Risperidone 6mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET
RISPERIDONE 0.5mg, 1mg, 2mg, 3mg, 4mg AND 6mg FILM-COATED TABLETS
(risperidone)
Information for people taking Risperidone Film-coated Tablets
This leaflet contains important information. Before you start to take your medicine, please read it carefully. If there is anything that you do not understand or if you need more information or advice, you should ask your pharmacist, nurse or doctor who will be pleased to help you.
This leaflet applies only to Risperidone Film-coated Tablets. Please do not throw it away, as you may need to refer to it again.
REMEMBER - This medicine has been prescribed for you only.
IN THIS LEAFLET
1 What your medicine does and what it is used for
2 Before you take your medicine
3 How to take your medicine
4 Possible side effects
5 How to store your medicine
6 Further information
1 WHAT YOUR MEDICINE DOES AND WHAT IT IS USED FOR
The name of your medicine is Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg or 6mg Film-coated Tablets and the active ingredient is risperidone.
Risperidone Film-coated Tablets are one of a group of medicines called antipsychotics. They are used to treat the following conditions:
• Schizophrenia, a condition that may cause symptoms such as confusion, hallucinations (e.g. hearing, seeing or sensing things that are not there), delusions, paranoia (unusual suspiciousness), and emotional and social withdrawal. You can take Risperidone Film-coated Tablets for both sudden (acute) and long-lasting (chronic) disorders.
• Symptoms of mania (suffering episodes of overactivity, extreme happiness or feeling irritable) if you have bipolar disorder.
• Persistent aggression (short-term treatment up to 6 weeks) in people with Alzheimer’s disease, in intellectually disabled children over 5 years of age and in adolescents with conduct disorder.
REMEMBER - This medicine has been prescribed for you only.
2. BEFORE YOU TAKE YOUR MEDICINE
Do not take your medicine
• If you have ever had an allergic reaction to risperidone or any of the ingredients listed in section ‘6 Further information’. An allergic reaction may be a rash, itching, swollen face or lips, or shortness of breath.
Take special care with your medicine
You should let your doctor know and ask their advice, if you suffer from, or have ever had:
• heart disease
• atrial fibrillation/arrhythmia (a heart rhythm disorder which usually involves a rapid heart rate)
• blood-vessel disease
• liver disease
• kidney disease
• Parkinson's disease
• epilepsy
• dementia
• a stroke
• a transient ischaemic attack (sometimes known as a mini-stroke)
• involuntary movements of the tongue, mouth and face
• a condition with symptoms of high temperature, muscle stiffness, sweating and a lowered level of consciousness (neuroleptic malignant syndrome)
• problems of overheating or controlling your body temperature
• low blood pressure
• problems with prolonged or painful erection
• high levels of the hormone, prolactin, in your blood or a tumour associated with this hormone
• diabetes - if you have diabetes or you have a risk of developing diabetes, your doctor should check your blood sugar levels regularly while you are taking Risperidone Film-coated Tablets.
• blood disorders - take special care with risperidone if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Risperidone Film-coated Tablets may cause you to gain weight. Significant weight gain may adversely affect your health. Your doctor should regularly measure your body weight.
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 for 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.
Before treatment is started your, or your child’s body weight may be measured and it may be regularly monitored during treatment.
Taking other medicines
Taking some medicines together can be harmful. Always tell your doctor, nurse or pharmacist if you are taking any other medicines, including medicines obtained without a prescription, especially:
• Medicines used to regulate your heartbeat (e.g. quinidine, procainamide, amiodarone) and to treat high blood pressure
• Verapamil, used to treat high blood pressure and angina
• Furosemide (diuretic or water tablet). Risperidone taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia
• Certain antidepressant medicines, e.g. amitriptyline, fluoxetine, paroxetine
• Certain antihistamines
• Antipsychotics, e.g. paliperidone
• Antimalarial medicines, e.g. mefloquine
• Opiates (certain medicines used for pain)
• Medicines taken for anxiety (e.g. diazepam) or to help you to sleep (tranquillisers)
• Levodopa, used to treat Parkinson’s disease
• Carbamazepine, phenytoin and phenobarbital (used to treat epilepsy)
• Rifampicin, used in the treatment of TB
• Cimetidine and ranitidine, used to treat heartburn and stomach ulcers
• Antiviral medicines used in AIDs treatment, e.g. indinavir and ritonavir
If you are not sure if any of the above applies to you, talk to your doctor before using this medicine.
Taking your medicine with food and drink
You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone Film-coated Tablets.
Pregnancy and breast-feeding
Before taking your medicine, tell your doctor if you are pregnant, breast-feeding or trying to become pregnant. Discontinuation of this medicine during pregnancy should not be done suddenly.
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 problem, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Driving and using machines
Taking Risperidone Film-coated Tablets may make you feel sleepy, dizzy or cause vision problems.
