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Risperidone 2 Mg Orodispersible Tablets

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Document: leaflet TEVA UK_PL 01656-0021 change

RISPERIDONE 0.5 mg ORODISPERSIBLE TABLETS RISPERIDONE 1 mg ORODISPERSIBLE TABLETS RISPERIDONE 2 mg ORODISPERSIBLE TABLETS


Risperidone


Medicines forParkinson’s disese (such levodopa)

Water tablets (diuretics) used forhear problems or swelling of parts ofyour

(suc^ as furosemide orchlorothiazide Risperidone taken by itselforwith furosemide, may have an increased ri stroke or deaih in elderly people with



Read all of this leaflet carefully before you

start using this medicine.

•    Keep this leafletYou may need to read it

•    ff9 ouhavean further uestionsask our doctor orpharmacist.

•    This medicine has been prescribed foryou. Do notpass itonto others. It mayharm them, even ifiheir symptoms areihe same

•    If any of ihe side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctoror pharmacist.


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1.    What Risperidone is and what it is used for

2.    Before you take Risperidone

3.    How to take Risperidone

4.    Possible side effects

5.    How to store Risperidone

6.    Further information

1 WHAT RISPERIDONE IS AND WHAT IT IS USED FOR


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Risperidone belongs to a group of medicines called ‘anti-psychotics’

orfeeUhings that are notthere, believe


hyperactive. Mania occurs In an illness • Short-term treatment (up to 6 weeks) of

themselves or others. Alternative (non-drug) treatments should have been used previously.


ie (blockers ofthe

aciaity of stomach).

Ifyou start or stop taking such medicines may need a differentdose of risperidone. Ifyou arenotsureif any ofthe above app to you, talk to your doctor orpharmacist before using Risperidone.

Taking Risperidone with food and drink

food.You should avoid drinking alcohol w taking Risperidone.

Pregnancy and breast-feeding

•    Talk toyour doctor before using Risperidone ifyou are pregnant, trying become prepnantor breast-feeding.Yo

•    Shaking, muscle stiffness and problem


Jring tf


monies of their pregnancy): shaking, muscle stiffness and/orweakness, sleepiness, agitation, breathing problems, and difficulty in feeding. Ifyour Babydevelops any of ihese symptoms you may need to contactyour doctor.


2 BEFORE YOU TAKE RISPERIDONE

Do not take Risperidone

• ifyou are allergic (hypersensitive) to risperidone or any of ihe other ingredients of Risperidone (listed in Section 6 below).


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Take special care with Risperidone

Checkwiih yourdoctor orpharmacist before taking Risperidone if:

•    You have a heart problem. Examples includean irregular heart rhyihm or ifyou are prone to low blood pressure orifyouare

Risperidone may cause low blood pressure. Yourdose mayneed to be adiusted.

•    You know of any factors which would

blood pressure, cardiovasculardisorder or

•    You have Parkinson’s disease or dementia


wimouttaiKing to yourdoctor first. Important information about some of the ingredients of Risperidone

Risperidone orodispersible tablets contain aspartame (E95l)whichisa source of phenylalanine. Aspartame may be harmful for people with phenylketonuria.

3 HOW TO TAKE RISPERIDONE How much to take For the treatment of schizophrenia

• The usual starting dose is 2 mg per day,

• ....... • ncreased to4mg perdayon


Yourc


experience this while taking Risperidone, contactyourdoctorstraight away.

•    You have problems controlling yourbody temperature or overheating

•    You have kidney problems

•    You have liverproblems

•    You have an abnormally high level of the hormone prolactin in yourBlood or ifyou have a tumour, which is possibly dependenton prolactin

•    You or someone else in your family hasa history of blood clots, as medicines like

Tell your doctor immediately if you experience

•    involuntary rhythmic movements of ihe tongue, mouth and face.Wiihdrawal of

•    fever, severe muscle stiffness, sweating or

disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may beneeded.

