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Document: leaflet MAH GENERIC_PL 04569-0809 change

• leaflet MAH BRAND_PLPI 20636-2318
• leaflet MAH GENERIC_PL 00289-0816
• leaflet MAH GENERIC_PL 00427-0239
• leaflet MAH GENERIC_PL 04569-0809
• leaflet MAH GENERIC_PL 20117-0066
• leaflet MAH GENERIC_PL 29831-0349

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PACKAGE LEAFLET: INFORMATION FOR THE USER

RiSPERiDONE 1 mg/ml ORAL SOLUTiON

(risperidone)

Read all of this leaflet carefully before you start

taking this medicine because it contains important

information for you.

•    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 for you 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.

What is in this leaflet:

1.    What Risperidone is and what it is used for

2.    What you need to know before you take Risperidone

3.    How to take Risperidone

4.    Possible side effects

5.    How to store Risperidone

6.    Contents of the pack and other information

1.    WHAT RispERIDoNE is AND WHAT IT is UsED For

Risperidone belongs to a group of medicines called 'anti-psychotics'. Risperidone is used to treat the 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.

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

2.    what you need to know before you take risperidone

Do not take Risperidone:

•    If you are allergic (hypersensitive) 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 Risperidone.

Warnings and precautions - Talk to your doctor or pharmacist before taking Risperidone 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 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 ever experienced involuntary movements of the tongue, mouth and face

•    You have ever had a condition whose symptoms include high temperature, muscle stiffness, sweating, or a lowered level of consciousness (also known as Neuroleptic Malignant Syndrome)

•    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 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.

•    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.

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

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

Elderly people with dementia - In elderly 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, 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. Before treatment is started 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 Risperidone - Please 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, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems

•    Medicines that cause a slow heart beat

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

•    Medicines to treat raised 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 elderly people with dementia.

The following medicines may reduce the effect of risperidone

•    Rifampicin (a medicine for treating 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, fluoxetine, tricyclic antidepressants

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

•    Phenothiazines, oral paliperidone (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.

Risperidone with food, drink and alcohol - You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone.

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 pharmacist before taking this medicine. Your doctor will decide if you can take it.

•    The following symptoms may occur in newborn babies, of mothers that have used Risperidone in the last trimester (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 section 4 Possible side effects).

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

3. how to take risperidone

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.

Elderly people

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

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

•    Your doctor will tell you which is the best for you.

For the 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.

Elderly 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.

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

Use in children and adolescents

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

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

0.25 mg per day

•    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 be not more than 6 weeks.

Children under 5 years old should not be treated with Risperidone 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. Doses increases should be slower in these patients. Risperidone should be used with caution in this patient group.

How to take Risperidone - Always take Risperidone exactly as your doctor has told you. You should check with your doctor 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 solution comes with a syringe (pipette). This should be used to help you measure the exact amount of medicine you need. Follow these steps:

1.    Remove the child resistant cap. Push the plastic screw cap down while turning it counter clockwise (Figure 1)

2.    Insert the syringe into the bottle

3.    While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millilitres or mg you need to take (Figure 2)

4.    Holding the bottom ring, remove the entire syringe from the bottle (Figure 3)

5.    Empty the syringe into any non-alcoholic drink, except for tea. Slide the upper ring down

6.    Close the bottle

7.    Rinse the syringe with some water.

if you take more Risperidone 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 or fits.

if you forget to take Risperidone

•    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 you 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 not stop taking this medicine unless told to do so by your doctor. Your symptoms may return or you may experience nausea, vomiting, sweating, sleeping difficulties and involuntary movement disorders. 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, Risperidone can cause side effects,

although not everybody gets them.

Stop taking Risperidone and contact your doctor

immediately or go to a hospital emergency department if

you experience any of the following:

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

•    develop lung infections, including serious lung infections such as pneumonia - you may have a very high temperature, cough up phlegm which may be bloody or frothy and feel very unwell.

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

•    sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of vision problems or slurred speech that last for less than 24 hours. These may be signs of a mini-stroke (TIA), stroke or reduced blood flow to the brain.

•    an abnormal heart rhythm, such as fluttering of the heart (fibrillation) or very slow or abnormal heart beat (heart block). These may be caused by abnormal electrical conduction of the heart and may be seen as abnormal electrical activity tracing of the heart (ECG). In some cases this can be life threatening.

•    if you are unresponsive to stimuli, have a low level of consciousness or fall unconscious, or experience fits (convulsions).

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

•    development of diabetes - a condition where the body is unable to control blood sugar levels correctly. You may feel very thirsty yet pass lots of urine, have an increased appetite yet feel tired and lethargic. If left untreated, this can cause you to fall into a coma or, potentially, life threatening complications of uncontrolled diabetes to develop.

•    infections with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/mouth. Risperidone may cause a severe reduction in the number of white blood cells and your resistance to infection may be decreased. A blood test will be taken to check for a possible reduction of white blood cells. It is important to tell your doctor that you are takingthis medicine.

•    inhale food into the breathing passages causing an infection, or have congestion of the lung (e.g. due to a build-up of phlegm).

•    have an infection under the skin, normally in the fatty layers of the thigh and buttock (cellulitis).

•    have an inability to urinate or incomplete emptying of the bladder.

•    have severe constipation, which may be due to an obstruction of intestine or a severe hardening and compaction of the faeces.

