What is Azitromicina 500mg used for

Azithromycin HEC 500mg film-coated tablets

Patient information sheet for Azithromycin HEC 500mg film-coated tablets

W) What is the most important thing you should know about this medicine?

W.1 Cardiac arrhythmias

Some active ingredients from the antibiotic class of so-called macrolides such as azithromycin, clarithromycin, erythromycin, roxythromycin can trigger cardiac arrhythmias, which in some cases could be life-threatening. Tell your doctor if you have heart problems or if you have known that your QT interval is prolonged. This risk of cardiac arrhythmias is increased if, for example, there is a depletion of potassium and / or magnesium in the blood as a result of diarrhea (see section 4).

W.2.Do not cancel prematurely

Adhere to the dosage and intake schedule prescribed by the doctor! The intake should not be discontinued or continued beyond the prescribed time without consulting a doctor.

W.3. Income intervals

Take the medicine at regular intervals. The intake intervals should be strictly adhered to so that the same and sufficient concentrations of the antibiotic can always act on the bacteria in your body and so that no so-called resistances arise that impair their effectiveness. (Example: Ingestion "twice a day" means that the tablets should be taken approx. 12 hours apart.)

W.4 Pseudomembranous colitis

Antibiotics can often cause diarrhea, which in some cases can be a sign of life-threatening bowel inflammation (pseudomembranous colitis). Ask your doctor or pharmacist for advice on prevention.

W.5 Allergic symptoms

Inform your doctor immediately if allergic symptoms (e.g. shortness of breath, skin rash, swelling in the neck or face area) occur.

In these cases, the antibiotic may have to be discontinued, please talk to your doctor.

W.6 Use of hormonal contraceptives

Women who use hormonal contraceptives should note that the effectiveness of drugs such as the pill may be reduced.

For complete information on this medicine, please read Chapters 1 to 6 below.

1. What is Azithromycin HEC 500mg film-coated tablets and what is it used for?

1.1 What are the properties of the medicinal product?

Azithromycin HEC 500mg film-coated tablets contains the active ingredient azithromycin, a drug from the group of so-called antibiotics or macrolides.

Azithromycin prevents sensitive bacteria from growing.

Azithomycin requires a prescription and should only be used on medical advice.

1.2 What strengths and dosage forms are there?

Oral azithromycin is usually available as

- film-coated tablets containing 250 mg, 500 mg or 600 mg azithromycin,

- 40 mg / ml suspension.

Your doctor will determine which strength and dosage form are suitable for your treatment.

1.3 Azithromycin is used

1.3.a) as 250 mg, 500 mg tablets or suspension (200 mg / 5 ml) for oral use

to treat the following infections caused by pathogens sensitive to azithromycin:

- Upper respiratory tract infections including sinusitis, inflammation of the throat (pharyngitis) and tonsillitis (tonsillitis)

- Lower respiratory tract infections, including bronchitis and mild to moderate community-acquired pneumonia

- inflammation of the middle ear (otitis media)

- skin and soft tissue infections

- urethral infections

- uncomplicated genital infections caused by Chlamydia trachomatis or Neisseria gonorrhoeae (non-multi-resistant strains)

1.3.b) as 600 mg tablets for HIV-infected patients

- alone or in combination with rifabutin to prevent infections caused by Mycobacterium avium intracellulare (MAI) patients in advanced stages (CD4 cell count equal to or less than 75 cells / mm3).

2. What must be considered before using Azithromycin HEC 500mg film-coated tablets?

2.1 Azithromycin HEC 500mg film-coated tablets must not be used

- if you are allergic (hypersensitive) to the active substance azithromycin, to other macrolide antibiotics or to any of the other ingredients of Azithromycin HEC 500mg film-coated tablets.

- if infected with erythromycin-resistant gram-positive bacterial strains (cross-resistance) and most strains of methicillin-resistant staphylococci.

If hypersensitivity reactions (allergic reactions) occur, the use of the drug should be interrupted and appropriate treatment initiated. Azithromycin HEC 500mg film-coated tablets should be used with caution in patients with severe liver disease.

