RISPERIDONE 0.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take risperidone tablets

Do not take Risperidone if you:

• are allergic (hypersensitive) to risperidone or any of the other ingredients (these are listed in Section 6).

Warnings and Precautions

Check with 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. It may cause low blood pressure. Your dose may need to be adjusted
• have ever experienced involuntary movements of the tongue, mouth and face
• 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
• have Parkinson’s disease or dementia
• are diabetic
• have epilepsy
• 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
• have problems controlling your body temperature or overheating
• have kidney problems
• have liver problems
• have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin.
• or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
• have had low levels of white blood cells in the past (which may or may not have been caused by other medicines)
• are planning to have an operation on your eye
• 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).

If you are not sure if any of the above applies to you, talk to 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 ofpre-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.

Risperidone commonly raises levels of a hormone called “prolactin”. This may cause side effects such as menstrual disorders or fertility problems in women, breast swelling in men (see Possible side effects). If such side effects occur, evaluation of the prolactin level in the blood is recommended.

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.

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.

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.

A small and inconclusive study has reported an increase in height in children who took risperidone, but whether this is an effect of the drug or due to some other reason is not known.

Other medicines and Risperidone Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , including medicines obtained without a prescription and herbal medicines.

The following medicines can affect Risperidone:

• 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 (quinine), heart rhythm problems (such as quinidine, propafenone), 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
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)

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 (e.g. used to treat psychosis or to calm down)
• cimetidine, ranitidine (blockers ofthe acidity of stomach)
• itraconazole and ketoconazole (medicines for treating fungal infections)
• certain medicines used in the treatment of HIVAIDS, such as ritonavir
• verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders

If you start or stop taking such medicine 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 Tablets 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 for advice before taking this medicine.
• 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 ‘prolactin’ that may affect male and female fertility (se possible side effects)

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 Tablets contain Lactose.

If your doctor has told you that you are intolerant of some sugars, discuss it with them before taking this medicine.

The 2 mg and 6 mg Risperidone tablets contain a colour called Sunset Yellow (E110) which may cause allergic reactions. Allergy is more common in those people who are allergic to aspirin.

| 3. How to take Risperidone Tablets |

• Always take these tablets exactly as advised by your doctor or pharmacist has told you. Check with 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 tablets should be swallowed with a drink of water.
• The score line is to only facilitate the breaking for ease of swallowing and not to divide in to equal doses.
• 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.
• Children and adolescents under 18 years old should not be treated with Risperidone for schizophrenia.
• 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.
• 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.
• Your doctor will tell you which is the best for you.
• 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 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. Dose increases should be slower in these patients. Risperidone should be used with caution in this patient group.

You should swallow your tablet with a drink of water.

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 amount of medicine you should take is explained under the ‘The recommended dose is’ sub-heading above.

If you take more Risperidone Tablets 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 heartbeats or fits.

If you forget to take a dose of Risperidone Tablets If necessary, take the missed dose when you remember however, if it is almost time for your next dose, skip the missed dose and then take your next dose when it is due.

If you miss two or more doses, contact your doctor.

Do not take a double dose to make up the forgotten dose

If you stop taking Risperidone Tablets

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 product, ask your doctor or pharmacist.

4. Possible side-effects

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

Tell your doctor immediately if you experience any of the following uncommon side effects (may affect up to 1 in 100 people):

• 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 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.
• 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)
• 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.

Tell your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):

• 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 of these symptoms seek medical advice immediately.
• 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 severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash or drop in blood pressure.
• Life threatening complications of uncontrolled diabetes.
• Yellowing of the skin and the eyes (jaundice).
• Inflammation of the pancreas
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)

The following side effects may happen:

Very Common (may affect more than 1 in 10 people):

• feeling sleepy, or less alert
• 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.

