Metronidazole Viñas 7.5 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metronidazole Viñas 7.5 mg/g gel

Metronidazole

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 others, even if they have the same symptoms as you, because it may 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.

Package leaflet contents

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

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

Metronidazol Viñas is a medicine in the form of a topical gel. It contains metronidazole, an antibiotic and antiprotozoal agent active against the inflammatory papulopustular component of rosacea.

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

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines by flushing them down the sink or into household waste.

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

2. What you need to know before using Metronidazole Viñas

Do not use Metronidazole Viñas:
- If you are allergic to metronidazole or to any of the other ingredients of this medicine (listed in section 6).
- If you have had allergic reactions to other nitroimidazole antibiotics (such as tinidazole).
- In case of central nervous system diseases (such as encephalopathy, seizures, or other neurological disorders) of any cause.
- If you have active neurological diseases (such as peripheral neuropathy).
- If you have had previous episodes of peripheral neuropathy while taking metronidazole or other nitroimidazoles.
- In case of severe liver disease (severe hepatic insufficiency).
- If you are taking disulfiram (used to treat alcoholism) or if you have taken it within the last two weeks.
- If you are taking products containing lithium.

Warnings and precautions
Talk to your doctor or pharmacist before taking Metronidazole Viñas if you have:
- Liver disease (hepatic insufficiency). Your doctor may adjust your dose.
- Kidney disease (renal insufficiency). Your doctor may adjust your dose.
- Epilepsy or other conditions that lower the seizure threshold.
- Blood disorders.
- Central or peripheral nervous system diseases.
- History of mononucleosis.

Metronidazole may cause peripheral neuropathy, especially with prolonged use. If you experience numbness, tingling, or burning sensations in your arms or legs, contact your doctor immediately.

Metronidazole may increase the risk of seizures, especially in patients with a history of epilepsy or other seizure disorders.

Metronidazole may interact with alcohol, causing a disulfiram-like reaction (flushing, headache, nausea, vomiting, rapid heartbeat). Avoid alcohol and alcoholic beverages during treatment and for at least 48 hours after stopping the medication.

Children
Metronidazole Viñas is not recommended for use in children under 12 years of age, due to insufficient safety and efficacy data.

Other medicines and Metronidazole Viñas
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• Disulfiram: Concurrent use may cause psychotic reactions. Do not take metronidazole if you have taken disulfiram within the last two weeks.
  
• Lithium: Metronidazole may increase lithium levels in the blood, increasing the risk of toxicity.
  
• Warfarin and other anticoagulants: Metronidazole may enhance their effect, increasing the risk of bleeding. Your doctor may need to adjust your anticoagulant dose.
  
• Phenytoin and phenobarbital: Metronidazole may increase blood levels of these anticonvulsants.
  
• Cyclosporine: Metronidazole may alter cyclosporine levels; monitoring is recommended.
  
• Fluorouracil: Increased risk of severe adverse reactions.
  
• Busulfan: Increased busulfan levels have been reported; monitor plasma concentrations.
  
• CYP3A4 inducers (e.g., rifampicin): May decrease metronidazole levels, reducing effectiveness.
  
• Alcohol and products containing alcohol: May cause a disulfiram-like reaction (see section 2).
  

Food and alcohol
Avoid alcohol and products containing alcohol (including medicines, mouthwashes, and topical products) during treatment and for at least 48 hours after stopping metronidazole. Alcohol may cause unpleasant reactions such as flushing, headache, nausea, vomiting, and rapid heartbeat.

Pregnancy, breastfeeding and fertility

• Pregnancy: Consult your doctor before using this medicine if you are pregnant or think you might be pregnant. Metronidazole crosses the placenta. Although no harmful effects have been consistently demonstrated in humans, it should only be used during pregnancy if clearly needed.
  

• First trimester: Use only if clearly necessary.
  

• Third trimester: May increase the risk of adverse effects in the newborn.
  

• Labour and delivery: High doses near term may cause adverse effects in the newborn.
  

• Animal studies: Have shown reproductive toxicity.
  

• Breastfeeding: Metronidazole passes into breast milk. Breastfeeding is not recommended during treatment and for at least 48 hours after the last dose. If short-term treatment is necessary, breastfeeding may be resumed 1–2 days after the last dose, discarding milk during that time.
  

• Fertility: No known effects on human fertility. Animal studies have not shown effects on fertility.
  

Driving and using machines
Metronidazole may cause dizziness, ataxia, or seizures. If you experience these symptoms, do not drive or operate machinery.

Do not use Metronidazol Viñas

• If you are allergic to metronidazole or to any of the other ingredients of this medicine (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 in blood components).

Contact between Metronidazole Viñas and the eyes must be avoided.

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

Other medicines and Metronidazole Viñas

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

Cosmetics may be used after application of metronidazole gel.

Pregnancy and lactation

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

The safety of Metronidazol Viñas in human pregnancy has not been established. Therefore, this medicine should only be used during pregnancy and lactation when strictly necessary, as determined by medical judgment.

Driving and Use of Machines

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

Metronidazole Viñas contains propylene glycol, methylparaben sodium salt, and propylparaben sodium salt

This medicinal product contains 35 mg of propylene glycol in each gram of product.

It may cause allergic reactions (possibly delayed) due to the presence of methylparaben sodium salt (E-219) and propylparaben sodium salt (E-217).

3. How to use Metronidazol Viñas

Follow exactly the administration instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Metronidazol Viñas is a medicine for application to the affected areas of skin.

The areas to be treated should be cleaned before applying the gel. Gently massage until completely absorbed.

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

Apply twice daily, in the morning and at night.

Use in children

Its use is not recommended in children.

Therapeutic results should become evident after three weeks. A maximum treatment duration of 2 months is recommended.

Your doctor will determine the duration of your treatment with Metronidazol Viñas.

Do not stop the treatment prematurely, as you may not achieve the desired effects.

If you use more Metronidazol Viñas than you should

If you apply more Metronidazol Viñas than recommended, remove the excess gel.

There is no experience of human intoxication with metronidazole gel.

In case of overdose, accidental ingestion, or contact with the eyes, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used.

If you forget to use Metronidazol Viñas

Do not apply a double amount to make up for missed doses. Continue treatment with the recommended dosage.

If you stop treatment with Metronidazol Viñas

If you interrupt treatment, consult your doctor or pharmacist.

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 may produce adverse effects, although not everyone experiences them.

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

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

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

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 via the Spanish Pharmacovigilance System for Human Medicines: https://notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metronidazol Viñas

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

Do not use Metronidazol Viñas after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6.

Composition of Metronidazole Viñas

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

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

Appearance of the product and contents of the package

Metronidazol Viñas is presented as a colorless or very slightly yellowish gel, in 30-gram aluminum tubes.

Marketing Authorization Holder and Manufacturer:

Laboratorios Viñas, S.A.
Provenza, 386
08025-Barcelona
Spain

Date of the most recent review of this package leaflet: June 2019

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