Terbinafine 250mg Tablets
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Rifampicin, a drug used for Infections |
These drugs may alter the time terbinafine stays in your body |
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Fluconazole, a drug used to treat fungal infections | |
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Cimetidine, a drug used for stomach ulcers | |
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Tricyclic antidepressant drugs such as amitriptyline for depression |
Terbinafine may increase the time these drugs stay in your body |
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Selective serotonin reuptake inhibitors (SSRIs), such as fluvoxamine, for depression | |
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Monoamine oxidase inhibitors (MAOIs), such as phenelzine, for depression |
Terbinafine may increase the time these drugs stay in your body |
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Tricyclic antidepressants (TCAs) for depression | |
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Caffeine | |
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Beta-blockers, such as atenolol, for high blood pressure |
4. Possible side effects
Package Leaflet : Information for the User
Terbinafine 250 mg Tablets
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.
The name of your medicine is Terbinafine
250 mg Tablets. In the rest of this leaflet it is
called Terbinafine Tablets.
In this leaflet:
1. What Terbinafine Tablets are and what they are used for
2. Before you take Terbinafine Tablets
3. How to take Terbinafine Tablets
4. Possible side effects
5. How to store Terbinafine Tablets
6. Further information.
1. What Terbinafine Tablets are and what they are used for
Terbinafine belongs to a group of medicines called antifungals. Terbinafine Tablets are used to treat a variety of fungal skin and nail infections.
2. Before you take Terbinafine Tablets
Do not take Terbinafine if:
• you are allergic to terbinafine hydrochloride or any of the other ingredients of Terbinafine Tablets.
• You have or have had any liver problems.
Children
Do not give Terbinafine Tablets to children.
Take special care with Terbinafine
Tell your doctor before you take Terbinafine Tablets if:
• you have liver problems
• you have psoriasis, a skin problem
• you have lupus erythematosus
• you have kidney problems.
• you are taking other medicines.
Certain blood disorders have been reported in patients treated with Terbinafine tablets.
If you develop a blood disorder please discuss treatment options with your doctor.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported rarely with the use of Terbinafine.
These potentailly life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.
Taking other medicines
If you are taking or have recently taken any of the following medicines, tell your doctor:
Oral contraceptive When taken at
(the “pill”) the same time
Terbinafine and the “pill” may cause menstrual bleeding and irregular periods
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and those obtained without a prescription.
Taking Terbinafine with food and drink
It does not matter when you take your Terbinafine Tablets in relation to food.
Pregnancy and breast-feeding
• If you are pregnant, or you think you may be pregnant or you are planning to become pregnant, tell your doctor. Terbinafine should not be used during pregnancy unless clearly necessary.
Your doctor will discuss with you the potential risks of taking Terbinafine during pregnancy.
• Do not take Terbinafine Tablets if you are breast-feeding
• Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You can drive or use machines whilst taking Terbinafine Tablets.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
3. How to take Terbinafine Tablets
Always take Terbinafine Tablets 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 250 mg tablet a day.
If you have kidney problems, you should take half the usual dose.
Do not remove the tablet from the blister until you are ready to take it. To obtain a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Unless told otherwise, you should swallow your tablets whole with water.
The length of treatment will depend upon your condition. For skin infections, this is usually two to six weeks. For nail infections this is usually six weeks to three months -some patients with a toe nail infection may need longer treatment.
Do not stop taking the medicine without talking to your doctor first.
If you have any further questions on the use of Terbinafine Tablets, ask your doctor or pharmacist.
If you take more Terbinafine than you should
If you take too many tablets, you may feel sick or suffer headache, stomach pain or dizziness. You should contact your doctor or pharmacist, or go to the nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.
If you forget to take Terbinafine
Do not take a double dose to make up for a forgotten tablet. If you occasionally forget to take a dose do not worry, just take the next dose when it is due.
Like all medicines, Terbinafine Tablets can cause side effects, although not everybody gets them.
Tell your doctor immediately if you
experience pains in your muscles or joints, wheezing, difficulty breathing or swallowing, swelling of your face, worsening skin rash, blistering or ulceration of the skin, mouth, eyes and genitals, itching or increased sensitivity to sunlight, symptoms of liver problems (such as itching or yellowing of the skin, nausea, vomiting, tiredness, stomach pain, dark urine or pale stools), you develop a sore throat or high fever or experience unusual bleeding or bruising. If the problem develops, treatment should be stopped immediately. Serious side effects include liver failure, which can lead to the need for a liver transplant or even death.
(continued over)
Very common (likely to affect more than 1 in every 100 people) side effects are:
• Feeling sick
• Mild stomach pain
• Diarrhoea
• Indigestion
• Feeling full or loss of appetite
• Skin rashes and/or Itchy skin
• Painful joints or muscles
Common (likely to affect 1 to 10 in every 100 people) side effects are:
• Headache
Uncommon (likely to affect 1 to 10 in every 100 people) side effects are:
• loss of disturbance of taste
Rare (likely to occur in more than 1 in every
10.000 but less than 1 in 1,000 people) side effects are:
• Giddiness or dizziness
• Numbness or tingling
• A feeling of discomfort
• Yellowing of the skin or whites of the eyes (called jaundice)
• Liver problems (possibly seen as feeling sick, vomiting, fever, dark urine or pale coloured stools).
• Taste loss and taste disturbance, which may lead to a reduction of appetite and significant weight loss in a few patients. You should tell your doctor if the altered sense of taste lasts for several days.
Very rare (likely to affect less than 1 in every
10.000 people) side effects are:
• Tiredness
• Pruritis
• Psoriasis
• Photosensitivity
• A feeling of dizziness or spinning
• Blood problems (possibly seen as more infections, severe chills, sore throats and mouth ulcers than usual, and more bleeding and bruising than normal)
• Serious allergic reactions (possibly seen as rash, swellings, blistering, shortness of breath or difficulty breathing)
• Depression
• Anxiety
• A worsening of existing psoriasis
• Hair loss
Side effects with an unknown frequency are as follows:
• Anaemia
• Allergic reactions
• Anxiety or depression
• Hearing impairment, deafness, ringing in one's ears
• Vasculitis
• Pancreatitis
• Liver problems (yellowing of your skin and whites of your eyes)
• Weight loss
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
6. Further information
What Terbinafine contains
- The active substance is terbinafine.
Each tablet contains terbinafine hydrochloride, equivalent to 250 mg of terbinafine.
- The other ingredients are microcrystalline cellulose, colloidal silica anhydrous, hypromellose, sodium starch glycollate Type A and magnesium stearate.
What Terbinafine looks like and contents of the pack
Terbinafine Tablets are white to off-white tablets with a 'T' on one side and score line on the reverse. The tablet can be divided into equal halves.
They come in blister packs containing 7, 14, 28, 30 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
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Product Name |
Reference Number |
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Terbinafine 250mg Tablets |
PL 29831/0197 |
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 08/2015.
5. How to store Terbinafine Tablets
Keep out of the reach and sight of children. Do not use Terbinafine Tablets after the expiry date that is stated on the carton.
The expiry date refers to the last day of that month.
Keep the blister in the outer carton in order to protect from light.
Do not use Terbinafine Tablets if they are discoloured (they should be white to off-white).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.
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