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

•    a severe allergic reaction resulting in difficulty in breathing and shock, a swollen face, sudden swelling of lips and eyes, tongue or throat; difficulty to swallow; hives

•    unexplained muscle pain, muscle cramps or muscle weakness (rhabdomyolysis)

•    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 breathing. If you notice any of these symptoms seek medical advice immediately

•    fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called'Neuroleptic Malignant Syndrome'). Immediate medical treatment may be needed

•    prolonged or painful erection. This is called priapism. Immediate medical treatment may be needed

•    severe pain in the stomach which reaches round through the back. This may be a sign of inflammation of the pancreas.

•    increased pressure in the eye (glaucoma), which can cause problems with vision and longer term serious problems with eyesight.

•    A lower than normal level of sodium in the blood, which may make you feel weak and confused with aching of muscles. This may be due to inappropriate secretion of a hormone (ADH) that causes the body to retain water and dilute the blood, reducing the amount of sodium. This may be associated with a dangerously excessive (more than

2 litres of water per day) intake of water.

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

•    Experience loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart beat, unusual muscle pain or feeling weak, tired or uncomfortable. These may be signs of a rare life-threatening complication of uncontrolled diabetes called diabetic ketoacidosis.

•    swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing

The following side effects may happen:

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, anxiety, sleepiness, depression, agitation, dizziness, feeling exhausted, sleep disorder

•    Vomiting, diarrhoea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache

•    Weight increased, increase in body temperature, increased appetite, decreased appetite

•    Shortness of breath, flu, blurred vision, infection or allergic reactions of the eye which can produce a sticky discharge, sinus infections, nose congestion, nose bleeding, cough

•    Urinary tract infection, bed wetting, inability to control when passing urine (incontinence)

•    Tremor, muscle spasm, involuntary movements of face or arms and legs, repetitive movements or abnormal postures associated with muscle contractions, joint and muscular pain, back pain, fluid retention in the body (e.g. swelling of arms and legs), pain in arms and legs

•    Rash, skin redness, infection of the ear

•    Fast beating heart, chest pain, high blood pressure

•    Falls

•    Blood prolactin hormone level increased.

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

•    Excessive drinking of water, thirst, stool incontinence, wind, hoarseness or voice disorder

•    Bladder infection, viral and other infection, tonsil infection, stomach infection, eye discharge, yeast infection of nails

•    Drop in blood pressure after standing, low blood pressure, feeling dizzy after changing body position, awareness of heart beating, heart rate decreased

•    Pain when passing urine, frequent passing of urine

•    Confused, disturbance in attention, excessive sleep, nightmares, nervousness, elated mood (mania), lack of energy and interest

•    Liver enzymes increased, 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)

•    Muscle weakness, excessive restlessness associated with muscle spasms and tremor, 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, hair loss, eczema, skin inflammation caused by mites, skin discoloration, thickening of skin, flushing, pins and needle like sensations, 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, breast pain or discomfort, decreased sexual drive, irregular menstruation, vaginal discharge

•    Fainting, gait disturbance, sluggishness, weight decreased, decreased appetite resulting in malnutrition and low body weight, feeling ' out of sorts', balance disorder, allergy, chills, abnormal coordination, abnormal taste

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

•    Crackly lung noise, trouble speaking, difficulty swallowing, coarse/whistling sound during breathing, flu-like illness

•    Ringing in ears, sensation of spinning and dizziness, face oedema.

Rare (may affect up to 1 in 1000 people):

•    Inability to reach orgasm, breast enlargement or swollen, hot, tender breasts

•    Dandruff

•    Coldness in arms and legs, tongue swelling, lip swelling, lip inflammation, hardening of parts of the body e.g. skin

•    Reduced visual clarity, eyelid margin crusting, eye rolling, problems with eye movement, complications during cataract surgery

•    Lack of emotion

•    Drug withdrawal syndrome

•    Fast shallow breathing, trouble breathing during sleep

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

•    Tremor in the head

•    Yellowing of the skin and the eyes (jaundice)

•    Low blood sugar

•    Presence of blood sugar (glucose) in the urine, low blood sugar, raised levels of insulin fats or (triglycerides) in the blood.

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

•    blockage of bowel (persistent constipation with swollen stomach and vomiting

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.

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 of the side effects gets serious, or if you notice, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly via 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

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 or bottle. The expiry date refers to the last day of that month. Do not store this medicine above 30°C.

Do not refrigerate or freeze. Store in the original package. Once the bottle is opened, any unused portion of Risperidone oral solution should be discarded after 4 months. 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 protect the environment.

6.    contents of the pack and other information

What Risperidone contains - The active substance is risperidone. Each 1 ml of oral solution contains 1 mg risperidone. The other ingredients are tartaric acid (E334), benzoic acid (E210), hydrochloric acid and purified water.

What Risperidone looks like and contents of the pack

Risperidone oral solution is clear and colourless. It is available in an amber glass bottles with a child-resistant cap containing of 30 ml, 60 ml, 100 ml and 120 ml. A syringe (pipette) supplied to facilitate accurate measurement. A pipette wiper and protective sheath are also supplied. Not all pack sizes may be marketed.

Marketing authorisation holder:

Mylan, Potters Bar, Hertfordshire, EN6 1 TL, England

Manufacturer:

McDermott Laboratories Ltd t/a Gerard Laboratories,

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland

This leaflet was last revised in 08/2014