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«Package leaflet: Information for the user Risperdal 0.5, 1, 2, 3, 4 and 6 mg film-coated tablets Risperdal Quicklet : 0.5, 1, 2, 3 and 4 mg ...»

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Package leaflet: Information for the user

Risperdal 0.5, 1, 2, 3, 4 and 6 mg film-coated tablets

Risperdal Quicklet : 0.5, 1, 2, 3 and 4 mg orodispersible tablets

Risperidone

Read all of this leaflet carefully before you start taking this medicine because it contains important

information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Risperdal is and what it is used for

2. What you need to know before you take Risperdal

3. How to take Risperdal

4. Possible side effects

5. How to store Risperdal

6. Contents of the pack and other information

1. What Risperdal is and what it is used for Risperdal belongs to a group of medicines called ‘anti-psychotics’.

Risperdal is used to treat the following:

• Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused

• Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called “bipolar disorder”

• Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others. Alternative (non-drug) treatments should have been used previously

• Short-term treatment (up to 6 weeks) of long-term, aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder.

Risperdal can help alleviate the symptoms of your disease and stop your symptoms from coming back.

2. What you need to know before you take Risperdal

Do not take Risperdal:

• If you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperdal.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperdal if:

• You have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure. Risperdal may cause low blood pressure. Your dose may need to be adjusted 1

• You know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain

• You have ever experienced involuntary movements of the tongue, mouth and face

• You have ever had a condition whose symptoms include high temperature, muscle stiffness, sweating or a lowered level of consciousness (also known as Neuroleptic Malignant Syndrome)

• You have Parkinson’s disease or dementia

• You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines)

• You are diabetic

• You have epilepsy

• You are a man and you have ever had a prolonged or painful erection

• You have problems controlling your body temperature or overheating

• You have kidney problems

• You have liver problems

• You have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour.

• You or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperdal.

As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarely with patients taking Risperdal, your doctor may check your white blood cell counts.

Risperdal may cause you to gain weight. Significant weight gain may adversely affect your health. Your doctor should regularly measure your body weight.

As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking Risperdal, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.

Risperdal commonly raises levels of a hormone called "prolactin". This may cause side effects such as menstrual disorders or fertility problems in women, breast swelling in men (see Possible side effects). If such side effects occur, evaluation of the prolactin level in the blood is recommended.

During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.





Elderly people with dementia In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by stroke.

During treatment with risperidone you should frequently see your doctor.

Medical treatment should be sought straight away if you or your care-giver notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.

Children and adolescents Before treatment is started for conduct disorder, other causes of aggressive behaviour should have been ruled out.

If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.

Before treatment is started your, or your child’s body weight may be measured and it may be regularly monitored during treatment.

–  –  –

Other medicines and Risperdal Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to talk to your doctor or pharmacist if you are taking any of the following:

• Medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these

• Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems, allergies (anti-histamines), some antidepressants or other medicines for mental problems

• Medicines that cause a slow heart beat

• Medicines that cause low blood potassium (such as certain diuretics)

• Medicines to treat raised blood pressure. Risperdal can lower blood pressure

• Medicines for Parkinson's disease (such as levodopa)

• Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much fluid (such as furosemide or chlorothiazide). Risperdal taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia.

The following medicines may reduce the effect of risperidone

• Rifampicin (a medicine for treating some infections)

• Carbamazepine, phenytoin (medicines for epilepsy)

• Phenobarbital If you start or stop taking such medicines you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone

• Quinidine (used for certain types of heart disease)

• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants

• Medicines known as beta blockers (used to treat high blood pressure)

• Phenothiazines (such as medicines used to treat psychosis or to calm down)

• Cimetidine, ranitidine (blockers of the acidity of stomach)

• Itraconazole and ketoconazole (medicines for treating fungal infections)

• Certain medicines used in the treatment of HIV/AIDS, such as ritonavir

• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.

• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

If you start or stop taking such medicines you may need a different dose of risperidone.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperdal.

Risperdal with food, drink and alcohol You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperdal.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can take it

• The following symptoms may occur in newborn babies, of mothers that have used Risperdal in the last trimester (last three months of their pregnancy): shaking, muscle stiffness, and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

• Risperdal can raise your levels of a hormone called "prolactin" that may impact fertility (see Possible side effects).

–  –  –

Risperdal film-coated tablets contain lactose The film-coated tablets contain lactose, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Risperdal 2 mg and 6 mg film-coated tablets also contain sunset yellow (E110) that may cause allergic reactions.

Risperdal Quicklet orodispersible tablets contain aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.

3. How to take Risperdal Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is as follows:

For the treatment of schizophrenia Adults

• The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day

• Your dose may then be adjusted by your doctor depending on how you respond to the treatment

• Most people feel better with daily doses of 4 to 6 mg

• This total daily dose can be divided into either one or two doses a day. Your doctor will tell you which is the best for you.

Elderly people

• Your starting dose will normally be 0.5 mg twice a day

• Your dose may then be gradually increased by your doctor to 1 mg to 2 mg twice a day

• Your doctor will tell you which is the best for you.

For the treatment of mania Adults

• Your starting dose will usually be 2 mg once a day

• Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment

• Most people feel better with doses of 1 to 6 mg once a day.

Elderly people

• Your starting dose will usually be 0.5 mg twice a day

• Your dose may then be gradually adjusted by your doctor to 1 mg to 2 mg twice a day depending on how much you respond to the treatment.

For the treatment of long-standing aggression in people with Alzheimer’s dementia Adults (including elderly people)

• Your starting dose will normally be 0.25 mg twice a day

• Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment

• Most people feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day

• Treatment duration in patients with Alzheimer’s dementia should be not more than 6 weeks.

–  –  –

• Children and adolescents under 18 years old should not be treated with Risperdal for schizophrenia or mania.

For the treatment of conduct disorder

The dose will depend on your child’s weight:

For children who weigh less than 50 kg

• The starting dose will normally be 0.25 mg once a day

• The dose may be increased every other day in steps of 0.25 mg per day.

• The usual maintenance dose is 0.25 mg to 0.75 mg once a day.

For children who weigh 50 kg or more

• The starting dose will normally be 0.5 mg once a day

• The dose may be increased every other day in steps of 0.5 mg per day.

• The usual maintenance dose is 0.5 mg to 1.5 mg once a day.

Treatment duration in patients with conduct disorder should be not more than 6 weeks.

Children under 5 years old should not be treated with Risperdal for conduct disorder.

People with kidney or liver problems Regardless of the disease to be treated, all starting doses and following doses of risperidone should be halved. Dose increases should be slower in these patients.

Risperidone should be used with caution in this patient group.

Method of administration For oral use Risperdal film-coated tablets

• You should swallow your tablet with a drink of water

• The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

Risperdal Quicklet orodispersible tablets Only remove a tablet from the blister when it is time to take your medicine.

• Peel open a blister to expose the tablet

• Do not push the tablet through the foil because it may break

• Remove the tablet from the blister with dry hands

• Place the tablet on your tongue straight away

• The tablet will begin disintegrating within seconds

• It can then be swallowed with or without water.

If you take more Risperdal than you should

• See a doctor right away. Take the medicine pack with you



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