Package Insert: Information for the User

Terbinafine Kern Pharma 250 mg Tablets EFG

Terbinafine

Read this package insert carefully before starting to take the medication.

• Keep this package insert as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

This medication 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)

Please read the following information before taking this medication.

Do not take this medication:

• If you are allergic (hypersensitive) to terbinafine or to any of the other components 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 this medication

• If you have kidney or liver problems, consult your doctor before taking this medication.
• If you have psoriasis, in very rare cases, the condition 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, if your skin or the white part of your eyes turns yellow, if you notice darkening of your 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.

Other medications and Terbinafina Kern Pharma

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 Terbinafina 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. cimetidine)
• some medications used to prevent organ rejection in transplant patients (e.g. ciclosporin).

Use in elderly patients

This medication can be administered to patients over 65 years of age. If you have pre-existing kidney problems, you may be prescribed a lower dose than usual. Terbinafina tablets are not recommended for patients with or who have had liver problems in the past.

Use in children

The experience with Terbinafina tablets in children is limited, therefore, it is not recommended for use in this type of patient.

Pregnancy and breastfeeding

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

Pregnancy

This medication should not be administered during pregnancy.

Breastfeeding

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

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

Driving and operating machinery

Terbinafina tablets do not affect the ability to drive and operate machinery.

Terbinafina Kern Pharma contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor, even if they differ from those contained in this leaflet. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

This medication is oral tablets. The tablets should be swallowed with the help of a little liquid (a glass of water). The tablet can be divided into equal doses.

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

It is possible that the complete resolution of symptoms of the infection will 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 Kern Pharma than you should

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

The main symptoms of acute intoxication 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 Kern Pharma

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.

The observed side effects are classified according to their frequency of occurrence: Very common (equal to or more than 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 1,000 patients); Rare (less than 1 in 1,000 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 rare or very rare side effects may be severe:

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 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.

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 it that generally recovers a few weeks after treatment interruption. This may lead, in very few patients, to a significant decrease in appetite and weight loss. Inform your doctor if the alteration of taste lasts for several days.

Very rare: Hair loss, intense weakness, skin eruptions of the type psoriasis, worsening

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not appearing in this leaflet. 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 out of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Terbinafina Kern Pharma

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

The other components (excipients) are: microcrystalline cellulose, hydroxypropyl cellulose, anhydrous colloidal silica, sodium carboxymethyl starch (potato starch without gluten), talc, and magnesium stearate.

Appearance of the product and contents of the packaging

Terbinafina Kern Pharma are tablets. The tablets are white, round, and scored. They are presented in packs of 14 and 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:December 2006

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/