Terbinafine Pensa 250 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Terbinafina pensa 250 mg tablets EFG

Read the entire leaflet carefully before you start taking 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 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.

Leaflet contents

1. What Terbinafina pensa is and what it is used for
2. What you need to know before taking Terbinafina pensa
3. How to take Terbinafina pensa
4. Possible side effects
5. How to store Terbinafina pensa
6. Contents of the pack and other information

1. What Terbinafina pensa is and what it is used for

Terbinafine belongs to a group of medicines called antifungals and works by preventing the growth of fungi.

Terbinafina pensa is used to treat the following fungal infections of the skin, scalp, and nails:

Tinea corporis (ringworm of the body).

Tinea cruris (jock itch or groin ringworm).

Tinea pedis (athlete's foot).

Tinea capitis (scalp ringworm).

Onychomycosis (fungal infection of the nails).

2. What you need to know before starting Terbinafina pensa

Read the following information before taking Terbinafina pensa

Do not take Terbinafina pensa

• if you are allergic to terbinafine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting Terbinafina pensa

• If you have kidney or liver problems, consult your doctor before taking this medicine.
• If you suffer from psoriasis, in very rare cases worsening of the disease has been reported.

It is important to inform your doctor immediately if you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, or unusual tiredness or weakness; if your skin or the whites of your eyes turn yellow, if you notice darkening of the urine or pale stools.

Inform your doctor immediately if you experience sore throat accompanied by fever and chills, unusual bleeding or bruising, or any severe skin problems.

Children

Experience with Terbinafina pensa 250 mg tablets in children is limited; therefore, use in this patient group is not recommended.

Elderly Patients

Terbinafina pensa 250 mg tablets can be administered to patients over 65 years of age. If there is a pre-existing renal problem, your doctor may prescribe a lower than usual dose. Terbinafina pensa 250 mg is not recommended for patients who have or have previously had hepatic problems.

Other Medicines and Terbinafina pensa

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including oral contraceptives, herbal remedies, and those obtained without a prescription.

There are other medicines that may alter the effect of Terbinafina pensa 250 mg tablets, for example:

• some antibiotics (e.g. rifampicin),
• some antidepressants (e.g. desipramine),
• some medicines used to treat heart problems (e.g. propafenone),
• some medicines used to treat high blood pressure (e.g. metoprolol),
• some medicines used to treat stomach ulcers (e.g. cimetidine),
• some medicines used to prevent organ rejection in transplant patients (e.g. ciclosporin).

.

Pregnancy and breastfeeding

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.

Terbinafine Pensa 250 mg tablets should not, in principle, be administered during pregnancy. Therefore, inform your doctor if you are pregnant or become pregnant during treatment before taking this medicine.

Consult your doctor or pharmacist before using any medicine during pregnancy.

Terbinafine passes into breast milk; therefore, its use is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medicine while breastfeeding.

Driving and Use of Machines

Terbinafina pensa 250 mg tablets have no effect on the ability to drive and use machines.

Terbinafina pensa 250 mg tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Terbinafine Pensa

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

Remember to take your medicine

Take Terbinafina pensa 250 mg tablets as directed by your doctor. Your doctor will determine the dose you need.

The recommended dose in adults is one tablet (250 mg) once daily.

Terbinafina pensa 250 mg tablets are tablets for oral administration. Swallow the tablets whole, without chewing, with a glass of water.

Duration of treatment

The duration of treatment will be determined by your doctor. Do not stop the treatment prematurely, as this could worsen your condition.

Complete resolution of infection symptoms may not occur until several weeks (skin and scalp) or months (nails) after the causative fungus has been eliminated.

If you take more Terbinafina pensa 250 mg tablets than you should

Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken.

The main symptoms of acute overdose may be gastrointestinal, e.g. nausea, abdominal pain, or vomiting; headache or a sensation of instability (dizziness) may also occur. If you experience any of these effects or any other unusual effects, consult your doctor.

If you forget to take Terbinafina pensa 250 mg tablets

Take the missed dose as soon as you remember, unless there are less than 6 hours remaining before the next scheduled dose.

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

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

Adverse effects are generally mild or moderate and transient.

Some adverse effects that occur rarely or very rarely may be serious:

Rarely, Terbinafina pensa 250 mg tablets may cause liver problems, and in very rare cases, these problems can be severe. Very rare adverse reactions include a decrease in certain blood cells, lupus (an autoimmune disease), or severe skin reactions, including allergic reactions.

Inform your doctor immediately:

• If you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, or unusual tiredness or weakness.
• If you notice that your skin or the whites of your eyes turn yellow, if your urine becomes unusually dark, or if you have pale stools.
• If you experience a sore throat accompanied by fever and chills.
• If you experience unusual bleeding or bruising.
• If you develop any skin problems.

Other adverse effects:

Very common (may affect more than 1 in 10 people): Nausea, mild abdominal pain, gastric discomfort, diarrhea, feeling of fullness in the stomach, loss of appetite, skin rash, joint or muscle pain.

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

Uncommon (may affect up to 1 in 100 people): Taste disturbance or loss of taste, which usually recovers within a few weeks after stopping treatment. This may lead, in very few patients, to decreased appetite and significant weight loss. Inform your doctor if taste disturbance lasts for several days.

Very rare (may affect up to 1 in 10,000 people): Hair loss, severe weakness, psoriasis-like skin eruptions, worsening of psoriasis.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Terbinafine pensa

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect from light.

Do not store this medicine in a warm place.

Do not use this medicine after the expiry date (CAD) stated on the blister and carton. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terbinafina pensa 250 mg tablets

• The active substance is terbinafine. Each tablet contains 250 mg of terbinafine (as hydrochloride).
• The other components (excipients) are: sodium carboxymethyl starch (type A) from potato, microcrystalline cellulose, hypromellose, anhydrous colloidal silica and magnesium stearate.

Appearance of the medicine and contents of the pack

Terbinafina pensa 250 mg tablets are white, oblong tablets, scored on both sides. They are available in packs of 14 and 28 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible for manufacturing

Laboratorios Liconsa, S.A

Avda. Miralcampo, nº 7.

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: March 2008

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