RISPERIDONE 0.5 MG ORODISPERSIBLE TABLETS - patient leaflet, side effects, dosage

yourcondition and vanes from person to 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 package as follows:

• 1. Hold the blisterat the edges and separate one blistercell from the rest ofthe blister by gently tearing along the perforations around it.

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

• 3. Tipthe tablet outontoyourhand.

• 4. Puttie tableton the tongue as soon as it is removed from tie packaging.

In a few seconds it begins disintegratingin the mouti and subsequently can be swallowed with orwithoutwaterThe mouth should be emptybefore placing the tablet onte tongue. You can also put the tablet in a full glass or cup ofwaterand drinkit straight away.

• If you take more Risperidone than you should Seeadoctorright away. Takethemedicine pack with you.
• In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy duetolowblood­pressure,orha­ve abnormal heart beats orfits.

If you forget to take Risperidone

• Ifyou forgetto take a dose, take itas soon as you remember it. However, if it is almost time foryournext dose, skip the missed dose and continue as usual. Ifyou miss two ormore doses, contactyour doctor.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Risperidone

You should notstop taking this medicine unlesstoldtodoso byyour doctor Your symptoms may return. Ifyour doctordecides to stop this medicine, your dose may be decreased gradually overa few days.

Ifyou have any furtherquestions on the use ofthis product, askyour doctororpharmacist

and eyes along with difficulty breathing, sudden weakness ornumbness ofthe face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes or strokes), involuntary movements of face, arms, or legs, ringing in ears, face oedema.

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

• Inability to reach orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
• Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling
• Lackofemotion
• Change in consciousness wit increased body temperature and twitching of muscles, oedema all overthe body, drug withdrawal syndrome, body temperature decreased
• Fast shallow breathing, trouble breating during sleep, chronic otitis media
• Obstruction ofintestine
• Reduced blood flow to the brain
• Decrease in white blood cells, inappropriate secretion of a hormone tat controls urinevolume
• Breakdown ofmuscle fibers and pain in muscles (rhabdomyolysis), movement disorder
• Coma due to uncontrolled diabetes
• Yellowing ofthe skin and the eyes (jaundice)
• Inflammation of the pancreas
• Lowbloodsugar

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 celltohelp you against infection)
• Prolonged and painful erection
• Dangerously excessive intake ofwater
• Blood clots in the veins especially in the legs (symptoms include swelling, pain and rednessin teleg),whichmay travel trough blood vessels to te lungs causing chest pain and difficulty in breathing. Ifyou notice any ofthese symptoms seek medical advice immediately

Like all medicines, Risperidone can cause side effect, although noteverybody get tiem. Very common: affects more than 1 userin 10

Common: affects 1 to10users in 100

Uncommon: affects 1to10 users in 1,000

Rare: affects 1 to10usersin 10,000

Veryrare: affectslessthan1u­serin

10,000

Not known: frequency cannot be estimated from the available data.

The following side effect may happen:

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

• Parkinsonism.This is a medical term that

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

Long-acting injectable risperidone formulation

The following side effect have been reported with te use of long-acting injectable risperidone formulation. Even ifyou arenot being treated with long acting injections of risperidone butyou experience any of the following, talk toyourdoctor

• Infection of the intestine
• Abscess underthe skin, tingling pricking or numbness of skin, inflammation ofthe skin
• Decrease in white blood cell counts that helps to protectyou against bacterial infection
• Depression
• Convulsion
• Eyeblinking
• Sensation ofspinningor swaying
• Slow beating heart high blood pressure
• Toothache, tongue spasm
• Buttockpain
• Weightdecreased.

_asleep. _

Common (affects 1 to 10 users in 100):

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.

• Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder
• Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth
• Weightincreased,in­creaseinbody temperature, decreased appetite
• Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred vision, nose congestion, nose bleeding, cough
• Urinary tract infection, bed wetting
• Muscle spasm, involuntary movement of face orarmsandlegs,jo­intpain, back pain, swelling of arms and legs, pain in arms and legs
• Rash, skin redness
• Fastbeatinghe­art,diestpain
• Blood prolactin hormone level increased.

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

• Excessive drinking ofwater, stool incontinence, thirsty, veryhard faeces, hoarseness orvoice disorder

Lung infection caused by inhaling of food into the breating passages, bladder infection, 'pink eye’, sinus infection,viral infection, ear infection, tonsil infection, infection underthe skin, eye infection, stomach infection, eye discharge, yeast infection of nails

• Abnormal electrical conduction of the heart drop in blood pressure after standing, low blood pressure, feeling dizzy afterchanging body position, abnormal electric activity tracing of tie heart (ECG), abnormal heart rhytm, awareness of heartbeating, heart rate increased or decreased
• Urinary retention, urinary incontinence, pain when passing urine, frequentpassing ofurine
• Confused, disturbance in attention, low level of consciousness, excessive sleep, ■ nervousness, elated mood (mania) lack of energy and interest

—— Liverenzymesin­creased,white­bloodcell count decreased, low haemoglobin or red blood cell count (anaemia), increase in eosinophils (special white blood cells), blood creatininephos­phokinase increased, decrease in platelet (blood cells that helpyou stop bleeding)

• Diabetes mellitus, high blood sugar
• Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, musculoskeletal chest pain, chest discomfort
• Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hairloss, skin inflammation caused by mites, skin discoloration, thickening of skin, flushing, reduced skin sensitivity to pain or touch, inflammation of oily skin
• No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge,enlar­gement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge
• Fainting, gaitdisturbance, sluggishness, decreased appetite resulting in malnutrition and low bodyweight, feeling 'out ofsorts’, balance disorder, allergy, oedema, speech disorder, chills, abnormal coordination
• Painful oversensitivity to light, increased blood flowtotie eye, eye swelling, dry eye, increase in tears
• Breating passage disorder, lung congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/whistling sound during breating, flu-like illness, sinus congestion
• Unresponsive tostimuli, loss of consciousness, sudden swelling oflips

Keep out of the reach and sight of children. Do not use aftterthe expiry date stated on the package.

This medicinal product does not require any special storage conditions.

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.

FURTHER INFORMATION

What Risperidone contains

• The active ingredientis risperidone. Each tablet contains 0.5 mg, 1mgor2 mg risperidone.
• Other ingredients 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.

This leaflet was last revised in June 2013.

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