Risperidone 2mg Orodispersible Tablets
TEVA UK Ref: 231-30-86518-X LEA RISPERIDONE OD TABS A/S TUK <KUT Version: 3 02 June 2014
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RISPERIDONE 2 mg, 3 mg, 4 mg and 6 mg ORODISPERSIBLE TABLETS
PACKAGE LEAFLET: INFORMATION F0RTHE USER
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 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.
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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, 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)
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inis muiuueb any pussiuia siua eneuis iiul listen in mis
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
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.
©WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE
Do not take Risperidone:
• Ifyou are allergic (hypersensitive) to risperidone or any of the other ingredients ofthis medicine (listed in section 6).
If you are not sure if the above applies to you, talkto your doctor or pharmacist before using Risperidone.
Warnings and precautions
Talkto 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 Parkinson's disease or dementia
• 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)
• 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, contact your doctor straight away.
• You have problems controlling your body temperature or
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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 and drink
You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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. Ifyour 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).
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment with Risperidone. Do not drive or use any tools or machines without talking to your doctor first.
Risperidone 3 mg contains tartrazine
Risperidone 3 mg OrodispersibleTablets contains tartrazine and may cause allergic reactions.
HOW TO TAKE RISPERIDONE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is as follows:
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 of4to6 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
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• You have kidney problems
• You have liver problems
• You have an abnormally high level ofthe hormone prolactin in your blood or ifyou 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.
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, talkto your doctor or pharmacist before using Risperidone.
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.
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 checkfor signs of high blood sugar. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
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. Ifyou are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
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 ifyou or your care-giver notice a sudden change in your mental state or sudden weakness or numbness ofyourface, 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, or your child's body weight may be measured and it may be regularly monitored during
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• 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.
Use in children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone for schizophrenia.
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 of1to6 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.
Use in children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone for bipolar mania.
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.
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 RisDeridone for conduct disorder.
If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
Other medicines and Risperidone
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 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 elderly people with dementia.
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.
Take the tablets as follows
Only remove a tablet from the blister when it is time to take your medicine.
• Do not push the tablet out of the pocket, as this will crush it
• Each strip contains tablets separated in pockets by perforations.Tear off one tablet pocket along the dotted lines (Figure 1):
• Carefully peel offthe lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3):
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2 |
3 |
• Keep your hands dry and take the tablet out of the strip
• The tablet should be placed on top of the tongue, where it will disperse within seconds and can then be swallowed with or without water.
Do not break or divide the tablets. Your mouth should be
empty before placing the tablet on the tongue.
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
• Ifyou 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 not take a double dose (two doses at the same time) to make up for a forgotten dose.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent passing of urine, inability to pass urine, pain when passing urine
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods, missed menstrual periods or other problems with your cycle (females)
• Development of breasts in men, leakage of milkfrom the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling ofthe face, mouth, eyes, or lips
• Chills, an increase in bodytemperature
• Achangeinthewayyouwalk
• Feeling thirsty, feeling unwell, chest discomfort, feeling "out of sorts", discomfort
• Increased liver transaminases in your blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in your
If you stop taking Risperidone
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 over a few days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you:
• Experience 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 if these symptoms seek medical advice immediately.
• Have dementia and experience 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.
• Experience fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be needed.
• Are a man and experience prolonged or painful erection. This is called priapism. Immediate medical treatment may be needed.
• Experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of risperidone may be needed.
• Experience severe allergic reaction characterized by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash or drop in blood pressure.
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, feeling sleepy or less alert.
Common (may affect up to 1 in 10 people):
• Pneumonia, infection of the chest (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, feeling like you have the flu
• Risperidone can raise your levels of a hormone called
blood, increased liver enzymes in your blood
• Procedural pain.
Rare (may affect up to 1 in 1,000 people):
• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sugar in the urine, low blood sugar, high blood triglycerides (a fat)
• Lack of emotion, inability to reach orgasm
• Neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness)
• Blood vessel problems in the brain
• Coma due to uncontrolled diabetes
• Shaking of the head
• Glaucoma (increased pressure within the eyeball), problems with movement of your eyes, eye rolling, eyelid margin crusting
• 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.
• Dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
• Severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure
• Dangerously excessive intake of water
• Irregular heart beat
• Blood clot in the legs, blood clot in the lungs
• Trouble breathing during sleep (sleep apnea), fast, shallow breathing
• Inflammation of the pancreas, a blockage in the bowels
• Swollen tongue, chapped lips, rash on skin related to drug
• Dandruff
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
• A delay in menstrual periods, enlargement of the glands in your breasts, breast enlargement, discharge from the breasts
• Increased insulin (a hormone that controls blood sugar levels) in your blood
• Priapism (a prolonged penile erection that may require surgical treatment)
• Hardening of the skin
• Decreased body temperature, a decrease in body temperature, coldness in arms and legs
• Symptoms of drug withdrawal
• Yellowing of the skin and the eyes (jaundice).
Very rare (may affect up to 1 in 10,000 people):
• Life threatening complications of uncontrolled diabetes
• Serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
• Lack of bowel muscle movement that causes blockage.
