Terbinafine 250mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Terbinafine 250 mg tablets ratiopharm
terfinafine hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
• 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 250 mg tablets is and what it is used for
2. Before you take Terbinafine 250 mg tablets
3. How to take Terbinafine 250 mg tablets
4. Possible side effects
5. How to storeTerbinafine 250 mg tablets
6. Further information
1. WHAT TERBINAFINE 250 MG TABLETS IS AND WHAT IT IS USED FOR
Terbinafine 250 mg tablets is a broad
spectrum antifungal that has a fungicidal
effect.
Terbinafine 250 mg tablets is used for
the treatment of fungal infections
• of the skin such as athlete's foot (caused by Tinea pedis), groin rash (caused by Tinea cruris) ringworm (caused by Tinea corporis)
• of the nails
2. BEFORE YOU TAKE TERBINAFINE 250 MG TABLETS
Do not take Terbinafine 250 mg tablets if
• you are allergic (hypersensitive) to terbinafine or any of the other ingredients of Terbinafine 250 mg tablets (see section 6. "Further Information").
• you have a severe liver problem
• you have a severe kidney problem
Take special care with Terbinafine 250 mg tablets if
• you develop high temperature (fever) or sore throat
• you have psoriasis (chronic skin disease)
• you have reduced kidney function (see section 3. "How to take Terbinafine 250 mg tablets")
Children
There is no experience with oral terbinafine in children and its use cannot therefore be recommended.
Liver
You should contact your doctor in case of liver problems. One or more of the following symptoms may occur such as inexplicably persistent nausea, loss of appetite, tiredness, vomiting, stomach pain in the upper right side, or jaundice, dark urine, loose stools or itching (due to bile products that are deposited in the skin).
Using 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.
Preparations that can cause increased or reduced effects of Terbinafine 250 mg tablets:
• rifampicin (an antibiotic)
• cimetidine (a medicine for stomach ulcers)
• medicine against depression (called tricyclic antidepressants, selective serotonin re-uptake inbibitors [SSRI] and monoamine oxidase inhibitors [MAO inhibitor])
• medicine for treating high blood pressure (beta blockers)
• oral contraceptives ("the pill"), irregular periods or breakthrough bleeding can occur
Other medicines may affect the effect of Terbinafine 250 mg tablets, and/or Terbinafine 250 mg tablets may affect the effect of other medicines. This is normally without practical significance.
If you want further information about this please ask your doctor or pharmacist.
Taking Terbinafine 250 mg tablets with food and drink
You may take Terbinafine 250 mg tablets with food and drink.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should not take Terbinafine 250 mg tablets if you are pregnant unless it is strictly necessary and only after consulting your doctor.
You must not takeTerbinafine 250 mg tablets if you are breast feeding, as Terbinafine 250 mg tablets is secreted in breast milk.
Driving and using machines
Terbinafine 250 mg tablets does not affect the ability to work safely or the ability to drive safely in traffic.
3. HOW TO TAKE TERBINAFINE 250 MG TABLETS
Always take Terbinafine 250 mg tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
The normal dose is 1 tablet Terbinafine 250 mg tablets (= 250 mg terbinafine) once a day.
Reduced kidney function
If you suffer from kidney problem, your doctor will probably prescribe half of the recommended dose.
The length of treatment depends on the location of the infection.
Recommended lengths of treatment:
Skin infections
Hair, scalp and skin infections (Tinea cruris,
Tinea corporis): 2-4 weeks
Athlete's foot
(Tinea pedis): 2-4 weeks
Athlete's foot (Tinea pedis interdigital,
plantar/moccasin type): up to 6 weeks
Nail infections
Fungal infection in
the fingernails: 6 weeks
Fungal infection in
the toenails: 6-12 weeks (if it
is require: up to 6 month)
If you have the impression that the effect of Terbinafine 250 mg tablets is too strong or too weak, talk to your doctor or pharmacist.
If you take more Terbinafine 250 mg tablets than you should
Contact the doctor, emergency department or pharmacy if you have taken more Terbinafine 250 mg tablets than is stated in this information, or more than the doctor has prescribed.
Symptoms of overdose may be headache, nausea, stomach pain and dizziness.
If you forget to take Terbinafine 250 mg tablets
Do not take a double dose to make up for forgotten individual doses. Continue taking your tablets as you normally would.
If you stop taking Terbinafine 250 mg tablets
You should stop treatment only in consultation with the doctor.
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 250 mg tablets can cause side effects, although not everybody gets them.
If you have any of the following side effects you must stop taking the preparation and contact your doctor immediately.
Serious side effects:
Rare (affects 1 to 10 users in 10.000):
• reduced liver function and in very rare cases liver failure with symptoms such as itching, inexplicably persistent nausea, loss of appetite, tiredness, vomiting, stomach pain in the upper right side, or jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems), dark urine or loose stools,
• allergic reactions (anaphylactic reaction),
• angioedema (swelling of the lips, face, throat or tongue)
Very rare (affects less than 1 user in 10.000):
• lupus erythematosus (a rheumatic disease with skin rash, kidney problems and changes in white blood cells),
• changes in blood values,
• severe skin reactions such as Stevens-Johnson syndrome (a serious illness with blistering of the skin, mouth, eyes and genitals),
• toxic epidermal necrolysis (a serious illness with blistering of the skin).
Non-serious side effects:
Common (affects 1 to 10 users in 100):
• Gastrointestinal problems such as indigestion, flatulence, lack of appetite, nausea, mild stomach pain and diarrhoea, rash, urticaria (reddening of the skin with itching),
• muscle and joint pain,
• headache,
• tiredness and a general feeling of being unwell.
Uncommon (affects 1 to 10 users in 1.000):
• taste disorders, including temporary loss of the sense of taste
Rare (affects 1 to 10 users in 10.000):
• dizziness,
• numbness and tingling ("pins and needles"),
• decreased touch-sensitiveness, cholestase (stoppage or suppression of bile flow),
• liver problems including hepatitis (liver inflammation) and increased liver enzymes,
• serum sickness like reaction
Very rare (affects less than 1 user in 10.000):
• hair loss,
• anxiety,
• depression,
• sensitivity to light, irregular and/or breakthrough bleeding,
• worsening of existing psoriasis,
• certain blood disorders including neutropenia, thrombocytopenia and agranylocytosis (these are reductions in the number of different types of blood cells).
Not known (frequency cannot be estimated from the available data):
• skin reaktion (Erythema multiforme)
Please tell you doctor or pharmacist if you have side effects that persist and are troublesome.
Some side effects may need treatment.
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 250 MG TABLETS
Keep out of the reach and sight of children.
Do not use Terbinafine 250 mg tablets after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Keep the blister in the outer carton.
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. FURTHER INFORMATION
What Terbinafine 250 mg tablets contains
The active substance is terfinafine hydrochloride.
Each tablet contains 250 mg terbinafine (as hydrochloride).
The other ingredients are Cellulose microcrystalline, Hypromellose,
Sodium starch glycolate, Silica colloidal anhydrous, Magnesium stearate.
What Terbinafine 250 mg tablets looks like and contents of the pack
Each tablet is a white, round tablet and a breakline on one side.
Your tablets are available in blister packs of 8, 14, 28, 30, 42, 56 and 98.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany.
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Terbinafine 250 mg tablets
Germany: Terbinafin-CT 250 mg
Tabletten
This leaflet was last approved in September 2009.
ratiopharm