Azithromycin

Azithromycin is an antibiotic that inhibits many bacteria responsible for infections.

This medicine should only be used as prescribed by a doctor for the treatment of the following infections:

• Respiratory tract infections, including pneumonia, acute worsening of chronic bronchitis, sinusitis, pharyngeal infection and angina,
• Otitis media,
• Skin and wound infections,
• Certain urinary tract and genital infections caused by Chlamydia.

What Does Azithromycin Contain?

1 x 250 mg film-coated tablet (white, capsule-shaped, labelled "AI 250") or 1 x 500 mg film-coated tablet (blue, capsule-shaped, labelled "AI 500", scored) contains:

Active ingredients

Azithromycin 250 mg or 500 mg as azithromycin dihydrate;

Excipients

Pregelatinised starch, calcium hydrogen phosphate, hypromellose, maize starch, microcrystalline cellulose, sodium dodecyl sulphate, magnesium stearate, polysorbate 80, talc, titanium dioxide.

Uses

For Azithromycin to be as effective as possible, it is essential that the dosage and duration of treatment prescribed by your doctor are strictly adhered to. Unless otherwise prescribed by your doctor, the following usual dosages apply:

Medicine is taken once a day.

The 250 mg film-coated tablets should be swallowed whole (do not split). The 500 mg film-coated tablets may be divided only to facilitate swallowing.

Film-coated tablets may be taken with or without food.

Adults

Infections of the urinary tract or genital organs due to Chlamydia.

A single dose of 1 g (4 film-coated 250 mg tablets or 2 film-coated 500 mg tablets).

All other indications

From day 1 to day 3: a dose of 500 mg (2 film-coated 250 mg tablets or 1 film-coated 500 mg tablet) once a day.

Children

The same dosing recommendations as for adults apply to the treatment of children weighing more than 45 kg. Please consult your doctor for treatment of children weighing less than 45 kg.

Do not change the prescribed dosage or duration of treatment on your own initiative. Contact your doctor or pharmacist if you feel that the efficacy of the medicine is too low or too high.

Side Effects

Azithromycin may cause the following side effects.

Common (in 1 to 10 out of 100 users)

Disorders of the gastrointestinal tract such as loss of appetite, nausea, vomiting, diarrhoea, loose stools, abdominal pain and cramps, digestive disorders and constipation. Please inform your doctor immediately if severe and persistent diarrhoea occurs during or after treatment with Azithromycin.

Occasional to frequent (affects 1 to 100 users out of 1,000)

Following the use of Azithromycin in neonates (treatment during the first 42 days of life), cases of narrowing of the pylorus (infantile hypertrophic pyloric stenosis, IHPS) have been reported. Contact your doctor if you experience vomiting or irritation when feeding your child.

Occasional (affects 1 to 10 users out of 1,000)

Bloating, fungal infections, vaginal inflammations, allergic reactions with skin rashes, pruritus and urticaria, nervousness, sleepiness, headaches, abnormal perceptions (paresthesia) and fatigue.

Rare (affects 1 to 10 in 10,000 users)

Syncope, dizziness, cramps, convulsions, hyperactivity, aggressive reactions, malaise, weakness, excitement, anxiety, low blood pressure, heart palpitations, heart rhythm disturbances, severe and persistent diarrhoea, photosensitivity (skin reactions associated with sunlight), severe skin rash, muscle disease (myasthenia gravis), joint pain and discolouration of the tongue. Taste/smell disorders and decreased sensitivity to touch.

Severe allergic reactions have been observed in rare cases. Please inform your doctor immediately if any of the above side effects or allergic symptoms such as skin rash, itching, redness, blisters, facial oedema or respiratory distress occur.

Particularly when high doses of Azithromycin are taken over a prolonged period, hearing problems, including ringing in the ears, deafness and complete/partial loss of hearing, have been observed in rare cases. Most of these symptoms have subsequently subsided. Consult your doctor if such symptoms occur.

Abnormal kidney, pancreas or liver function (including inflammation of the pancreas, inflammation of the liver and jaundice, liver failure, acute renal failure) has been observed in rare cases. Consult your doctor if abdominal pain, loss of appetite, tiredness or yellowing of the skin occur.

If you notice any side effects, please inform your doctor or pharmacist. This applies in particular to side effects not mentioned in this package leaflet.

Precautions

Light sensitivity reactions may occur during treatment with Azithromycin (skin rashes). Consequently, please avoid direct sunlight and solariums when taking this drug and for at least 7 days afterwards.

