AZYDROP 15mg/g, SINGLE-DOSE SOLUTION EYE DROPS

2. What you need to know before using AZYDROP

DO NOT USE AZYDROP

-If you are allergic to.

Warnings and Precautions

Consult your doctor or the doctor treating your child, or your pharmacist or nurse before starting to use AZYDROP

• If an allergic reaction occurs, you should discontinue treatment and consult your doctor.
• If you do not see improvement after three days of starting treatment or if abnormal signs occur, you should consult your doctor.
• In view of your eye infection, the use of contact lenses is not recommended.

This medication is for ocular use only.

Do not inject or ingest.

U

If you are using any other medication for application in the eye, you should:

apply the other eye medication,

wait 15 minutes,

apply Azydrop last.

Inform your doctor or the doctor treating your child or your pharmacist if you are using or have recently used any other medication.

Pregnancy

Azydrop can be used during pregnancy.

Your doctor may prescribe this medication during pregnancy if necessary.

Breastfeeding

Some data indicate 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 become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

You may experience temporary blurred vision after ocular administration of the product. Wait until your vision returns to normal before driving a vehicle or using any machine.

3. How to use AZYDROP

This medication is intended for administration in the eye (ocular use).

Always use this medication exactly as your doctor or the doctor treating your child has indicated. In case of doubt, consult your doctor or the doctor treating your child or your pharmacist again.

Dosage

The recommended dose for adults (including elderly patients) and children from birth to 17 years of age is one drop in the eye(s) to be treated twice a day: 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 product, it is unnecessary to prolong treatment beyond three days, even if you have residual signs of the bacterial infection.

Method of Administration

For proper administration of Azydrop:

• wash your hands carefully before and after using the product,
• apply one drop in the eye to be treated while looking up and gently pulling the lower eyelid down,
• avoid touching the eye and eyelids with the tip of the dropper of the single-dose container,
• discard the single-dose container after use. Do not save it for later use.

DO NOT INJECT, DO NOT INGEST

If you forgot to use AZYDROP

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

If you interrupt treatment with AZYDROP

Always consult your doctor if you are considering interrupting treatment.

If you have any doubts about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Azydrop can cause side effects, although not everyone experiences them.

Inform your doctor immediately if you experience any of the symptoms described below after taking this medication, as they may be serious.

Uncommon: may affect 1 in 100 people:

• Severe allergic reaction causing inflammation of the face or throat (angioedema).

Unknown: frequency cannot be estimated from available data

• severe skin reactions: rash, skin eruption, blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)), rash accompanied by other symptoms such as fever, inflammation of the glands, and an increase in eosinophils (a type of white blood cell), eruption with a appearance of small red spots associated with itching (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)), generalized erythema with desquamation over large areas of the body (exfoliative dermatitis), skin eruption characterized by the rapid appearance of areas of red skin dotted with small pustules (small blisters filled with white/yellow liquid) (Acute Generalized Exanthematous Pustulosis (AGEP)).

Stop taking azithromycin if you develop these symptoms and contact your doctor or seek immediate medical attention.

The following side effects were observed after administration of the product:

Very common: may affect more than 1 in 10 people:

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

Common: may affect up to 1 in 10 people:

• blurred vision,
• sticky eye sensation,
• foreign body sensation.

Uncommon: may affect 1 in 100 people:

• Allergic reaction (hypersensitivity),
• Conjunctival inflammation (may be due to infection or allergy) (conjunctivitis),
• Allergic conjunctival inflammation (allergic conjunctivitis),
• Corneal inflammation (keratitis),
• Itching of the eyelids (eyelid eczema),
• Dry skin, redness, swelling of the eyelids (eyelid edema),
• Ocular allergy,
• Tearing,
• Redness of the eyelids (eyelid erythema),
• Redness of the conjunctiva (conjunctival hyperemia).

Reporting of Side Effects

If you experience any side effects, consult your doctor or the doctor treating your child, or your pharmacist or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//: notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of AZYDROP

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date indicated on the box and on the single-dose container. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25°C.

• Keep the single-dose containers in the envelopeto protect them from light.

Discard the single-dose container with any remaining solution immediately after its first use. Do not save it for later use.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Contents of the Container and Additional Information

Composition of Azydrop

• 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 with 250 mg of solution contains 3.75 mg of azithromycin dihydrate.

• The other components are medium-chain triglycerides.

Appearance of the Product and Contents of the Container

Azydrop is an eye drop solution (solution for ocular use) presented in single-dose containers, each containing 0.25 g of product. It is a clear, colorless or slightly yellowish oily liquid.

The box contains six single-dose containers in an envelope, which are sufficient for one treatment.

Marketing Authorization Holder

Laboratoires Théa

12, rue Louis Blériot

F-63017 Clermont-Ferrand Cedex 2

France

Manufacturer

Laboratoire UNITHER

1 rue de l’Arquerie 50200

Coutances

France

Or

Laboratoires Théa

12, rue Louis Blériot

F-63017 Clermont-Ferrand Cedex 2

France

Local Representative

Laboratorios Thea, S.A.

C/ Enric Granados, nº 86-88, 2ª planta

08008 Barcelona

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

Germany, Austria, Bulgaria, Czech Republic, Cyprus, Denmark, Slovenia, Finland, France, Greece, Netherlands, Ireland, Iceland, Italy, Luxembourg, Norway, Poland, Portugal, United Kingdom, Romania, and Sweden: AZYTER

Spain: AZYDROP

Date of revision of this package leaflet: October 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.