Leaflet: information for the user

Terbinafine Combix 250 mg tablets EFG

Terbinafine hydrochloride

Read 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

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

2. What you need to know before starting to take Terbinafine Combix

3. How to take Terbinafine Combix

4. Possible side effects

5. Storage of Terbinafine Combix

6. Contents of the pack and additional information

Terbinafina Combix belongs to a group of medicines called antifungals. It is used to treat superficial fungal infections, of the skin and scalp (ringworm), and of the nails (onychomycosis).

Do not take Terbinafina Combix

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

Warnings and precautions

Be especially careful with Terbinafina Combix if

• you have liver problems or any disease that may affect your liver
• you have psoriasis (a skin disease with red, elevated patches on the skin covered with silver scales)
• you have kidney problems
• you are prone to severe infections (agranulocytosis) or severe skin diseases with blister formation (toxic epidermal necrolysis). Stop taking this medicine and consult your doctor immediately (see section 4).

Interaction of Terbinafina Combix with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medicine.

• Rifampicin (an antibiotic) (reduces the level of terbinafine in the blood)
• Cimetidine (a medicine for ulcers and stomach heartburn) increases the level of terbinafine in the blood
• Medicines used to treat depression such as clomipramine, lofepramine, or paroxetine
• Medicines used to treat high blood pressure or heart problems such as atenolol or carvedilol (beta-blockers)
• Medicines used to treat rapid or irregular heartbeat, such as antiarrhythmics, e.g., flecainide, propafenone
• Certain medicines used to treat Parkinson's disease such as monoamine oxidase inhibitors, e.g., selegiline
• Oral contraceptives (the pill). Irregular periods and abnormal menstrual bleeding may occur in women.

Terbinafina Combix with food, drinks, and alcohol

The intake of food and drinks has no influence on the treatment with terbinafine.

Pregnancy, breastfeeding, and fertility

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

Do not take Terbinafina Combix unless your doctor tells you to if you are pregnant, think you may be pregnant, or are breastfeeding. If you become pregnant while taking this medicine, inform your doctor as soon as possible.

Driving and operating machines

Terbinafina Combix should not affect your ability to drive or operate machines.

Follow exactly the administration instructions for Terbinafina Combix tablets as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults and elderly patients: The usual dose is 250mg (one tablet) once a day.

The duration of treatment depends on the infection and its severity.

For skin infections, the treatment duration is usually between 2 and 6 weeks.

For scalp infections, the treatment duration is usually approximately 4 weeks.

For nail infections, treatment usually lasts between 6 and 12 weeks, although some patients with foot nail infections may need treatment for up to 6 months.

Patients with liver or kidney disorders: A lower dose may be necessary.

The tablet should be swallowed whole with water. It can be taken with or without food.

Complete resolution of the signs and symptoms of the infection may not occur until several weeks after treatment interruption and infection cure.

If you take more Terbinafina Combix than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, the nearest hospital, or call the Toxicological Information Service at 91 562 04 20, indicating the medication and amount ingested. Symptoms of overdose include headache, dizziness (nausea), epigastric pain (stomach pain), and vertigo.

If you forget to take Terbinafina Combix

Do not take a double dose to compensate for the missed dose, take it as soon as you remember.

If you interrupt treatment with Terbinafina Combix

Do not discontinue treatment with terbinafina without consulting your doctor, even if the infection heals. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Terbinafina Combix may cause side effects, although not everyone will experience them.

You should stop taking Terbinafina Combix and consult your doctor immediately if you experience any of the following symptoms:

Rare side effects, which may affect up to 1 in 1,000 people:

• Severe allergic reaction that causes breathing difficulties or dizziness (anaphylactic reactions)

Very rare side effects, which may affect up to 1 in 10,000 people:

• Severe disease with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)
• Severe disease with blistering of the skin (toxic epidermal necrolysis)
• Severe allergic reaction that causes facial or throat inflammation (angioneuritic edema).

The following side effects have also been reported:

Very frequent side effects, which may affect more than 1 in 10 people:

• Cutaneous eczema
• Eczema with nodules (urticaria)
• Joint pain (arthralgia)
• Muscle pain (myalgia).

Frequent side effects, which may affect up to 1 in 10 people:

• Loss of appetite (anorexia)
• Headache
• Swelling
• Abdominal pain (abdominal pain)
• Diarrea
• Indigestion (dyspepsia)
• Sensation of dizziness (nausea)
• Blood tests showing changes in liver function.

Rare side effects, which may affect up to 1 in 100 people:

• Loss of taste (ageusia)
• Alterations in taste (dysgeusia).

Frequent side effects, which may affect up to 1 in 1,000 people:

• Allergic reactions
• Dizziness
• Reduction of tactile sense or sensations (hypoesthesia)
• Prickling or numbness (paresthesias)
• Changes in liver function, including cholestasis (reduction of bile flow through the bile ducts in the liver)
• Liver insufficiency
• Fatigue (fatigue)
• General feeling of discomfort (general malaise).

Very rare side effects, which may affect up to 1 in 10,000 people:

• Severe reduction in the number of white blood cells, making them more prone to infections (agranulocytosis)
• Severe reduction in the number of neutrophils, making them more prone to infections (neutropenia)
• Reduction in the number of platelets (cells that help blood clot), increasing the risk of bleeding or hematomas (thrombocytopenia)
• Onset or worsening of existing lupus erythematosus of the skin or systemic (large patches of red skin, joint pain, and fever)
• Anxiety

• Severe eczema that may include skin peeling (erythema multiforme)
• Depression
• Sensation of dizziness or feeling that everything is spinning (vertigo)
• Weight loss
• Sensitivity to light
• Worsening of existing psoriasis (skin disease with red, elevated patches covered in silver scales)

• Hair loss
• Irregular periods
• Unexpected vaginal bleeding
• Severe reduction in red blood cells, which may cause weakness, hematomas, or increased susceptibility to infections (pancytopenia).

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

Keep out of sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Terbinafina Combix

- The active ingredient is terbinafine. Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride)

- The other components (excipients) are: microcrystalline cellulose (E460i), sodium carboxymethyl starch (type A), anhydrous colloidal silica, hypromellose (E464) and magnesium stearate.

Appearance of the product and contents of the packaging

White to off-white, biconvex, round, scored on one face and smooth on the other tablets.

The tablet can be divided into equal doses.

Terbinafina Combix 250 mg tablets are available in PVDC/PVCAluminum blister packs containing 14 or 28 tablets.

Marketing Authorization Holder

Combix, S.L.U.

C/Badajoz, 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Last review of this leaflet was in February 2012

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