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LAMISIL 250MG TABLETS

Active substance(s): TERBINAFINE / TERBINAFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LAMISIL® 250MG TABLETS
TERBINAFINE 250MG TABLETS
(terbinafine hydrochloride)

Your medicine is available using the above names
Lamisil 250mg Tablets or Terbinafine 250mg Tablets but will be
referred to as Lamisil Tablets throughout this leaflet.

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.
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3.
4.
5.
6.

What Lamisil Tablets are and what they are used for
Things to consider before you start to take Lamisil Tablets
How to take Lamisil Tablets
Possible side effects
How to store Lamisil Tablets
Further information

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.
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Are you pregnant or trying to become pregnant?
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Do you have any problems with your kidneys or liver?
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Do you have psoriasis?
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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:
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Rifampicin for infections
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Cimetidine for gastric problems such as indigestion or ulcer
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Antidepressants including tricyclic antidepressants,
SSRIs (selective serotonin reuptake inhibitors),
or MAOIs (monoamine oxidase inhibitors)
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Oral contraceptives (as irregular periods and breakthrough
bleeding may occur in some female patients)
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Beta-blockers or anti-arrhythmics for heart problems
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Warfarin, a medicine used to thin your blood
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Medicines to treat heart problems (e.g. propafenone,
amiodarone)
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Ciclosporin, a medicine used to control your body’s immune
system in order to prevent rejection of transplanted organs
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Medicines used to treat fungal infections (e.g. fluconazole,
ketoconazole)
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Medicines used to treat cough (e.g. dextromethorphan)
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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?

1. What Lamisil Tablets are and what they
are used for

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.

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

3. How to take Lamisil Tablets

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

2. Things to consider before you start to take
Lamisil Tablets

The doctor will decide what dose of Lamisil 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.

Some people MUST NOT take Lamisil Tablets.
Talk to your doctor if:
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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

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The usual dose for adults, including the elderly, is 250mg
once a day.
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For skin infections continue taking the tablets for
2 to 6 weeks.
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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.
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If your kidneys are not working very well, your doctor may
reduce the dose of Lamisil Tablets you take.
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Swallow the tablets whole with a glass of water.
Each blister pack will have the days of the week printed on, which
will translate as follows:
LU
Monday

MA
Tuesday

SA
Saturday

DO
Sunday

MI
Wednesday

JU
Thursday

VI
Friday

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.

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:
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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
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Severe skin reactions including rash, light sensitivity,
blistering or wheals
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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)
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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)

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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:ƒ
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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:
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Feeling unwell, dizzy
Numbness or tingling

Up to 1 in 10,000 people have experienced:
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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).

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 help provide more information
on the safety of this medicine.

5. How to store Lamisil Tablets
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Protect from light.
Leave your tablets in the foil. Only remove them when it is
time to take your medicine.
Keep out of the sight and reach of children.
Do not use this product after the expiry date (Exp) printed
on the carton and blister.
If your doctor decides to stop your treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return it to your
pharmacist who will advise you.
Do not throw them away with your normal household water
or waste. This will help to protect the environment.

6. Further information
Each tablet contains 250mg terbinafine (as the hydrochloride).
The tablets also contain the following inactive ingredients:
magnesium stearate, colloidal anhydrous silica,
hydroxypropylmethylcellulose, microcrystalline cellulose and
sodium carboxymethyl starch.
Lamisil Tablets are round, white coloured tablets, engraved with
‘LAMISIL’ and ‘250’ on one side and a breakline on the other.
Lamisil Tablets are available in calendar blister packs containing
14 and 28 tablets.
Manufactured by:
Novartis Farmaceutica, S.A., Ronda Santa Maria, 158,
08210 Barbera del Valles, Barcelona, Spain
or
Novartis Farmaceutica, S.A., Gran Via de les Corts Catalanes,
764, 08013 - Barcelona, Spain.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0461

POM

Leaflet revision and issue date (Ref): 20.06.14
LAMISIL® is a registered trademark of Novartis AG.
If you would like the leaflet in a different format, please contact
01302 365000 and ask for the Regulatory Department.

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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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