METRONIDAZOL VIÑAS 7.5 mg/g GEL

Introduction

Package Leaflet: Information for the User

Metronidazole Viñas 7.5 mg/g Gel

Metronidazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Metronidazole Viñas and what is it used for
2. What you need to know before you use Metronidazole Viñas
3. How to use Metronidazole Viñas
4. Possible side effects
5. Storage of Metronidazole Viñas
6. Contents of the pack and other information

1. What is Metronidazole Viñas and what is it used for

Metronidazole Viñas is a medicinal product in the form of a gel for cutaneous use. It contains metronidazole, an antibiotic and antiprotozoal active against the inflammatory papular-pustular component of rosacea.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

This medicinal product is indicated for the treatment of inflammatory papules, pustules, and erythema (redness of the skin) of acne rosacea.

2. What you need to know before you use Metronidazole Viñas

Do not use Metronidazole Viñas

• If you are allergic to metronidazole or any of the other components of this medicinal product (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Metronidazole Viñas.

• If you have a history of blood dyscrasias (abnormalities of blood components).

Metronidazole Viñas should be kept away from the eyes.

In case of local irritation, the frequency of application should be reduced or treatment should be temporarily or permanently discontinued, according to clinical judgment.

Other Medicines and Metronidazole Viñas

Tell your doctor if you are using, have recently used, or might use anticoagulants such as coumarin or warfarin or any other medicinal product.

Cosmetics can be used after applying the metronidazole gel.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.

The safety of Metronidazole Viñas in human pregnancy has not been established. Therefore, this medicinal product should only be used during pregnancy and breastfeeding when strictly necessary, according to medical judgment.

Driving and Using Machines

No effects on the ability to drive and use machines have been described.

Metronidazole Viñas contains propylene glycol, methyl parahydroxybenzoate, sodium salt, and propyl parahydroxybenzoate, sodium salt

This medicinal product contains 35 mg of propylene glycol per gram of product.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (E-217).

3. How to Use Metronidazole Viñas

Follow exactly the administration instructions of this medicinal product indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Metronidazole Viñas is a medicinal product for application on the affected skin areas.

The areas to be treated should be cleaned before applying the gel. A gentle massage should be performed until the gel is fully absorbed.

A small amount of gel is needed to cover the usually affected areas with a thin layer.

Apply twice a day, in the morning and at night.

Use in Children

It is not recommended for use in children.

Notable therapeutic results should be observed after three weeks. A maximum treatment duration of 2 months is recommended.

Your doctor will indicate the duration of your treatment with Metronidazole Viñas.

Do not stop treatment before, as you will not achieve the desired effects.

If You Use More Metronidazole Viñas Than You Should

If you apply more Metronidazole Viñas than you should, remove the excess gel.

There is no experience of intoxication in humans with the metronidazole gel.

In case of overdose, accidental ingestion, or eye contact, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicinal product and the amount used.

If You Forget to Use Metronidazole Viñas

Do not make a double application to compensate for forgotten doses. Continue treatment with the recommended posology.

If You Interrupt Treatment with Metronidazole Viñas

In case of treatment interruption, consult your doctor or pharmacist.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Due to the minimal absorption of metronidazole when applied to the skin, the side effects described are local.

Frequent (may affect up to 1 in 10 people):

• Lacrimation (if the gel is applied too close to the eyes).
• Transient redness
• Moderate dryness
• Burning and skin irritation

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metronidazole Viñas

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

Do not use Metronidazole Viñas after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice changes in the appearance of the gel.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the pharmacy's SIGRE collection point. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6.

Composition of Metronidazole Viñas

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• The other components (excipients) are: propylene glycol, carbomer, methyl parahydroxybenzoate, sodium salt (E-219), disodium edetate, propyl parahydroxybenzoate, sodium salt (E-217), sodium hydroxide, and purified water.

Appearance of the Product and Contents of the Packaging

Metronidazole Viñas is presented as a colorless or slightly yellowish gel, in aluminum tubes of 30 grams.

Marketing Authorization Holder and Manufacturer:

Laboratorios Viñas, S.A.

Provenza, 386

08025-Barcelona

Spain

Date of Last Revision of this Leaflet: June 2019

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