TERBINAFINE ALTER 250 mg TABLETS

2. What you need to know before taking Terbinafine Alter

Do not take Terbinafine Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Terbinafine Alter

• if you have kidney or liver problems, consult your doctor before taking this medication.
• if you have psoriasis (a skin disease), as in very rare cases, the disease may worsen.

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, or if 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 in children is limited; therefore, its use is not recommended in these patients.

Elderly patients

Terbinafine Alter can be administered to patients over 65 years of age.

Patients with kidney problems

In case of pre-existing kidney problems, a lower dose than usual may be prescribed.

Patients with liver problems

Terbinafine Alter is not recommended for patients with current or past liver problems.

Other medications and Terbinafine Alter

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medications, including those purchased without a prescription.

There are other medications that may alter the effect of Terbinafine Alter, 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.

Pregnancy

Terbinafine Alter should not be administered during pregnancy. Therefore, before taking this medication, inform your doctor if you are pregnant or become pregnant during treatment.

Breastfeeding

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

Driving and using machines

Terbinafine Alter does not affect the ability to drive or use machines.

Terbinafine Alter contains sodium

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

3. How to take Terbinafine Alter

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

Dosage:

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

Treatment duration:

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 infection symptoms may not occur until several weeks (skin and scalp) or months (nails) after the disappearance of the fungus causing the infection.

Method of administration:

Terbinafine Alter is administered orally in tablet form. Swallow the tablets whole, without chewing, with a glass of water.

If you take more Terbinafine Alter than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

The main symptoms of acute poisoning 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 Alter

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 cause 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 Alter 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, 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):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 several days.

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

Reporting side effects

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

5. Storage of Terbinafine Alter

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Terbinafine Alter

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

Appearance of the product and package contents

Terbinafine Alter 250 mg is presented in tablet form. The tablets are scored, oblong, and white. They are available in packs of 14 or 28 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Liconsa, S.A.

Avda. Miralcampo, 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Madrid

Spain

Date of the last revision of this package leaflet:April 2006