Aziter

Package Leaflet: Information for the Patient

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

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult your doctor, the doctor treating your child, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms 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 trachomatiscommon 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, consult your doctor, the doctor treating your child, pharmacist, or nurse

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

Azyter and Other Medications

In case other eye medications need to be used, the following should be done:
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first, administer another eye medication,

wait 15 minutes,

then administer Azyter as the last one.
Inform your doctor, the doctor treating your child, or pharmacist about all medications currently or recently used by the patient, as well as any planned medications.

Pregnancy

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

Breastfeeding

There is limited data indicating that azithromycin passes into breast milk.
This medication can be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.

Driving and Operating Machinery

After administration, temporary blurred vision may occur. In such cases, wait until the symptoms resolve before driving or operating machinery.

3. How to Use Azyter

Azyter should only be used for eye administration (eye drops).
This medication should always be used as directed by your doctor. In case of doubts, consult your doctor, the doctor treating your child, or pharmacist.
Dosage
The recommended dose for adults (including the elderly) and children from birth to 17 years is 1 drop twice a day to the affected eye: one drop in the morning and one drop in the evening.
Treatment duration is 3 days.

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

Administration method:
To properly administer Azyter, follow these steps:

• wash your hands carefully before and after administering the medication,
• looking up and gently pulling down the lower eyelid, administer one drop to the affected eye,
• do not touch the eye surface or eyelids with the tip of the single-dose container,
• after use, discard the single-dose container. Do not store it for reuse.

DO NOT INJECT, DO NOT SWALLOW

Missing a Dose of Azyter

Do not take a double dose to make up for a missed dose.

Stopping Azyter Treatment

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Always consult your doctor if you decide to stop treatment.
In case of further doubts about using this medication, consult your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Azyter can cause side effects, although not everybody gets them.

Inform your doctor immediately if you experience any of the following symptoms after using this medication, as they can 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 accompanying symptoms such as fever, swollen lymph nodes, and increased eosinophil count (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 over 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 these skin symptoms occur, discontinue azithromycin and contact a doctor or go to the emergency room immediately.

The following side effects have been reported with the use of the medication:
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 stickiness of the eyelids,
• 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 skin on the eyelids (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

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If you experience any side effects, including any side effects not listed in the leaflet, inform your doctor, the doctor treating your child, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 side effects will help gather more information on the safety of the medication.

5. How to Store Azyter

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the outer packaging and single-dose container. The expiration date is the last day of the specified month.

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

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

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medications. 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, equivalent to 14.3 mg of azithromycin. One single-dose container contains 3.75 mg of azithromycin dihydrate in 250 mg of solution.
• 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 made of LDPE, containing 0.25 g of medication, in a sachet, in a cardboard box. Azyter is a clear, colorless to slightly yellowish, oily liquid.
The cardboard box contains 6 single-dose containers in a sachet, which is sufficient for a single treatment course.
For more detailed information, contact 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:

Laboratoire UNITHER, 1 rue de l’Arquerie, 50200 Coutances, France
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Parallel Importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Greece, the country of export: 56059/25-08-2015

Parallel Import Authorization Number: 152/24

This medicinal product is authorized 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

Date of Leaflet Approval: 12.04.2024

[Information about the trademark]
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