Prospect: Information for the Patient

Terbinafine pensa 250 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isTerbinafine pensaand for what it is used

2. What you need to know before starting to takeTerbinafine pensa

3. How to takeTerbinafine pensa

4. Possible adverse effects

5. Storage ofTerbinafine pensa

6. Contents of the package and additional information

Terbinafina belongs to a group of medications known as antifungals and acts by preventing the development of fungi.

Terbinafina pensa is used for the treatment of the following fungal skin, scalp, and nail infections:

Tinea corporis(body ringworm).

Tinea cruris(inguinal ringworm or jock itch).

Tinea pedis(athlete's foot or foot ringworm).

Tinea capitis(scalp ringworm).

Onychomycosis (nail ringworm).

Read the following information before taking Terbinafine pensa

Do not take Terbinafine pensa

• if you are allergic to terbinafine or any of the other components 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, 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, in case your skin or the white part of your eyes turns yellow, you observe 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

The experience with Terbinafine pensa 250 mg tablets in children is limited, therefore, it is not recommended for use in this type of patient

Older patients

Terbinafine pensa 250 mg tablets can be administered to patients over 65 years of age. If there is a pre-existing renal problem, you may be prescribed a lower than usual dose.Terbinafine pensa 250 mg is not recommended for patients with or who have had liver problems in the past.

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 those obtained without a prescription.

There are other medications that may modify the effect of Terbinafine pensa 250 mg tablets, for example:

• 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. cimetidina).
• some medications used to prevent organ rejection in transplant patients (e.g. ciclosporina).

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Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 a medication during pregnancy.

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

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

Driving and operating machinery

Terbinafine pensa 250 mg tablets have no effect on the ability to drive and operate machinery.

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”

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

Remember to take your medication

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

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

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

Treatment duration

The treatment duration will be established by your doctor. Do not discontinue treatment beforehand, as this may worsen your condition.

It is possible that the complete resolution of symptoms of the infection 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 Terbinafina pensa 250 mg tablets than you should

Consult your doctor, pharmacist, or callthe Toxicological Information Service telephone 91 562 04 20indicating the medication and the amount used.

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

If you forgot to take Terbinafina pensa 250 mg tablets

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

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effectsare generally mild or moderate, and temporary.

Some side effects that appear rarely or very rarely, may be serious:

Rarely, Terbinafine 250 mg tablets may cause problems in the liver 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 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 white of your eyes turns yellow, that your urine is unusually dark or that 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 problem.

Otherside 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, pain in the joints or muscles.

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 it that usually recovers a few weeks after treatment interruption.This may 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 of the type psoriasis, worsening of psoriasis.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Store in the original packaging to protect from light.

Do not store this medication in a warm place.

Do not usethis medicationafter the expiration date CADthat appears on the blister and box. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Terbinafina pensa 250 mg tablets

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

Appearance of the product and content of the packaging

Terbinafina pensa 250 mg tablets are oblong, white, scored tablets. They are presented in packs of 14 and 28 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Liconsa, S.A

Avda.Miralcampo, nº 7.

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this prospectus:March 2008

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/