2.2 Special care is required when taking Azithromycin HEC 500mg film-coated tablets

Talk to your doctor or pharmacist before taking Azithromycin HEC 500mg film-coated tablets:

- If you have liver disease or symptoms of impaired liver function (e.g. rapidly progressive exhaustion together with jaundice, dark urine, tendency to bleed or a certain brain disease [hepatic encephalopathy]) your doctor should carry out liver function tests / liver examinations and, if necessary, stop treatment with azithromycin.

- if you have kidney problems. Please speak to your doctor.

- if you suffer from a nervous or psychiatric illness

- if you are using ergot alkaloids at the same time: Since the simultaneous use of ergot alkaloids and macrolide antibiotics (group of antibiotics to which azithromycin belongs) accelerated the development of symptoms of intoxication with ergot alkaloids (ergotism), you should use azithromycin and ergot alkaloid- Do not use derivatives at the same time.

- if you suffer from irregular heartbeat. Prolongation of heart repolarization and QT interval have been observed with other macrolides, which can lead to arrhythmias and torsades de pointes. A similar effect cannot be completely ruled out with azithromycin (see section 4).

Therefore:

- Azithromycin HEC 500mg film-coated tablets should not be used in patients with existing QT prolongation.

- Azithromycin HEC 500mg film-coated tablets should not be used at the same time as other active substances that prolong the QT interval, such as certain antiarrhythmics, cisapride and terfenadine.

- Azithromycin HEC 500 mg film-coated tablets should not be used in patients with electrolyte imbalances, especially not if there is a decrease in the levels of potassium and magnesium in the blood.

- Azithromycin HEC 500mg film-coated tablets should not be used in patients with certain heart diseases (clinically relevant bradycardia, cardiac arrhythmias or severe heart failure).

- Azithromycin HEC 500mg film-coated tablets should be used with caution in elderly patients: elderly patients may be more sensitive to drug effects on the QT interval.

Serious, severe inflammation of the mucous membrane of the intestine (pseudomembranous enterocolitis) has been reported after the use of macrolide antibiotics (a group of antibiotics to which azithromycin belongs). This should be taken into account if patients develop diarrhea after initiating treatment with azithromycin. If you experience severe, persistent diarrhea during or after (up to 2 months) treatment with Azithromycin HEC 500mg film-coated tablets, please contact your doctor immediately.

During treatment with Azithromycin HEC 500 mg film-coated tablets, the occurrence or worsening of symptoms of a certain muscle disorder (myasthenia gravis) have been reported.

Note on other ingredients: Oral medicinal products may contain different types of sugar. Therefore, please only take this after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

If you have to adhere to a diabetic diet, you should consider the sugar content (bread units "BE").

If you are on a restricted sodium diet, you should consider sodium levels.

2.2.a) Children

The efficacy and safety of azithromycin for MAI prophylaxis have not been investigated in patients under 18 years of age.

Azithromycin is not suitable for use in children under 1 year of age. Azithromycin dry juice is available for children and adolescents weighing less than 45 kg. For them, the dosage is based on body weight. Precise information can be found in the dosage instructions.

2.2.b) Elderly patients

Elderly patients receive the recommended adult dose. It should be noted that they may be more prone to severe arrhythmias (torsade de pointes arrhythmias) than younger patients.

2.2.c) Pregnancy

Ask your doctor or pharmacist for advice before taking / using any medicine.

Azithromycin HEC 500mg film-coated tablets should only be given to pregnant women in exceptional cases where there is a possible risk to life and no alternative therapy, as a final assessment of the safety of this therapy is not yet possible.

2.2.d) Breastfeeding

It is not known whether azithromycin, the active substance in Azithromycin HEC 500mg film-coated tablets, is excreted in breast milk.

Among other things, it can lead to sensitization and irritation of the intestinal flora and fungus colonization in the breastfed infant. It is recommended that you express and discard your milk during treatment and for 2 days after completing treatment. Breastfeeding can then be resumed.

2.2.e) Ability to drive and use machines

According to previous experience, azithromycin generally has no influence on the ability to concentrate and react. However, the occurrence of side effects (see section 4 "What side effects are possible?") May change the ability to react and impair the ability to actively drive and use machines.

