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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Erythromycin/Zinc diacetate dihydrate

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zineryt is and what it is used for
2. What you need to know before using Zineryt
3. How to use Zineryt
4. Possible adverse effects
5. How to store Zineryt
6. Contents of the pack and other information

1. What Zineryt is and what it is used for

Zineryt is a medicine containing two active substances: erythromycin and zinc diacetate dihydrate. Erythromycin is an antibiotic belonging to a group of antibiotics known as macrolides, and zinc has anti-inflammatory properties.

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

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

Do not use Zineryt

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

Warnings and precautions

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

This medicine is for external use only.

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

The use of antibiotics may lead to the emergence of microorganisms resistant to erythromycin (loss of antibiotic efficacy); see further under "Use of other medicines".

Children

Its use is not recommended in children.

Using Zineryt with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Especially if you are currently using or have recently used antibiotics belonging to the group known as macrolides, or other antibiotics such as lincomycin, clindamycin, and chloramphenicol, since cross-resistance may occur, meaning it could lead to the emergence of resistant microorganisms.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Zineryt during pregnancy unless clearly necessary.

It should not be administered during breastfeeding.

Driving and operating machinery

This medicine does not affect the ability to drive or operate machinery.

3. How to use Zineryt

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For external use only.

Dosage in adults:

Apply the cutaneous solution twice daily (in the morning and evening) to the face or other affected skin areas, freshly washed, (not only on the lesions themselves) to cover the entire treatment area.

Treatment is generally recommended for 10–12 weeks, during which time most cases show satisfactory improvement. If there is no improvement or if the condition worsens, treatment should be discontinued.

Method of administration:

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

Allow to dry. Once dry, no stains remain on the skin or on 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

• Uncommon adverse effects (may affect up to 1 in 100 people): Sensation of burning on the skin, irritation or mild skin redness, dryness, itching, and peeling.

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

Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zineryt

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

• Unreconstituted (powder and solvent): Store below 25°C.
• After reconstitution: Store below 25°C for up to 5 weeks. Record the date of reconstitution on the carton and on the vial containing the reconstituted solution.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zineryt

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

Appearance of the product and contents of the container

High-density polyethylene bottles fitted with polypropylene screw caps.

Supplied in a pack containing one bottle with powder and another bottle with solvent for reconstitution to obtain 30 ml or 70 ml of solution.

An applicator-dispenser consisting of a spring-loaded device with a sponge is included.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and 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

Manufacturer

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Date of the most recent review of this summary: September 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/