LAMISIL TABLETS 250MG

Active substance: TERBINAFINE HYDROCHLORIDE

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LAMISIL® Tablets 250 mg

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1.  hat Lamisil Tablets are and what
W
they are used for

• 
Antidepressants including tricyclic
antidepressants, SSRIs (selective serotonin
reuptake inhibitors), or MAOIs (monoamine
oxidase inhibitors)

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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.

(terbinafine)

Terbinafine, the active ingredient in Lamisil
Tablets, is an antifungal medicine.

Patient Information Leaflet

Lamisil Tablets are used to treat a number of
fungal infections of the skin and nails.

• 
Oral contraceptives (as irregular periods
and breakthrough bleeding may occur in
some female patients)

What you need to know about
Lamisil Tablets

2.  hings to consider before you start to
T
take Lamisil Tablets

• 
Beta-blockers or anti-arrhythmics for
heart problems

Your doctor has decided that you need this
medicine to help treat your condition.

Some people MUST NOT take Lamisil Tablets.
Talk to your doctor if:
• 
you think you may be allergic to terbinafine
or to any of the other ingredients of Lamisil
Tablets. (These are listed in Section 6.)

• 
Warfarin, a medicine used to thin your blood

The usual dose for adults, including the
elderly, is 250 mg once a day.

• 
Medicines to treat heart problems
(eg propafenone, amiodarone)

•  skin infections continue taking the
For
tablets for 2 to 6 weeks.

• 
Ciclosporin, a medicine used to control
your body’s immune system in order to
prevent rejection of transplanted organs

•  nail infections treatment usually lasts
For
for between 6 weeks and 3 months,
although some patients with toenail
infections may need to be treated for
6 months or longer.

Please read this leaflet carefully before
you start to take your medicine. It contains
important information. Keep the leaflet in a
safe place because you may want to read
it again.
If you have any other questions, or if there is
something you don’t understand, please ask
your doctor or pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not
be the right medicine for them even if their
symptoms seem to be the same as yours.
If any side effects get serious, or if you notice
any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
W
1.  hat Lamisil Tablets are, and what they
are used for
T
2.  hings to consider before you start to take
Lamisil Tablets
3. How to take Lamisil Tablets
4. Possible side effects
5. How to store Lamisil Tablets
6. Further information

• you are breast-feeding
You should also ask yourself these questions
before taking Lamisil Tablets. If the answer to
any of these questions is YES, tell your doctor
or pharmacist because Lamisil Tablets might
not be the right medicine for you.
• 
Are you pregnant or trying to become
pregnant?

• 
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 have any problems with your
Do
kidneys or liver?
• Do you have psoriasis?

You should have blood tests before and during
treatment with Lamisil Tablets to monitor your
liver function.

•  you have systemic lupus
Do
erythematosis (SLE)?
Children should not normally be given
Lamisil Tablets.
Are you taking other medicines?
Some medicines can interfere with your
treatment. Tell your doctor if you are taking
any of the following:
• Rifampicin for infections
• 
Cimetidine for gastric problems such as
indigestion or ulcer

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Will there be any problems with driving or
using machinery?
Some people have reported feeling dizzy or
giddy while they are taking Lamisil Tablets.
If you feel like this you should not drive or
operate machinery.

3. How to take Lamisil Tablets
The doctor will decide what dose of Lamisil

If
•  your kidneys are not working very well,
your doctor may reduce the dose of Lamisil
Tablets you take.
Swallow the tablets whole with a glass
• 
of water.
What if you forget to take a dose?
If you miss taking a Lamisil Tablet, do not
worry. Take it as soon as you remember.
Take your next tablet at the usual time, then
carry on as normal until you have finished all
the tablets. It is important that you finish all
the tablets you have been given unless your
doctor tells you to stop taking them.
What if you take too many tablets?
All tablets can be risky if you take too many.
If you take too many Lamisil Tablets at once,
tell your doctor or hospital casualty
department as soon as possible. Take your
medicine pack with you so that people can
see what you have taken.
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4. Possible side effects
Lamisil Tablets are suitable for most people,
but, like all medicines, they 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), increase in liver enzymes which
may be noted on a blood test result
• 
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 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)

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.
Up to 1 in 100 people have experienced:
Taste loss and taste disturbance. This usually
disappears within several weeks after 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. There have also been
reports of some people experiencing anxiety
or symptoms of depression as a result of these
taste disturbances.
Up to 1 in 1,000 people have experienced:
• Feeling unwell, dizzy
• Numbness or tingling
Up to 1 in 10,000 people have experienced:
• Feeling tired
• 
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
• 
Psoriasis like skin eruptions, or worsening
of any psoriasis including a rash or
eruption of small pus containing blisters
• Vertigo
• Hair loss

• 
Onset or worsening of 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:
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.

5. How to store Lamisil Tablets
Store the tablets in their original pack away
from direct light. Store below 25ºC.
Keep all medicines out of the reach and sight
of children.
Do not take the tablets after their expiry date
which is printed on the outside of the pack.
If your doctor tells you to stop taking Lamisil
Tablets, please take any unused tablets back
to your pharmacist to be destroyed. Only keep
the tablets if the doctor tells you to. Do not
throw them away with your normal household
water or waste. This will help to protect
the environment.

6. Further information
Lamisil Tablets are round, whitish or very pale
yellow tablets marked with a score line on
one side and ‘LAMISIL 250’ on the other, and
they contain 250 mg of the active ingredient
terbinafine. They also contain the inactive
ingredients magnesium stearate, colloidal
anhydrous silica, hydroxypropylmethylcellulose,
sodium carboxymethyl starch and
microcrystalline cellulose.
They come in blister packs of 7, 14 or
28 tablets. Not all pack sizes are marketed.
The product licence holder is
Novartis Pharmaceuticals UK Limited, Frimley
Business Park, Frimley, Camberley, Surrey,
GU16 7SR, England.
Lamisil Tablets are made by
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West Sussex,
RH12 5AB, England.
The leaflet was revised in September 2012.
If you would like any more information,
or would like the leaflet in a different format,
please contact Medical Information at
Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
LAMISIL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

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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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