2.3 Interactions with other medicinal products

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

Various interactions with other drugs are known of macrolide antibiotics, which are based on a possible impairment of the degradation of various drugs, especially in the liver, when used at the same time. This can mean that these agents can trigger certain undesirable side effects. Azithromycin behaves differently in various respects, but in some cases insufficient knowledge is available.

These include:

- Dihydroergotamine or non-hydrogenated ergot alkaloids, which can lead to circulatory disorders, especially in the fingers and toes, due to a vasoconstricting effect and which should therefore not be used at the same time as azithromycin for safety's sake

- Digoxin, which can lead to increased digoxin levels due to delayed breakdown in the intestine

- Ciclosporin, in which, in the event of a simultaneous use with azithromycin, the ciclosporin level should be checked and the dose adjusted if necessary

- Zidovudine, which may be more effective with azithromycin

- rifabutin. Blood count disorders have been observed in people who have received azithromycin and rifabutin at the same time (see section 4 under "Blood and lymphatic system disorders").

Attention should be paid to a possible parallel resistance between azithromycin and macrolide antibiotics (such as erythromycin) as well as lincomycin and clindamycin. Simultaneous administration of several preparations from this group of substances is therefore not recommended.

On the other hand, corresponding studies have shown that the drugs listed below do not experience the interactions known from the simultaneous use of macrolides:

- theophylline. As a precaution, however, it is recommended to watch out for typical signs of increased theophylline levels when azithromycin and theophylline derivatives are administered at the same time.

- warfarin. However, there have been reports of increased anticoagulation following concomitant use of azithromycin and oral coumarin-type anticoagulants. Although a causal relationship has not been established, the frequency of prothrombin time controls should be considered.

- Terfenadine. Rare cases have been reported in which the possibility of an interaction could not be completely ruled out, but on the other hand no specific evidence for such an interaction could be found. Caution should be exercised when using azithromycin and terfenadine at the same time.

- Mineral antacids. The simultaneous intake of mineral antacids and azithromycin resulted in decreased peak serum concentrations without changing the bioavailability of azithromycin. You should therefore only take mineral antacids and azithromycin at intervals of 2 to 3 hours.

- Cimetidine had no effect on the rate and extent of azithromycin absorption. It can therefore be taken at the same time as azithromycin.

- Didanosine. Its effectiveness is not affected by azithromycin.

- nelfinavir. This resulted in increased concentrations of azithromycin. No significant side effects were observed and no dose adjustment is required.

Azithromycin HEC 500mg film-coated tablets should not be taken with other drugs that prolong the QT interval.

The following drugs have not shown interactions with azithromycin in clinical trials: atorvastatin (however, from post-marketing experience certain muscle disorders [rhabdomyolysis] have been reported in patients receiving azithromycin in combination with various statins), carbamazepine, cetirizine, efavirenz, fluconazole, indinavir, Methylprednisolone, midazolam, sildenafil, triazolam, trimethoprim / sulfamethoxazole. However, caution is advised when these substances are used concomitantly with Azithromycin HEC 500 mg film-coated tablets.

3.How to take Azithromycin HEC 500mg film-coated tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

3.1 Type of application

Swallow the film-coated tablets whole with plenty of water. You can take the film-coated tablets with or without food. If you need to take a digestive medicine medicine such as an antacid at the same time, take azithromycin at least 1 hour before or 2 hours after the antacid.

Suspension: It should only be taken after a suspension has been prepared. Shake the bottle with the prepared suspension vigorously before each use. A measuring spoon and a dosing syringe are usually included in each package to facilitate dosing. The measuring spoon usually has markings to help measure the correct dose. After ingestion, children should be given tea or juice to remove all of the administered dose from their mouths. The suspension should be taken either at least 1 hour before or at least 2 hours after a meal.

As a rule, the 3-day therapy is carried out in the appropriate dosage for both children and adults. Alternatively, the respective total dose can also be used as a 5-day therapy in the form described. The effectiveness of azithromycin in the treatment of pneumonia has been sufficiently proven. In most cases, the application of the 3-day therapy regimen also appears to be sufficient.

