Terbinafine 250 Mg Tablets
PHARMACODE
AREA
PACKAGE LEAFLET: INFORMATION FOR THE USER
Terbinafine 250 mg tablets
(Terbinafine hydrochloride)
PHARMACODE
AREA
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 symptoms 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 is and what it is used for
2. What you need to know before you take Terbinafine
3. How to take Terbinafine
4. Possible side effects
5. How to store Terbinafine
6. Content of the pack and other information
1. What Terbinafine is and what it is used for
The name of your medicine is Terbinafine. Terbinafine belongs to a family of medicines called antifungals. It is used in the treatment of a variety of fungal infections of the skin and nails.
Terbinafine is used to treat patients with fungal infections of the skin and nails. It attacks and kills the fungus which is causing your infection.
2. What you need to know before you take Terbinafine
Do not take Terbinafine
♦ If you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6)
♦ if you are breast feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine if:
♦ You have ever had liver or kidney problems
♦ You have or experienced thickened patches of red/silver skin (psoriasis) or facial rash, joint pain, muscle disorder, fever (cutaneous and systemic lupus erythematosus). Terbinafine can make these problem worse.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Terbinafine.
Children
Terbinafine is not recommended for use in children.
Other medicines and Terbinafine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, oral contraceptives or herbal medicines. This is because Terbinafine can affect the way some other medicines work. Also some other medicines can affect the way Terbinafine works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
♦ Rifampicin - used to treat infections
♦ Cimetidine - used to treat stomach problems such as indigestion or stomach ulcers.
♦ Oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients).
♦ Anti-depressants- including tricyclic anti-depressants such as desipramine, SSRIs (selective serotonin reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors)
♦ Beta-blockers or anti-arrhythmics for heart problems
♦ Warfarin, a medicine used to thin your blood
♦ Medicines to treat heart problems (eg propafenone)
♦ Anti-fungals - used to treat fungal infections such as fluconazole or ketoconazole.
♦ Dextromethorphan - used in some cough medicines
♦ Ciclosporin, a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs
♦ Caffeine- used in some pain killers or cold remedies.
If any of the the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Terbinafine.
Terbinafine with food and drink
Terbinafine may increase the effects of caffeine in your drinks.
Pregnancy and breast-feeding
If you are pregnant or brest-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicines.
Do not take Terbinafine if you are pregnant or trying to become pregnant You should stop breast-feeding if you are prescribed this medicine.
Driving and using machines
Terbinafine can cause dizziness. If you feel dizzy after taking this medicine, do not drive or use any tools or machines.
3. How to take Terbinafine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
Your doctor will decide the right dose of terbinafine and will tell you how long to take your medicine for. Follow your doctor's instructions exactly and never change the dose yourself. Ask your doctor or pharmacist if you are unsure about how much medicine to take or when to take it.
The recommended dose for adults and older people is 250 mg once a day. If your liver or kidneys are not working very well, your doctor may reduce the dose.
The length of your treatment with Terbinafine will depend on the type of infection you have, how severe it is and what part of your body is affected.
♦ For skin infections, terbinafine is usually taken for between 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.
Taking this medicine
♦ You should take Terbinafine by mouth.
♦ Swallow the tablets whole with a glass of water
♦ Terbinafine can be taken with or without food.
If you take more terbinafine than you should
Cipla Inventory Code
If you take too much Terbinafine, tell your doctor or go to the hospital straight away. Take your medicine pack with you so that people can see what you have taken. You may get a headache, stomach pain, feel sick or dizzy.
XXXXX
PHARMACODE
AREA
If you forget to take Terbinafine
If you miss taking a Terbinafine tablet, do not worry. Take it as soon as you remember, unless it is less than 4 hours before your next dose is due. In this case, wait and take your next tablet at the usual time. Then carry on as normal until you have finished all the tablets.Do not take a double dose to make up for a forgotten dose.
PHARMACODE
AREA
If you stop taking Terbinafine
It is important that you finish all the tablets you have been given unless your doctor tells you to stop taking them.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and see a doctor or go to hospital straight away, if you notice any of the following serious side effects you may need urgent medical treatment:
♦ severe allergic reaction - the signs may include difficulty breathing, swelling of your lips, face, throat or tongue, flushing, stomach cramps or joint pain, stiffness, rash or swollen lymph glands. You may also become unconscious,
♦ yellowing of your skin or eyes. Unusually dark urine or pale faeces, unexplained feeling of sickness, being sick, stomach problems, loss of appetite or unusual tiredness or weakness - these may be signs of liver problems,
♦ a sore throat with fever and shivering - signs that the medicine has affected your blood cells,
♦ a sore throat, with fever, tiredness and ulcers appearing on your mouth or lips - signs of a problem with your immune system
♦ unusual bleeding or bruising - signs that the medicine has affected your blood cells,
♦ stomach pain which spreads to your back - signs of “pancreatitis”
♦ unexplained muscle weakness and pain or having dark red-brown urine - signs of “muscle necrosis”.
♦ feeling unusually tired, weak or breathless and looking pale - signs of “anaemia”,
♦ onset or worsening of a condition called psoriasis (a long-term illness with symptoms including thickened patches of red and silver skin),
♦ onset or worsening of a condition called Lupus (a long-term illness with symptoms including fever, facial skin rash and pain in the muscles and joints),
♦ severe skin rash (including light sensitivity, swelling, blistering, scales or wheals),
♦ skin rash, fever, itching, feeling tired or if you notice purplish-reddish spots under your skin - signs that your blood vessels have become inflamed.
If you get any of the serious side effects listed above, stop taking Terbinafine and see a doctor or go to hospital straight away. Other side effects include:
Talk to your doctor or pharmacist if you notice any of the following side effects.
Very common: may affect more than 1 in 10 people
♦ indigestion,
♦ nausea
♦ abdominal pain
♦ diarrhoea.
♦ joint pain and muscle pain.
Common: may affect up to 1 in 10 people
♦ Headache
Uncommon: may affect up to 1 in 100 people
♦ Taste loss and taste disturbance (which usually returns to normal within few weeks of discontinuation of the medication).
A very small number of patients have reported prolonged taste disturbance. As a result, in very few severe cases, a reduction in the amount of food eaten has led to significant weight loss.
Rare: may affect up to 1 in 1,000 people
♦ Loss of sensitivity to touch
♦ Feeling unwell, tired or dizzy
♦ Numbness or tingling
Very rare: may affect up to 1 in 10,000 people
♦ Vertigo
Not known: It is not known how often these happen
♦ Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
♦ Anxiety, depression
♦ loss of sense of smell or reduced ability to smell
♦ Ringing in the ears
♦ Inflammation of blood vessels, often with skin rash
♦ Abnormal muscle breakdown which can lead to kidney problems
♦ Fatigue
♦ Fever
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 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
Keep this medicine out of the sight and reach of children.
Do not use terbinafine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C. Keep the blister in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Content of the pack and other information
What Terbinafine contains
♦ The active substance is terbinafine. Each tablet contains 250 mg terbinafine (as terbinafine hydrochloride)
♦ The other ingredients of the tablets are microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate, colloidal anhydrous silica, hypromellose (15 cP).
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
What Terbinafine looks like and contents of the pack
PHARMACODE
AREA
Terbinafine 250 mg Tablets are white circular, biconvex, tablets with TF embossed on one side and deep score on the other side. Terbinafine Tablets are available in packs containing 14 and 28 tablets. Not all pack sizes may be marketed Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer:
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom.
This leaflet was last revised in 12/2014
|
PHARMACODE AREA | |
Cipla Inventory Code