Medication Guide App

LAMISIL TABLETS 250MG

Active substance: TERBINAFINE HYDROCHLORIDE

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Description:
Lamisil Tab 250mg GB
Line/Plant: CP
Proof No:
1
Date:
16 Oct 2012
Author: EL
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Code direction (537)

LAMISIL® Tablets 250 mg

Top

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

(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.

What you need to know about
Lamisil Tablets

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

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.)

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

T e mplat e

Material code 1406659a

reuptake inhibitors), or MAOIs (monoamine
oxidase inhibitors)
• 
Oral contraceptives (as irregular periods
and breakthrough bleeding may occur in
some female patients)

• Rifampicin for infections
• 
Cimetidine for gastric problems such as
indigestion or ulcer
• 
Antidepressants including tricyclic
antidepressants, SSRIs (selective serotonin

Bottom

18 May 2007
Fold code - Flat

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.

•  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.

• 
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

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.

Are you taking other medicines?
Some medicines can interfere with your
treatment. Tell your doctor if you are taking
any of the following:

Revision No. 1

• 
Warfarin, a medicine used to thin your blood

• 
Are you pregnant or trying to become
pregnant?

Children should not normally be given
Lamisil Tablets.

180 x 300 mm Landscape

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

• 
Medicines used to treat fungal infections
(eg fluconazole, ketoconazole)

• Do you have psoriasis?

C96 (CP1/2)

• 
Beta-blockers or anti-arrhythmics for
heart problems

• 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.

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

A3

• 
Medicines used to treat cough
(eg dextromethorphan)
• Caffeine

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
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

•  your kidneys are not working very well,
If
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.

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.
GB 1406659a

Top

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
• 
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 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.
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
• Vertigo
• 
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:
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.

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.

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 June 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

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.

GB 1406659a

Bottom

Code direction (537)

Dummy

1. What Lamisil Tablets are and what
they are used for
Terbinafine, the active ingredient in Lamisil
Tablets, is an antifungal medicine.

LAMISIL® Tablets 250 mg

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

(terbinafine)
Patient Information Leaflet

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

What you need to know about 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
i
­ngredients of Lamisil Tablets. (These
are listed in Section 6.)
• you are breast-feeding

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.

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?
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)

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

563934 GB WEH.indd 1

  
Dimension:

563934 GB WEH

297 x 190 mm

Replaced no.: 420196 GB WEH

Drawing no.:

Gebrauchsinformation 190 x 297 mm

Product:

Leaflet LAMISIL SYSTEMIC TAB 250mg GB

Colours:

Pantone 314 C

Pres. Type:

GB



Code-no.:

000

Proof date:

15.10.2012

Visual code: N.A.

Colour/technical: Cutting
Receiving plant:

Wehr

News Gothic MT Pro Regular, Bold Cond., Italic
Used fonts: 
Smallest font size/line spacing/scale:
Smallest font size:
Smallest vectorized text:



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.
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
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.

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.

563934 GB WEH

15.10.12 16:11





• 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
c
­ ontrol 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

9 pt/11 pt/100%
6 pt

Body text (News Gothic MT Pro Regular)
Techn./Art. No. (News Gothic MT Pro Condensed)



  

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
• 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 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. 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
• Vertigo
• 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:
Psoriasis like skin eruptions, or worsening
of psoriasis, severe skin reactions
i
­ncluding a rash or eruption of small
pus containing blisters. 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

563934 GB WEH.indd 2

Dimension:

563934 GB WEH

297 x 190 mm

Replaced no.: 420196 GB WEH

Drawing no.:

Gebrauchsinformation 190 x 297 mm

Product:

Leaflet LAMISIL SYSTEMIC TAB 250mg GB

Colours:

Pantone 314 C

Pres. Type:

GB

Code-no.:

000

Proof date:

15.10.2012


Visual code: N.A.

Colour/technical: Cutting
Receiving plant:

Wehr

Used fonts: 
News Gothic MT Pro Regular, Bold Cond., Italic
Smallest font size/line spacing/scale:
Smallest font size:
Smallest vectorized text:



If any of the symptoms become
t
­ roublesome, 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 25°C.
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.

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 June 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

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

563934 GB WEH

15.10.12 16:11





ringing in the ears, flu like symptoms,
increase in blood of a muscle enzyme
called creatine phosphokinase (may be
found on a blood test).

9 pt/11 pt/100%
6 pt

Body text (News Gothic MT Pro Regular)
Techn./Art. No. (News Gothic MT Pro Condensed)

Expand view ⇕

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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