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 in a blood test (which may or may not cause symptoms). Symptoms of high prolactin occur uncommonly and may include in men breast swelling, difficulty in getting or maintaining erections, decreased sexual desire 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, or fertility problems.
• 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 ofbreath
• 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, bed wetting
• 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
• 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
• Over sensitiveness of the eyes to light, Dry eye, Increased tears, Redness of the eyes
• Sensation of spinning (vertigo), Ringing in the ears, Ear pain
• 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 ofbreathing 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
• Abnormal posture, Joint stiffness, Joint swelling, Muscle weakness, Neck pain
• Frequent passing of urine, Inability to pass urine, Pain when passing urine
• Development of breasts in men, leakage of milk from the breasts, sexual dysfunction, Erectile dysfunction, ejaculation disorder, breast pain, breast discomfort, vaginal discharge
• Loss of menstrual periods, Missed menstrual periods or other problems with your cycle (females),
• Increased liver transaminases in your blood, increased GGT (a liver enzyme called gamma-glutamyl transferase) in your blood, increased liver enzymes in your blood
• 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.
• 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
• Sleep walking
• Sleep-related eating disorder
• Not moving or responding while awake (catatonia)
• 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,
• Dangerously excessive intake of water
• Irregular heart beat
• Trouble breathing during sleep (sleep apnea), Fast, shallow breathing
• A blockage in the bowels
• Swollen tongue, Chapped lips, Rash on skin related to drug
• Dandruff
• 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
• Decreased body temperature, Coldness in arms and legs
• Symptoms of drug withdrawal

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

• Life threatening complications ofuncontrolled diabetes.
• Sudden swelling of face, lips, throat or tongue along with difficult breathing.
• Lack of bowel muscle movement that causes blockage. 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 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 the Yellow Card Scheme at: or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store risperidone tablets

• Keep the medicine out of the sight and reach of children.
• Do not use the tablets after the expiry date printed on the pack.
• Do not store above 25°C. Store in the original package.
• Do not 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 Risperidone Tablets contain

• The active substance is risperidone. Each Risperidone film-coated tablet contains either 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 6 mg of risperidone.

The other ingredients are:

• Risperidone film-coated tablets:

Tablet core: Lactose monohydrate, Cellulose microcrystalline (E 460), Maize starch, Starch pregelatinised, Sodium Lauryl Sulfate, Silica Colloidal anhydrous, Magnesium Stearate Film-Coating: Hypromellose (E464), Purified Talc (E 555B), Titanium dioxide (E 171), Macrogol – 6000 (E 490).

Also Contains:

• Risperidone 0.5mg film-coated tablets: Film-Coating: Red Ferric Oxide (E172)
• Risperidone 2mg film-coated tablets: Film-Coating: Sunset Yellow (E110)
• Risperidone 3mg film-coated tablets: Film-Coating: Quinoline Yellow (E104)
• Risperidone 4mg film-coated tablets:

Film-Coating: Quinoline Yellow (E104), Indigo Carmine (E132)

• Risperidone 6mg film-coated tablets: Film-Coating: Quinoline Yellow (E104), Sunset Yellow (E110)
• What the tablets look like and contents of the pack 0.5mg : Red coloured, film coated, caplet shaped, biconvex tablets with “0.5” debossed on one side and “B/L” debossed on either side of the scored notch on the other side.
• 1mg : White coloured, film coated, caplet shaped, biconvex tablets with “1” debossed on one side and “B/L” debossed on either side of the scored notch on the other side
• 2mg : Orange coloured, film coated, caplet shaped, biconvex tablets with “2” debossed on one side and “B/L” debossed on either side of the scored notch on the other side
• 3mg : Yellow coloured, film coated, caplet shaped, biconvex tablets with “3” debossed on one side and “B/L” debossed on either side of the scored notch on the other side.
• 4mg : Green coloured, film coated, caplet shaped, biconvex tablets with “4” debossed on one side and “B/L” debossed on either side of the scored notch on the other side
• 6mg :Yellow coloured, film-coated, round, biconvex tablets with “BL” debossed on one side and “6” on the other side.
• Risperidone 0.5mg Tablets are packed in blister pack of 20 tablets.
• Risperidone 1mg Tablets are packed in blister pack of 20 and 60 tablets.
• Risperidone 6mg Tablets are packed in blister pack of 28 tablets.

MarketingAutho­risation Holder and Manufacturer:

Name and address:

Bristol Laboratories Ltd,

Unit 3, Canal side, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG,

United Kingdom.

