TERBINAFINE TABLETS 250MG

Active substance: TERBINAFINE HYDROCHLORIDE

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S1498 LEAFLET Lamisil 20121011

PACKAGE LEAFLET: INFORMATION FOR THE USER

LAMISIL TABLETS
TERBINAFINE TABLETS 250mg
(terbinafine hydrochloride)
The name of your medicine is as above and will be referred to as
Lamisil Tablets throughout the following leaflet.
What you need to know about Lamisil Tablets
Your doctor has decided that you need this medicine to help treat
your condition.



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.
Will there be any problems with driving or using machinery?



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.

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.



If you have any other questions, or if there is something you
don’t understand, please ask your doctor or pharmacist.

3. HOW TO TAKE LAMISIL TABLETS



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:

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.

1. What Lamisil Tablets are, and what they are used for
2. Things to consider before you start to take Lamisil Tablets
3. How to take Lamisil Tablets

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

4. Possible side effects



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

5. How to store Lamisil Tablets



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.

6. Further information
1. WHAT LAMISIL TABLETS ARE AND WHAT 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. THINGS TO CONSIDER BEFORE YOU START TO 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.

 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.
Some side effects can be serious



Are you pregnant or trying to become pregnant?

Stop taking the tablets and tell your doctor immediately if you
notice any of the following rare symptoms:



Do you have any problems with your kidneys or liver?





Do you have psoriasis?

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)

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

The most common side effects are:-

6. FURTHER INFORMATION



Headache

What Lamisil Tablets contains



Stomach problems such as loss of appetite, ache, indigestion,
feeling bloated or sick



Each Lamisil tablet contains 281.25mg of the active ingredient
terbinafine hydrochloride, equivalent to 250mg terbinafine.



Diarrhoea





Itching, rash or swelling



Pains in the muscles and joints

Lamisil Tablets also contain the following: magnesium stearate,
colloidal silicon dioxide, hypromellose, microcrystalline
cellulose, and sodium starch glycollate.

The side effects listed below have also been reported.

What Lamisil Tablets looks like and contents of the pack


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.

The Lamisil tablets are off-white and coded LAMISIL 250 on
one side with a breakline on the reverse.



Lamisil Tablets are available as blister packs of 14 or 28
tablets.

There have also been reports of some people experiencing anxiety
or symptoms of depression as a result of these taste disturbances.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Up to 1 in 100 people have experienced:

Product Licence holder

Up to 1 in 1,000 people have experienced:


Feeling unwell, dizzy

Manufacturer



Numbness or tingling

This product is manufactured by


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



Onset or worsening of a condition called lupus (a long-term
illness with symptoms including skin rash and pain in the
muscles and joints)



Novartis Farmaceutica S.A, 08013 Barcelona, Spain.

POM

PL No.: 19488/1498

Leaflet revision date: 11 October 2012

Vertigo



Novartis Farmaceutica S.A, Fontcoberta 1, 08034, Barcelona,
Spain.

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



Lamisil Tablets should be protected from light. Store below
25°C. Keep the tablets in the foil; only remove them when it is
time to take your medicine.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will advise you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

Lamisil is a registered trademark of Novartis AG, Switzerland.
S1498 LEAFLET Lamisil 20121011

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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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