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RISPERDAL 1 mg TABLETS /
RISPERIDONE l mg TABLETS /
RISPERDAL 2mg TABLETS /
RISPERIDONE 2mg TABLETS
(risperidone)

This product is available using any of the above names but will be referred to as Risperidone 1mg / 2mg Tablets throughout the following:

Patient Information Leaflet
Please read this information about Risperidone 1mg / 2mg Tablets carefully before you start taking your tablets.
It contains all the information you should need to know.

If you have any further questions or are not sure about anything, ask your doctor or pharmacist.
Please keep this information in a safe place, you may wish to refer to it again.

The medicine is called Risperidone Tablets. Each film-coated tablet contains 1 mg of the active ingredient risperidone, and is oblong and white. It is coded 'RIS 1' with a breakline on one side and plain on the reverse.
OR
The medicine is called Risperidone 2mg Each film-coated tablet contains 2 mg of the active ingredient risperidone, and is oblong and white. It is coded 'RIS 2' with a breakline on one side and plain on the reverse.

Risperidone 1mg Tablets also contain the following:
lactose, maize starch, microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulphate and propylene glycol.

Risperidone 2mg Tablets also contain the following:
lactose, maize starch, microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulphate, propylene glycol, titanium dioxide (E171), talc and sunset yellow FCF aluminium lake (E110).

Risperidone l mg / 2mg Tablets are available in blister packs containing 60 tablets.

Risperidone belongs to a group of medicines called antipsychotics and is used to improve thoughts, feeling andlor behaviour when these are disturbed In certain medical conditions.

Why you need to take this medicine:
Risperidone Tablets are used to treat conditions which affect the way you think, feel and/or act. These conditions may cause symptoms such as confusion, hallucinations (eg hearing, sensing or seeing things, which are not there), delusions, paranoia (unusual suspiciousness), and emotional and social withdrawal. People with these conditions may also feel depressed, guilty or anxious or tense.

Risperidone Tablets may be taken for acute (sudden) and chronic (long-­lasting) disorders.

Before you take your medicine:
Make sure it is safe for you to take Risperidone Tablets

If you answer YES to any of the following questions DO NOT use Risperidone l mg / 2mg Tablets. Tell your doctor.

  • Have you ever had an allergic reaction to Risperidone Tablets, risperidone or any of the other ingredients of these tablets? (an allergic reaction may include rash, itching, swollen lips or face, shortness of breath).

  • Are you breast feeding?

Check to see if any of the following apply to you, and consult your doctor before starting to take the medicine if the answer is YES to any of them:

  • Are you pregnant, think you might be pregnant or are you trying to become pregnant? If so you should talk to your doctor who will decide if you should take Risperidone 1mg / 2mg Tablets.

  • It you suffer from any of the following problems, you may need to be more closely supervised during treatment and the dosage may need to be altered.

  • Do you suffer from heart or blood vessel disease?

  • Do you suffer from kidney or liver disease?

  • Do you suffer from Parkinson's disease or epilepsy?

  • Are you taking carbamazepine (used to treat epilepsy or facial neuralgia - severe pain attacks in the face)? This may change the effect of Risperidone l mg / 2mg Tablets. Tell your doctor if you start or stop taking this drug as you may need a different dose of Risiperidione 1mg 1 2mg Tablets.

  • Are you taking any medicines for anxiety, medicines to help you sleep (tranquillisers), certain painkillers, antidepressants or some antihistamines (e.g. chiorpheniramine)? Taking Risperidone 1mg / 2rng Tablets as well may make you feel drowsy. Only take any of these as well as Risperidone Tablets if your doctor tells you that you can.

Are you taking any medicines for Parkinson's disease?

You should tell your doctor if you are taking any other medicines whether prescribed for or bought without prescription.

If you are not sure what to do, check with your doctor or pharmacist.

Warnings:
Risperidone 1mg /  2mg Tablets may make you put on weight, so you should try to eat moderately while taking these tablets.

You should be careful how much alcohol you drink whilst taking Risperidone Tablets. The combined effect of alcohol and the tablets may make you feel drowsy.

As with other drugs of this type, Risperidone Tablets could cause uncontrollable movements, mainly of the face or tongue. If this happens, consult your doctor.

Very rarely Risperidone Tablets might also cause fever, faster breathing, sweating, muscle stiffness and reduced consciousness. If any of these occur, STOP taking the tablets and contact your doctor immediately.

Risperidone Tablets may affect your alertness so you should not drive or operate machinery until the doctor sees how the tablets affect you.

Sunset yellow FCF aluminium lake (E110) can cause allergic type reactions including asthma.

Allergy is more common in those people who are allergic to aspirin.

When to take your tablets:
Follow the doctor's instructions, and check the directions on the pharmacy label, which should tell you how many tablets to take in a day. If it does not or you are unsure, ask your doctor or pharmacist.

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

This will 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.

The dose for adults and the elderly should be individually set by your doctor and if necessary increased only gradually.

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.

Risperidone Tablets is only for those aged 15 years and over.
The dose of Risperidone Tablets will be started gradually over the first days of treatment. Your doctor will probably recommend 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 in the morning and 2mg in the evening).

However, if you have not used Risperidone Tablets before, your doctor may recommend a more gradual increase.

The dosage will then be set to suit your needs but will normally be 4mg to 6mg 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. Some patients may require less than 4mg for a good effect.

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 feet better. It is important that you carry on taking Risperidone Tablets for as long as your doctor tells you to.

What to do if an overdose is taken:
If too many tablets are taken consult your doctor or get someone to take you to your nearest hospital casualty department IMMEDIATELY.

Do not drive yourself. Remember to take the leaflet and any tablets with you, so that the doctor in charge knows what you have taken.

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

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

If you are not sure what to do, ask your doctor or Pharmacist

Side-Effects:
As with all medicines Risperidone Tablets can cause unwanted side-effects in some patients. The tablets are generally well-tolerated. There are usually few side-­effects when Risperidone Tablets are taken in the way your doctor, nurse or pharmacist has prescribed.

Sometimes Risperidone  Tablets may cause side effects such as:
sleeplessness, agitation, anxiety and headache.

Occasionally the following effects may occur:
sleepiness, tiredness, concentration difficulties, blurred vision, dizziness, indigestion, nausea (feeling sick), vomiting (being sick), stomach ache, constipation, sexual potency problems, leakage of urine, runny or blocked nose, liver problems, local skin rash or swelling, or other allergic reactions suck as itching, swollen face or lips, shortness of breath. Swelling of the ankles may occur.

Some people may feel dizzy in the early stages of treatment, especially when getting up from a lying 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 Risperidone Tablets is reduced by your doctor or if your doctor prescribes 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. Risperidone Tablets 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 some cases,
the blood pressure may fall slightly in the early stages of treatment, resulting in dizziness.  This will usually pass off automatically. Somewhat later in treatment increased blood pressure may occur, but this is very rare.

In rare cases,
Risperidone Tablets 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,
Risperidone Tablets 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, Risperidone Tablets could cause uncontrollable movements, mainly of the face or tongue. Should this occur, talk to your doctor.

You should also see your doctor if you feel any other unusual or unexpected side effects not mentioned above during or after taking Risperidone Tablets. He or she (or it?) will have more information about Risperidone Tablets and will tell you what to do.

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

Storage:
Risperidone Tablets should be stored below30*C in a dry place and protected from light. The tablets should be kept in the original container.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

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

IMPORTANT.
This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

This is not the complete information about Risperidone. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who has access to additional information.

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Huddersfield One - Depression, December 2002
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