During treatment with Azithromycin, rare serious allergic reactions such as swelling of the skin and mucous membranes, face, tongue and larynx, palpitations, a fall in blood pressure (leading to syncope and shock) and respiratory distress or difficulty in breathing, as well as serious skin reactions (red swellings with numerous small pustules (acute generalised exanthematous pustulosis), Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome) have been observed. These serious clinical symptoms, accompanied by the formation of bullae and ulcers, mainly affect mucous membranes. In addition, typical lesions also appear on the skin (redness of the skin the size of a coin with elevation of the skin or bullae in the centre). High fever and physical depression are also common. Azithromycin should be stopped at the first sign of such allergic reactions and the doctor contacted.

Azithromycin should be used with caution if you suffer from heart disease, if you are taking other medicines that may cause heart rhythm disorders or if you suffer from electrolyte disturbances.

Please tell your doctor or pharmacist if:

• you know that you suffer from heart muscle disease or irregular or slow heartbeats, or that you have a peculiarity on the electrocardiogram (ECG) known as "long QT".
• if you are taking antiarrhythmics, antidepressants, antibiotics or antipsychotics.
• if you are taking hydroxychloroquine or chloroquine (for the treatment of diseases such as rheumatoid arthritis or for the treatment or prevention of malaria). Taking these medicines at the same time as azithromycin may increase the risk of adverse reactions affecting the heart.
• if you suffer from electrolyte disorders.

Azithromycin should be administered with caution to elderly patients, who may be more sensitive to drug-induced effects on the heart (cardiac rhythm disorders).

If you suffer from liver failure, you should only take Azithromycin under the strict supervision of your doctor. If you experience symptoms of hepatitis (inflammation of the liver), such as weakness, malaise, loss of appetite, nausea or vomiting, tiredness, yellowing of the eyes (conjunctiva) and skin, or discoloured stools, you should contact your doctor immediately.

Please inform your doctor if you suffer from impaired kidney function.

Please inform your doctor if you suffer from persistent severe diarrhoea during or after treatment with Azithromycin. In this case, stop the preparation and do not take medicines that inhibit intestinal peristalsis (the movements of the intestine).

During treatment with Azithromycin, the appearance or worsening of symptoms of a muscular disease (myasthenia gravis) has been reported.

Following the use of Azithromycin in neonates (treatment during the first 42 days of life), cases of narrowing of the pylorus (hypertrophic stenosis of the infantile pylorus, IHPS) have been reported. Contact your doctor in the event of vomiting or irritation when feeding your child.

During treatment with this drug, do not take any medicines containing ergotamine or ergotamine derivatives (e.g. Dihydergot, Bellergal, Cafergot).

Do not take this antibiotic at the same time as medicines to treat stomach acid (antacids).

Please tell your doctor if you are taking medicines that suppress the immune system (immunosuppressants), anticoagulants (medicines to thin the blood), cardiac glycosides (such as digoxin and colchicine) or medicines for migraine, allergies, HIV infection or tuberculosis.

Post-marketing muscular disorders (rhabdomyolysis) have been reported in patients taking Azithromycin and cholesterol-lowering drugs (statins) at the same time.

This medication has less than 1 mmol of sodium (23 mg) per film-coated tablet, meaning it is essentially "sodium-free."

This medicine may affect reactions, driving ability and the ability to use tools or machines!

What else do you need to consider?

The antibiotic substance in Azithromycin is not effective against all the micro-organisms that cause infectious diseases. Using the wrong antibiotic or the wrong dose can lead to complications. So never use it on your own initiative to treat another illness or another person. Similarly, you should not use this medication for a new infection without first consulting a doctor.

When should Azithromycin not be used?

Patients with a known or suspected hypersensitivity (allergy) to azithromycin, erythromycin or other macrolide or ketolide antibiotics should not take this drug.

Please tell your doctor if you have ever experienced side effects when taking antibiotics or if you have not tolerated treatment with Azithromycin well.

Notes on storage

This medicine should not be used past the expiration date indicated by "EXP" on the container.

Store in the original packaging. Do not store above 30°C.

Keep out of the reach of children.

Additional information

At the end of treatment, please return the packaging of Azithromycin, together with any remaining medicine, to the person who gave it to you (doctor or pharmacist) for proper disposal.

Pregnancy and Breastfeeding

Please inform your doctor if you are pregnant or breast-feeding. Animal studies have not shown any harm to the foetus. However, there is insufficient experience of the treatment of pregnant women with Azithromycin. Antibiotic should only be used during pregnancy if clinically necessary and if the expected benefits outweigh the potential risks.

The medicinal product passes into breast milk. Consequently, Azithromycin should not be used during breast-feeding or breast-feeding should be discontinued.

ˆ Back to top of page