Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg and 6mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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.
In this leaflet:
- 1. What Risperidone Tablets are and what they are used for
- 2. Before you take Risperidone Tablets
- 3. How to take Risperidone Tablets
- 4. Possible side effects
- 5. How to store Risperidone Tablets
- 6. Further information
What Risperidone Tablets Are And What They Are Used For
Risperidone Tablets belong to the group of medicines called antipsychotics. It is used to treat conditions which affect the way you think, feel and/ or act. These conditions may cause symptoms such as confusion, hallucinations (e.g. hearing, seeing or sensing things which are not there), delusions, unusual suspiciousness (paranoia), emotional and social withdrawal. People with these conditions may also feel depressed, guilty, anxious or tense.
Risperidone Tablets may be taken for both sudden (acute) and long-lasting (chronic) disorders.
In addition, Risperidone Tablets may be used to control the symptoms of mania for people with bipolar disorder.
Before You Take Risperidone Tablets
Do not take Risperidone Tablets:
If you are hypersensitive (allergic) to risperidone or any of the other ingredients of Risperidone Tablets. An allergic reaction may be recognised as a rash, itching, swollen face or lips or shortness of breath.
It is important to talk to your doctor BEFORE you take this medicine if you have any of the following conditions:
- you have or have had a history of dementia
- you have suffered a stroke or a transient ischemic attack (temporary reduction in the blood flow to the brain which may cause temporary paralysis or loss of speech)
- you suffer from heart or blood vessel disease
- you have other risk factors associated with blood vessel disease, including high blood pressure, diabetes or you are a smoker
- you have a heart disorder called atrial fibrillation
- you have Parkinson’s Disease
- epilepsy (seizures or fits)
- liver disease (including jaundice) or kidney disease
You may get drowsy if you drink alcohol while you are taking Risperidone Tablets. It is therefore advisable to avoid drinking any alcohol.
Pregnancy and Breast-feeding
Risperidone Tablets are not recommended in pregnancy. If you are pregnant or planning to become pregnant, talk to your doctor or pharmacist before taking any medicine. You should not take this medicine if you are pregnant or breastfeeding.
Driving and using machines:
Risperidone can affect your alertness so you should not drive or operate machinery until your doctor sees how the tablets affect you.
Important information about some of the ingredients of Risperidone:
These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Taking other medicines:
Always tell your doctor, nurse or pharmacist if you are taking any other medicines because taking some medicines together can be harmful.
In particular you should take care when taking any of the following medicines as they may reduce the effects of Risperidone or may make you more drowsy:
- dopamine agonists eg Levodopa
- phenothiazines used to treat psychosis
- tricyclic antidepressants such as benzodiazepine used to treat anxiety and help you sleep
- beta blockers used to treat high blood pressure
Only take these medicines while you are on Risperidone if your doctor says that you can:
Tell your doctor if you are taking furosemide or other diuretic medicines, also known as water tablets. These medicines may be used to treat high blood pressure, or to treat swelling in parts of the body caused by the build up of too much fluid. Studies in elderly patients have shown that taking Risperidone in combination with diuretics may be harmful.
Your doctor will decide if you can take Risperidone and if the dose will need to be altered.
A drug called carbamazepine, commonly used to treat epilepsy or facial neuralgia (severe pain attacks in the face), or others such as fluoxetine or Paroxetine (medicines for treating depression) may affect liver enzymes. This can change the effect of Risperidone, so you should tell your doctor if you start or stop taking such medication, as you may need a different dose of Risperidone.
While Taking Risperidone Tablets
- You should be careful how much alcohol you drink. The combined effect of Risperidone and alcohol might make you feel drowsy.
- Risperidone might affect your alertness so you should not drive or operate machinery until the doctor sees how the tablets affect you.
- If you have diabetes or you have a risk of getting diabetes, your doctor may check your blood sugar levels while you are taking Risperidone. (See also “Possible side effects”).
How To Take Risperidone Tablets
Your doctor will decide the correct dose for you to take and how long you will need to continue taking your medicine. Check the label and if you are not sure ask your doctor or pharmacist. Tablets can be taken with or without food.
Patients with conditions which affect the way you think, feel or act
Adults and adolescents over 15 years
The usual starting dose for the first two days of treatment is 2 mg for Day 1 followed by 4 mg on Day 2. This can be taken as single dose or as half the dose in the morning and half the dose in the evening.
However your doctor may recommend a more gradual increase in the dose.
Depending on the effects of the medicine your doctor will set your dosage to suit you. This is usually between 4 mg and 6 mg daily. Some patients may require less than 4 mg for a good effect.
