Package leaflet: Information for the user

Risperidone 0.5 mg film-coated tablets Risperidone 1 mg film-coated tablets Risperidone 2 mg film-coated tablets Risperidone 3 mg film-coated tablets Risperidone 4 mg film-coated tablets Risperidone 6 mg film-coated tablets

Risperidone

Read all of this leaflet carefully before you start taking this medicine because It contains Important Information foryou.

•    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 foryou 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.

The name of the medicine is Risperidone Film-Coated

tablets (also referred to as Risperidone or Risperidone Tablets throughout this leaflet). Risperidone tablets are available in six strengths: 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg.

What is in this leaflet:

1.    What Risperidone tablet is and what it is used for

2.    What you need to know before you take Risperidone tablet

3.    How to take Risperidone tablet

4.    Possible side effects

5.    Howto store Risperidone tablet

6.    Contents of the pack and other information.

1. What Risperidone tablet is and what it is used for

Risperidone belongs to a group of medicines called

'antipsychotics'.

Risperidone tablet is used to treatthe 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.

2. What you need to know before you take Risperidone tablet

Do not take Risperidone tablet

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidone tablet 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. Risperidone tablet may cause low blood pressure. Your dose may need to be adjusted

•    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 Parkinson's disease or dementia

•    You are diabetic

•    You have epilepsy

•    You are a man and you have ever had a prolonged or painful erection. If you experience this while taking Risperidone tablet, contact your doctor straight away

•    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 tumour, which is possibly dependent on prolactin

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

•    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)

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.

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.

Tell your doctor Immediately If you experience

•    involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of risperidone may be needed

•    fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome). Immediate medical treatment may be needed.

If you are not sure if any of the above applies to you, talk to your doctoror pharmacist before using Risperidone tablets.

Risperidone tablet may cause you to gain weight.

Older people with dementia

In older 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, vision problems or slurred speech, even for a short period of time. These may be signs of a stroke.

Children and adolescents

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

Before treatment is started in 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.

Other medicines and Risperidone tablet

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 (such as quinine, mefloquine), heart rhythm problems (such as quinidine, dysopyramide, procainamide, propafene, amiodarone, sotalol), allergies (anti-histamines), some antidepressants (such as amitriptyline, maprotiline) or other medicines for mental problems

•    Medicines that cause a slow heart beat

•    Medicines that cause low blood potassium or magnesium (e.g. certain diuretics)

•    Medicines to treat elevated blood pressure. Risperidone 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). Risperidone taken by itself or with furosemide, may have an increased risk of stroke or death in older people with dementia.

The following medicines may reduce the effect of risperidone

•    Rifampicin (a medicine fortreating 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, fluoxetines, tricyclic antidepressants

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

•    Phenothiazines (e.g. used to treat psychosis or to calm down)

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

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 Risperidone tablet.

Risperidone tablet with food and drink

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

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 pharmacistforadvice before taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used Risperidone in the lasttrimester (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.

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

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with Risperidone tablets. Do not drive or use any tools or machines without talking to yourdoctorfirst.

Risperidone tablet contain sodium lauryl sulphate and lactose monohydrate

Your medicine also includes certain inactive ingredients namely sodium lauryl sulphate and lactose monohydrate. Each risperidone 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg tablet contains 0.5 mmol of sodium pertablet. This should be taken into consideration for patients on a controlled sodium diet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Risperidone 2 mg tablets also contain sunset yellow (E110)

Risperidone 2 mg tablets also contains a coloring agent sunset yellow (E110), which may cause allergic reactions.

3. How to take Risperidone tablet

be not more than 6 weeks.

Children under 5 years old should not be treated with Risperidone tablets 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.

Risperidone film-coated tablet

You should swallow yourtablet with a drink of water.

If you take more Risperidone tablet than you should

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

•    In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats orfits.

If you forget to take Risperidone tablet

•    If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor

•    Do nottake a double dose (two doses atthe same time) to make up fora forgotten dose.

If you stop taking Risperidone tablet

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 overafew days.

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

4. Possible side effects

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 much to take

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.

Older people

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

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

•    Yourdoctor will tell you which is the bestforyou.

Children and adolescents

•    Children and adolescents under 18 years old should not be treated with Risperidone tablets for schizophrenia.

Forthe 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.

Older 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.

Children and adolescents

•    Children and adolescents under 18 years old should not be treated with Risperidone tablets for bipolar mania.

