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Package leaflet: Information for the user

Risperoc 0.5 mg orodispersible tablets

Risperoc 1 mg orodispersible tablets

Risperoc 2 mg orodispersible tablets

Risperidone

Read all of this leaflet carefully before you start taking this medicinebecause 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is inthis leaflet:

1. What Risperoc is and what it is used for

2. What you need to know beforeyou take Risperoc

3. How to take Risperoc

4. Possible side effects

5. How to store Risperoc

6. Contents of the pack and other information

1. What Risperocis and what it is used for

Risperoc contains the active substance risperidone. Itbelongs to a group of medicines called ‘anti-psychotics’.

Risperoc 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.

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

2. What you need to know before you take Risperoc

Do not take Risperoc if:

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

Warnings and precautions

Talk toyour doctor or pharmacist before taking Risperoc 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. Risperoc 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 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 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 have Parkinson’s disease or dementia

• You know that you have had a low level 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.

• 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 possible prolactin-dependent tumour.

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

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 Risperoc, your doctor may check your white blood cell counts.

Risperoc 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 Risperoc, your doctor should check for 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. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.

Olderpeople with dementia

In older people 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 forconduct 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 treatment.

If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.

Othermedicines and Risperoc

Tellyour 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, allergies (anti-histamines), some antidepressants or other medicines for mental problems

• Medicines that cause a slow heart beat

• Medicines that cause low blood potassium (such as certain diuretics)

• Medicines to treat raised blood pressure. Risperoc 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). Risperoc 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 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 (used to treat high blood pressure)

• Phenothiazines (such as medicines 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 Risperoc.

Risperoc with food, drink and alcohol

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

Pregnancy,breast-feedingand 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 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 who have used Risperoc 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.

• Risperoc 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 Risperoc. Do not drive or use any tools or machines without talking to your doctor first.

Risperoccontainsaspartame and sorbitol

Aspartame (E951) is a source of phenylalanineand maybe harmful for people with phenylketonuria.

Sorbitol is a type of sugar.If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to takeRisperoc

Always take this medicine exactly as your doctor has told you. Checkwith 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 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 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.

Olderpeople

• 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.

Olderpeople

• 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 olderpeople)

• 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.

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.

Use in children and adolescents

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

• For the treatment of conduct disorder 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 Risperoc for conduct disorder.

Method of administration

Risperocis for oral use.

Risperocorodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause damage to the tablet. Remove a tablet from the package with dry hands as follows:

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or without water. The mouth should be empty before placing the tablet on the tongue.

Risperocorodispersible tablets can be taken with a meal or between meals.

If you take more Riperoc 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 Risperoc

• 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 not take a double dose (two doses at the same time) to make up for a forgotten dose

If you stop taking Risperoc

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following serious side effects:

Uncommon: may affect up to 1in 100 people

• Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body). Take action at once if you experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of Risperoc may be needed.

• 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 or “mini” stroke caused by a sudden loss of blood supply to the brain. You are under special risk, if you have dementia.

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

• Neuroleptic Malignant Syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness). Immediate medical treatment may be needed.

• Priapism (a prolonged penile erection that may require surgical treatment)

Very rare: may affect up to1 in 10,000people

• Life threatening complications of uncontrolled diabetes

• Serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing

Not known:frequency cannot be estimated from the available data

The following other side effects may happen:

Very common: may affect more than 1 in 10 people

• Parkinsonism: This condition may include: slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement “freezing up” and then restarting. Other signs of parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face

• Feeling sleepy or less alert

• Headache, difficulty falling or staying asleep.

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 "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, diarrhea, 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), anemia, 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

• Unresponsive to stimuli, loss of consciousness, low level of consciousness

• Convulsion (fits), fainting

• 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 of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness skin

• Oversensitivity of the 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 of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval from your heart, slow heart rate, abnormal electrical tracing of the 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 Risperoc 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 win

• 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

• 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 milk from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge

• Swelling of the face, mouth, eyes, or lips

• Chills, an increase in body temperature

• A change in the way you walk

• 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 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

• 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 Risperoc. 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

• Hardening of the skin

• A decrease in body temperature, coldness in arms and legs

• Symptoms of drug withdrawal

• Yellowing of the skin and the eyes (jaundice).

The following side effect has been seen with the use of another medicine called paliperidone that is very similar to risperidone, so it can also be expected with Risperoc: 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store RisperocKeep this medicineout of the sight and reach of children.

Do not usethis medicineafter the expiry date which is stated on the blister and outer carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Donot throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use . These measures will help protect the environment.

6. Contents of the pack and other information

What Risperoc contains

The active substance is risperidone

Each Risperoc orodispersible tablet contains 0.5 mg, 1 mg or 2 mg of risperidone.

The other ingredients are mannitol, basic butylated methacrylate copolymer, povidone K25, microcrystalline cellulose, low-substituted hydroxypropylcellulose, aspartame (E951), crospovidone, red iron oxide (E172), spearmint flavour (containing in particular sorbitol (E420)), peppermint flavour (containing in particular sorbitol (E420), levomenthol), calcium silicate, magnesium stearate.

What RISPEROC looks like and contents of the pack

Round, slightly convex, pink marbled orodispersible tablets.

Pack sizes: 10, 20, 28, 30, 50, 56, 60, 98 and 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany:

RISPERIDON 1 A PHARMA 0,5 MG SCHMELZTABLETTEN

RISPERIDON 1 A PHARMA 1 MG SCHMELZTABLETTEN

RISPERIDON 1 A PHARMA 2 MG SCHMELZTABLETTEN

Sweden:

Risperoc 0,5 MG munsönderfallande tablett

Risperoc 1 MG munsönderfallande tablett

Risperoc 2 MG munsönderfallande tablet

This leaflet was last revisedin 19 March 2014

<[to be completed nationally]>.