Ifyou arenotsureif any of the above applies

toyou, talk to yourdoctor orpharmacist

beforeusingRisperidone.


ir depending oi Most people feel be


Elderly people


Children and adolescents

old should not be treated with Risperio


For the treatment of mania


byyour doctordepending c respond to the treatment Most people feel betterwitt


Elderly people


measure your bodyweight.

As diabetes mellitus orworsening of pre-existing diabetes mellitus have been seen with patients taking Risperidone, yourdoctor

patients with pre-existing diabetes mellitus blood glucose should be monitored regularly. Elderly people with dementia

In elderly patients wiih dementia, there is an increased risk ofstroke. You shouldnot take

During treatmentwith risperidone you should frequently see yourdoctor.

Medical treatment should be sought straight

sudden weakness ornumbess ofyour face, armsorlegs, especially ononeside,or slurred speech, even for ashort period of time.These maybe signs ofa stroke.

Children and adolescents

Before treatment is started in conduct


day depending on how much you respond Children and adolescents

old should not be treated with Risperidone

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

•    Your starting dosewill normally be 0.25mg

•    Yourdose may then be gradually adiusted byyour doctordepending on howyou respond to the treatment

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


For the treatment of conduct disorder in children and adolescents

The dosewill depend on yourchild’sweigh


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

Before ireatment is started your, oryour child's bodyweight may be measured anditmaybe regularlymonitored during treatment.

Taking other medicines

are taking or have recently taken any other

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

to help you calm down ('benzodiazepines) orsome medicines forpain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these

• Medicines that may change ihe electrical activity ofyour heart, sucFi as medicines formalaria, heart rhythm problems (such

some antidepressants orothermedicines


treated with Rispendone forconduct disorder. People with kidney or liver problems

Regardless ofthe disease to be treated, all starting doses and following doses of risperidone should be halved. Dose increases should be slower in ihese patients. Risperidone should be used with caution in


•    Medicines that cause low blood potassium

•    Medicines to treatelevated blood pressure.


How to take Risperidone

Always take Risperidone exactly


person. The amount ofmedicine you should take is explained underthe 'How much to take’ sub-heading below.


Risperidone 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


and eyes along with difficulty breathing, sudden weakness ornumbness ofthe

or instances of    SKS

mini-strokes or strokes), involuntary movements of face, arms, or legs, ringing

Rare (affects 1 to 10 users in 10,000):


by gently tearing along the perforations

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


is removed from he packaging.

In a few seconds it begins disintegrating in the mouh and subsequently can be swallowed


emptybefore placing the tablet onhe tongue. You can also put the tablet in a full glass or cup ofwaterand drink it straight away.


•    Dandruff

lip swelling/lip inflammation

•    Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling

•    Change in consciousness wiih increased body temperature and twitching of

withdrawal syndrome, body temperature decreased

•    Fast shallow breathing, trouble breathing during sleep, chronic otitis media

•    Obstruction of intestine

•    Reduced blood flow to the brain

•    Decrease in white blood cells, inappropriate secretion of a hormone that

•    Breakdown ofmuscle fibers and pain in muscles (rhabdomyolysis), movement


If you take more Risperidone than you should

• See a doctor rightaway. Take themedicine


If you forget to take Risperidone

• Ifyou forgetto take a dose, take it as soon as you remember it. However, if it is almost time foryournext dose, skip the

* Do not take a double dose (two doses at the same time) to make up for a forgotten


If you stop taking Risperidone

You should notstop taking this medicine unlesstoldtodoso byyour doctor. Your symptoms may return. Ifyour doctordecides

decreased gradually overa few days.


•    Coma due to uncontrolled diabetes

•    Yellowing ofthe skin and the eyes

•    Inflammation of the pancreas

Very rare (affects less than 1 user in 10,000):

•    Life threatening complications of uncontrolled diabetes.

