Leaflet: information for the user

Metronidazole Vaginal Gel 7.5 mg/g

Metronidazole

Read this leaflet carefully before you start using the medicine, as 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.

Contents of the leaflet

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

Metronidazol Viñasis askin gel medication. It contains metronidazol, an active antibacterial and antiprotozoal agent against the inflammatory papulopustular component of rosacea.

This medicationis indicated for the treatment of inflammatory papules, pustules, and erythema (skin redness) of rosacea.

Do not use Metronidazol Viñas

- If you are allergic to metronidazol,or to any of the other components ofthis medication (listed in section 6).

Warnings and precautions

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

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

Metronidazol Viñas should be avoided from coming into contact with the eyes.

In case of local irritation, the frequency of application should be reduced or the treatment should be temporarily or definitively interrupted, according to clinical criteria.

Other medications and Metronidazol Viñas

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

Cosmetics may be used after applying the metronidazol gel.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of Metronidazol Viñas in human pregnancy has not been established. Therefore, this medication should be used in pregnancy and breastfeeding only when strictly necessary according to medical criteria.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

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

This medication contains 35 mg of propylene glycol in each 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).

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

Metronidazol Viñas is a medication for application on affected skin areas.

The treatment areas should be cleaned before applying the gel. A gentle massage should be performed until complete absorption.

A small amount of gel is needed to cover the 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 Metronidazol Viñas.

Do not discontinue treatment prematurely, as this may not achieve the desired effects.

If you use more Metronidazol Viñas than you should

If more Metronidazol Viñas is applied than necessary, remove the excess gel.

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

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

If you forget to use Metronidazol Viñas

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

If you interrupt treatment with Metronidazol Viñas

Consult your doctor or pharmacist if treatment is interrupted.

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 everyone will experience them.

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

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

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

Do not use Metronidazole Vaginal Gelafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medicationif you observe changes in the appearance of the gel.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Metronidazol Viñas Composition

-The active ingredient is metronidazole. Each gram of gel contains 7.5 mg of metronidazole.

• 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.

Product Appearance and Packaging Contents

Metronidazol Viñas is presented in the form of a colorless or very slightly yellowish gel, in aluminum tubes of 30 grams.

Marketing Authorization Holder and Responsible Manufacturer:

Laboratorios Viñas, S.A.

Provenza, 386

08025-Barcelona

Spain

Last Review Date of this Leaflet: June 2019

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