The treating doctor decides on the duration of use in HIV-infected patients for MAI prevention. In clinical studies, the majority of patients have been treated for less than one year, and individual patients have been treated for more than 2 years.

Please talk to your doctor or pharmacist if you have the impression that the effect of Azithromycin HEC 500mg film-coated tablets is too strong or too weak.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) For infections caused by pathogens sensitive to azithromycin

3.2.a.1 The dosage for children from 1 year of age and adolescents up to 45 kg body weight (body weight)

Dosage is based on body weight, with 10 mg azithromycin per kg body weight taken once a day for 3 days or 10 mg / kg body weight once on the first day and 5 mg / kg body weight daily on days 2 to 5 (exception: Streptococcal pharyngitis).

Depending on body weight, the following table is used to dose as follows:

Body weight 10 kg: 1st-3rd Day 100 mg azithromycin per day (corresponds to e.g. 2.5 ml suspension (40 mg / ml) once a day).

Body weight 12 kg: 1st-3rd Day 120 mg azithromycin per day (corresponds to e.g. 3 ml suspension (40 mg / ml) once a day).

Body weight 14 kg: 1st-3rdDay 140 mg azithromycin per day (corresponds to e.g. 3.5 ml suspension (40 mg / ml) once a day).

Body weight 16 kg: 1-3. Day 160 mg azithromycin per day (corresponds to e.g. 4 ml suspension (40 mg / ml) once a day).

Body weight 17 to 25 kg: 1-3. Day 200 mg azithromycin per day (corresponds to e.g. 5 ml suspension (40 mg / ml) once a day).

Body weight 26-35 kg: 1-3. Day 300 mg azithromycin per day (corresponds to e.g. 7.5 ml suspension (40 mg / ml) once a day).

Body weight 36-45 kg: 1-3. Day 400 mg azithromycin per day (corresponds to e.g. 10 ml suspension (40 mg / ml) once a day).

Alternatively, 5-day therapy can be carried out, with azithromycin being given 10 mg / kg body weight on the first day and 5 mg / kg body weight on the following 4 days:

Body weight 10 kg: 1st day 100 mg azithromycin (2.5 ml suspension 40 mg / ml); Days 2-5: 1.25 ml suspension (40 mg / ml) once a day.

Body weight 12 kg: 1st day 120 mg azithromycin (3 ml suspension 40 mg / ml); Days 2-5: 1.5 ml suspension (40 mg / ml) once a day.

Body weight 14 kg: 1st day 140 mg azithromycin (3.5 ml suspension 40 mg / ml); Days 2-5: 1.75 ml suspension (40 mg / ml) once a day.

Body weight 16 kg: 1st day 160 mg azithromycin (4 ml suspension 40 mg / ml); Days 2-5: 2 ml suspension (40 mg / ml) once a day.

Body weight 17 to 25 kg: 1st day 200 mg azithromycin (5 ml suspension 40 mg / ml); Days 2-5: 2.5 ml suspension (40 mg / ml) once a day.

Body weight 26-35 kg: 1st day 300 mg azithromycin (7.5 ml suspension 40 mg / ml); Days 2-5: 3.75 ml suspension (40 mg / ml) once a day.

Body weight 36-45 kg: 1st day 400 mg azithromycin (10 ml suspension 40 mg / ml); Days 2-5: 5 ml suspension (40 mg / ml) once a day.

In the case of otitis media, the total dose is also 30 mg / kg body weight azithromycin. This total dose can be administered as a single dose, 3-day therapy or 5-day therapy (according to the dosage scheme mentioned above).

In the case of throat inflammation caused by streptococci (streptococcal pharyngitis), 10 mg / kg body weight or 20 mg / kg body weight azithromycin is given daily for 3 days. However, the daily dose must not exceed 500 mg. In clinical studies, both dosages showed comparable clinical efficacy. At 20 mg / kg body weight, however, the number of bacteria killed was higher. However, penicillin remains the first choice for treating throat infections caused by Streptococcus pyogenes. This also applies to the prevention of rheumatic fever. The maximum total dose in children corresponds to the usual adult dose of 1500 mg azithromycin in all indications.

