Terbinafine 250mg Tablets
PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER
Terbinafine 250mg Tablets
Terbinafine
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 effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Terbinafine is and what it is used for
2. Before you take Terbinafine
3. How to take Terbinafine
4. Possible side effects
5. How to store Terbinafine
6. Further information
1. What Terbinafine is and what it is used for
Terbinafine 250mg Tablets (hereinafter referred to as Terbinafine) belong to a family of medicines called antifungals. They are used in the treatment of a variety of fungal infections of the skin and nails. Terbinafine attacks and kills the fungus which is causing your infection.
2. Before you take Terbinafine
Do not take Terbinafine:
■ if you are allergic (hypersensitive) to terbinafine or any of the other ingredients of Terbinafine Tablets (see section 6 for other ingredients).
■ if your nail changes are a result of a primary bacterial infection.
Take special care and tell your doctor if you have or have had:
■ any liver problems or have had any diseases which may affect your liver
■ psoriasis or other skin disorder
■ any kidney problems
■ autoimmune disorders
■ fever or any bacterial infection.
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.
You must tell your doctor or pharmacist if you are already taking any of the following medicines: rifampicin for infections
■ cimetidine for gastric problems such as indigestion or ulcer
■ antidepressants including tricyclic antidepressants, SSRIs (selective serotonin reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors)
■ oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients)
■ beta-blockers or anti-arrhythmics (including digoxin) for heart problems
■ medicines to treat fungal infections e.g. fluconazole, ketoconazole and
■ medicines to treat coughs e.g. dextromethorphan
■ warfarin, a medicine used to thin your blood
■ medicines to treat heart problems (eg propafenone)
■ ciclosporin, a medicine used to control your body's immune system in order to prevent rejection of transplanted organs
■ caffeine.
Taking Terbinafine with food and drink
Swallow your tablets whole with a glass of water. Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you may be pregnant or are breast-feeding your baby, you should not take Terbinafine. Driving and operating machinery If you feel dizzy while taking Terbinafine you should not drive or operate machinery.
3. How to take Terbinafine
Always take Terbinafine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is one tablet (250mg) a day taken whole with a glass of water.
For skin infections Terbinafine 250mg Tablets are usually taken for 2 to 6 weeks. For nail infections treatment usually lasts between 6 weeks and 3 months although some patients with toenail infections may need to be treated for 6 months or longer.
Terbinafine 250mg Tablets are not recommended for children.
If you take more Terbinafine than you should
Tell your doctor or pharmacist and go to your nearest casualty department immediately.
If you forget to take Terbinafine If you forget to take a tablet, take one as soon as you remember. Do not take a double dose to make up for a forgotten dose.
(continued overleaf)
4. Possible side effects
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to collect more information on the safety of this medicine by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.
Like all medicines, Terbinafine can cause side effects, although not everybody gets them.
Stop taking Terbinafine and contact your doctor immediately if you notice any of the following serious but rare side effects:
■ severe skin reactions (these may include rashes with redness, swelling, blistering, peeling or increased sensitivity to sunlight, they may also make you feel generally unwell and cause a fever)
■ severe allergic reactions (these may cause difficulty breathing, dizziness, swelling of the face and/or throat, flushing, rash, fever, swollen lymph nodes or pain in the muscles and joints)
■ weakness, unusual bleeding, bruising, tiredness, breathlessness on exertion, or frequent infections (this may be a sign of blood disorders)
■ inflammation of blood vessels which may cause purple spots to develop under the skin
■ severe abdominal pain which spreads to the back with fever, nausea and vomiting (possible signs of pancreatitis)
■ unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown)
If you notice any of the following side effects speak to your doctor or pharmacist:
Common side effects (likely to affect up to 1 in 10 people)
■ headache
■ poor appetite or a slight sick feeling, indigestion
■ mild abdominal pain, fullness, diarrhoea
■ itching
■ skin rash (which may itch and be red, smooth or raised)
Uncommon side effects (likely to affect up to 1 in 100 people)
■ Taste loss and taste disturbance. This usually resolves on discontinuation of the medication.
Rare side effects (likely to affect up to 1 in 1000 people)
■ feeling unwell
■ numbness or tingling
■ hair loss
Very rare side effects (likely to affect up to 1 in 10,000 people)
■ depression and anxiety
■ onset or worsening of systemic lupus erythematosus (auto-immune condition where body attacks itself by mistake ) affecting the skin and/or other body organs
■ dizziness Frequency not known:
■ psoriasis-like skin eruptions or worsening of any psoriasis
■ lost or reduced sense of smell which may be permanent
■ flu-like symptoms
■ tiredness
■ impaired hearing, hissing and/or ringing in the ears
■ increased blood levels of an enzyme called creatine phosphokinase (found in a blood test)
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
Keep your tablets out of the reach and sight of children.
Do not use the tablets after the expiry date on the product packaging.
The product does not require any special storage conditions within Europe.
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 contains
The tablets contain the active ingredient terbinafine hydrochloride equivalent to 250mg terbinafine.
The tablets also contain the following inactive ingredients: magnesium stearate, colloidal anhydrous silica, hypromellose, microcrystalline cellulose and sodium starch glycolate.
What Terbinafine looks like and contents of the pack
Terbinafine Tablets are white, round tablets with the letter T and breakline on opposite face.
Terbinafine Tablets are available in packs containing 14 and 28 tablets.
Marketing Authorisation Holder
Manx Pharma Ltd., Taylor Group House, Wedgnock Lane Warwick, CV34 5YA, United Kingdom.
Manufacturer
Manx Healthcare Ltd., Taylor Group House Wedgnock Lane, Warwick, CV34 5YA, United Kingdom. Other formats
To request a copy of this leaflet in Braille, large MANX print or audio please call 01926 482511.
This leaflet was last revised in August 2012 wip urn: 080812,gt01-pil-I17