Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Azyter
15 mg/g, eye drops, solution in single-dose container
Azithromycinum dihydricum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor, the doctor treating the child, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

What Azyter is and what it is used for
Important information before using Azyter
How to use Azyter
Possible side effects
How to store Azyter
Contents of the pack and other information

1. What Azyter is and what it is used for

Azyter contains azithromycin, an antibiotic belonging to the macrolide group.
Azyter is used for local treatment of various bacterial eye infections in adults (including elderly people) and in children from birth up to 17 years of age.

Bacterial conjunctivitis,
Trachomatous conjunctivitis (a bacterial eye infection caused by Chlamydia trachomatis, occurring in developing countries).

2. Important information before using Azyter

When NOT to use Azyter:

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

Warnings and precautions
Before starting treatment with Azyter, consult a doctor, the child's treating physician, pharmacist, or nurse:

If an allergic reaction occurs, discontinue use of the medicine and seek medical advice.
If there is no improvement after three days of treatment or if unusual symptoms occur, consult a doctor.
If there is an eye infection, wearing contact lenses is not recommended. This medicine is intended for ocular use only. Do not inject or take orally.

Azyter and other medicines
If other eye medications need to be used, follow these steps:
 First, administer the other eye medicine,
 wait 15 minutes,
 then instill Azyter as the last medication.

Inform your doctor, the child's treating physician, or pharmacist about all medicines currently or recently used, as well as any medicines planned for future use.

Pregnancy
Azyter may be used during pregnancy.
The treating physician may prescribe Azyter to a pregnant woman if deemed necessary.

Breast-feeding
Limited data indicate that azithromycin passes into breast milk.
This medicine may be used during breast-feeding.
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Blurred vision may occur temporarily after instillation. In such cases, wait until symptoms resolve before driving or operating machinery.

3. How to use Azyter

Azyter must be used only for the eyes (ophthalmic administration).
This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult your
physician, the child's treating physician, or pharmacist.

Dosage
The recommended dose for adults (including elderly patients) and for children from birth up to 17 years of age is 1 drop twice daily into the affected eye(s): one drop in the morning and one drop in the evening.
The duration of treatment is 3 days.
Because the medicine has prolonged action, it is not necessary to use it for longer than 3 days, even if mild symptoms of infection persist.

Method of administration:
To correctly administer Azyter, follow these steps:

Wash your hands carefully before and after instilling the drops.
Look upward and gently pull down the lower eyelid; instill one drop into the affected eye.
Do not touch the surface of the eye or eyelids with the tip of the single-dose container.
After use, the single-dose container must be discarded. Do not store it for reuse.

DO NOT INJECT, DO NOT SWALLOW
Missed dose of Azyter
Do not use a double dose to make up for a missed dose.
Stopping Azyter treatment
Always consult your doctor before deciding to discontinue treatment.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor if any of the following symptoms occur after using this medicine,
as these symptoms may be serious.
Uncommon: may affect 1 in 100 patients:

severe allergic reaction causing swelling of the face or throat (angioedema).

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

severe skin reactions: skin rash, skin lesions, blisters on the skin, mouth, eyes and genital organs (Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)), skin rash associated with other accompanying symptoms such as fever, swollen lymph nodes and increased eosinophil count (a type of white blood cells), appearance of a rash consisting of small, itchy red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)), generalized erythema with extensive skin peeling (exfoliative dermatitis), skin eruptions characterized by the rapid appearance of red skin areas covered with small pustules (small pustules filled with whitish-yellow fluid) (Acute Generalized Exanthematous Pustulosis (AGEP)). If any of these skin symptoms occur, azithromycin should be discontinued immediately and medical advice should be sought urgently or emergency care should be obtained.

The following adverse reactions have been reported after using the medicine:
Very common: may affect more than 1 in 10 patients:

transient eye discomfort (itching, burning, stinging).

Common: may affect up to 1 in 10 patients:

blurred vision,
sensation of sticky eyelids,
sensation of a foreign body in the eye.

Uncommon: may affect 1 in 100 patients:

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Azyter

Keep this medicine 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 stated month.

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

Each single-dose container should be immediately discarded after first use,
even if not all of the contents have been used. Do not store for reuse.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Azyter contains

The active substance is azithromycin dihydrate. One gram of solution contains 15 mg of azithromycin dihydrate, equivalent to 14.3 mg of azithromycin. Each single-dose container contains 3.75 mg of azithromycin dihydrate in 250 mg of solution.
The other ingredient is medium-chain triglycerides.

What Azyter looks like and contents of the pack
Azyter is a solution for ocular administration (eye drops, solution) in single-dose containers containing 0.25 g of solution. Azyter is a clear, colourless to slightly yellow, oily liquid.
The carton contains 6 single-dose containers made of LDPE, packed in a sachet, providing sufficient amount for one course of treatment.
For further information about the medicinal product, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Greece, the country of export: 56059/25-08-2015
Parallel import licence number: 140/24
This medicinal product is authorised for sale 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