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LAMISIL TABLETS 250MG

Active substance: TERBINAFINE HYDROCHLORIDE

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3. How to take Lamisil Tablets
4. Possible side effects
5. How to store Lamisil Tablets
6. Further information

LAMISIL® Tablets 250 mg
(terbinafine)
Patient Information Leaflet

1.  hat Lamisil Tablets are and what
W
they are used for
Terbinafine, the active ingredient in Lamisil
Tablets, is an antifungal medicine.
Lamisil Tablets are used to treat a number
of fungal infections of the skin and nails.

2.  hings to consider before you start
T
to take Lamisil Tablets
What you need to know about Lamisil Tablets
Your doctor has decided that you need this
medicine to help treat your condition.
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:
1.  hat Lamisil Tablets are, and what they
W
are used for
2.  hings to consider before you start to
T
take Lamisil Tablets

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.)
• 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?
• Do you have any problems with your
kidneys or liver?
• Do you have psoriasis?
• Do you have systemic lupus
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
• Antidepressants including tricyclic
antidepressants, SSRIs (selective
serotonin reuptake inhibitors), or MAOIs
(monoamine oxidase inhibitors)
• Oral contraceptives (as irregular periods
and breakthrough bleeding may occur
in some female patients)
• Beta-blockers or anti-arrhythmics for
heart problems
• 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 Lamisil Tablets to
monitor your liver function.
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
Tablets you should take. Always take the

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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 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.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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 provide
more information on the safety of this
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.

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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 and
manufacturer is Novartis Pharmaceuticals
UK Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England.
Lamisil Tablets may also be manufactured
by Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West
Sussex, RH12 5AB, England.
The leaflet was revised in May 2015.
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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