Leaflet: information for the user

Zineryt 40 mg/ml + 12 mg/ml powder and solvent for cutaneous solution

Erythromycin/Zinc dihydrate acetate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Zineryt is a medication that contains two active ingredients: erythromycin and zinc dihydrochloride. Erythromycin is an antibiotic that belongs to a group of antibiotics called macrolides, and zinc has anti-inflammatory effects.

Zineryt is a topical medication used for the treatment of mild to moderate acne vulgaris in adults.

Do not use Zineryt

If you are allergic to erythromycin or other macrolide antibiotics, to zinc dihydrate acetate or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

This medication is for external use only.

Avoid contact with the eyes and mucous membranes as it contains ethanol (alcohol). In case of accidental contact with the eyes, rinse with plenty of water and consult your doctor if necessary.

The use of antibiotics may lead to the appearance of microorganisms resistant to erythromycin (loss of antibiotic efficacy), see more in "Use of other medications".

Children

It is not recommended for use in children.

Use of Zineryt with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Especially if you are using or have used recently macrolide antibiotics or other antibiotics such as lincomycin, clindamycin and chloramphenicol, as they may produce cross-resistance, that is, it may lead to the appearance of resistant microorganisms.

Pregnancy, breastfeeding and fertility

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.

Do not use Zineryt if you are pregnant unless it is clearly necessary.

It should not be administered during breastfeeding.

Driving and operating machinery

Its use does not alter the ability to drive vehicles or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

External use only.

Dosage in adults:

Apply the topical solution twice a day (in the morning and at night), to the face or other affected skin areas, after washing, (not just on the lesions) to cover the total area to be treated.

Generally, treatment is recommended for 10-12 weeks, during which time a satisfactory improvement is observed in most cases. If there has been no improvement or worsening, administration of the preparation should be discontinued.

Administration form:

Apply by tilting the bottle downwards and rubbing the applicator-dispenser on the skin while gently pressing. The amount of liquid obtained depends on the pressure applied to the skin.

Allow to dry. After drying, there are no stains on the skin or clothing that comes into contact with the treated area.

Zineryt should only be used by the same person to avoid contamination.

INSTRUCTIONS FOR CORRECT ADMINISTRATION OF THE PREPARATION

PREPARATION

If you use more Zineryt than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

− Rare adverse effects (may affect up to 1 in 100 people): Burning sensation on the skin, skin irritation or mild redness, dryness, itching, and peeling.

− Very rare adverse effects (may affect up to 1 in 10,000 people): Hypersensitivity reactions (allergic reactions).

Seek medical attention as soon as possibleif you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthema). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, evenif it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

−Without reconstitution (powder and solvent): Store below 25°C.

−After reconstitution: Store below 25°C for a maximum of 5 weeks. Note the date of reconstitution on the box and on the bottle of the reconstituted solution.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Zineryt

• The active principles are erythromycin and zinc dihydrate acetate. Each ml of reconstituted solution contains 40 mg of erythromycin and 12 mg of zinc dihydrate acetate.
• The other components (excipients) are: diisopropyl sebacate and anhydrous ethanol.

Appearance of the product and content of the container

High-density polyethylene bottles with polypropylene screw-top caps.

It is supplied in a container that contains a bottle with the powder and another bottle containing the 30 ml or 70 ml reconstitution solvent.

A dispenser-applicator consisting of a spring-loaded accessory with a sponge is included.

Only some container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local representative

Laboratorios Rubió. S.A.

Industria 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Responsible manufacturer

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Last review date of this leaflet: September 2018

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