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

Adults (including older 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.

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

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

•    The dose may be increased every other day in steps of 0.25mgperday

•    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

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Serious side effects

If any of the following side effects happen, stop taking

Risperidone and tell your doctor immediately or go to the

casualty department at your nearest hospital.

•    Severe allergic reaction resulting in difficulty in breathing and shock, swollen mouth, face, lip or tongue, itching, fever, skin rash or drop in blood pressure

•    Sudden swelling of lips and eyes along with difficulty breathing, sudden weakness or numbness of the 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),

•    Tardive dyskinesia: Twitching or jerking that you cannot control in your face, tongue, or other parts of your body. Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of Risperidone may be needed

•    Inflammation of the pancreas (symptoms include severe upper stomach pain, often with nausea and vomiting)

•    Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately

•    Prolonged and painful erection

•    Fever, muscle stiff ness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be needed

Other side effects

Very Common (may affect more than 1 in 10 people):

•    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 or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, 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 of the forehead (an abnormal reflex)

•    Headache, difficulty falling or staying asleep.

•    Drowsiness, sleepiness

Common (may affect up to 1 in 10 people):

•    Fatigue, restlessness, inability to sit still, irritability, anxiety, depression, dizziness, poor attention, feeling exhausted, sleep disorder

•    Vomiting, diarrhoea, indigestion, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth

• Weight increased, increase in body temperature, decreased appetite

•    Difficulty breathing, lung infection (pneumonia), flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills, infection of the breathing passages, blurred vision, nose congestion, nose bleeding, cough, sinus infection, ear infection

•    Urinary tract infection (bladder infection)

• Muscle spasm, musculoskeletal pain, involuntary movements of face or arms and legs, joint pain, back pain, swelling of arms and legs, pain, toothache

•    Dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, ortwitching

•    Dystonia: This is a condition involving slow or sustained involuntary contraction of muscles. While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, eye discharge, mouth, tongue or jaw.

•    Rash, skin redness

•    Fast beating heart, chest pain

•    Fall, tremors

•    High blood pressure

•    Blood prolactin hormone level increased.

Uncommon (may affect up to 1 in 100 people):

•    Excessive drinking of water, stool incontinence, thirsty, very hard faeces, wind, increase in body temperature

•    Lung infection caused by inhaling of food into the breathing passages, bladder infection, 'pink eye', viral infection, tonsil infection, infection under the skin, infection confined to a single area of skin or part of the body, eye infection, stomach infection, yeast infection of nails

•    Abnormal electrical conduction of the heart, interruption in conduction between the upper and lower parts of the heart, drop in blood pressure after standing, low blood pressure, feeling dizzy after changing body position, abnormal electric activity tracing of the heart (ECG), prolongation of the QT interval in ECG, abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased

•    Urinary incontinence, inability to pass urine, pain when passing urine, frequent passing of urine

•    Confused, disturbance in attention, low level of consciousness, nervousness, nightmare, elated mood (mania) psychomotor hyperactivity

•    Blood sugar increased, diabetes mellitus (excessive thirst, increased appetite with weight loss, feeling tired, drowsy, weak, depressed, irritable and generally unwell, and passing large amounts of urine), increased cholesterol in your blood, liver enzymes increased, white blood cell count decreased, low haemoglobin or red blood cell count (anaemia), increase in eosinophils (special white blood cells ), blood creatinine phosphokinase increased, decrease in platelets (blood cells that help you stop bleeding), no granulocytes (a type of white blood cell to help you against infection)

•    Muscle weakness, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort, procedural pain, discomfort

•    Convulsions

•    Reduced blood flow to the brain

•    Loss orabnormal sense of taste

•    Skin lesion, skin disorder, eczema, hives, dry skin, intense itching of skin, acne, hair loss, 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, leakage of milk from the breasts, enlargement of breast in men, breast pain and discomfort, decreased sexual drive, irregular menstruation, menstrual disorder, vaginal discharge

•    Fainting, gait abnormal, loss of appetite, weight decreased, feeling 'out of sorts', balance disorder, speech disorder, chills, abnormal coordination

•    Painful oversensitivity to light, increased blood flow to the eye, dry eye, increase in tears

•    Breathing passage disorder, lung congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/whistling sound during breathing, sinus congestion

•    Unresponsive to stimuli, loss of consciousness

•    Ringing in ears, sensation of spinning or swaying, face edema.

