Azyter

Azithromycin dihydrate.

It is a clear, colourless to slightly yellow, oily liquid.
The active substance is azithromycin dihydrate. Each gram of solution contains 15 mg of azithromycin dihydrate equivalent to 14.3 mg of azithromycin. One single-dose container of 250 mg solution contains 3.75 milligrams of azithromycin dihydrate.
Excipients/Inactive Ingredients: The other ingredient is triglycerides, medium-chain.

Pharmacotherapeutic class: antibiotic. ATC code: S01AA26.
AZYTER contains azithromycin, an antibiotic belonging to the macrolide class.

AZYTER is used for the local treatment of certain eye infections of bacterial origin in adults (including the elderly) and in children from birth to 17 years of age: Purulent bacterial conjunctivitis; trachoma conjunctivitis (particularly ocular infection due to bacteria called Chlamydia trachomatis, found or occurring in developing countries).

This medicine is intended to be administered into the eye (ocular use).
Always use this medicine exactly as advised by the doctor or the doctor treating the child. Advise the patient/parent to check with the doctor or pharmacist if not sure.
Dosage: The recommended dose for adults (including the elderly) and children from birth to 17 years of age is one drop twice a day in the eye(s) to be treated: one drop in the morning and one drop in the evening.
The duration of treatment is three days.
Because of the prolonged action of the product, it is unnecessary to continue the treatment beyond three days even if the patient has still residual signs of the bacterial infection.
If the patient forgets to use AZYTER: Do not use a double dose to make up for a forgotten dose.
If the patient stops using AZYTER: The doctor should always be consulted if the patient is considering stopping the treatment.
If the patient has any further questions on the use of this product, advise the patient to ask the doctor or pharmacist.
Method of administration: For a proper administration of AZYTER: Wash hands thoroughly before and after using the product.
Introduce one drop into the eye to be treated while looking up and pulling the lower eyelid down slightly.
Avoid touching the eye and eyelids with the dropper tip of the single-dose container.
Discard the single-dose container after use. Do not keep it for subsequent use.
Do not inject. Do not swallow.

Do not use AZYTER 15 mg/g, eye drops, solution in single-dose container: If the patient is allergic to the active substance (azithromycin), to any other antibiotic from the macrolide class or to triglycerides, medium-chain or any of the other ingredients of this medicine (listed in Description).

Take special care with AZYTER: If an allergic reaction occurs, the patient should stop the treatment and advise the patient to consult the doctor.
Dermatologic reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients on azithromycin therapy.
If the patient sees no improvement within three days after the start of the treatment or if abnormal signs occur, the patient should consult the doctor.
In view of eye infection, the wearing of contact lenses is not recommended.
This medicine is only intended for ocular use. Do not inject or swallow it.
Driving and using machines: The patient may experience temporary blurred vision after ocular administration of the product. Wait until the patient has recovered normal vision before driving a vehicle or using any machine.

Pregnancy: AZYTER can be used during pregnancy.
The doctor may prescribe this medicine while the patient is pregnant, if he/she considers it to be necessary.
Breast-feeding: Limited data indicate that azithromycin is excreted in breast milk, this medicine can be used during breast-feeding.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, advise the patient to ask the doctor or pharmacist for advice before taking this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Advise the patient to inform the doctor immediately in case any of the following symptoms is experienced after taking this medicine as the symptoms can be severe.
Uncommon: may affect 1 in 100 people: serious allergic reaction which causes swelling of the face or throat (angioedema).
Not known: frequency cannot be estimated from the available data: serious skin reactions: skin rash, skin eruption, blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)), skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell), rash appearance as small, itchy red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)), generalized erythema with scaling over large areas of the body (Dermatitis Exfoliative), skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid) (Acute Generalized Exanthematous Pustulosis (AGEP)).
Stop taking azithromycin if the patient develops these skin symptoms and advise the patient to contact the doctor or seek medical attention immediately.
The following side effects were observed upon administration of the product: Very common: may affect more than 1 in 10 people: transient eye discomfort (itching, burning, stinging).
Common: may affect up to 1 in 10 people: blurred vision, sticky eye sensation, foreign body sensation.
Uncommon: may affect 1 in 100 people: allergic reaction (hypersensitivity); inflammation of the conjunctiva (could be due to infection or allergy) (conjunctivitis); allergic inflammation of the conjunctiva (allergic conjunctivitis); inflammation of the cornea (keratitis); itchy skin on the eyelids (eczema eyelids); dry, red, swelling of the eyelids (eyelid oedema); eye allergy; eye watering; redness of the eyelids (erythema of eyelids); redness of the conjunctiva (conjunctival hyperaemia).
Reporting of side effects: If the patient gets any side effects, advise the patient to talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed.

If the patient is using any other medicine to be applied in the eye, the patient should: apply the other ophthalmic medicine, wait for 15 minutes, apply AZYTER last.
Advise the patient to inform the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.

To preserve the efficacy of this drug: 1) Use antibiotic only when prescribed.
2) Strictly follow the prescription.
3) Do not re-use an antibiotic without medical prescription, even if treating a similar illness.
4) Never give the antibiotic to another person, maybe it is not adapted to his illness.
5) After completion of treatment, return at the chemist's shop all unused drugs in order to achieve a suited elimination of this drug.

Do not store above 25°C.
Keep the single-dose containers in the sachet in order to protect from light.
Discard the opened single-dose container with any remaining solution after first use immediately. Do not keep it for subsequent use.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Eye Anti-Infectives & Antiseptics

S01AA26 - azithromycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.

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