Terbinafine 250mg Tablets
The following have also been reported:
• Psoriasis like skin eruptions, or worsening of psoriasis
• Disorders of sense of smell which may be permanent
• Impaired hearing, hissing and/or ringing in the ears
• Flu like symptoms, fever
• Increase in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. He/she may want to give you a different medicine.
You can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or filling a paper form available from your local pharmacy.
5. HOW TO STORE TERBINAFINE TABLETS
• Keep out of the reach and sight of children.
• This product does not require any special storage conditions within Europe.
• Do not use after the expiry dates stated on the box. 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Terbinafine tablets contain:
The active substance is terbinafine hydrochloride.
The other ingredients are: Magnesium stearate, colloidal anhydrous silica, hydroxypropylmethylcellulose, microcrystalline cellulose and sodium starch glycollate.
What Terbinafine tablets look like and contents of the pack
Terbinafine tablets are white, round tablets with the letter 'T' and breakline on the opposite face.
Terbinafine 250mg tablets are available in packs containing 14 Tablets and 28 Tablets.
| POM |
PL 21880/0099
This leaflet was last approved June 2013
MA Holder and Batch release site:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Terbinafine 250mg Tablets
Terbinafine Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Terbinafine tablets are and what they are used for
2. What you need to know before you take Terbinafine tablets
3. How to take Terbinafine tablets
4. Possible side effects
5. How to store Terbinafine tablets
6. Contents of the pack and other information
1. WHAT TERBINAFINE TABLETS ARE AND WHAT THEY ARE USED FOR
Terbinafine hydrochloride, the active ingredient in these tablets, belongs to a family of medicines called antifungals.
Terbinafine tablets are used to treat a variety of fungal infections of the skin and nails.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TERBINAFINE TABLETS
Do not take Terbinafine tablets if you:
• are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).
• have a fungal infection of the nail but the nail damage is due to a previous or existing bacterial infection.
Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine tablets if you:
• have any liver problems or have had any diseases which may affect your liver.
• have psoriasis
• have kidney problems
• are pregnant or planning to become pregnant. If you do become pregnant whilst taking Terbinafine tablets tell your doctor.
• are breast feeding.
Speak to your doctor or pharmacist before taking these tablets if any of the above points apply to you.
Other medicines and Terbinafine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In particular, tell your doctor BEFORE starting your medicine if you are taking any of the following:
• Rifampicin used in the treatment of infection
• Cimetidine used in the treatment of peptic ulcers (ulcer of stomach or small intestine)
• Oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients)
• Antidepressants including tricyclic antidepressants (e.g. desipramine), SSRIs (selective serotonin reuptake inhibitors e.g. fluoxetine), or MAOIs (monoamine oxidase inhibitors)
• Beta-blockers, used for high blood pressure and heart failure (when the heart is unable to pump blood effectively around the body) e.g. metoprolol
• Ciclosporin, used to suppress the immune system after transplant surgery
• Anti anyth mi cs used for irregular heart rhythms e.g. flecainide, propafenone, amiodarone
• Medicines used to treat fungal infections (eg fluconazole, ketoconazole)
• Medicines used to treat cough (eg dextromethorphan)
• Warfarin, a medicine used to thin the blood
• Caffeine, found in some over-the-counter cough and cold remedies
Pregnancy and breastfeeding:
Talk your doctor if you are pregnant, planning to become pregnant or breast-feeding.
Driving and using machines:
Some people have reported feeling dizzy or giddy while they are taking Terbinafine
tablets. If you feel like this do not drive or operate machinery.
3. HOW TO TAKE TERBINAFINE TABLETS
Always take Terbinafine tablets exactly how your doctor has told you to. Check with your doctor or pharmacist if you are not sure.
Terbinafine tablets should only be taken by mouth. Swallow your tablets whole with a glass of water.
You doctor will tell you how many tablets to take and when to take them.
• For skin infections Terbinafine tablets are usually taken for between 2 to 6 weeks.
• For nail infections treatment usually lasts between 6 weeks and 3 months although some patients with nail infections may need to be treated for 6 months or longer.
• If your kidneys are not working very well, your doctor may reduce the dose of Terbinafine tablets you take.
Terbinafine tablets are not recommended for children.
If you take more Terbinafine tablets than you should
Taking too many tablets at once can be dangerous. If you take too many tablets tell your doctor. If you are unable to contact your doctor go to your local hospital casualty department at once. Take your medicine pack with you so that people can see what you have taken.
If you forget to take Terbinafine tablets
If you forget to take your tablet, take another as soon as you remember or wait until it is time to take your next dose then go on as before.
If you stop taking Terbinafine tablets
You should take Terbinafine tablets for as long as your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Terbinafine Tablets can cause side effects, although not everybody
gets them.
Serious side effects
Stop taking the tablets and contact your doctor or hospital emergency department
IMMEDIATELY if you develop any of the following symptoms:
• Difficulty breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions)
• Symptoms such as rash, fever, itching, tiredness or if you notice appearance of purplish spots under the skin surface (signs of blood vessel inflammation)
• Severe upper stomach pain which spreads to the back (possible signs of pancreas inflammation)
• Unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown)
• Severe skin reactions including rash, light sensitivity, peeling and blistering of the skin, mouth, eyes and genitals and numerous pus filled spots with fever
• Weakness, unusual bleeding, bruising, fever and frequent infections (these may be signs of a blood disorder)
• Yellowing of your skin or eyes, unusually dark urine or pale stools, unexplained persistent nausea, stomach problems, fever, loss of appetite, unusual tiredness or weakness and confusion (this may indicate serious liver problems)
Other side effects
The following side effects may also occur:
Very common (affects more than 1 user in 10)
• Feeling of fullness, loss of appetite, mild stomach pains, indigestion, nausea (feeling sick) and diarrhoea
• Skin reactions like itching, rash or hives
• Muscle and joint pains
Common (affects 1 to 10 users in 100):
• Headache
Uncommon (affects 1 to 100 users in 1,000)
• Taste loss and taste disturbance. This usually resolves on discontinuation of the medication. Sometimes, the taste disturbance may last for a longer time in a small number of patients, with loss of appetite and weight loss. There have also been reports of some people experiencing anxiety or symptoms of depression as a result of these taste disturbances.
Rare (affects 1 to 10 users in 10,000):
• Feeling generally unwell (malaise), tiredness (fatigue)
• Numbness or tingling of the arms or legs
• Dizziness
• Hair loss
Very Rare (affects less than 1 user in 10,000):
• Vertigo (dizziness)
• Onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints)
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