iMeds.se

Risperat

Information för alternativet: Risperat 4 Mg Munsönderfallande Tablett, Risperat 3 Mg Munsönderfallande Tablett, visa andra alternativ

Package leaflet: Information for the patient


Risperat 3mg orodispersible tablets

Risperat 4mg orodispersible tablets


risperidone


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

.


What is in this leaflet:

1. What Risperatis and what it is used for

2. What you need to knowbefore you take Risperat

3. How to take Risperat

4. Possible side effects

5. How to store Risperat

6. Contents of the pack and otherinformation

1. What Risperat is and what it is used for


Risperat contains the active substance risperidone. It belongs to a group of medicines called ‘anti-psychotics’.


Risperat is used to treat the following:



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


2. What you need to know before you take Risperat


Do not take Risperat:

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 Risperat.


Warnings and precautions

Talk to your doctor or pharmacist before taking Risperat:

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


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


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 Risperat, your doctor may check your white blood cell counts.


Risperat 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 Risperat, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.


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.


Older people with dementia

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

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


Other medicines and Risperat

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:


The following medicines may reduce the effect of risperidone

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

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 Risperat.


Risperat with food, drink and alcohol

You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperat.


Pregnancy, breast-feeding and fertility

Risperat can raise your levels of a hormone called “prolactin” that may impact fertility (see section 4 “Possible side effects”).


Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with Risperat. Do not drive or use any tools or machines without talking to your doctor first.


Risperatcontains aspartame and sorbitol

Aspartame is a source of phenylalanine and may be harmful for people with phenylketonuria.

Sorbitol is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


3. How to take Risperat


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


Your doctor will tell you how much medicine to take and for how long. This will depend on your condition and varies from person to person.


The recommended dose is as follows:


For the treatment of schizophrenia


Adults


Older people


For the treatment of mania


Adults


Older people


For the treatment of long-standing aggression in people with Alzheimer’s dementia


Adults (including older people)


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.


Use in children and adolescents


For children who weigh less than 50 kg


For children who weigh 50 kg or more

The starting dose will normally be 0.5 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 Risperat for conduct disorder.


Method of administration

Risperatis for oral use.


Risperat orodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause damage to the tablet. Remove a tablet from the package with dry hands as follows:

Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

Pull up the edge of the foil and peel foil off completely.

Tip the tablet out onto your hand.

Put the tablet on the tongue as soon as it is removed from the packaging.

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or without water. The mouth should be empty before placing the tablet on the tongue.

Risperat orodispersible tablets can be taken with a meal or between meals.


If you take more Risperat than you should


If you forget to take Risperat


If you stop taking Risperat

You should not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop this medicine, your dose may be decreased gradually over a few days.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Tell your doctor immediately if you:


The following side effects may happen:


Very common: may affect more than 1 in 10 people


Common: may affect up to 1 in 10 people


Uncommon: may affect up to 1 in 100 people


Rare: may affect up to 1 in 1,000 people


Very rare: may affect up to 1 in 10,000 people

Lack of bowel muscle movement that causes blockage.


The following side effect has been seen with the use of another medicine called paliperidone that is very similar to risperidone, so it can also be expected with Risperat: Rapid heartbeat upon standing.


Additional side effects in children and adolescents

In general, side effects in children are expected to be similar to those in adults.

The following side effects were reported more often in children and adolescents (5 to 17 years) than in adults: feeling sleepy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhoea, and incontinence (lack of control) of urine.


Reporting of side effects

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

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Risperat


Keep this medicine out of the sight and reach of children.


Do not use this medicine after the exiry date which is stated on the blister and outer carton after EXP.The expiry date refers to the last day of that month.


Store in the original blister in order to protect from moisture.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how tothrow away medicinesyou no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Risperat contains


What Risperat looks like and contents of the pack

Round (diameter = 9 mm), slightly convex, pink marbled orodispersible tablets.


Pack sizes: 10, 20, 28, 30, 56, 60, 98 and 100 orodispersible tablets.

Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

To be completed nationally.



This medicinal product is authorised in the Member States of the EEA under the following names:


Name of the Member State

Name of the medicinal product

Sweden

Risperat



France

Risperidone Sandoz



This leaflet was last revised in 22 April 2015