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

E-mail :

Risperidone 0.5mg film-coated Tablets;

PL 17907/0210

Risperidone 1mg film-coated Tablets;

PL 17907/0211

Risperidone 2mg film-coated Tablets;

PL 17907/0212

Risperidone 3mg film-coated Tablets;

PL 17907/0213

Risperidone 4mg film-coated Tablets;

PL 17907/0214

Risperidone 6mg film-coated Tablets;

PL 17907/0215

This leaflet was last revised in May 2019.

To request a copy of this leaflet in a Braille, large print or audio then please contact the licence holder at the address (or telephone, fax, email) above.

V12 07–05–19 D0

10

2. what you need to know before you take risperidone tablets

Do not take Risperidone if you:

• are allergic (hypersensitive) to risperidone or any of the other ingredients (these are listed in Section 6).

Warnings and Precautions

Check with 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. It may cause low blood pressure. Your dose may need to be adjusted
• have ever experienced involuntary movements of the tongue, mouth and face
• 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
• have Parkinson’s disease or dementia
• are diabetic
• have epilepsy
• 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
• have problems controlling your body temperature or overheating
• have kidney problems
• have liver problems
• have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin.
• or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
• have had low levels of white blood cells in the past (which may or may not have been caused by other medicines)
• are planning to have an operation on your eye
• 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).

If you are not sure if any of the above applies to you, talk to 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 check for signs of high blood sugar. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.

Risperidone commonly raises levels of a hormone called “prolactin”. This may cause side effects such as menstrual disorders or fertility problems in women, breast swelling in men (see Possible side effects). If such side effects occur, evaluation of the prolactin level in the blood is recommended.

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.

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.

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.

A small and inconclusive study has reported an increase in height in children who took risperidone, but whether this is an effect of the drug or due to some other reason is not known.

Other medicines and Risperidone Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , including medicines obtained without a prescription and herbal medicines.

The following medicines can affect Risperidone:

• 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 (quinine), heart rhythm problems (such as quinidine, propafenone), 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
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)

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 (e.g. used to treat psychosis or to calm down)
• cimetidine, ranitidine (blockers of the acidity of stomach)
• itraconazole and ketoconazole (medicines for treating fungal infections)
• certain medicines used in the treatment of HIV AIDS, such as ritonavir
• verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders

If you start or stop taking such medicine 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 Tablets 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 for advice before taking this medicine.
• 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 ‘prolactin’ that may affect male and female fertility (see possible side effects)

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 Tablets contain Lactose.

If your doctor has told you that you are intolerant of some sugars, discuss it with them before taking this medicine.

The 2 mg and 6 mg Risperidone tablets contain a colour called Sunset Yellow (E110) which may cause allergic reactions. Allergy is more common in those people who are allergic to aspirin.

3. How to take Risperidone Tablets

• Always take these tablets exactly as advised by your doctor or pharmacist has told you. Check with 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 tablets should be swallowed with a drink of water.
• The score line is to only facilitate the breaking for ease of swallowing and not to divide in to equal doses.

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.
• Children and adolescents under 18 years old should not be treated with Risperidone for schizophrenia.
• 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.
• Your doctor will tell you which is the best for you.
• 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 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. Dose increases should be slower in these patients. Risperidone should be used with caution in this patient group. You should swallow your tablet with a drink of water.

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 amount of medicine you should take is explained under the ‘The recommended dose is’ sub-heading above.

If you take more Risperidone Tablets 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 heartbeats or fits.

If you forget to take a dose of Risperidone Tablets

If necessary, take the missed dose when you remember however, if it is almost time for your next dose, skip the missed dose and then take your next dose when it is due.

If you miss two or more doses, contact your doctor.

Do not take a double dose to make up the forgotten dose

If you stop taking Risperidone Tablets

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 product, ask your doctor or pharmacist. XXXXXXX

110 I

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|4. Possible side-effects|

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

Tell your doctor immediately if you experience any of the following uncommon side effects (may affect up to 1 in 100 people):

• 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 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.
• 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)
• 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.

Tell your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):

• 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 of these symptoms seek medical advice immediately.
• 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 severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash or drop in blood pressure.
• Life threatening complications of uncontrolled diabetes.
• Yellowing of the skin and the eyes (jaundice).
• Inflammation of the pancreas
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)

The following side effects may happen:

Very Common (may affect more than 1 in 10 people):

• feeling sleepy, or less alert
• 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.