3.2.a.2.Dosing in case of otitis media (acute otitis media)

In the case of otitis media, the total dose is also 30 mg per kg of body weight.

This total dose can also be taken as a single dose, otherwise as above as 3-day therapy or 5-day therapy.

3.2.a.3.Dosage for inflammation of the throat caused by streptococci (streptococcal pharyngitis)

As an alternative to the 3-day therapy regimen mentioned above (a1), the doctor can prescribe a double dose (20 mg azithromycin per kg body weight once per day). However, the daily dose must not exceed 500 mg, corresponding to 12.5 ml of a prepared 40 mg / ml suspension. The dose of the whole

Treatment should not exceed 1500 mg in children.

3.2.b) Adolescents over 45 kg body weight and adults

Azithromycin is taken on a 3-day or 5-day regimen:

3-day regimen: Take 500 mg azithromycin once a day.

5-day regimen: Take 500 mg azithromycin on day 1. Take 250 mg of azithromycin on days 2, 3, 4, and 5.

Dosage for the treatment of uncomplicated genital infections caused by:

- Chlamydia trachomatis: 1-day treatment regimen: The total dose is 1,000 mg azithromycin taken at once.

- Neisseria gonorrhea: the recommended dose is 1,000 mg or 2,000 mg azithromycin in combination with 250 or 500 mg ceftriaxone according to local clinical treatment guidelines. If you are allergic to penicillin and / or cephalosporins, your doctor should consult local treatment guidelines.

3.2.c) Patients with kidney or liver problems

Dosage in patients with impaired renal function: No dose adjustment is required in patients with mild to moderate renal impairment (GFR: 10 to 80 ml / min).

No dose adjustment is required in patients with mild to moderate hepatic impairment.

Please talk to your doctor in advance if you have liver or kidney problems. Your doctor will then decide if the dose needs to be adjusted.

3.2.d) For the prevention of infections caused by Mycobacterium avium intracellulare (MAI) in adult HIV patients

- Prevention with 600 mg azithromycin: The dosage is 2 film-coated tablets with 600 mg (1200 mg azithromycin) once a week. The efficacy and safety of other therapy schemes have not yet been investigated (see also Section 4).

- Prevention with the combination of azithromycin and rifabutin: The combination of 2 film-coated tablets with 600 mg azithromycin once a week with 300 mg rifabutin per day was more effective than the respective monotherapy in a clinical study, but the rate of discontinuation of therapy due to adverse drug effects was significantly higher.

Elderly patients also receive the dosage described.

3.3 If you use more Azithromycin HEC 500 mg film-coated tablets than you should

You may feel uncomfortable. There may also be other side effects such as numbness or diarrhea. Contact your doctor or the nearest hospital emergency department immediately. If possible, take the medicine with you so that the doctor knows what you have taken.

3.4 If you forget to use Azithromycin HEC 500 mg film-coated tablets

If too little Azithromycin HEC 500mg film-coated tablets has been taken, the missing amount can be taken immediately after this has been noticed. The next dose will then be taken at the originally scheduled time.

If a dose has been completely forgotten, the missed dose must not be taken at the next appointment, but the intake should be extended by one day.

In any case, the total amount of Azithromycin HEC 500mg film-coated tablets prescribed by the doctor should be taken (even if the total intake time is extended by 1 day) and your doctor should be informed accordingly.

3.5 Effects if treatment with Azithromycin HEC 500 mg film-coated tablets is discontinued

Always take Azithromycin HEC 500mg film-coated tablets until the end of the therapy regimen, even if you are already feeling better. If you stop treatment too soon, the infection may flare up again. In addition, the bacteria can become resistant to this medicine and are more difficult to treat.

4. What are the possible side effects?

Like all medicines, Azithromycin HEC 500mg film-coated tablets can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100 but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

The following extremely rare side effects can under certain circumstances be acutely life-threatening. If you are affected by any of the side effects listed below, stop taking Azithromycin HEC 500mg film-coated tablets and contact your doctor as soon as possible.

