Terbinafine 250mg Tablets
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Patient Information Leaflet
Terbinafine 250 mg Tablets
(terbinafine 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 further questions, please ask your doctor or your 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 are and what they are 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 Store Terbinafine 250 mg Tablets
6. Further Information
Terbinafine 250 mg Tablets act by attacking and killing fungus which causes infection. Your doctor has prescribed the medicine for you to treat fungal infections of the skin and nails or for the treatment of ringworm.
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
• You suffer from severe liver problems
• You suffer from severe kidney problems
Take special care with Terbinafine 250 mg Tablets Please tell your doctor or pharmacist if:
• You have psoriasis
• You have liver problems or you have had a history of liver disease
• You have kidney problems
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines can interfere with terbinafine so consult your doctor or pharmacist before taking any other medication. In particular, tell your doctor if you are taking any of the following medicines
- Rifampicin (an antibiotic)
- Cimetidine (for treating excess stomach acid)
- Oral contraceptives
- Antidepressants
- Beta blockers
Taking Terbinafine 250 mg Tablets with food and drink
Terbinafine 250 mg Tablets should be swallowed whole with a glass of water, with or without food.
Pregnancy and breast-feeding
Ask you doctor or pharmacist for advice before taking any medicine. The use of Terbinafine 250 mg Tablets during pregnancy is not recommended.
Terbinafine 250 mg Tablets should not be used whilst breast-feeding as it passes into the breast milk.
Driving and using machines
Terbinafine 250 mg Tablets do not affect your ability to drive or operate machines.
Your doctor will decide what the right dose for you to take is and how long you will need to continue taking the medicine. If you suffer from kidney problems you may be given a different dose to that suggested below. Check the label and if you're not sure ask your doctor or pharmacist. You should take your tablet whole with a glass of water.
If you suffer from kidney problems you may be given a different dose to that suggested below.
For skin infections the usual dose is 250 mg per day for between 2 and 6 weeks depending on the site and severity of the infection. For nail infections the treatment may be for longer between 6 and 12 weeks. With toe nail infections the treatment may be up to 6 months.
Take the tablets for as long as directed by your doctor. It is important that you complete the course of treatment.
if you take more Terbinafine 250 mg Tablets than you should
Contact your doctor immediately or go to your nearest Accident and Emergency department. Take along this leaflet, the container, even if it is empty and any remaining tablets, so that the medical staff know exactly what you have taken. Symptoms of overdose may include headache, nausea, stomach pain and dizziness.
if you forget to take Terbinafine 250 mg Tablets
If you forget to take a tablet, take another as soon as you remember or wait until the next dose is due then continue as before. Do not take a double dose to make up for a forgotten dose.
Like all medicines, Terbinafine 250 mg Tablets can have side effects, although not everybody gets them.
if you notice any of the following serious side effects, stop taking Terbinafine 250 mg Tablets and contact a doctor immediately:
• Angioedema (serious allergic reactions which causes swelling of the face and throat).
• Severe skin reactions such as Steven-Johnson Syndrome (blistering of the skin, mouth, eyes and genitals), photosensitivity (increased sensitivity to sunlight), and toxic epidermal necrolysis (blistering and loss of skin).
• Abnormal liver function including jaundice (yellowing of the skin and eyes) and hepatitis (liver inflammation).
Common (affecting less than 1 person in 10)
Headache, poor appetite, feeling sick, indigestion, mild stomach pains or a feeling of fullness, diarrhoea, itchy skin rash or swelling.
Uncommon (affecting less than 1 person in 100)
Loss or decrease of the sense of taste. This usually resolves slowly once you have stopped taking the medicine.
Rare (affecting less than 1 person in 1000)
Paraesthesia (pins and needles sensation), hypoaesthesia (numbness), dizziness, malaise (vague illness) and fatigue (tiredness).
Arthralgia (joint pain) and myalgia (muscle pain) can occur in association with allergic skin reactions.
If you experience any of these side effects, stop taking your medicine and tell your doctor immediately.
Very rare (affecting less than 1 person in 10,000)
Exacerbation of psoriasis, loss of hearing, reduction in the number of different types of blood cells which may increase the risk of severe infection, bleeding and may cause shortness of breath and tiredness (agranulocytosis, neutropenia, thrombocytopenia).
Anxiety and depression.
Cutaneous or systemic lupus erythematosus (condition which causes a wide variety of symptoms such as joint pain, kidney problems, rash and fever).
If you start to feel tired and unwell, develop a high temperature or sore throat, or become prone to more infections, whilst taking Terbinafine, please contact your doctor immediately as this could be a sign that there is a change in your blood cells.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. sTORiNG TERBiNAFiNE 250 MG TABLETs
Keep out of the reach and sight of children.
Keep the blister in the outer carton.
Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.
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.
What Terbinafine 250 mg Tablets contain
The active substance is terbinafine. Each tablet contains 250 mg terbinafine as terbinafine hydrochloride. The other ingredients in the tablets are magnesium stearate, silica colloidal anhydrous, croscarmellose sodium, hypromellose and microcrystalline cellulose.
What Terbinafine 250 mg Tablets look like and the content of the pack
White, 11mm round, flat tablets, with score lines on both sides and embossed on one side of the tablet with'Tabove the score and“1” below the score.
Pack sizes:
Terbinafine 250 mg Tablets are supplied in blister packs of 14 or 28 tablets.
Marketing Authorisation Holder
Consilient Health Ltd., 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland.
Product Licence Number: PL 24837/0003
Manufacturer
McGregor Cory Limited, Middleton Close, Banbury, Oxon, OX16 4RS.
P0088
This leaflet was last revised in September 2010