Patients with bipolar disorder
Adults and adolescents over 15 years
The usual starting dose is 2 mg once daily. Your doctor may increase your dose gradually if necessary. Most people will feel better with doses between 1 and 6 mg daily. Your doctor will tell you what dose suits your particular situation.
Your treatment should be reviewed regularly and changed if appropriate.
Important - never take more than a total of 16 mg per day.
- Risperidone is only for those aged 15 years and over.
- If you are elderly or have a liver or kidney disorder, you should take half the above doses. You will be told how many tablets you need to take.
- Do not stop your treatment just because you feel better. It is important that you carry on taking Risperidone for as long as your doctor has told you to.
- If you stop taking Risperidone, you should do so gradually, especially if you have been taking a high dose, unless your doctor has told you otherwise. Stopping treatment suddenly may cause effects such as feeling sick, vomiting, sweating, sleeplessness, muscle stiffness or jerky movements, or your original medical problem may come back. Always follow your doctor’s instructions carefully.
- If you miss a tablet, take your next tablet as usual and continue your course.
- Always read the label. If you are in any doubt as to what tablets you should take you should contact your nurse or pharmacist.
- If you take more Risperidone tablets than you were told to, or if someone else has taken any Risperidone tablets, contact a doctor or hospital straight away.
Possible Side Effects
Like all medicines, Risperidone Tablets can have side effects. Some side effects are common, some are uncommon and some are rare.
Occasionally strokes or transient ischemic attacks may occur. If you experience sudden weakness or numbness of the face, arms or legs especially on one side, or instances of slurred speech seek urgent medical attention.
Rarely Risperidone may cause a desire to drink large amounts of water. You might experience marked changes in your body temperature or uncontrollable movements, mainly of the face and tongue. Rare cases of convulsions (fits) have also been reported. If any of these occur you should contact your doctor as soon as possible.
Very rarely you may develop symptoms of high blood sugar such as thirst or increased frequency of passing water. There are rare experiences of fever, faster breathing, increased sweating, muscle stiffness and drowsiness. If these symptoms occur you should stop taking the tablets and contact a doctor at once.
If you experience continuous erection of the penis, contact your doctor immediately.
When Risperidone is taken for a long period of time women may suffer from milk secretion, loss in their monthly period or changes in the regularity of their periods. Men may experience breast swelling. If these symptoms persist contact your doctor.
In some cases, the blood pressure may fall slightly in the early stages of the treatment, resulting in dizziness. This will usually pass off automatically. Somewhat later in the treatment, increased blood pressure may also occur, but this is very rare.
The following events are less serious but you may wish to discuss them with your doctor or pharmacist if they become troublesome or last a long time:
Commonly difficulty sleeping, agitation, anxiety and headaches, increase in appetite and weight gain.
Less common effects are sleepiness, feeling tired, dizziness particularly when standing up, heart palpitations, difficulty concentrating, constipation, heartburn, feeling or being sick, stomach ache, blurred vision, difficulty with obtaining an erection, with ejaculation and reaching orgasm, incontinence, runny or blocked nose, skin rashes and other allergic reactions such as itching, swollen face or lips. Changes in the white blood cell count which may make you more prone to minor infections and cause tiredness.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storing Risperidone Tablets
Keep out of the reach and sight of children.
For 0.5mg Tablets: Do not store above 30°C. All other pack presentations: No Special storage conditions.
Do not use after the expiry date stated on the carton, bottle or foil.
Further Information
The active substance is risperidone. There are 6 strengths available containing 0.5mg, 1mg, 2mg, 3mg, 4mg and 6mg risperidone per tablet.
The other ingredients are lactose anhydrous, microcrystalline cellulose, pregelatinised starch, magnesium stearate, hypromellose, macrogol 6000, and titanium dioxide (E171). The 0.5mg also contains yellow iron oxide (E172).
Risperidone 0.5 mg tablets are light yellow, oval, biconvex, scored 8x5mm film coated tablets, with the marking “T”.
Risperidone 1 mg tablets are white, oval, biconvex, scored, 8x5mm film coated tablets, with the marking “T1”.
Risperidone 2 mg tablets are white, oval, biconvex, scored, 10x5mm film coated tablets, with the marking “T2”.
Risperidone 3 mg tablets are white, oval, biconvex, scored, 11x6.5mm film coated tablets, with the marking “T3”.
Risperidone 4 mg tablets are white, oval, biconvex, scored, 14x7.5mm film coated tablets, with the marking “T4”.
Risperidone 6 mg tablets are white, oval, biconvex, scored, 16x8.5mm film coated tablets, with the marking “T”.
The tablets are supplied in blister packs of 20, 28 and 60 tablets.
Who makes your medicine
Marketing Authorisation Holder:
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This leaflet was last revised in June 2009
ACTPL085
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