TERBINAFINE PENSA 250 mg TABLETS

2. What you need to know before taking Terbinafine Pensa

Read the following information before taking Terbinafine Pensa

Do not take Terbinafine Pensa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Terbinafine Pensa

• If you have kidney or liver problems, consult your doctor before taking this medication.
• If you have psoriasis, in very rare cases, a worsening of the disease has occurred.

It is essential that you immediately inform your doctor if you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, or unusual fatigue or weakness, in case your skin or the whites of your eyes turn yellow, you notice dark urine or 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.

Children

Experience with Terbinafine Pensa 250 mg tablets in children is limited; therefore, its use is not recommended in this type of patient.

Elderly patients

Terbinafine Pensa 250 mg tablets can be administered to patients over 65 years of age. If there is pre-existing kidney damage, a lower dose than usual may be prescribed. Terbinafine Pensa 250 mg is not recommended in patients with current or past liver problems.

Other medications and Terbinafine Pensa

Please inform your doctor or pharmacist if you are using or have recently used other medications, including oral contraceptives, herbal remedies, and over-the-counter medications.

There are other medications that may alter the effect of Terbinafine Pensa 250 mg tablets, such as:

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

.

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 medication.

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

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

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

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

Driving and using machines

Terbinafine Pensa 250 mg tablets have no effect on the ability to drive or use machines.

Terbinafine Pensa 250 mg tablets contain sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

3. How to take Terbinafine Pensa

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication

Take Terbinafine Pensa 250 mg tablets as your doctor has indicated. He will determine the dose you need.

The recommended dosein adults is one tablet (250 mg) once a day.

Terbinafine Pensa 250 mg tablets are 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 treatment before, as it may worsen your condition.

It is possible that the 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 Pensa 250 mg tablets than you should

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

The main symptoms of acute overdose may be gastrointestinal, such as 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 Pensa 250 mg tablets

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 medications, this medication can have side effects, although not everyone will experience them.

Side effects are generally mild or moderate and temporary.

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

Rarely, Terbinafine Pensa 250 mg 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 is 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(may affect more than 1 in 10 people): Nausea, mild abdominal pain, stomach 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): Alteration of taste or loss of taste, which usually recovers a few weeks after treatment is discontinued. This can lead, in very few patients, to a decrease in appetite and significant weight loss. Inform your doctor if the alteration of taste lasts for several days.

Rare(may affect up to 1 in 10,000 people): Hair loss, intense weakness, skin eruptions like psoriasis, worsening of psoriasis.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Terbinafine Pensa

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

Store in the original package to protect from light.

Do not store this medication in a warm place.

Do not use this medication after the expiration date (CAD) shown on the blister pack and carton. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Terbinafine Pensa 250 mg tablets

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

Appearance of the product and contents of the pack

Terbinafine Pensa 250 mg tablets are white, oblong, and 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

Laboratorios Liconsa, S.A.

Avda. Miralcampo, nº 7.

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last revision of this package leaflet:March 2008

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