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 in a blood test (which may or may not cause symptoms). Symptoms of high prolactin occur uncommonly and may include in men breast swelling, difficulty in getting or maintaining erections, decreased sexual desire 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, or fertility problems.
• 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, bed wetting
• 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
• 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
• Over sensitiveness of the eyes to light, Dry eye, Increased tears, Redness of the eyes
• Sensation of spinning (vertigo), Ringing in the ears, Ear pain
• 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
• Abnormal posture, Joint stiffness, Joint swelling, Muscle weakness, Neck pain
• Frequent passing of urine, Inability to pass urine, Pain when passing urine
• Development of breasts in men, leakage of milk from the breasts, sexual dysfunction, Erectile dysfunction, ejaculation disorder, breast pain, breast discomfort, vaginal discharge
• Loss of menstrual periods, Missed menstrual periods or other problems with your cycle (females),
• Increased liver transaminases in your blood, increased GGT (a liver enzyme called gamma-glutamyl transferase) in your blood, increased liver enzymes in your blood
• 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.
• 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
• Sleep walking
• Sleep-related eating disorder
• Not moving or responding while awake (catatonia)
• 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,
• Dangerously excessive intake of water
• Irregular heart beat
• Trouble breathing during sleep (sleep apnea), Fast, shallow breathing
• A blockage in the bowels
• Swollen tongue, Chapped lips, Rash on skin related to drug
• Dandruff
• 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
• Decreased body temperature, Coldness in arms and legs
• Symptoms of drug withdrawal

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

• Life threatening complications of uncontrolled diabetes.
• Sudden swelling of face, lips, throat or tongue along with difficult breathing.
• Lack of bowel muscle movement that causes blockage.

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 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 the Yellow Card Scheme at: yellowcard or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store risperidone tablets

• Keep the medicine out of the sight and reach of children.
• Do not use the tablets after the expiry date printed on the pack.
• Do not store above 25°C. Store in the original package.
• Do not 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 Risperidone Tablets contain

• The active substance is risperidone. Each Risperidone film-coated tablet contains either 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 6 mg of risperidone.

The other ingredients are:

• Risperidone film-coated tablets:

Tablet core: Lactose monohydrate, Cellulose microcrystalline (E 460), Maize starch, Starch pregelatinised, Sodium Lauryl Sulfate, Silica Colloidal anhydrous, Magnesium Stearate

Film-Coating: Hypromellose (E464), Purified Talc (E 555B), Titanium dioxide (E 171), Macrogol – 6000 (E 490).

Also Contains:

• Risperidone 0.5mg film-coated tablets:

Film-Coating: Red Ferric Oxide (E172)

• Risperidone 2mg film-coated tablets: Film-Coating: Sunset Yellow (E110)
• Risperidone 3mg film-coated tablets:

Film-Coating: Quinoline Yellow (E104)

• Risperidone 4mg film-coated tablets:

Film-Coating: Quinoline Yellow (E104), Indigo Carmine (E132)

• Risperidone 6mg film-coated tablets:

Film-Coating: Quinoline Yellow (E104), Sunset Yellow (E110)

What the tablets look like and contents of the pack

• 0.5mg : Red coloured, film coated, caplet shaped, biconvex tablets with “0.5” debossed on one side and “B/L” debossed on either side of the scored notch on the other side.
• 1mg : White coloured, film coated, caplet shaped, biconvex tablets with “1” debossed on one side and “B/L” debossed on either side of the scored notch on the other side
• 2mg : Orange coloured, film coated, caplet shaped, biconvex tablets with “2” debossed on one side and “B/L” debossed on either side of the scored notch on the other side
• 3mg : Yellow coloured, film coated, caplet shaped, biconvex tablets with “3” debossed on one side and “B/L” debossed on either side of the scored notch on the other side.
• 4mg : Green coloured, film coated, caplet shaped, biconvex tablets with “4” debossed on one side and “B/L” debossed on either side of the scored notch on the other side
• 6mg :Yellow coloured, film-coated, round, biconvex tablets with “BL” debossed on one side and “6” on the other side.
• Risperidone 0.5mg Tablets are packed in blister pack of 20 tablets.
• Risperidone 1mg Tablets are packed in blister pack of 20 and 60 tablets.
• Risperidone 6mg Tablets are packed in blister pack of 28 tablets.