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TERBINAFINE 250MG TABLETS

Active substance(s): TERBINAFINE / TERBINAFINE HYDROCHLORIDE

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TERBINAFINE 250mg TABLETS

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 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.

Pharmacide

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Package Leaflet: Information for the Patient

IN THIS LEAFLET
1. What Terbinafine 250mg Tablets are and what they are used for
2. What you need to know before you take Terbinafine 250mg
Tablets
3. How to take Terbinafine 250mg Tablets
4. Possible side effects
5. How to store Terbinafine 250mg Tablets
6. Contents of the pack and other information

1.

WHAT TERBINAFINE 250mg TABLETS ARE AND WHAT
THEY ARE USED FOR

The name of this medicine is Terbinafine 250mg Tablets. Terbinafine
acts by attacking and killing fungus which causes infection. Your
doctor has prescribed the medicine for you to treat fungal infections
of the skin and nails or for the treatment of ringworm.

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TERBINAFINE 250mg TABLETS

Contraindications
Do not take Terbinafine 250mg Tablets if you have:
• Ever had an allergic reaction to terbinafine or to any of the other
ingredients listed in section 6, contents of the pack and other
information. An allergic reaction may include a rash, itching,
difficulty breathing or swelling of the face, lips, throat or tongue.
• Severe kidney or liver problems
• Are breast-feeding
Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine
250mg Tablets if you:
• Are pregnant or trying to become pregnant
• Suffer from psoriasis
• Have liver problems
• Develop any of the following within two months of starting
treatment with this medicine: itching, a feeling of sickness that
won’t go away, reduced appetite, tiredness, yellowing of the
whites of the eyes or skin, being sick, fatigue, stomach pain, dark
urine or pale coloured stools, high temperature, sore throat
• Have kidney problems
• Suffer from an auto-immune condition e.g. lupus erythematosus
Other medications and Terbinafine 250mg tablets
Check with your doctor or pharmacist if you are taking or have
recently taken any other medicines even those not prescribed by a
doctor. In particular tell your doctor if you are taking any of the
following:
• Rifampicin for tuberculosis (can make terbinafine less effective)
• Cimetidine for indigestion or stomach ulcers (can cause
terbinafine blood levels to rise)
• Antidepressants including tricyclic antidepressants (e.g.
amitriptyline or desipramine), SSRIs (selective serotonin
re-uptake inhibitors, e.g. fluoxetine or paroxetine) or MAOIs
(monoamine oxidase inhibitors, e.g. moclobemide)
• Beta blockers for treating high blood pressure such as atenolol,
metoprolol or propranolol (blood levels of these medicines may
rise when taken with terbinafine)
• Oral contraceptives (irregular periods or breakthrough bleeding
may occur)
• Antiarrhythmics – to treat abnormal heart rhythms
• Ciclosporin (used in transplant patients) – may be less effective if
taken with terbinafine
• Medicines used to treat fungal infections (e.g. fluconazole,
ketoconazole)
• Medicines used to treat cough (e.g. dextromethorphan)

• Warfarin for thinning your blood
• Caffeine
Pregnancy and breast-feeding
Do not take Terbinafine 250mg Tablets if you are pregnant unless
your doctor considers it absolutely necessary. Do not take this
medicine whilst breast-feeding.
Driving and using machinery
Terbinafine 250mg Tablets may make you feel dizzy or fatigued.
Make sure you are not affected before you drive or operate
machinery.

3.

HOW TO TAKE TERBINAFINE 250mg TABLETS

Always take this medication exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure. Your doctor will decide what the right dose is for you to take
and how long you will need to continue taking the medicine. If you
suffer from kidney problems you may be given a different dose to
that suggested below.
The recommended dose is:
Adults (including the elderly)
The usual oral dosage is one 250mg tablet once daily. The length of
your course of treatment will depend on the nature and severity of
infection. Take your tablet with a glass of water.
• For skin infections the usual dose is 250mg per day for between 2
and 6 weeks depending on the site and severity of the infection.
• For nail infections the treatment may be for longer - between 6
and 12 weeks. With toenail infections the treatment may be for 6
months.
• If you have kidney problems your doctor may reduce the dose of
Terbinafine 250mg Tablets you take.
Children
Terbinafine 250mg Tablets are not recommended for use in children.
If you take more Terbinafine 250mg Tablets than you should
If you (or someone else) take too many tablets, or if you think a child
has swallowed any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
Take this leaflet and any remaining tablets with you to show the
doctor.
If an overdose has been taken there may be signs such as
headache, feeling sick, upper abdominal pains and dizziness.
If you forget to take Terbinafine 250mg Tablets
If you forget to take a tablet, take one as soon as you remember,
unless it is nearly time to take the next one.
Never take two doses together. Take the remaining doses at the
correct time.
If you stop taking Terbinafine 250mg Tablets
Take the tablets for as long as directed by your doctor, it is important
that you complete the course of treatment. This is to ensure that the
CP.TBF.250T.IS.V6P1

