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Risperidon Stada

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Document: Risperidon STADA film-coated tablet ENG PL change


Package leaflet: Information for the user


Risperidon STADA 0.5 mg film-coated tablets

Risperidon STADA 1 mg film-coated tablets

Risperidon STADA 2 mg film-coated tablets

Risperidon STADA 3 mg film-coated tablets

Risperidon STADA 4 mg film-coated 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 Risperidon STADA is and what it is used for

2. What you need to know before you take Risperidon STADA

3. How to take Risperidon STADA

4. Possible side effects

5. How to store Risperidon STADA

6. Contents of the pack and other information


1. What Risperidon STADA is and what it is used for


Risperidon STADA belongs to a group of medicines called 'anti-psychotics'.


Risperidon STADA is used to treat the following:


2. What you need to know before you take Risperidon STADA


DO NOT take Risperidon STADA:

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 Risperidon STADA.


Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidon STADA if:


Tell your doctor immediately if you experience


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


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


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


As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking risperidone, 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.


Elderly people with dementia

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

During treatment with Risperidon STADA 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 in conduct disorder, other causes of aggressive behaviour should have been ruled out.


If during treatment with Risperidon STADA 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 Risperidon STADA

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 Risperidon STADA

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


The following medicines may increase the effect of Risperidon STADA

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


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


Risperidon STADA with food, drink and alcohol

You can take this medicine with or without food.

You should avoid drinking alcohol when taking Risperidon STADA.


Pregnancy, breast-feeding and fertility


Driving and using machines

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


Risperidon STADA contains lactose and sunset yellow

Risperidon STADA film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


Risperidon STADA 2 and 3 mg film-coated tablets contain sunset yellow as colouring agent, which may cause allergic reactions.


3. How to take Risperidon STADA


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 amount of medicine you should take is explained under the 'How much to take' sub-heading below.


How muchto take


For the treatment of schizophrenia


Adults


Elderly people


Use in children and adolescents

Children and adolescents under 18 years old should not be treated with Risperidon STADA for schizophrenia.


For the treatment of mania


Adults


Elderly people


Use in children and adolescents

Children and adolescents under 18 years old should not be treated with Risperidon STADA for bipolar mania.


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


Adults (including elderly people)


For the treatment of conduct disorder in children and adolescents


The dose will depend on your child's weight:


For children who weigh less than 50 kg


For children who weigh 50 kg or more


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


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


People with kidney or liver problems

Regardless of the disease to be treated, all starting doses and following doses of Risperidon STADA should be halved. Dose increases should be slower in these patients.


Risperidon STADA should be used with caution in this patient group.


Method of administration


You should swallow your tablet with a drink of water.


The tablets which contain score line can be divided into equal doses. The score line tablet must be broken with both index fingers and thumbs along the score line.


For doses not realisable/practicable with these strengths, other strengths are available.


If you take more Risperidon STADA than you should


If you forget to take Risperidon STADA


If you stop taking Risperidon STADA

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):

Infection of the breathing passages, bladder infection, eye infection, tonsillitis, fungal infection of the nails, infection of the skin, an infection confined to a single area of skin or part of the body, viral infection, skin inflammation caused by mites


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


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


The following side effect has been seen with the use of another medicine called paliperidone that is very similar to risperidone, so these can also be expected with Risperidon STADA: 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 Risperidon STADA


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


Do not store above 30 C.

Keep the blister in the outer carton in order to protect from light.

Store in the original tablet container in order to protect from light.


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


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



6. Contents of the pack and other information


What Risperidon STADA contains


The active substance is risperidone.

Risperidon STADA 0.5 mg film-coated tablets: Each film-coated tablet contains 0.5 mg risperidone.

Risperidon STADA 1 mg film-coated tablets: Each film-coated tablet contains 1 mg risperidone.

Risperidon STADA 2 mg film-coated tablets: Each film-coated tablet contains 2 mg risperidone.

Risperidon STADA 3 mg film-coated tablets: Each film-coated tablet contains 3 mg risperidone.

Risperidon STADA 4 mg film-coated tablets: Each film-coated tablet contains 4 mg risperidone.



The other ingredients are:


Tablet core:

lactose monohydrate, maize starch, cellulose microcrystalline, magnesium stearate (E470b), Silica colloidal anhydrous (E551) and sodium laurilsulfate.


Film coating:


What Risperidon STADA looks like and contents of the pack


The tablets are available in different strengths: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg per tablet. The different strengths can be identified in the different colour and shape:



Risperidon STADA 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg film-coated tablets are packed in blister strips containing 6, 10, 20, 28, 30, 50, 56, 60, 100 (5 x 20) tablets. There are also Risperidon STADA 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg plastic bottles containing 50, 100 or 250 tablets.


Not all pack sizes may be marketed.



Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>


Marketing Authorisation Holder:

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany


Manufacturer:


STADA Arzneimittel AG

Stadastraβe 2-18

D-61118 Bad Vilbel

Germany


Centrafarm Services. B.V.

Nieuwe Donk 9

NL-4871 AC Etten Leur

The Netherlands


LAMP S. PROSPERO S.P.A.

Via Giorgi 27

41100 Modena (MO)

Italy


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


Denmark: Risperidon "Stada"

Finland: Risperidone STADA

Sweden: Risperidon STADA


This leaflet was last revised in 11 May 2016