Terbinafine 250mg Tablets
Terbinafine250mgTablets /?G/0f1 " WU1
Active ingredient: terbinafine hydrochloride.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or pharmacist or nurse.
• This medicine has been prescribed foryou only. 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.
What is 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. Howto take Terbinafine Tablets
4. Possible side effects
5. Howto store Terbinafine Tablets
6. Contents ofthe pack and other information
1. What Terbinafine Tablets are and what they are used for
Terbinafine is one of a group of medicines called antifungals. These medicines act by attacking and killing fungus that causes certain types of infection.
Terbinafine Tablets are used to treat:
• Fungal infections ofthe skin and nails
• Ringworm
2. What you need to know before you take Terbinafine Tablets
Do not take Terbinafine Tablets:
• If you are hypersensitive (allergic, having a reaction with symptoms such as itching, rash or difficulty breathing) to terbinafine or any ofthe ingredients in the tablets, refer to Section 6, What terbinafine tablets contain.
• Ifyou suffer from severe liver problems.
• Ifyou suffer from severe kidney problems.
• you are breast-feeding.
Warnings and Precautions
Tell your doctor before you start taking these tablets if:
• you are pregnant or trying to become pregnant.
• you have systemic lupus erythematosis (SLE).
• you have liver problems or you have a history of liver disease.
• you have psoriasis.
• you have kidney problems.
Other medicines and Terbinafine Tablets
Please tell your doctor or pharmacist ifyou are taking any of the following medicines:
• Rifampicin for tuberculosis.
• Cimetidine for indigestion or stomach ulcers.
• Tricyclic or SSRI antidepressants such as nortriptyline or imipramine
• Beta blockers for treating high blood pressure such as atenolol, metaprolol or Propranolol.
• Oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients)
• Monoamine oxidase inhibitors type B e.g phenelzine, used to treat depressive illnesses
• Warfarin, a medicine used to thin your blood
• Medicines to treat heart problems (eg propafenone, amiodarone)
• Ciclosporin, a medicine used to control your body's immune system in order to prevent rejection of transplanted organs
• Medicines used to treat fungal infections (eg fluconazole, ketoconazole)
• Medicines used to treat cough (eg dextromethorphan)
• Caffeine
Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
You should have blood tests before and during treatment with Terbinafine Tablets to monitor your liverfunction.
Pregnancy and Breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor may advise you to discontinue these tablets. You should not use Terbinafine tablets if you are breast-feeding or are planning to breast-feed your baby.
Driving and using machines:
Terbinafine tablets do not affect the ability to drive or operate machinery.
Ifyou feel dizziness after taking Terbinafine tablets,you should avoid driving vehicle or using machines.
3. How to take Terbinafine Tablets
The doctor will decide what dose of Terbinafine Tablets you should take. Always take the tablets exactly as your doctor has told you to. The dose will be on the pharmacist's label. Check the label carefully.
It should tell you how many tablets to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking the tablets for as long as you have been told unless you have any problems.
In that case, check with your doctor.
The usual dose for adults, including the elderly, is 250 mg once a day.
• For skin infections continue taking the tablets for 2 to 6 weeks.
• For nail infections treatment usually lasts for between 6 weeks and 3 months, although some patients with toenail 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.
• Swallow the tablets whole with a glass of water.
Terbinafine Tablets are not recommended for use in children.
If you take more Terbinafine Tablets than you should:
If you swallow too many tablets or someone else accidentally takes your medicine, contactyour doctor, pharmacist or nearest hospital straight away. If an overdose has been taken there may be signs such as headache, feeling sick, upper chest pain and dizziness.
If you forget to take Terbinafine Tablets:
Try to take Terbinafine Tablets daily as prescribed. If you forget to take a tablet, take another one as soon as you remember or wait until the next dose is due then continue as before. Never take two doses together. Take the remaining doses at the correct time.
Ifyou stop taking Terbinafine Tablets:
Do not stop taking Terbinafine Tablets without first discussing it with your doctor. It is important that you complete the course of treatment.
If you have any further questions on the use of Terbinafine Tablets askyour doctor or pharmacist.
4. Possible side Effects
Like all medicines, this medicine can sometimes cause side effects. Any side effects are usually mild or moderate and don't last for too long.
Some side effects can be serious Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:
• Yellowing of your skin or eyes. Unusually dark urine or pale faeces, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (this may indicate liver problems)
• Severe skin reactions including rash, light sensitivity, blistering or wheals
• Weakness, unusual bleeding, bruising, abnormal pale skin, unusual tiredness, or weakness or breathlessness on exertion or frequent infections (this may be a sign of blood disorders)
• Difficulty breathing, dizziness, swelling mainly ofthe 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)
The most common side effects are:-
• Headache
• Stomach problems such as loss of appetite, ache, indigestion, feeling bloated or sick
• Diarrhoea
• Itching, rash or swelling
• Pains in the muscles and joints.
The side effects listed below have also been reported.
Uncommon (may affect up to I in 100 people):
Taste loss and taste disturbance. This usually disappears when you stop taking the medicine. However, a very small number of people, (less than I in 10,000), have reported that the taste disturbance lasts for some time and, as a result, they go off their food and lose weight.
There have also been reports of some people experiencing anxiety or symptoms of depression as a result of these taste disturbances.
Rare (may affect up to I in 1,000 people):
• Feeling unwell, dizzy.
• Numbness ortingling.
Very rare (may affect up to I in 10,000 people):
• Feelingtired.
• Decrease in the number of some blood cells. You may notice that you seem to bleed or bruise more easily than normal, or you may catch infections easily and these might be more severe than usual.
• Depression and anxiety.
• Psoriasis like skin eruptions, or worsening of any psoriasis.
• Vertigo.
• Onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints).
Frequency not known (frequency cannot be estimated from the available data):
Psoriasis like skin eruptions, or worsening of psoriasis, severe skin reactions including a rash or eruption of small pus containing blisters. Signs of blood disorders: weakness, unusual bleeding, bruising or frequent infections.
Disorders of sense of smell which may be permanent, impaired hearing, hissing and/or ringing in the ears, flu like symptoms, increase in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test).
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.
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 Website at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Terbinafine Tablets
Keep out ofthe sight and reach of children.
Do not use Terbinafine Tablets after the expiry date which is stated on the carton.
Keep the tablets in the outer carton.
6. Further information
What Terbinafine Tablets contain
The active substance is terbinafine. Each tablet contains 250mg of terbinafine hydrochloride.
The other ingredients are magnesium stearate, silica colloidal anhydrous, croscarmellose sodium, hypromellose and microcrystalline cellulose.
What Terbinafine Tablets look like and contents of the pack
Terbinafine tablets are white round tablets.
The tablets are supplied in blister packs of 14 and 28 tablets.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited
Cheshire House, Gorsey Lane, Widnes, Cheshire, WA80RR UK
Date leaflet last revised: September 2015.
| POM |
PL20395/0045