Aziter

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Azyter

15 mg/g, eye drops, solution in a single-dose container

Azithromycin dihydrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, the doctor treating the child, a pharmacist, or a nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Azyter and what is it used for
• 2. Important information before using Azyter
• 3. How to use Azyter
• 4. Possible side effects
• 5. How to store Azyter
• 6. Package contents and other information

1. What is Azyter and what is it used for

Azyter contains azithromycin, a macrolide antibiotic.
Azyter is used to treat various bacterial eye infections in adults (including the elderly) and children from birth to 17 years.

• purulent conjunctivitis,
• inclusion conjunctivitis (a bacterial eye infection caused by Chlamydia trachomatis, common in developing countries).

2. Important information before using Azyter

When NOT to use Azyter:

• if the patient is allergic to azithromycin, other macrolide antibiotics, or medium-chain triglycerides.

Warnings and precautions

Before starting to use Azyter, you should consult a doctor, the doctor treating the child, a pharmacist, or a nurse.

• If an allergic reaction occurs, you should stop using the medicine and consult a doctor.
• If there is no improvement after three days of using the medicine or if unusual symptoms occur, you should consult a doctor.
• If you have an eye infection, it is not recommended to wear contact lenses. The medicine is for eye use only. Do not inject or take the medicine orally.

Azyter and other medicines

If you need to use other eye medicines, you should:
1. use the other eye medicine first,
2. wait 15 minutes,
3. use Azyter last.

• You should tell your doctor, the doctor treating the child, or pharmacist about all the medicines you are currently using or have recently used, as well as any medicines you plan to use.

Pregnancy

Azyter can be used during pregnancy.
The doctor may prescribe Azyter to a pregnant woman if they consider it necessary.

Breast-feeding

There is limited data indicating that azithromycin passes into breast milk.
This medicine can be used during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

After using the eye drops, temporary blurred vision may occur. In such cases, you should wait until the symptoms disappear before driving or operating machinery.

3. How to use Azyter

Azyter should only be used in the eyes (eye administration).
This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor, the doctor treating the child, or pharmacist.
Dosage
The recommended dose for adults (including the elderly) and children from birth to 17 years is one drop twice a day into the affected eye(s): one drop in the morning and one drop in the evening.
The treatment duration is 3 days.

Since the medicine has a prolonged effect, it is not necessary to use it for more than 3 days, even if minor symptoms of the infection still persist.

Method of administration:
To use Azyter correctly, you should:

• wash your hands carefully before and after using the medicine,
• looking up and gently pulling down the lower eyelid, put one drop into the affected eye,
• not touch the eye surface or eyelids with the tip of the single-dose container,
• after use, the single-dose container should be discarded. Do not store it for reuse.

DO NOT INJECT, DO NOT SWALLOW

Missing a dose of Azyter

You should not use a double dose to make up for a missed dose.

Stopping the use of Azyter

You should always consult your doctor if you decide to stop the treatment.
If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

You should immediately inform your doctor if you experience any of the following symptoms after using this medicine, as they may be serious.

Uncommon: may affect up to 1 in 100 people:

• severe allergic reaction, which causes swelling of the face or throat (angioedema).

Frequency not known: frequency cannot be estimated from the available data

• severe skin reactions: skin rash, skin eruptions, blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)), skin rash with other accompanying symptoms, such as fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell), appearance of a rash in the form of small, itchy red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)), generalized redness with skin peeling on large areas of the body (exfoliative dermatitis), skin eruptions characterized by rapid onset of areas of red skin covered with small pustules (Acute Generalized Exanthematous Pustulosis (AGEP)). If you experience these skin symptoms, you should stop using azithromycin and immediately contact your doctor or go to the emergency room.

Reported side effects:
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,
• feeling of eyelid stickiness,
• feeling of a foreign body in the eye.

Uncommon: may affect up to 1 in 100 people:

• allergic reactions (hypersensitivity),
• conjunctivitis (possibly due to infection or allergy),
• allergic conjunctivitis,
• keratitis,
• itching of the eyelid skin (blepharitis),
• dryness, redness, and swelling of the eyelids (eyelid edema),
• eye hypersensitivity,
• tearing,
• redness of the eyelids (blepharitis),
• redness of the conjunctiva (conjunctival hyperemia).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Azyter

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

• Do not store above 25°C.
• Store single-dose containers in the sachetto protect from light.

Each single-dose container should be discarded immediately after the first use, even if not all of the contents have been used. Do not store it for reuse.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Azyter contains

• The active substance is azithromycin dihydrate. One gram of solution contains 15 mg of azithromycin dihydrate, which corresponds to 14.3 mg of azithromycin. One single-dose container contains 3.75 mg of azithromycin dihydrate in 250 mg of solution.
• The other ingredients are medium-chain triglycerides.

What Azyter looks like and what the package contains

Azyter is an eye drop solution (eye drops, solution) in single-dose containers containing 0.25 g of the medicine. Azyter is a clear, colorless to slightly yellowish, oily liquid.
A cardboard box contains 6 single-dose containers with LDPE in a sachet, which is sufficient for a single treatment course.
For more detailed information on the medicine, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Manufacturer:

Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Laboratoire UNITHER
1 rue de l’Arquerie
50200 Coutances
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Greece, the country of export:56059/25-08-2015

Parallel import authorization number: 140/24

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Sweden, United Kingdom ....................................................................................................................... – Azyter
Spain ..................................................................................................................... – Azydrop

Date of leaflet approval: 29.03.2024

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