doctor and do not take any other medicines before consulting him. Inform him if the diarrhea continues.

you have or have had kidney disease in the past.

you have diseases or any heart complaints.

Contact your doctor immediately if you experience palpitations or other similar disturbances, dizziness or weakness during treatment.

you have myasthenia gravis (a condition that causes some muscles to become weak)

you are currently taking migraine medicines containing ergotamine derivatives, for example ergotamine. These drugs should not be taken simultaneously with azithromycin, as there is a possibility of the so-called ergotism (appearance of bruising of the limbs, lameness).

It is important to know that serious allergic reactions (rarely life-threatening), such as swelling of the face, lips, tongue and/or throat, shortness of breath, wheezing in the chest, can sometimes occur during treatment with this medicine.

Some of them may appear again, due to the prolonged retention of the drug in the tissues.

If allergic reactions occur or are suspected, you should immediately stop taking the medicine and contact your doctor.

Azithromycin ABR capsules are not suitable for use in children with a body weight of less than 45 kg, due to the impossibility of accurate dosing.

Other medicines and Azithromycin ADR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to tell your doctor if you are taking:

drugs that can affect heart rhythm and conduction (lead to prolongation of the QT-interval in the cardiogram)

A serious and difficult-to-control arrhythmia may occur.

medicines that reduce the acidity of the stomach, so antacid products

The time between separate receptions should be no less than 2 hours.

cyclosporine (suppresses organ or bone marrow rejection after transplantation)

It is necessary for the doctor to assess the benefit of the simultaneous administration of azithromycin with cyclosporine. In patients in whom this is imperative, cyclosporine plasma levels should be monitored and the dose adjusted if necessary.

warfarin, coumarin anticoagulants (reduce blood clotting)

There is an increased risk of bleeding when they are used simultaneously with azithromycin. Your doctor may decide that monitoring of prothrombin time or other laboratory parameters is necessary.

digoxin (used to treat heart disease) and colchicine (used to treat gout and familial Mediterranean fever)

The levels of digoxin and colchicine in the blood when taken simultaneously with azithromycin may increase.

ergotamine and other ergotamine derivatives

It is possible to develop ergotism, manifested by bluing of the limbs, lameness (see Warnings and precautions).

nelfinavir

Simultaneous administration with azithromycin leads to an increase in the concentration of azithromycin.

rifabutin (antibiotic)

A decrease in the number of white blood cells is possible.

Azithromycin ADR with food, drink and alcohol

Azithromycin ABD should be taken at least 1 hour before or 2 hours after a meal.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding

you think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine. Sufficient and well-controlled studies in pregnant women are lacking. During pregnancy, azithromycin should be used only if there is no other alternative. It is not known whether azithromycin is excreted in human milk. Therefore, azithromycin should be used in nursing women only if there is no other alternative. Your doctor will assess whether it is possible for you to be treated with azithromycin if you are pregnant or breast-feeding. He will assess the balance between the benefit for you and the risks for your baby.

Driving and using machines

There are no data on the adverse effect of Azithromycin ADR on the ability to drive and operate machinery.

Azithromycin ABD contains lactose monohydrate and azorubin

This product contains lactose (milk sugar) as an excipient, which is why it is not suitable for people with congenital or acquired intolerance to certain sugars. If your doctor has told you that you have such an intolerance, consult him before taking this product.

The gelatin capsule contains the coloring agent azorubin, carmoisine (E122), which may cause allergic reactions.

3. How to take Azithromycin ADR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose for adults and children weighing more than 45 kg is:

for the treatment of infections of the upper and lower respiratory tract, of the skin and soft tissues (except for erythema migrans), 1 capsule per day for 3 days;

for moderate acne: 500 mg once daily for 3 consecutive days, followed by 500 mg once weekly for the next 9 weeks. The second week's dose should be taken 7 days after the first dose. The next 8 weeks should be taken 1 tablet once a day at 7 daily intervals;

for erythema migrans (first stage of the so-called Lyme disease): 2 capsules (1000 mg) once on the first day, followed by 1 capsule (500 mg) from the second to the fifth day, as a single daily intake;

for the treatment of sexually transmitted infections caused by the chlamydia microorganism, the dose is 2 capsules (1000 mg) once.

Your doctor will determine the appropriate dose and treatment regimen for your acne or other skin and soft tissue infections.

Azithromycin ABR capsules are not suitable for use in children with a body weight of less than 45 kg, due to the impossibility of accurate dosing.

If you have kidney or liver disease, your doctor may prescribe a treatment with doses other than those indicated.

Method of application

Azithromycin ADR capsules are taken whole, once a day. Like many other antibiotics, the product should be taken at least one hour before or two hours after food.

If you have taken more than the required dose of Azithromycin ADR

If you have taken more than the prescribed dose, contact your doctor immediately or go to the nearest hospital.

