Aziter

Package Leaflet: Information for the Patient

Azyter,

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

Azithromycin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is AZYTER and what is it used for

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

• Purulent conjunctivitis,
• inclusion conjunctivitis (this is a bacterial eye infection caused by Chlamydia trachomatiscommon in developing countries).

2. Important information before using Azyter

When NOT to use Azyter:

• if you are allergic to azithromycin, other macrolide antibiotics, or to triglycerides with a medium chain length.

Warnings and precautions

Before starting treatment with Azyter, tell your doctor, pharmacist, or nurse:

• If an allergic reaction occurs, stop using the medicine and consult a doctor.
• If there is no improvement after three days of treatment or if unusual symptoms occur, consult a doctor.
• If you have an eye infection, do not wear contact lenses. This medicine is for use in the eye only. Do not inject or swallow the medicine.

AZYTER and other medicines

If you need to use other eye medicines, you should:
1.
first put in the other eye medicine,
2.
wait 15 minutes,
3.
then put in Azyter as the last one.
Tell your doctor, pharmacist, or nurse about all the medicines you are taking or have recently taken, and about any medicines you plan to take.

Pregnancy

Azyter can be used during pregnancy.
Your doctor may prescribe Azyter to you if you are pregnant, if he considers 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, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

After putting in the drops, there may be a temporary blurring of vision. In such cases, wait until the symptoms resolve before driving or operating machinery.

3. How to use Azyter

Azyter should only be used in the eye (for ophthalmic use).
Use this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor, pharmacist, or nurse.
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.
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 some symptoms of the infection still persist.

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

• wash your hands carefully before and after putting in the drops,
• look up and gently pull down the lower eyelid to put 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 should be thrown away. Do not store it for reuse.

DO NOT INJECT, DO NOT SWALLOW

Missing a dose of Azyter

Do not use a double dose to make up for a forgotten dose.

Stopping treatment with Azyter

Always consult your doctor if you decide to stop treatment.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Immediately tell your doctor if you experience any of the following symptoms after using this medicine, 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 other accompanying symptoms such as fever, swelling of lymph nodes, and increased number of 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 peeling of the skin 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 any of these skin symptoms, stop using azithromycin and contact your doctor or go to the emergency room immediately.

Reported side effects after using the medicine:
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),
• inflammation of the conjunctiva (possibly due to infection or allergy) (conjunctivitis),
• 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

If you experience any side effects, including any not listed in this leaflet, tell your doctor, 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
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azyter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and on the single-dose container. The expiry date refers to the last day of that month.

• Do not store above 25°C.
• Single-dose containers should be stored in the sachetto protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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, 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 triglycerides of saturated fatty acids with a medium chain length.

What Azyter looks like and contents of the pack

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 carton box contains 6 single-dose containers in a sachet, which is sufficient for a single treatment course.

Marketing authorization holder and manufacturer

Marketing authorization holder:
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
5200 COUTANCES
FRANCE

This medicinal product 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 last revision of the leaflet: 11/2021