You should not drive or operate machinery until your doctor can assess how the tablets affect you.
Important information about some of the ingredients of your medicine
The 1 mg tablets contain lactose. If you have been told you are intolerant to some sugars, please contact your doctor before taking this product.
The 0.5 mg and 3 mg tablets contain E110 (sunset yellow). E110 can cause allergic reactions. You are more likely to be allergic if you are allergic to aspirin.
3. HOW TO TAKE YOUR MEDICINE
Your doctor will tell you how many Risperidone Film-coated Tablets to take and how long you should continue to take them. This will depend on your needs and your doctor will adjust the number and strength of the tablets to suit you.
You should take your medication with some water. You can take this as a single dose or as half the dose in the morning and half the dose in the evening.
The usual doses are described below.
Adults
• Schizophrenia: A starting dose as follows: 2mg on Day One, followed by 4mg on Day Two. Your doctor will increase the dose as required. Most people benefit from a daily dose of between 4mg and 6mg a day.
• Bipolar disorder: Between lmg and 6mg a day.
• Persistent aggression in Alzheimer’s disease (short-term treatment of 6 weeks): A starting dose of 0.25mg twice daily, increasing to 0.5mg twice daily for most patients. Some people benefit from a dose of 1mg twice daily.
Your doctor will tell you what dose suits your particular situation. Your treatment should be regularly reviewed and changed if appropriate.
Elderly people:
• Schizophrenia & bipolar disorder: The starting dose is usually 0.5mg twice per day. This can be increased up to 2mg twice daily.
• Persistent aggression in Alzheimer’s disease (short-term treatment of 6 weeks): A starting dose of 0.25mg twice daily, increasing to 0.5mg twice daily for most patients. Some people benefit from a dose of 1mg twice daily.
Children and adolescents (between 5 and 18 years of age)
• Schizophrenia & bipolar disorder: Not recommended
• Conduct disorder (short-term treatment of 6 weeks):
• Not recommended in children younger than 5 years of age.
• For children/adolescents weighing more than 50kg, the starting dose is 0.5mg once daily, increasing to 1.5mg once daily if required.
• For children/adolescents weighing less_than 50kg, this dose is halved.
People with kidney or liver problems
All doses should be halved. Dose increases should be slower in these patients.
If you take more of your medicine then you should
If you take more tablets than you were told to, or if someone else has taken any of your medication, contact a doctor or hospital straight away.
Important - never take more than 16mg of risperidone a day.
If you forget to take your medicine
If you miss a tablet, take your next tablet as usual and continue your course.
If you stop taking your medicine
Stopping treatment suddenly may cause effects such as feeling sick, vomiting, sweating, sleeplessness, muscle stiffness, jerky movements or your original medical problem may come back. Always follow your doctor's instructions carefully.
Do not stop your treatment just because you feel better. It is important that you carry on taking the tablets for as long as your doctor has told you to.
If you stop taking the tablets, you should do so gradually, especially if you have been taking a high dose, unless your doctor has told you otherwise.
Always read the label. If you are not sure what tablets you should take, you should contact your pharmacist.
Like all medicines, this medicine can have side effects. There are usually few side effects when you take Risperidone Film-coated Tablets in the way your doctor, nurse or pharmacist has recommended. Do not be alarmed by this list of possible side effects, as you may not suffer from any of them.
STOP taking this medication and go to your doctor or casualty department IMMEDIATELY if you notice any of the following:
- Allergic reaction - signs may include: rash, itching; swelling of face, lips or tongue; shortness of breath
- Sudden feeling of weakness or numbness in your face, arms or legs, especially on one side or if your speech is slurred - these may be signs of a stroke
- 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
- Fever, muscle stiffness, sweating or a lowered level of consciousness (signs of neuroleptic malignant syndrome)
- Prolonged or painful erection
- Involuntary movements of the tongue, mouth and face
Tell your doctor if you notice any of the following:
Very Common (affects more than 1 user in 10)
- Parkinsonism. Symptoms include: increase in saliva secretion or watery mouth, muscle stiffness, drooling, jerks when bending the limbs, slow body movements, no expression on the face, small, shuffling, hurried steps and lack of normal arm movements when walking
- Headache, difficulty sleeping
Common (affects 1 to 10 users in 100)
- Restlessness, inability to sit still, anxiety, irritability
- Tremor, muscle spasms, shakiness, twitching
- Dizziness, drowsiness, tiredness, weakness, poor attention
- Vomiting, feeling sick, indigestion, dry mouth
- Diarrhoea, constipation, stomach pain or discomfort
- Rash, skin redness