Common symptoms of overdosing on antibiotics from this group include reversible hearing loss, severe nausea, vomiting, and diarrhea.

The doctor will decide if any kind of treatment is needed if you have taken a higher dose.

If you forget to take Azithromycin ADR

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

If you stop taking Azithromycin ADR

Do not stop taking your capsules if you feel better until your doctor tells you to. If you stop taking the medicine too soon, the infection may return or your condition may worsen.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience:

sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash and itching (especially all over the body);

severe or prolonged diarrhea that contains blood or mucus during treatment or after its discontinuation, as this may be a manifestation of serious inflammation of the intestines;

severe skin rash accompanied by redness and formation of scales and blisters;

fast or irregular heartbeats;

low blood pressure;

serious skin reactions:

blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);

blistering of the skin as a manifestation of a severe skin reaction (toxic epidermal necrolysis);

a skin rash of small itchy red bumps accompanied by other common symptoms such as fever, swollen glands and an increase in eosinophils (a type of white blood cell) (drug reaction with eosinophilia and systemic symptoms (DRESS));

a skin rash that is characterized by the rapid appearance of areas of reddened skin dotted with small pustules (small blisters filled with white/yellow fluid) (acute generalized eczematous pustulosis (AGEP)).

Stop taking azithromycin if you develop these skin symptoms and contact your doctor or get medical help right away.

The following adverse drug reactions are possible during treatment with azithromycin:

Very common (occurring in more than 1 in 10 products taken) - abdominal pain, nausea, diarrhoea, increased flatulence and bloating.

Common (affects at least 1 in 100 and less than 1 in 10 people taking

the product) - deafness, vomiting, indigestion, fatigue, joint pain, rash, itching, loss of appetite, anorexia, dizziness, headache, numbness of hands and feet, change in taste, impaired vision, decreased number of lymphocytes (a type of white blood cell), decreased number of eosinophils (a type of white blood cell), decreased level of bicarbonate in the blood.

Uncommon (seen in at least 1 in 1,000 and in less than 1 in 100 people taking the product) - hearing disorders, tinnitus, fungal infections in the mouth and vagina, a decrease in the number of all white blood cells, severe allergic a reaction that causes swelling of the face or throat, nervousness, reduced sensitivity to touch, drowsiness, insomnia, palpitations (feeling of the heartbeat), gastritis, constipation, inflammation of the liver, Stevens-Johnson syndrome blistering of the skin, mouth, eyes and genitals), photosensitivity (increased skin sensitivity to sunlight), urticaria (hives), chest pain, swelling, malaise, weakness, increased values ​​of certain laboratory blood parameters ( liver enzymes, bilirubin, urea, creatinine), altered level of potassium in the blood.

Rare (occurring in at least one in 10,000 and less than one in 1,000 people taking the product) - agitation, feeling dizzy or light-headed, impaired liver function, a skin rash that is characterized by the rapid appearance of areas of reddened skin dotted with small pustules (small blisters filled with white/yellow fluid) /AGEP/, a skin rash of small itchy red bumps accompanied by other common symptoms such as fever, swollen glands and an increase in eosinophils (a type of white blood cell ) /DRESS/.

With an unknown frequency (the frequency cannot be determined from the available data) - low blood pressure, aggressiveness or anxiety, hyperactivity, muscle weakness, heart rhythm disturbances, loss or disturbance of the sense of smell, loss of taste, discoloration of the tongue, inflammation of the pancreas , pseudomembranous colitis (severe, persistent or bloody diarrhoea, which may be associated with stomach pain or fever), inflammation of the kidneys or kidney failure, jaundice or liver failure (sometimes life-threatening), low platelet counts in the blood, anaemia, severe skin reactions with the formation of scales and blisters on the skin (toxic epidermal necrolysis, erythema multiforme), changes in heart rhythm and conduction, changes in the electrocardiogram.

If any of the side effects become serious or you experience any side effects not described in this leaflet, please contact your doctor or pharmacist.

5. How to store Azithromycin ADR

Keep out of the reach of children.

At a temperature below 25°C.

Do not use Azithromycin ADR after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not use Azithromycin ABD if you notice a change in the appearance of the capsules.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Azithromycin ADR contains

The active substance in one capsule is azithromycin dihydrate, eq. of azithromycin 500 mg

The other ingredients are sodium lauryl sulfate, lactose, monohydrate/maize starch (85:15), magnesium stearate.

The gelatin capsule contains titanium dioxide (color E171), gelatin, azorubin/carmoisine (color E122).

What Azithromycin ADR looks like and what it contains

Hard gelatin capsules with a white body and a pink cap, containing white or almost white powder, the presence of conglomerates is allowed, which disintegrate under pressure.

Hard gelatin capsules of 3 (three) pieces or 6 (six) pieces in a PVC/AL foil blister.

1 (one) blister with leaflet: patient information in a cardboard box.