Customer: IS

Originated by: AWG (MAT)

Colours

Product: Terbinafine 250mg Tablets
Dimensions: 200mm x 300mm
Item Code: CP.TBF.250T.IS.V6P1
Proof No and Date: 1

04/04/16

Revision: Update in line with the Brand Leader
ARTWORK FOR SUBMISSION
Supersedes: CP.TBF.250T.IS.V5P4

Pantone
280

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects although not
everybody gets them. 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, rash or eruption of small pus-containing blisters
• Weakness, unusual bleeding, bruising, frequent infections (e.g.
sore throats and fever) - these may be signs of blood disorders
• Allergic reactions – signs may include difficulty breathing,
dizziness, swelling mainly of the face and throat, flushing,
cramping abdominal pain, stiffness, rash, fever or
swollen/enlarged lymph nodes
• Inflammation of blood vessels – may cause rash, fever, itching,
tiredness or the appearance of purplish spots under the skin
surface
• Severe upper stomach pain which spreads to the back (may be
caused by pancreatitis)
• Muscle damage (symptoms may include muscle weakness and
pain or dark coloured urine)
The side effects listed below have also been reported.
Very common (may affect more than 1 in 10 people)
• Stomach problems such as ache, indigestion, feeling bloated or
sick
• Diarrhoea
• Decreased appetite
• Itching, rash, hives
• Pains in the muscles and joints

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.

Pharmacide

infection is completely cured and lessen the chance of its return after
you stop taking the tablets.

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 medicines.

5.

HOW TO STORE TERBINAFINE 250mg TABLETS

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Keep the blister in the outer carton.
Do not use after the expiry date stated on the carton.
Store in the original package.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer need, these measures will help protect the environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Terbinafine 250mg Tablets contain
The active substance is terbinafine; each tablet contains 250mg
terbinafine as terbinafine hydrochloride.
The tablets also contain magnesium stearate, silica colloidal
anhydrous, croscarmellose sodium, hypromellose and
microcrystalline cellulose.
What Terbinafine 250mg Tablets look like and contents of the
pack
The tablets are white, round and flat, scored on both sides and
marked ‘T’ above and ‘1’ below the score on one side.
They are supplied in blister packs of 14 and 28 tablets.
Not all pack sizes may be marketed.

Common (less than 1 in 10 and more than 1 in 100 people)
• Headache

Marketing Authorisation Holder:
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.

Uncommon (less than 1 in 100 and more than 1 in 1,000 people)
• Taste loss and taste disturbance. This usually disappears when
you stop taking the medicine. However, a very small number of
people, (less than 1 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.

Distributed by:
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT,
U.K.

Rare (less than 1 in 1,000 and more than 1 in 10,000 people)
• Feeling unwell, dizziness
• Numbness or tingling
Very rare (less than 1 in 10,000 people)
• Alopecia (hair loss)
• Anxiety or symptoms of depression as a result of taste
disturbances
• Vertigo (spinning motion)
• Parotid swelling (swelling of one of the salivary glands situated
just in front of the ear)
• Onset or worsening of a condition called lupus (a long-term illness
with symptoms including skin rash and pain in the muscles and
joints)

Company responsible for release of this medicine:
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT,
U.K.
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent,
TN24 0GR, U.K.
Product Licence Number: PL 06453/0060
This leaflet was last revised in December 2015.

Unknown frequency (cannot be estimated from the available
information)
• Anaemia (symptoms may include pale skin and feeling tired)
• Loss of smell
• Impaired hearing or ringing in the ears
• Exhaustion/tiredness
• Fever
• Flu-like illness
• Psoriasis-like skin eruptions, or worsening of any psoriasis
• Increased amount of a muscle enzymes in your blood (creatinine
kinase)
CP.TBF.250T.IS.V6P1

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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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