Unknown frequency of occurrence (frequency

cannot be estimated from the available data):

•    Severe allergic reaction resulting in difficulty in breathing and shock

•    No granulocytes (a type ofwhite blood cell to help you against infection)

•    Prolonged and painful erection

•    Dangerously excessive intake ofwater


ofthis product, askyour doctororpharmacist 4 POSSIBLE SIDE EFFECTS

effects, although noteverybody gets hem'. Very common:    affects more than 1 userin 10

Common:    affects 1 tolOusers in 100

Uncommon:    affects 1to10 users in 1,000

Rare:    affects 1 tolOusersin 10,000

Veryrare:    affectslessthanluserin

10,000

Not known: frequency cannot be estimated

The following side effects may happen:

Very common (affects more than 1 user in 10):

includes many symptoms. Each individual symptom may occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion orwatery mouth, musculoskeletal stiffness, drooling,

reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping ofthe forehead (an abnormal reflex).

• Headache, difficulty falling or staying

Common (affects 1 to 10 users in 100):

to sit still, irritability anxiety, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder

increased appetite, abdominal pain or


breathing. Ifyou notice any ofthese symptoms seek medical advice immediately.

Long-acting injectable risperidone formulation

The following side effects have been reported with ihe use of long-acting injectable

being treated with long acting injections of risperidone butyou experience any of the

• Abscess underthe skin, tingling pricking


• Decrease in white blood cell counts that helps to protectyou against bacterial



•    Sensation ofspinningor swaying

•    Slow beating heart high blood pressure

•    Toothache, tongue spasm

•    Buttockpain

•    Weightdecreased.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 HOW TO STORE RISPERIDONE Keep out of the reach and sight of children.

package.


•    Weightincreased,increaseinbody temperature, decreased appetite

•    Difficulty breathing, lung infection

breathing passages, blurred vision, nose congestion, nose bleeding, cough

•    Muscle spasm, involuntary movements of

pain, swelling of arms and legs, pain in arms and legs

•    Rash, skin redness

•    Fastbeatingheart,chestpain

•    Blood prolactin hormone level increased. Uncommon (affects 1 to 10 users in 1,000):

•    Lung infection caused'by inhaling of food into the breathing passages, bladder

stomach infection, eye discharge, yeast

•    Abnormal electrical conduction of the heart drop in blood pressure after

after changing body position, abnormal electric activity tracing of ihe heart (ECG), abnormal heart rhylhm, awareness of heart beating, heart rate increased or decreased

pain when passing urine, frequentpassing


Medicines should not be disposed of via wastewater or household waste. Ask your

[pharmacist how to dispose of medicines no onger required. These measures will help to protect the environment.

6 FURTHER INFORMATION

What Risperidone contains

• The active ingredient is risperidone. Each tablet contains 0.5 mg, 1mgor2 mg

• of^eringredients are mannitol (E421), basic butylated methacrylate copolymer, povidone K-25, microcrystalline cellulose, hydroxypropylcellulose, aspartame (E951), crospovidone, red iron oxide (E172), spearmint flavour, peppermint flavour, calcium silicate, magnesium stearate. What Risperidone looks like and contents of the pack

Orodispersible tablets:

Tablets are round, slightly convex, pink marbled tablets.

Contents ofthe packs: 20, 28, 30, 50, 56, 60,

98 orlOO tablets in blisters.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Krka, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novomesto,Slovenia.


This leaflet was last revised in June 2013.


energy and interest

count decreased, low haemoglobin or re> blood cell count (anaemia), increase in eosinophils (special white blood cells), blood creatininephosphokinase increased, decrease in platelets (blood cells that helpyou stop bleeding) Diabetes mellitus, high blood sugar Muscle weakness, muscle pain, ear pain, illing, abnormal


Session,'

itching of sk


: stiffness,


culoskeletal


No menstruation, sexual dysfunction, erectile dysfunction, eiaculation disorder, breast discharge,enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge

decreased appetite resulting in


eye, increase in tears • Breathing passage disorder, lung

congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum,


• Unresponsive to stimuli,loss of

consciousness, sudden swelling of lips


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