INFORMATION FOR PEOPLE TAKING RISPERDAL™ LIQUID
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 liquid.
Please do not throw it away as you may need to refer to it again.
WHAT IS YOUR MEDICINE?
The name of your medicine is Risperdal n and its active ingredient is risperidone.
Risperdal liquid is a clear colourless solution which contains 1 mg of risperidone per millilitre (ml). The liquid contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide and water It is available in bottles containing 100 ml.
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 Licence (PL number 0242/0199) for this medicine is held by Janssen-Cilag Ltd. Saunderton, High Wycombe, Bucks HP14 4HJ.
Risperdal liquid is manufactured by Janssen Pharmaceutica, Beerse, Belgium
WHAT IS YOUR MEDICINE USED FOR?
Risperdal is used to treat conditions which affect the way you think, feel and/or act. These conditions may cause symptoms such as
confusion, hallucinations (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.
WHAT YOU SHOULD KNOW BEFORE YOU START YOUR TREATMENT
BEFORE TAKING ANY MEDICINE - always tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.
WHEN NOT TO USE YOUR MEDICINE
Do not use Risperdal if you have had an allergic reaction to Risperdal or any of the ingredients listed in the 'What is your
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.
Heart or blood vessel disease
Liver or kidney disease
If you suffer from any of these problems, tell your doctor before taking any Risperdal. 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 are pregnant, think you might be pregnant or are planning to become pregnant, you should talk to your doctor who will decide
if you can take Risperdal.
Do not breast feed if you are taking Risperdal. Ask your doctor for advice
Risperdal may make you put on weight so you should try to eat moderately while taking this medicine.
Always tell your doctor nurse or pharmacist if you are taking any other 'W medicines because taking some medicines together can be harmful.
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.
Driving or operating machinery
Risperdal might affect your alertness so you should not drive or operate machinery until the doctor sees how it affects you .
HOW TO USE YOUR MEDICINE
It does not matter whether you take Risperdal with or without food. The liquid can be swallowed directly or mixed
with some mineral water, orange juice or black coffee. If mixed in this way, the drink must be taken within 4 hours of mixing.
Instructions for using the pipette with Risperdal liquid
HOW MUCH SHOULD YOU TAKE?
Your doctor will tell you how much Risperdal to take and for how long you should continue to take it. This will vary from person to person and your doctor will adjust the amount of liquid to suit you. It is very important that you take the correct amount.
Remember - each millilitre (ml) of liquid is equivalent to 1 mg.
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:
The dosage will then be set to suit your needs but is normally 4mg, 6mg or 8mg (or 4ml, 6ml or 8ml) 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 (or 16ml) 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 much liquid 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.
WHAT TO DO IF YOU FORGET TO TAKE YOUR MEDICINE
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 dose after the first 3 days, do not take the missed dose but take your next dose as usual and continue your course.
If you are in any doubt as to how much liquid you should take you should contact your nurse or pharmacist.
IF YOU TAKE TOO MUCH OF YOUR MEDICINE
IF YOU THINK YOUR MEDICINE MAKES YOU FEEL ILL
There are usually few side effects when Risperdal is taken in the way your doctor nurse or pharmacist has described.
Sometimes Risperdal may cause side 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 this persists, 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 either 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 liquid 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 doctor, nurse or pharmacist.
Please also refer to the 'Special Precautions' sections above.
HOW TO STORE YOUR MEDICINE
As with all medicines, Risperdal liquid should be kept in a safe place where children cannot reach it. Store the liquid in
its original container at room temperature (15°C-30°C) and protect it from freezing. Do not use the liquid after the expiry date printed on the packaging. In addition, the liquid should not be used for longer than 3 months after the bottle has first been opened. Always return any leftover medicine to your pharmacist. Only keep it if your doctor tells you to.
This leaflet was prepared in November 1995.