Terbinafine Alter 250 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terbinafine Alter 250 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the leaflet:

1. What Terbinafine Alter is and what it is used for
2. What you need to know before taking Terbinafine Alter
3. How to take Terbinafine Alter
4. Possible adverse effects
5. How to store Terbinafine Alter
6. Contents of the pack and other information

1. What Terbinafine Alter is and what it is used for

Terbinafine belongs to a group of medicines called antifungals and works by preventing the growth of fungi.

Terbinafine Alter is used to treat the following fungal infections of the skin, scalp, and nails:

Tinea corporis (ringworm of the body).

Tinea cruris (jock itch or groin ringworm).

Tinea pedis (athlete's foot).

Tinea capitis (scalp ringworm).

Onychomycosis (fungal infection of the nails).

2. What you need to know before starting Terbinafine Alter

Do not take Terbinafine Alter

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Terbinafine Alter

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

It is important that you inform your doctor immediately if you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, or unusual tiredness or weakness, if your skin or the whites of your eyes turn yellow, or if you notice darkening of the 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

If you have pre-existing kidney problems, you may be prescribed a lower than usual dose.

Patients with liver problems

Terbinafine Alter is not recommended in patients who currently have or have previously had liver problems.

Other medicines and Terbinafine Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

There are other medicines that may alter the effect of Terbinafine Alter, for example:

• 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. ciclosporin).

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and using machines

Terbinafine Alter has no effect on the ability to drive or use machines.

Terbinafine Alter contains sodium

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

3. How to take Terbinafine Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Dosage:

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

Duration of treatment:

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

Complete resolution of infection symptoms may not occur until several weeks (skin and scalp) or months (nails) after the causative fungus has disappeared.

Method of administration:

Terbinafine Alter tablets are for oral use. 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Terbinafine Alter

Take the missed dose as soon as you remember, unless there are less than 6 hours remaining until the next scheduled dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are generally mild or moderate and transient.

Some adverse effects that occur rarely or very rarely may be serious:

Rarely, Terbinafina Alter 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 tiredness 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 skin problems.

Other adverse effects:

Very common (may affect more than 1 in 10 people): nausea, mild abdominal pain, gastric discomfort, diarrhoea, 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): taste disturbance or loss of taste, which usually recovers within a few weeks after stopping treatment. This may lead, in very few patients, to decreased appetite and significant weight loss. Inform your doctor if taste disturbance lasts for several days.

Very rare (may affect up to 1 in 10,000 people): hair loss, severe weakness, psoriasis-like skin eruptions, worsening of psoriasis.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Terbinafine Alter

Keep this medicine 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 blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terbinafine Alter

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

Nature of the product and contents of the pack

Terbinafine Alter 250 mg is presented as tablets. The tablets are divisible, with a score line on both sides, oblong in shape and white in colour. 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)
Spain

Date of the most recent review of this leaflet: April 2006