- Shortness of breath, cough, sore throat, nose congestion, nosebleeds
- Fast heartbeat
- Bed-wetting
- Increased weight, increased and decreased appetite
- Blurred vision
- Joint pain, back pain, chest pain
- Involuntary movements of face or arms and legs
- Respiratory infections, flu
- Urinary tract infections
- Fever
- Swelling/pain in arms and legs
- Blood prolactin hormone level increased
Uncommon (affects 1 to 10 users in 1000)
- Low blood pressure
- Abnormal electric activity tracing of the heart (ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased
- Diabetes mellitus, blood glucose increased
- Anaemia (signs may include tiredness and paleness)
- White blood cell count decreased (may lower immunity)
- Blood creatinine phosphokinase increased
- Decrease in platelets (blood cells that help you stop bleeding)
- Increased blood cholesterol and triglycerides (blood fats)
- Liver enzymes increased
- Lower level/loss of consciousness, fainting, problems with balance, reduced response time, reduced sense of touch
- Excessive sleep
- Eye infections, eye discharge, oversensitivity to light, increased blood flow to the eye, eye swelling, dry eye, increase in tears
- Ringing in the ears, ear pain
- Wheezing, congestion of airways, trouble speaking, voice disorder, difficulty swallowing
- pneumonia
- Painful urination, frequent or uncontrolled urination
- Stool incontinence, very hard faeces
- Skin problems, (such as skin lesions, dry skin, itching of skin, acne, hair loss, skin inflammation caused by mites, skin discolouration, flushing, thickening of skin), face swelling
- Infection under the skin
- Uncontrolled movements of the face
- Muscle weakness, neck pain
- Abnormal posture or walk, abnormal coordination
- Abnormal taste
- Anorexia, excessive thirst
- Ear, tonsil and nail infections
- Chills
- Confusion, nervousness, elevated mood
- Lack of energy and interest
- Absence of menstrual periods, vaginal discharge
- Low sex drive, erectile dysfunction, breast development in men, breast discharge
Rare (affects 1 to 10 users in 10,000)
- Feeling cold
- Coma due to uncontrolled diabetes
- Altered secretion of a hormone that controls urine volume
- Generalised swelling
- Glaucoma, eye rolling, reduced vision
- Lack of emotion
- Sleep apnoea (pauses in breathing while asleep), hyperventilation (deep rapid breathing)
- Chronic otitis media
- Low blood sugar
- Obstruction of intestine
- Reduced blood flow to the brain
- Inflammation of the pancreas (may cause sudden severe upper abdominal pain)
- Lip inflammation
- Dandruff
- Muscle tissue damage (rhabdomyolysis)
- Tremor of the head
- Drug withdrawal syndrome
- Jaundice (yellowing of the skin and whites of the eyes)
- Inability to reach orgasm
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):
- No granulocytes (type of white blood cell to help fight against infection)
- Prolonged painful erection
- Dangerously excessive intake of water.
If any of the side effects get serious or if your medicine affects you in any other way, you should tell your doctor, nurse or pharmacist.
Reporting of Side Effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. HOW TO STORE YOUR MEDICINE
Do not use after the expiry or use-before date on the carton.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store the tablets above 25°C.
Always return any leftover medicine to your pharmacist. Only keep it if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What your medicine contains
Risperidone Film-coated Tablets contain 0.5mg, 1mg, 2mg, 3mg, 4mg or 6mg of risperidone.
Each film-coated tablet also contains several inactive ingredients. These include: microcrystalline cellulose, starch pregelatinised, magnesium stearate, hypromellose and titanium dioxide (E171).
The tablets also contain:
0.5mg: talc, propylene glycol, quinoline yellow (E104) and sunset yellow (E110).
1mg: lactose monohydrate and macrogol/PEG 4000.
2mg: talc, propylene glycol and quinoline yellow (E104).
3mg: talc, propylene glycol and sunset yellow (E110).
4mg: talc, macrogol/PEG 4000, indigotine (E132) and quinoline yellow (E104).
6mg: talc, propylene glycol, quinoline yellow (E104), macrogol/ and indigotine (E132).
What your medicine looks like and contents of the pack
The tablets come in the following packs:
0.5mg film-coated tablets (cream, round, biconvex tablets with ‘58’ embossed on one side) 20 tablets 1mg film-coated tablets (white, round, biconvex tablets with ‘59’ embossed on one side) 20 or 60 tablets 2mg film-coated tablets (yellow, round, biconvex tablets with ‘60’ embossed on one side) 60 tablets 3mg film-coated tablets (peach, round, biconvex tablets with 306’ embossed on one side) 60 tablets 4mg film-coated tablets (green, round, biconvex tablets with ‘307’ embossed on one side) 60 tablets 6mg film-coated tablets (light green, round, biconvex tablets with ‘308’ embossed on one side) 28 tablets
Who has made your medicine?
The product licence holder is Relonchem Limited, Cheshire House, Gosey Lane, Widnes WA8 0RP
The manufacturer of this medication is Pharmathen S.A., 6 Dervenakion Street, Pallini, Athens, 15351, Greece.
This leaflet was revised February 2014.