Azyter

Azyter 15 mg/g, eye drops, solution in single-dose container
Azithromycin dihydrate

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, the doctor treating your child, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are similar to yours, as it may be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

Contents of this leaflet:

1. What Azyter is and what it is used for
2. What you need to know 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 Azyter is and what it is used for

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

• Purulent bacterial conjunctivitis,
• Trachomatous conjunctivitis (a specific eye infection caused by the bacterium Chlamydia trachomatis, found or occurring in developing countries).

2. What you need to know before using AZYTER

Do NOT use Azyter

• If you are allergic to azithromycin, to any other antibiotic of the macrolide class, or to medium-chain triglycerides.

Warnings and precautions
Talk to your doctor, or the doctor treating your child, or to a pharmacist or nurse before using AZYTER.
Be careful with Azyter, especially

• In case of allergic reaction, stop treatment and consult your doctor.
• If you do not observe improvement within three days of starting treatment or if unusual signs appear, consult your doctor.
• Due to your eye infection, wearing contact lenses is not recommended.

This medicine is for topical ophthalmic use only.
Do not inject, do not swallow.
Other medicines and AZYTER
If you are using any other eye medication, you must:
 apply the other ophthalmic medicine first,
 wait 15 minutes,
 then apply Azyter last.
Tell your doctor, the doctor treating your child, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy
Azyter may be used during pregnancy.
Your doctor may prescribe this medicine to you during pregnancy if considered necessary.
Breast-feeding
Limited data indicate that azithromycin is excreted in breast milk; this medicine may be used during breast-feeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience transient blurred vision after ocular administration of the medicine. Wait until your vision returns to normal before driving or operating machinery.

3. How to use AZYTER

This medicine is intended for ocular administration (ophthalmic use).
Always use this medicine exactly as instructed by your doctor or the doctor treating your child. If you have any doubts, consult your doctor, the doctor treating your child, or the pharmacist.

Dosage
The recommended dose in adults (including the elderly) and children from birth to 17 years of age is one drop twice daily in the affected eye(s): one drop in the morning and one drop in the evening.
The duration of treatment is three days.
Due to the prolonged action of the drug, it is not necessary to continue treatment beyond three days, even if you still have residual signs of the bacterial infection.

Method of administration
For correct administration of Azyter:

• Wash your hands thoroughly before and after using the medicine.
• Instill one drop into the affected eye by looking upward and gently pulling down the lower eyelid.
• Avoid touching the eye or eyelids with the tip of the single-dose container.
• Dispose of the single-dose container after use. Do not keep it for later use.

DO NOT INJECT, DO NOT INGEST
If you forget to use Azyter
Do not use a double dose to make up for the missed dose.
If you stop using Azyter
Always consult your doctor if you are considering stopping the treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if you experience any of the following symptoms after taking this medicine,
as these symptoms can be serious.
Uncommon: may occur in 1 out of 100 people:

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

Not known: frequency cannot be estimated from the available data

• Serious skin reactions: skin rash, skin eruption, blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)), skin rash associated with other symptoms such as fever, swollen glands, and increased eosinophils (a type of white blood cells) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)), widespread erythema with peeling of large areas of the body (exfoliative dermatitis), rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid) (Acute Generalized Exanthematous Pustulosis (AGEP)). Discontinue azithromycin if you develop these skin symptoms and contact your doctor or seek immediate medical assistance.

The following adverse effects have been observed with the use of this product:
Very common: may occur in more than 1 out of 10 people

• transient eye discomfort (itching, burning, pain).

Common: may occur in up to 1 out of 10 people

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

Uncommon: may occur in 1 out of 100 people

• allergic reaction (hypersensitivity),
• inflammation of the conjunctiva (may be due to infection or allergy) (conjunctivitis),
• allergic inflammation of the conjunctiva (allergic conjunctivitis),
• inflammation of the cornea (keratitis),
• itching of the skin of the eyelids (eyelid eczema),
• dryness, redness, and swelling of the eyelids (eyelid edema),
• ocular allergy,
• increased tearing, redness of the eyelids (eyelid erythema),
• redness of the conjunctiva (conjunctival hyperemia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 stated on the outer carton and on the single-dose container.
The expiry date refers to the last day of that month.

• Do not store above 25ºC.
• Keep the single-dose containers inside the sachet to protect them from light.

Immediately discard the opened single-dose container together with any remaining solution after first use.
Do not store it for later use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azyter contains

• The active substance is azithromycin dihydrate. Each gram of solution contains 15 mg of azithromycin dihydrate, equivalent to 14.3 mg of azithromycin. A single-dose container containing 250 mg of solution has 3.75 milligrams of azithromycin dihydrate.
• The other component is medium-chain triglycerides.

Description of the appearance of Azyter and contents of the pack
Azyter is an ophthalmic solution (eye drops, solution) supplied in single-dose containers, each containing 0.25 g of product. It is a clear, oily liquid, colourless to slightly pale yellow.
The pack contains 6 single-dose containers in a sachet, sufficient for one course of treatment.

Marketing Authorisation 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
or
Laboratoire UNITHER
ZI de la Guérie
50211 COUTANCES CEDEX
FRANCE

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, UK:
AZYTER
Spain: AZYDROP