Terbinafine 250mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER TERBINAFINE 250mg TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Terbinafine tablets are and what they are used for
2. What you need to know before you take Terbinafine tablets
3. How to take Terbinafine tablets
4. Possible side effects
5. How to store Terbinafine tablets
6. Contents of the Pack and other information
1. What Terbinafine tablets are and what they are used for
Terbinafine tablets belong to a group of medicines called antifungals. Terbinafine is used to treat fungal infections of the skin and nails.
2. What you need to know before you take Terbinafine tablets
Do not take Terbinafine tablets if you
• are allergic (hypersensitive) to Terbinafine or any of the other ingredients of Terbinafine tablets (see list of ingredients in section 6).
• An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• have a severe kidney problem
• have a severe liver problem
Take special care with Terbinafine tablets (and speak to your doctor) if you
• have liver problems or a disease which may affect your liver
• have kidney problems
• have psoriasis (skin disease with raised red patches of skin covered with silvery scales)
• develop severe reduction in the number of white blood cells which make infections more likely (agranulocytosis) or serious illness with blistering of the skin (toxic epidermal necrolysis).
• You should stop taking Terbinafine tablets and see your doctor immediately if you experience these side effects which are known to occur very rarely (affecting fewer than 1 in 10,000 patients) (see section 4).
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking
• the antibiotic rifampicin for tuberculosis (decreases the level of terbinafine in your blood)
• cimetidine for indigestion or stomach ulcers (increases the level of terbinafine in your blood)
• medicines used to treat depression including tricyclic and SSRIs antidepressants like clomipramine, nortriptyline, desipramine, fluoxetine, and paroxetine
• medicines used to treat high blood pressure or heart problems such as beta blockers e.g. atenolol
• medicines used to treat a fast or irregular heart beat such as antiarrhythmics e.g. flecainide, propafenone
• medicines used to treat Parkinson's disease such as monoamine oxidase inhibitors e.g. selegiline
• oral contraceptives (the pill) as irregular periods or breakthrough bleeding may occur in female patients
• ciclosporin (medicine used to prevent rejection of organs or tissues following a transplant or to treat certain skin conditions like psoriasis and eczema or to treat rheumatoid arthritis)
• tolbutamide for diabetes
• triazolam for relieving anxiety and/or trouble sleeping
• terfenadine for hay fever or other allergies
It may still be all right for you to be given Terbinafine tablets and your doctor will be able to decide what is suitable for you.
Taking Terbinafine tablets with food and drink
Food/meals have no influence on the effectiveness of Terbinafine. Terbinafine may be taken with or without food.
Pregnancy and breast-feeding
You should not take Terbinafine tablets if you are pregnant unless your doctor tells you to. If you become pregnant whilst taking this medicine, you should tell your doctor as soon as possible.
You should not take Terbinafine tablets if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Terbinafine tablets can rarely cause dizziness. If affected, you should not drive or operate machinery.
3. How to take Terbinafine tablets
Dosage
Always take Terbinafine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults and the elderly: The usual dose is 250 mg (one tablet) once daily.
The length of treatment depends on the infection. For general skin infections, your treatment will probably last for 4 weeks.
Treatment for skin infections affecting the genital area will normally last between 2 to 4 weeks and those involving the feet may last between 2 to 6 weeks.
For nail infections, your treatment may last between 6 weeks and 3 months, although treatment for toenail infections may continue for 6 months or longer.
Patients with a liver or kidney disorder: a reduced dose may be required.
Method of Administration
The tablet should be swallowed whole with water. They may be taken with or without food.
If you take more Terbinafine tablets than you should
Contact your doctor, pharmacist or nearest hospital immediately. The symptoms of overdose are headache, feeling sick (nausea), epigastric (tummy) pain and dizziness.
If you forget to take Terbinafine tablets
If you miss a dose, take it as soon as possible. However, if it is nearly time for your next dose, skip the missed dose and carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Terbinafine tablets
Do not stop taking terbinafine without consultation with your doctor, even if the infection heals.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Terbinafine tablets can cause side effects, although not everybody gets them.
The following side effects are important and will require immediate action if you experience them. You should stop taking Terbinafine and see your doctor immediately if the following symptoms occur:
Rare side effects, affecting fewer than 1 in 1000 patients:
• serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reactions)
Very rare side effects, affecting fewer than 1 in 10,000 patients:
• serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson's syndrome)
• serious illness with blistering of the skin (toxic epidermal necrolysis)
• serious allergic reaction which causes swelling of the face or throat (angioneurotic oedema)
The following side-effects have also been reported:
Very common side effects, affecting more than or equal to 1 in 10 patients:
• skin rash • lumpy rash (hives)
• joint pain (arthralgia) • muscle pain (myalgia)
Common side effects, affecting up to 1 in 10 patients:
• loss of appetite (anorexia)
• bloating
• diarrhoea
• feeling sick (nausea)
headache
abdominal (tummy) pain indigestion (dyspepsia)
blood tests which show changes in the way the liver is working
Uncommon side effects, affecting fewer than 1 in 100 patients:
• loss of taste (ageusia) • disturbances in taste (dysgeusia)
Rare side effects, affecting fewer than 1 in 1000 patients:
• allergic reactions
• dizziness
• reduced sense of touch or sensation (hypoaesthesia)
• tingling or numbness (paraesthesia)
• changes in liver function including cholestasis (reduced flow of bile down the bile ducts in the liver)
• liver failure
• tiredness (fatigue)
• general feeling of being unwell (malaise)
Very rare side effects, affecting fewer than 1 in 10,000 patients:
• severe reduction in the number of white blood cells which make infections more likely (agranulocytosis)
• reductions in the number of white blood cells called neutrophils, which make infections more likely (neutropenia)
• reduction in blood platelets (cells that help blood to clot), which increases risk of bleeding or bruising (thrombocytopenia)
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia)
• cause or worsening of existing skin or systemic lupus erythematosis (large areas of red skin patches, painful joints and fever)
• anxiety
• severe rash that may include peeling of skin (erythema multiforme)
• depression
• a feeling of dizziness or “spinning” (vertigo)
• weight loss
• sensitivity to light
• worsening of existing psoriasis (skin disease with raised red patches of skin covered with silvery scales)
• hair loss
• irregular periods
• unexpected vaginal bleeding
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Terbinafine tablets
Keep out of the sight and reach of children.
This medicinal product does not require special temperature storage conditions. Keep blister in the outer carton.
Do not take this medicine after the expiry date, which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
If you notice any visible signs of deterioration in the tablets, such as chipped, broken or discoloured tablets, take them to your pharmacist for advice before taking them.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the Pack and other information
What Terbinafine tablets contain:
The active substance is terbinafine.
Each tablet contains 250 mg of terbinafine (as 281.29mg terbinafine hydrochloride).
The other ingredients are: cellulose microcrystalline (E460), sodium starch glycolate, hypromellose (E464), silica, colloidal anhydrous, magnesium stearate (E572), ferric oxide E172 (Iron oxide red).
What Terbinafine tablets look like and contents of the pack
Terbinafine tablets are light pink with a mottled surface that is round and biconvex with “250” written on one side and break line on the other side. Blister packs of 14 or 28 or 42 or 56 tablets in cartons.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DAWA Limited.
5 Sandridge Close,
Harrow, Middlesex HA1 1XD,
United Kingdom.
Manufacturer
Orchid Europe Limited Building 3, Chiswick Park,
566 Chiswick High Road,
London W4 5YA, United Kingdom
This leaflet was last revised in 12/2012
(Ref: 0225-2) (210x325mm)