Terbinafine Kern Pharma 250 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terbinafine Kern Pharma 250 mg tablets EFG

Terbinafine

Read all of this leaflet carefully before you start taking this medicine.

• 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 must not be given 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 Terbinafine Kern Pharma is and what it is used for
2. What you need to know before taking Terbinafine Kern Pharma
3. How to take Terbinafine Kern Pharma
4. Possible side effects
5. How to store Terbinafine Kern Pharma
6. Contents of the pack and other information

1. What Terbinafine Kern Pharma is and what it is used for

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

This medicine 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 taking Terbinafine Kern Pharma

Read the following information before taking this medicine.

Do not take this medicine:

• If you are allergic (hypersensitive) to terbinafine or to any of the other components of this medicine (listed in section 6).
• If you have severe kidney or liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

• 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 that you immediately inform your doctor if you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, or unusual tiredness or weakness; or if your skin or the whites of your eyes turn yellow, your urine becomes darker, or your stools become pale.

Immediately inform your doctor if you experience a sore throat accompanied by fever and chills, unusual bleeding or bruising, or any serious skin problems.

Other medicines and Terbinafine Kern Pharma

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

There are other medicines that may alter the effect of Terbinafine 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).

Use in elderly patients

This medicine can be administered to patients over 65 years of age. If you have pre-existing kidney problems, you may be prescribed a lower than usual dose. Terbinafine tablets are not recommended for patients who currently have or have previously had liver problems.

Use in children

Experience with Terbinafine tablets in children is limited; therefore, use in this patient group is not recommended.

Pregnancy and breastfeeding

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

Pregnancy

This medicine should not be used during pregnancy.

Breastfeeding

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

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

Driving and using machines

Terbinafine tablets have no effect on the ability to drive or operate machinery.

Terbinafine Kern Pharma contains sodium

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

3. How to take Terbinafine Kern Pharma

Follow exactly the instructions for use of this medicine given by your doctor, even if they differ from those contained in this leaflet. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

This medicine consists of tablets for oral administration. The tablets should be swallowed with a little liquid (a glass of water). The tablet may be divided into equal doses.

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

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

If you take more Terbinafine Kern Pharma than you should

In case of overdose or accidental ingestion, contact 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.

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

If you forget to take Terbinafine Kern Pharma

Take the missed dose as soon as you remember, unless less than 6 hours remain before your 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.

The observed adverse effects are classified according to their frequency of occurrence as follows: Very common (affecting 1 or more out of 10 patients); Common (less than 1 in 10 but more than 1 in 100 patients); Uncommon (less than 1 in 100 but more than 1 in 1,000); Rare (less than 1 in 1,000 but more than 1 in 10,000); Very rare (less than 1 in 10,000).

The adverse effects are generally mild or moderate and transient.

Some adverse effects occurring rarely or very rarely may be serious:

Rarely, Terbinafine tablets may cause liver problems, and in very rare cases these problems may be severe. Very rare adverse reactions include a decrease in certain blood cells, lupus (an autoimmune disease), or serious 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, your urine becomes unusually dark, or you have pale stools.
• If you experience 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: Nausea, mild abdominal pain, gastric discomfort, diarrhoea, feeling of fullness in the stomach, loss of appetite, skin rash, joint or muscle pain.

Common: Headache.

Uncommon: Taste disturbance or loss of taste, which usually resolves 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: Hair loss, severe weakness, psoriasis-like skin eruptions, worsening of skin conditions.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Terbinafine Kern Pharma

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

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

Medicines should 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 unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terbinafine Kern Pharma

The active substance is terbinafine hydrochloride. Each tablet contains 250 mg of terbinafine.

The other components (excipients) are: microcrystalline cellulose, hydroxypropylcellulose, anhydrous colloidal silica, sodium carboxymethylstarch (from potato, gluten-free), talc and magnesium stearate.

Appearance of the product and contents of the pack

Terbinafine Kern Pharma tablets are white, round and scored. They are available in packs of 14 and 28 tablets.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: December 2006

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/