Terbinafine 250mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Terbinafine 250 mg 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 side effect 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 is and what it is used for
2. Before you take Terbinafine
3. How to take T erbinafine
4. Possible side effects
5. How to store Terbinafine
6. Further information.
1. WHAT TERBINAFINE IS AND WHAT IT IS USED FOR
Terbinafine belongs to a group of medicines called antifungals. It is used to treat a variety of fungal infections of the skin such as athlete’s foot groin infections, ringworm and also onychomycosis ( a fungal infection of the nails).
2. BEFORE YOU TAKE TERBINAFINE Do not take Terbinafine if you
• are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of these tablets
• you have severe liver or kidney problems Take special care with Terbinafine
You should tell your doctor before taking this medicine if you:
• have psoriasis, a skin condition causing red scaly patches (see section 4)
• have a liver or a kidney problem, taking Terbinafine Mylan is not recommended
• if you have symptoms during treatment that may indicate a blood disorder, for example, you bleed or bruise more easily than normal or you are more prone to infections, inform your doctor.
If during treatment with terbinafine one of the following symptoms occur:
• high fever or sore throat, severe pruritus, severe skin diseases or skin diseases where mucosa is affected
• allergic condition which causes joint pain, skin rashes and fever Stop using terbinafine and consult your doctor (see section 4)
Your doctor may perform a blood test before beginning treatment.
Taking other medicines
Please tell your doctor if you are taking any other medicines including medicines obtained without a prescription, herbal medicines or any of the following:
• rifampicin, an antibiotic used to treat infections
• cimetidine (for stomach ulcers or heartburn)
• medicines used to treat fungal infections such as fluconazole, ketoconazole
• medicines used to treat irregular heart rhythm e.g. amiodarone, flecainide
• antidepressant medicine such as amitriptyline, desipramine, fluoxetine, fluvoxamine, phenelzine, tranylcypromine
• oral contraceptives, when taken at the same time may cause menstrual bleeding and irregular periods
• caffeine
• medicines for high blood pressure called beta-blockers such as atenolol, propranolol, labetolol
• medicines used to treat the symptoms of Parkinson’s disease eg. selegiline
• ciclosporin, a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs
• warfarin, a medicine used to thin your blood
Taking Terbinafine with food and drink
Food and drink has no effect on this medicine.
Pregnancy and breast-feeding
If you are pregnant or planning to become pregnant, speak to your doctor before taking Terbinafine. Do not take this medicine if you are breast-feeding as terbinafine can pass into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy or giddy, you should avoid driving vehicles or using machines.
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.
It is important that you complete the course of treatment as directed by your doctor, even if your condition improves.
• Swallow the tablets with a glass of water The usual dose is:
Adults (including the elderly)
Take one 250 mg tablet a day. For skin infections treatment usually lasts for two to six weeks. For nail infections treatment usually lasts for six to twelve weeks, although some patients with toenail infections may need to be treated for six months.
Patients with reduced kidney or liver function
Terbinafine is not recommended in patients with reduced kidney or liver function.
Children and adolescents
Terbinafine is not recommended for children and adolescents under 18 years.
If you take more Terbinafine than you should
Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include headache, feeling sick, stomach pain and dizziness.
If you forget to take Terbinafine
Take your dose as soon as you remember unless it is nearly time for your next dose. Never take two doses at the same time.
If you stop using Terbinafine
Do not stop taking Terbinafine without talking to your doctor first. It is important to finish the course of treatment as directed by your 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 can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking the tablets and tell your doctor immediately or go to your nearest hospital emergency department:
Rare side effects (affecting fewer than 1 in 1,000 people)
• allergic skin reactions such as skin rashes, red itchy swollen skin, swelling of the face or throat, tightness of the chest and difficulty breathing
• hypersensitivity reaction which can cause fever, swelling, skin rash, enlargement of the lymph nodes
• liver problems, which may cause dark urine or pale stools, yellowing of the skin or whites of the eyes, itching of the skin, feeling generally unwell
• joint or muscle pain
• severe skin reactions including itching, sensitivity to light, blistering of the skin, mouth, eyes and genitals, flaking or peeling of the skin
Other side effects (frequency not known):
• abnormal muscle breakdown (weakness or pain) which can lead to kidney problems
• inflammation of the pancreas which causes severe pain in the abdomen and back
Very Common side effects (affecting more than 1 in 10 people):
• loss of appetite
• bloating of the stomach
• stomach pain
• diarrhoea
• indigestion
• feeling sick
• skin rash or nettle-like rash (hives)
• joint or muscle pain
Common side effects (affecting fewer than 1 in 10 people)
• headache
• tiredness, feeling generally unwell
Uncommon side effects (affecting fewer than 1 in 100 people)
• loss or change of taste, usually reversible on stopping treatment
Rare side effects (affecting fewer than 1 in 1,000 people)
• dizziness
• loss or reduction of sense of touch
• tingling, pins and needles
Very rare side effects (affecting fewer than 1 in 10,000 people)
• a reduction in white blood cells which can cause more infections than usual, eg. fever, chills
• a reduction in blood platelets which can cause unusual bruising or bleeding of the skin
• anxiety, depression
• sensitivity of the skin to light
• worsening of psoriasis (skin rash with thickened patches of red skin, often with silvery scales)
• worsening of SLE (lupus), an allergic reaction causing joint pain, skin rashes and fever
• hair loss
• break-through bleeding during the menstrual cycle in some women and irregular cycles
Other side effects (frequency not known):
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• loss of smell
• loss or reduction in hearing
• ringing in the ears
• inflammation of blood vessels, often with skin rash
• flu-like illness, fever
• weight loss
• increase in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test)
If any side effect gets serious, or if you notice any side effects not mentioned in the leaflet, please tell your pharmacist or doctor.
5. HOW TO STORE TERBINAFINE Keep out of the reach and sight of children.
Do not take Terbinafine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of that month.
There are no special storage requirements.
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 active substance is terbinafine hydrochloride equivalent to 250 mg of terbinafine.
- The other ingredients are colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc.
What Terbinafine looks like and the contents of the pack
Terbinafine comes as a white round tablet marked 'TF/250' on one side and 'G' on the other. Terbinafine is available in plastic bottles or blister packs of 7, 8, 14, 28, 30, 42, 56, 98, 100 or 250 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire EN6 1TL This leaflet was last approved in 10/2012
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