Package Insert: Information for the Patient

AZYDROP 15 mg/g, eye drop solution in single-dose container

Azithromycin dihydrate

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor, or the doctor treating your child or pharmacist or nurse.
• This medication has been prescribed only to you, or your child and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is AZYDROP and for what it is used

2. What you need to know before starting to use AZYDROP

3. How to use AZYDROP

4. Possible adverse effects

5. Storage of AZYDROP

6. Contents of the package and additional information

AZYDROP contains azithromycin, an antibiotic that belongs to the class of macrolides.

AZYDROP is used for the local treatment of certainbacterial eye infectionsin adults (including elderly patients) and in children from birth to 17 years of age.

• purulent bacterial conjunctivitis,
• trachomatous conjunctivitis (particularly infections caused by the bacteria calledChlamydia trachomatis,existing or appearing in developing countries).

NouseAZYDROP

-Youareallergic toazithromycin, any other type of macrolide antibiotic, or medium-chain triglycerides.

Warnings and precautions

Consult your doctoror the doctor treating your child,oryour pharmacist or nurse before starting to useAZYDROP

• If you experience an allergic reaction, you must stop treatment and consult your doctor.
• If you do not see improvement after three days of starting treatment or if abnormal signs occur, you must consult your doctor.
• Given your eye infection, it is not recommended to use contact lenses.

This medication isonly for ocular use.

Do not inject or ingest.

Use ofAZYDROP withother medications

If you are using any other eye medication, you must:

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 used or may have used recently 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating 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 operating any machine.

This medication is intended to be administered in the eye (ocular use).

Always use this medication exactly as your doctor or the doctor treating your child has instructed. If in 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 affected eye(s) twice a day: one drop in the morning and one drop in the afternoon.

The treatment duration 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

To administer Azydrop properly:

• Wash your hands carefully before and after using the product,
• Apply one drop in the eye to be treated while looking upwards and gently pulling the lower eyelid downwards,
• Avoid touching the eye and eyelids with the tip of the dropper from the single-use container,
• Discard the single-use container after use. Do not store it for reuse.

DO NOT INJECT, DO NOT INGEST

If you forgot to use AZYDROP

Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with AZYDROP

Always consult your doctor if you are considering interrupting treatment.

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

Like all medicines, Azydrop may cause side effects, although not everyone will experience them.

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

Rare: may affect 1 in 100 people:

- Severe allergic reaction that causes facial or throat inflammation (angioedema).

Unknown: the frequency cannot be estimated from available data

- Severe skin reactions: hives, skin rash, blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson Syndrome (SSJ) or Toxic Epidermal Necrolysis (TEN)), hives accompanied by other symptoms such as fever, gland inflammation, and increased eosinophils (a type of white blood cell), rash with small red spots associated with itching (drug reaction with eosinophilia and systemic symptoms (DRESS)), generalized erythema with peelingover large areas of the body (exfoliative dermatitis), skin rash characterized by the rapid appearance of red skin areas dotted with small pustules (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 ocular discomfort (pruritus, burning, itching).

Common: may affect up to 1 in 10 people:

• Blurred vision,
• Sensation of sticky eyes,
• Sensation of foreign body.

Rare: 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 (eczema palpebrarum),
• Dry, red, swollen eyelids (edema palpebrarum),
• Ocular allergy,
• Excessive tearing,
• Redness of the eyelids (erythema palpebrarum),
• Redness of the conjunctiva (conjunctival hyperemia).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or the doctor treating your child, or your pharmacist or nurse, even if it ispossibleside effects that do not appear in this leaflet.You can also report them directly throughSpanish System for Pharmacovigilance of Medicines for Human Use: https//: notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date indicated on the box and on the single-use packaging. The expiration date is the last day of the month indicated.

• Do not store at a temperature above25ºC.

• Keep thesingle-use packagingin the overto protect itfrom light.

Dispose of the single-use packaging with any remaining solution immediately after its first use. Do not store it to use again.

Medications should not be thrown away through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 packaging

Azydrop is an eye solution (eye drops in solution) that is presented in single-dose containers, which contain0.25 gof product. It is an oily, transparent, colorless, or slightly yellow liquid.

The box contains six single-dose containers in a pouch, which are sufficient for a treatment.

Manufacturer

Laboratoires Théa

12, rue Louis Blériot

F-63017 Clermont-Ferrand Cedex 2

France

Responsible for manufacturing

Laboratoire UNITHER

1 rue de l’Arquerie50200

Coutances

France

O

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, 2nd floor

08008 Barcelona

This medicine is authorized in the member states of the European Economic Areawiththe 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

Revision date of this leaflet: October 2018

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