Severe acute hypersensitivity reactions (e.g. anaphylaxis): In the event of an extremely rare but possibly life-threatening hypersensitivity reaction (e.g. anaphylactic shock), treatment with Azithromycin HEC 500mg film-coated tablets must be interrupted immediately and all usual emergency measures (e.g. administration of antihistamines, corticosteroids, artificial respiration if necessary).

Other possible side effects:

4.1.a) Very common

- diarrhea

4.1.b) Often

- A headache

- vomiting, stomach pain, nausea

- Changes in laboratory values ​​detectable in the blood or urine (decreased lymphocyte count and bicarbonate, increased eosinophil count, count of basophils, monocytes and neutrophils)

4.1.c) Occasionally

- Fungal diseases (e.g. candidiasis, oral candidiasis), infection of the vagina, pneumonia, bacterial diseases, inflammation of the pharynx, gastrointestinal inflammation, respiratory diseases, rhinitis

- certain changes in the blood count (leukopenia, neutropenia, eosinophilia)

- Swelling and water retention in the skin, hypersensitivity reactions

- loss of appetite

- nervousness, insomnia

- Dizziness, drowsiness, taste disturbance, impaired body sensation

- visual disturbances

- ear disorders

- palpitations

- hot flashes

- Difficult breathing, nosebleeds

- Constipation, flatulence, indigestion, difficulty swallowing, inflammation of the gastric mucosa, distended abdomen, dry mouth, belching, mouth ulcers, excessive saliva, loose stools

- rash, itching, hives, inflammation of the skin, dry skin, excessive sweating

- Osteoarthritis, muscle pain, back pain, neck pain

- Difficult emptying of the bladder, kidney pain

- Menstrual disorders, testicular disease

- Swelling (water retention) (in rare cases fatal), weakness, malaise, tiredness, swelling of the face, chest pain, fever, pain, swelling in other places

Changes in laboratory values ​​that can be detected in the blood or urine (aspartate aminotransferase, alanine aminotransferase, bilirubin, urea, creatinine, alkaline phosphatase, chloride, glucose, platelet count and bicarbonate level increased, hematocrit decreased, changed potassium values, changed sodium values)

- Complications after surgery.

4.1.d) Rarely

- restlessness

- Liver dysfunction, jaundice, biliary obstruction

- photosensitivity.

4.1.e) Not known (frequency cannot be estimated from the available data)

Colon inflammation

- certain changes in the blood count (thrombocytopenia, haemolytic anemia)

- severe (sometimes life-threatening) hypersensitivity reactions

- Aggression, fear, confusion (delirium), delusions (hallucination)

- Sudden loss of consciousness, seizures, decreased sensitivity to touch, overactivity, loss of smell / taste, impaired sense of smell, muscle disease

- hearing impairment including deafness and / or ringing in the ears (tinnitus)

- Cardiac arrhythmia, lengthening of a specific section in the electrocardiogram

- low blood pressure

- discoloration of the tongue, inflammation of the pancreas

- Liver failure (which in rare cases leads to death), inflammation of the liver, liver damage

- Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)

- joint pain

- inflammation of the kidneys, acute kidney failure

4.1.f) Side effects that may or very likely result from the prophylaxis or treatment of a Mycobacterium avium infection

The data come from clinical studies or post-market surveys.

These side effects differ either in type or in frequency from side effects reported for an immediate-release drug or a prolonged-release drug.

Very common: diarrhea, abdominal pain, nausea, gas, abdominal discomfort, loose stools

Common: loss of appetite, dizziness, headache, impaired body sensation, taste disturbance, impaired vision, numbness, rash, itching, joint pain, fatigue.

Rare: decreased sensitivity to touch, hearing impairment, ringing in the ears (tinnitus), palpitations, liver inflammation, severe skin rashes (Stevens-Johnson syndrome), photosensitivity reaction, weakness, malaise.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert. You can also report side effects directly via the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, 53175 Bonn, website: http://www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. How should Azithromycin HEC 500 mg film-coated tablets be stored?

Store Azithromycin HEC 500mg film-coated tablets at normal room temperature or, if recommended by the manufacturer, in the refrigerator.

Keep the medicine in the original packaging.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack. If necessary, please also note the shelf life after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; July 2015 (4)