TERBINAFINE KERN PHARMA 250 mg TABLETS

2. What you need to know before you take Terbinafine Kern Pharma

Read the following information before taking this medicine.

Do not take this medicine:

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• If you have kidney or liver problems, consult your doctor before taking this medicine.
• If you have psoriasis, in very rare cases, the disease may worsen.

It is essential to inform your doctor immediately if you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, or unusual fatigue or weakness, or if your skin or the whites of your eyes turn yellow, your urine becomes unusually dark, or you have pale stools.

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

Other medicines and Terbinafine Kern Pharma

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

There are other medicines that may affect the action of Terbinafine tablets, such as:

• 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., cyclosporine).

Use in elderly patients

This medicine can be administered to patients over 65 years of age. If there is pre-existing kidney problems, a lower dose may be prescribed. Terbinafine tablets are not recommended in patients with a history of liver problems.

Use in children

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

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 taken 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 do not affect the ability to drive or use machines.

Terbinafine Kern Pharma contains sodium

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

3. How to take Terbinafine Kern Pharma

Follow the instructions for administration of this medicine exactly as indicated 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 in adults is one tablet (250 mg) once daily.

This medicine is film-coated tablets for oral administration. The tablets should be swallowed with a little liquid (a glass of water). The tablet can be divided into equal doses.

The duration of treatment will be determined by your doctor. Do not stop treatment before, as it may worsen your condition.

It is possible that complete resolution of the infection symptoms may not occur until several weeks (skin and scalp) or months (nails) after the disappearance of the fungus causing the infection.

If you take more Terbinafine Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

The main symptoms of acute poisoning can be gastrointestinal, e.g., nausea, abdominal pain, or vomiting, but may also include headache or a feeling of instability (dizziness). If you experience any of these effects or any other unusual effect, consult your doctor.

If you forget to take Terbinafine Kern Pharma

Take another as soon as you remember, unless it is less than 6 hours before the next dose.

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

4. Possible side effects

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

Side effects are classified according to their frequency of occurrence: Very common (at least 1 in 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 1000 patients); Rare (less than 1 in 1000 but more than 1 in 10,000 patients); Very rare (less than 1 in 10,000 patients).

Side effects are generally mild or moderate and transient.

Some side effects that appear rarely or very rarely can be serious:

Rarely, Terbinafine tablets can 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 fatigue 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 a sore throat accompanied by fever and chills.
• If you experience unusual bleeding or bruising.
• If you develop any severe skin problems.

Other side effects:

Very common: Nausea, mild abdominal pain, gastric discomfort, diarrhea, feeling of fullness in the stomach, loss of appetite, skin rash, joint or muscle pain.

Common: Headache.

Uncommon: Alteration of taste or loss of taste, which usually recovers a few weeks after treatment discontinuation. This can lead, in very few patients, to a decrease in appetite and significant weight loss. Inform your doctor if the taste alteration lasts for several days.

Very rare: Hair loss, intense weakness, skin rash like psoriasis, worsening.

If you think any of the side effects are serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

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

5. Storage of Terbinafine Kern Pharma

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients (excipients) are: microcrystalline cellulose, hydroxypropylcellulose, colloidal anhydrous silica, sodium starch glycolate (from gluten-free potato), talc, and magnesium stearate.

Appearance of the product and pack contents

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

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet:December 2006

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