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LAMISIL TABLETS/TERBINAFINE 250mg TABLETS

(Terbinafine hydrochloride)

Your medicine is available using either of the above-names 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.

In this leaflet:

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

4)    Possible side effects

5)    How to store Lamisil Tablets

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.

•    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 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.

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, pharmacist or nurse.

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

•    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. Protect from light.

•    Keep the tablets in the foil, only remove them when it is time to take your medicine.

•    KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor decides to stop taking your tablets, please take them back to the pharmacist for safe disposal. Only keep your medicine if you doctor tells you to.

•    If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist.

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

6)    Further information.

What Lamisil Tablets contains

It contains the active ingredient, Terbinafine Hydrochloride 281.25mg, equivalent to 250mg terbinafine,

Lamisil Tablets also contain the following:

magnesium stearate, colloidal silica, methylhydroxypropylcellulose, microcrystalline cellulose, and sodium carboxymethyl starch.

What Lamisil Tablets looks like and the contents of the pack

Lamisil Tablets are off-white coded tablets.

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

PL 10383/0282    POM!

Who makes and repackages your medicine:

Your medicine is manufactured by Novartis Farmaceutica SA, Gran Via de les Corts Catalanes, 764 08013 Barcelona, Spain. Procured from within the EU and repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 27.03.2014