TERBINAFINE 250 MG TABLETS

Active substance: TERBINAFINE HYDROCHLORIDE

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If you take more terbinafine than you should, contact your doctor. In the case of an overdose, contact the nearest hospital
casualty department immediately.
It is important to take terbinafine as directed by your doctor.
If you forget to take a dose, take it as soon as you remember.
Do not take a double dose to make up for a forgotten dose. If you are worried, ask your doctor or pharmacist for advice.
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Terbinafine 250 mg Tablets
(Terbinafine hydrochloride)

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.
In this leaflet:
1. What Terbinafine is and what it is used for
2. Before you take Terbinafine
3. How to take Terbinafine
4. Possible side effects
5. How to store Terbinafine
6. Further information

4. POSSIBLE SIDE EFFECTS

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.
The active ingredient contained in the tablets is terbinafine. The tablets contain terbinafine hydrochloride equivalent to 250 mg
terbinafine.
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. BEFORE YOU TAKE TERBINAFINE
Do not take Terbinafine

if you are a child under 12 years of age.

if you suspect that you have had an allergic reaction to, or have been upset by any of the ingredients in terbinafine (listed
in "What Terbinafine contains”).

if you have any liver problems or have you had any disease which may have affected your liver.

if you have psoriasis.

if you have any kidney problems.

if you are pregnant, or planning to become pregnant. If you do become pregnant whilst taking Terbinafine, tell your doctor.

if you are breast feeding.
Terbinafine is not recommended for children.
Taking other medicines
Some medicines can interfere with your treatment, so make sure to check with your doctor or pharmacist before taking any
other medications. In particular, tell your doctor if you are taking any of the following:
• Rifampicin
• Cimetidine
• Oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients).
• Antidepressants
• Beta-blockers or anti-arrhythmics for heart problems
• Warfarin, a medicine used to thin your blood
• Medicines to treat heart problems (eg propafenone)
• Ciclosporin, a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs
• Caffeine
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you go into hospital, let the medical staff know you are taking terbinafine.
Pregnancy and breast-feeding
You should not take terbinafine if you are pregnant or are breast feeding unless your doctor has specifically recommended it.
Breast feeding should be discontinued in case you are required to take terbinafine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Patients who experience dizziness as an undesirable effect should not drive or operate machinery.

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 usual dose is 250 mg a day.
• 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.
Do not chew. Swallow your tablets with a glass of water.

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3. HOW TO TAKE TERBINAFINE

5. HOW TO STORE TERBINAFINE
Keep out of the reach and sight 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. Leave your tablets in the foil. Only remove them when it is time to take your medicine.
Store below 25°C. Keep the blister in the outer carton in order to protect from light.
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 protect the environment.

6. FURTHER 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
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
APSLA Limited, Bayview House, 49 North Strand Road, Dublin 3, Ireland.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, C.P. House, 97 – 107 Uxbridge Road, Ealing, London W5 5TL.
Distributed by:
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, C.P. House, 97 – 107 Uxbridge Road, Ealing, London W5 5TL.
This leaflet was last revised in March 2010
For more information on terbinafine or for this leaflet in formats suitable for the blind and partially-sighted, please contact
APC Pharmaceuticals & Chemicals (Europe) Ltd, telephone number 0208 326 3220

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1. WHAT TERBINAFINE IS AND WHAT IT IS USED FOR

Like all medicines, terbinafine tablets may occasionally cause side effects, although not everybody gets them. Side effects are
often mild to moderate and may wear off after a while.
Common side effects (affects 1 to 10 users in 100):
• Headache
• Poor appetite or a slight sick feeling
• Indigestion
• Mild abdominal pain or fullness
• Diarrhoea
• Itching, rash or swelling
• Pain in the muscles and joints, which may occur as part of a hypersensitivity (allergic) reaction along with allergic skin
reactions (rash, swelling).
Uncommon side effects (affects 1 to 10 users in 1,000):
• 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 side effects (affects 1 to 10 users in 10,000):
• Feeling unwell, tired or dizzy
• Numbness or tingling
If you notice any of the following rare symptoms occurring stop taking your medication and tell your doctor immediately:• Yellowing of your skin or eyes (this may indicate liver problems)
• Severe skin rash (swelling, blistering or wheals – raised itchy areas of skin which could be a sign of an allergy)
• Weakness, unusual bleeding, bruising or frequent infections (this may be a sign of blood disorders)
Very rare side effects (affects less than 1 user in 10,000):
• Feeling tired
• Decrease in the number of some blood cells
• Depression and anxiety
• Worsening of psoriasis symptoms
• Vertigo
May cause or worsen a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints)
The following have also been reported:
• 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.
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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