This leaflet contains important information Before you start to take your medicine, please read it carefully all the way through. If there is anything that you do not understand or if you need more information or advice, you should ask your pharmacist, nurse or doctor who will be pleased to help you

This leaflet applies only to Risperdal tablets. Please do not throw it away as you may need to refer to it again.

Risperdal tablets are oblong There are four strengths of tablets:

• White tablets contain 1 mg of risperidone and are marked Ris/1
• Orange tablets contain 2mg of risperidone and are marked Ris/2
• Yellow tablets contain 3mg of risperidone and are marked Ris/3
• Green tablets contain 4mg of risperidone and are marked Ris/4

The 1 mg tablets are available in packs containing 6 or 20 tablets The 6 tablet pack is designed for patients who are taking Risperdal for the first time. The 2, 3 and 4mg tablets are available in packs containing 60 tablets.

The tablets contain the following inactive ingredients: lactose, maize starch, microcrystalline cellulose, hypromellose, magnesium stearate. colloidal anhydrous silica, sodium lauryl sulphate and propylene glycol.

• 2mg tablets also contain titanium dioxide (E171), talc and sunset yellow (E110)
• 3mg tablets also contain titanium dioxide (E171), talc and quinoline yellow (E104)
• 4mg tablets also contain titanium dioxide (E171), talc, quinoline yellow (E104) and indigo carmine (E132)

Risperdal is one of a group of medicines called antipsychotics which improve thoughts, feelings and/or behaviour when these are disturbed in certain medical conditions

The UK Product Licences for the four strengths of this medicine (PL numbers 0242/0166, 0242/0187, 0242/0188, 0242/0189) are held by Janssen-Cilag Ltd, Saunderton, High Wycombe, Bucks HP14 4HJ. In Ireland, the Product Authorisations (PA numbers 545/31/1, 545/31/2, 545/31/3, 545/31/4) are held by Janssen Pharmaceutical Ltd, Little Island, County Cork

Risperdal tablets are manufactured by Janssen Cilag SpA, Latina, Italy

(e g hearing, seeing or sensing things which are not there), delusions, unusual suspiciousness (paranoia), emotional and social withdrawal People with these conditions may also feel depressed, guilty, anxious or tense. Risperdal may be taken for both sudden (acute) and long-lasting (chronic) disorders

REMEMBER - This medicine has been prescribed for you only

BEFORE TAKING ANY MEDICINE - always tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.

medicine?' section above. An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath. If this applies to you, tell your doctor

As with other drugs of this type, Risperdal could cause uncontrollable movements mainly of the face or tongue. Should this occur, talk to your doctor

Very rarely, Risperdal might cause fever, faster breathing, sweating, muscle stiffness and reduced consciousness. If this occurs. stop taking the liquid and contact a doctor at once.

If you suffer from any of these problems, tell your doctor before taking any Risperdal tablets. You may need to be more closely supervised during treatment and the dosage may have to be altered

Elderly people should be given a lower dose of Risperdal than is prescribed for other adults (see 'How much should you take?').

if you can take Risperdal.

Risperdal may make you put on weight so you should try to eat moderately while taking this medicine.

In particular, if you are taking any of the following, taking Risperdal as well may make you feel more drowsy: medicines taken for anxiety or to help you to sleep (tranquillisers), certain painkillers, some antihistamines (such as chlorpheniramine) and certain antidepressants. Only take any of these medicines while you are on Risperdal if your doctor says that you can.

A drug called carbamazepine, commonly used to treat epilepsy or facial neuralgia (severe pain attacks in the face), may change the effect of Risperdal, so tell your doctor if you start or stop taking this drug as you may need a different dose of Risperdal.

Also tell your doctor if you are taking medicines for Parkinson's disease before taking any Risperdal .

You should be careful how much alcohol you drink. The combined effect of Risperdal and alcohol might make you feel drowsy.

It does not matter whether you take Risperdal tablets with or without food Swallow the correct number of tablets with some liquid

vary from person to person and your doctor will adjust the number and strength of the tablets to suit you. Do not be surprised therefore if you are given differently coloured tablets from time to time It is very important that you take the correct amount

Remember - the tablets come in four different colours according to their strength:

• white = 1mg
• orange = 2mg
• yellow = 3mg
• green = 4mg

Always read the label on your medicine and follow your doctor's instructions carefully. Ask your pharmacist or nurse if you are not sure about anything.

Risperdal is only for those aged 15 years and over

The dose should be increased gradually over the first three days of treatment so your doctor will probably have recommended the following dosage to start with:

• Day 1 - 2mg (as a single dose or as 1 mg in the morning and 1 mg in the evening)
• Day 2 - 4mg (as a single dose or as 2mg n the morning and 2mg in the evening)
• Day 3 - 6mg (as a single dose or as 3mg in the morning and 3mg in the evening)

The dosage will then be set to suit your needs but is normally 4mg, 6mg or 8mg a day, either as a single dose or split into two doses, one to be taken in the morning and one to be taken in the evening.

Important - never take more than a total of 16mg per day.

If you are elderly or have a liver or kidney disorder, you should take half the above doses You will be told how many tablets you need to take.

Do not stop your treatment just because you feel better. It is important that you carry on taking Risperdal for as long as your doctor has told you to

If you miss a dose in the initial treatment period of 3 days, take it as soon as possible instead of your next dose and then continue to take the remaining doses in the order described above. Then continue at whatever dose your doctor has prescribed

If you miss a tablet after the first 3 days, do not take the missed dose but take your next dose as usual and continue your course.

hospital straight away

effects such as headache, sleeplessness, anxiety or agitation. Occasionally the following effects may occur: sleepiness, tiredness. dizziness, difficulty in concentrating, blurred vision, constipation, indigestion, feeling or being sick (nausea or vomiting), stomach ache, sexual potency problems, leakage of urine, runny or blocked nose, liver problems, local skin rash or swelling, or other allergic reactions such as itching, swollen face or lips, or shortness of breath.

Some people may feel dizzy in the early stages of treatment, especially when getting up from a Iying or sitting position. This will usually pass off on its own but if it does not, tell your doctor.

Sometimes trembling, pronounced muscle stiffness or spasm, slowness of movement, excess saliva or restlessness can occur but this will usually disappear if your dose of Risperdal is reduced by your doctor or if your doctor prescribes you an additional medicine.

After prolonged use, women may suffer from milk secretion, an absence of their monthly period or changes in the regularity of their periods. Men may experience breast swelling If these persist, tell your doctor.

Risperdal may make you put on weight so you should try to eat moderately while taking this medicine.

Occasionally, mild blood cell changes have been reported.

In rare cases, Risperdal may cause a desire to drink large amounts of water. You might also experience marked changes in your body temperature. Rare cases of convulsions have also occurred If any of these occurs, contact your doctor as soon as possible.

Very rarely, Risperdal might cause fever, faster breathing, sweating, muscle stiffness and reduced consciousness If this occurs, stop taking the tablets and contact a doctor at once.

As with other drugs of this type, Risperdal could cause uncontrollable movements, mainly of the face or tongue. Should this occur, talk to your doctor.

If your medicine affects you in any other way, you should tell your doctors nurse or pharmacist.

Please also refer to the 'Special precautions' sections above.

in their original container at room temperature (15ºC-30ºC) in a dry place and out of strong sunlight. Do not use the tablets after the expiry date printed on the packaging. Always return any left-over medicine to your pharmacist. Only keep it if your doctor tells you to.

This leaflet was revised on 9 May 1995.

™TRADEMARK.