The following side effect has been seen with the use of
prolactin found on a blood test (which may or may not cause symptoms). When symptoms of high prolactin occur, they may include in men breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction. In women they may include breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.
• Weight gain, increased appetite, decreased appetite
• Sleep disorder, irritability, depression, anxiety, restlessness
• 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, mouth, tongue or jaw.
• Dizziness
• Dyskinesia:This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, or twitching.
• Tremor (shaking)
• Blurry vision, eye infection or "pink eye"
• Rapid heart rate, high blood pressure, shortness of breath
• Sore throat, cough, nosebleeds, stuffy nose
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache
• Rash, skin redness
• Muscle spasms, bone or muscle ache, back pain, joint pain
• Incontinence (lack of control) of urine
• Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Fall.
Uncommon (may affect up to 1 in 100 people):
• Infection of the breathing passages, bladder infection, eye infection, tonsillitis, fungal infection of the nails, infection of the skin, an infection confined to a single area of skin or part of the body, viral infection, skin inflammation caused by mites
• Decrease in the type of white blood cells that help to protect you against infection, white blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding), anaemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in your blood
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar, excessive drinking of water
• Weight loss, loss of appetite resulting in malnutrition and low body weight
• Increased cholesterol in your blood
• Elated mood (mania), confusion, decreased sexual drive, nervousness, nightmares
• Tardive dyskinesia (twitching or jerking movements 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.
• Sudden loss of blood supply to brain (stroke or "mini" stroke)
• Unresponsive to stimuli, loss of consciousness, low level of consciousness
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 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 theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
HOWTO 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 blister and carton.The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.
CONTENTS OFTHE PACK AND OTHER INFORMATION
What Risperidone contains
• The active substance is risperidone. Each orodispersible tablet contains 2, 3, 4 or 6 mg of risperidone
• The other ingredients are mannitol, sodium starch glycolate (type A) and peppermint flavour.The tablets also contain the following colours:
3 mg: tartrazine (E102)
4 mg: erythrosine (E127)
6 mg: indigo carmine (E132).
What Risperidone looks like and the contents of the pack
• Orodispersible tablet
• Risperidone 2 mg OrodispersibleTablets are white, flat, round tablets, plain on both sides, rough on borders and face
• Risperidone 3 mg OrodispersibleTablets are light yellow, flat, round tablets, plain on both sides, rough on borders and face
• Risperidone 4 mg OrodispersibleTablets are mottled light
• Convulsion (Tits), Tainting
• A restless urge to move parts of your body, balance disorder, abnormal coordination, dizziness upon standing, disturbance in attention, problems with speech, loss or abnormal sense oftaste, reduced sensation ofskin to pain and touch, a sensation oftingling, pricking, or numbness of skin
• Oversensitivity ofthe eyes to light, dry eye, increased tears, redness of the eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (an abnormal heart rhythm), an interruption in conduction between the upper and lower parts ofthe heart, abnormal electrical conduction ofthe heart, prolongation ofthe QT interval from your heart, slow heart rate, abnormal electrical tracing ofthe heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
• Low blood pressure, low blood pressure upon standing (consequently, some people taking Risperidone may feel faint, dizzy, or may pass out when they stand up or sit up suddenly, flushing
• Pneumonia caused by inhaling food, lung congestion, congestion of breathing passages, crackly lung sounds, wheezing,voice disorder, breathing passage disorder
• Stomach or intestinal infection, stool incontinence, very hard stool, difficulty swallowing, excessive passing of gas or wind
• Hives (or "nettle rash"), itching, hair loss, thickening of skin, eczema, dry skin, skin discoloration, acne, flaky, itchy scalp or skin, skin disorder, skin lesion
• An increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown pink, Tlat, round tablets, plain on both sides, rough on borders and face
• Risperidone 6 mg OrodispersibleTablets are blue, flat, round tablets, plain on both sides, rough on borders and face
• The 2 mg tablets are available in pack sizes of 1,14,15, 20, 28, 30, 56, 60, 90, 98 & 500 tablets, hospital pack: 50, 60, 90, 98 & 500 orodispersible tablets
• The 3 mg tablets are available in pack sizes of 1,14,15, 20, 28, 30, 56, 60, 84, 90 & 98 tablets, hospital pack: 50, 60,84,90 & 98 orodispersible tablets
• The 4 mg tablets are available in pack sizes of 1, 14, 15, 20, 28, 30, 56, 60, 84, 90 & 98 tablets, hospital pack: 50, 60,84,90 & 98 orodispersible tablets
• The 6 mg tablets are available in pack sizes of 1, 14, 15, 20, 28, 30, 56, 60, 90 & 98 tablets, hospital pack: 50, 56, 60, 90 & 98 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer:
Teva Operations Poland Sp. z.o.o., Sienkiewicza 25 Str, 99 300
Kutno, Poland.
This leaflet was last revised in 05/2014.
PL 00289/1005-8
795 x 230
TEVA UK LIMITED 86518-X