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

•    Inability to reach orgasm, a delay in menstrual periods

•    Dandruff

•    Hard lump

•    Drug allergy, coldness in arms and legs, lip inflammation

•    Glaucoma (high pressure in the eye)

•    Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Risperidone. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine.

•    Lack of emotion

•    Edema all over the body, drug withdrawal syndrome, body temperature decreased

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

•    Obstruction of intestine

•    Shaking of head

•    Blood vessel problems in the brain

•    Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume, sugar in the urine, high blood triglycerides (a fat), increased insulin (a hormone that controls blood sugar levels) in your blood, low blood sugar

•    Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder

•    Coma due to uncontrolled diabetes

•    Yellowing of the skin and the eyes (jaundice)

•    Enlargement of the glands in your breasts, breast enlargement, breast discharge

•    Swollen tongue

•    Dangerously excessive intake of water.

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

•    Life threatening complications of uncontrolled diabetes, (which includes symptoms such as loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heartbeat, unusual muscle pain orfeeling weak, tired or uncomfortable)

•    Complete bowel obstruction (ileus).

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 risperidone: Rapid heartbeat upon standing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Risperidone Tablet

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last date of that month.

Do not store above 25° C

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

6. Contents of the pack and other information

What Risperidone tablets contain

Each Risperidone 0.5 mg film-coated tablet contains 0.5 mg risperidone

Each Risperidone 1 mg film-coated tablet contains 1 mg risperidone

Each Risperidone 2 mg film-coated tablet contains 2 mg risperidone

Each Risperidone 3 mg film-coated tablet contains 3 mg risperidone

Each Risperidone 4 mg film-coated tablet contains 4 mg risperidone

Each Risperidone 6 mg film-coated tablet contains 6 mg risperidone

Risperidone tablets also contain inactive ingredients: These are microcrystalline cellulose, lactose monohydrate, pregelatinised starch, sodium lauryl sulphate, magnesium stearate, colloidal anhydrous silica, hypromellose and titanium dioxide. (E171).

0.5 mg tablets also contain Opadry II 31G 56729 brown, macrogols, talc and red iron oxide (E172).

1    mg tablets also contain Opadry 20H 58983 white, propylene glycol, talc and hydroxypropyl cellulose.

2    mg tablets also contain Opadry II 31G 53291 orange, macrogols, talc and sunset yellow FCF (E110).

3mg tablets also contain Opadry II 31G 52408 yellow, macrogols, talc and Quinoline yellow aluminium lake

4mg tablets also contain Opadry II 31G 51195 green, macrogols, Quinoline yellow aluminium lake and FD & C Blue no.2.

6mg tablets also contain Opadry II 31G 52408 yellow, macrogols, talc and Quinoline yellow aluminium lake

What Risperidone tablets look like and the contents of the pack

Risperidone 0.5 mg film-coated tablets are brown coloured, film coated, oval shaped tablets with a scoreline on both sides and 'RSN' and '0.5' debossed on either side of the scoreline on one side of the tablet.

Risperidone 1 mg film-coated tablets are white coloured, film coated, capsule shaped tablets with a scoreline on both sides and 'RSN' and '1' debossed on either side of the scoreline on one side of the tablet.

Risperidone 2 mg film-coated tablets are peach coloured, film coated, capsule shaped tablets with a scoreline on both sides and 'RSN' and '2' debossed on either side of the scoreline on one side of the tablet.

Risperidone 3 mg film-coated tablets are yellow coloured, film coated, capsule shaped tablets with a scoreline on both sides and 'RSN' and '3' debossed on either side of the scoreline on one side of the tablet.

Risperidone 4 mg film-coated tablets are green coloured, film coated, capsule shaped tablets with a scoreline on both sides and 'RSN' and '4' debossed on either side of the scoreline on one side of the tablet.

Risperidone 6 mg film-coated tablets are yellow coloured, film coated, capsule shaped tablets with a scoreline on both sides and 'RSN' and '6' debossed on either side of the scoreline on one side of the tablet.

Risperidone tablets are available in blister strips of 7,10,20, 28,30 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Manufacturer:

Ranbaxy Ireland Limited,

Spafield, Cork Road, Cashel,

Co. Tipperary,

Republic of Ireland.

Marketing Authorisation Holder:

Ranbaxy (UK) Ltd Building 4, Chiswick Park 566 Chiswick High Road London, W45YE United Kingdom

This leaflet was revised in May 2014.