Risperidone Grindeks 4 mg film-coated tablets

• 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Risperidone Grindeks is and what it is used for
2. What you need to know before you take Risperidone Grindeks
3. How to take Risperidone Grindeks
4. Possible side effects
5. How to store Risperidone Grindeks
6. Contents of the pack and other information

• If you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Risperidone Grindeks.

Talk to your doctor or pharmacist before taking Risperidone Grindeks if:

• You have a heart problem. Examples include an irregular heartbeat or if you are prone to low blood pressure, or if you are taking medicines for your blood pressure. Risperidone Grindeks 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 disease or blood vessel problems in the brain
• 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 lowered level of consciousness (also known as Neuroleptic Malignant Syndrome)
• 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
• 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
• You or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.

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

As dangerously low numbers of a certain type of white blood cell needed to fight infection in the blood has been seen very rarely in patients taking Risperidone Grindeks, your doctor may check your white blood cell counts.

Risperidone Grindeks 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 in patients taking Risperidone Grindeks, 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 the 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.

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by a stroke.

During treatment with risperidone, you should frequently see your doctor.

Medical treatment should be sought straight away if you or your caregiver 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.

Before treatment is started for conduct disorder, other causes of aggressive behaviour should have been ruled out.

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

Before treatment is started your or your child’s body weight may be measured and it may be regularly monitored during treatment.

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

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 these
• Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems, allergies (antihistamines), 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. Risperidone Grindeks can lower blood pressure
• Medicines for Parkinson’s disease (such as levodopa)
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)
• Water tables (diuretics) used for heart problems or swelling of parts of your body due to a buildup of too much fluid (such as furosemide or chlorothiazide). Risperidone Grindeks taken by itself or with furosemide, may have an increase risk of stroke or death in elderly 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 and 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)
• 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 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 taking Risperidone Grindeks.

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

• 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 this medicine.
• The following symptoms may occur in newborn babies of mothers that have taken Risperidone Grindeks 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 Grindeks can raise your levels of a hormone called ‘prolactin’ that may impact fertility (see Possible side effects).

Dizziness, tiredness and vision problems may occur during treatment with Risperidone Grindeks. Do not drive or use any tools or machines without talking to your doctor first.

Risperidone Grindeks contains lactose, 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.

One of the ingredients in Risperidone Grindeks 2 mg film-coated tablets is Sunset Yellow FCF (E110) that may cause allergic reactions.

One of the ingredients in Risperidone Grindeks 4 mg film-coated tablets is Tartrazine (E102) that may cause allergic reactions.

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 or 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.

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.

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 (0.25 ml of risperidone oral solution1 mg/ml) 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.
• The duration of treatment in patients with Alzheimer’s dementia should be not more than 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperidone Grindeks 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 (0.25 ml of risperidone oral solution1 mg/ml) 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 (0.25 ml to 0.75 ml of risperidone oral solution 1 mg/ml) 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 Grindeks for conduct disorder.

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.

For oral use.

• You should swallow your tablet with a little water.
• Risperidone Grindeks 2 mg and 6 mg film-coated tablets have a score line on one side, but Risperidone Grindeks 4 mg film-coated tablets have a double score on one side. The tablet can be divided into equal doses.

• 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 with standing and walking; feel dizzy due to low blood pressure, or have abnormal heartbeats or fits.

• 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.

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.

• 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 time. These may be signs of a stroke.
• Experience tardive dyskinesia (twitching or jerking movements thet 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 need.

• Experience blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), 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 consciousness (a disorder called ‘Neuroleptic Malignant Syndrome’). Immediate medical treatment may be needed.
• Are a man and experience prolonged and painful erections. This is called priapism. Immediate medical treatment may be needed.
• Experience severe allergic reaction characterised by fever, swelling mouth, face, lips or tongue, shortness of breath, itching, skin rash or drop in blood pressure.

The following other side effects may also happen:

Very common side effects (may affect more than 1 in 10 people):

• Difficulty falling or staying asleep.
• 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 salivation and/or drooling, and a loss of expression on the face.
• Feeling sleepy or less alert.
• Headache.

Common side effects (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
• Raised 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 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 may 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 side effects (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 the 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, a low white blood cell count, decrease in platelets (blood cells that help you stop bleeding), anaemia, decrease in red blood cells, increase in eosinophils (a type of white blood cells) 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, an 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 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 stools, difficulty swallowing, excessive passing of gas or wind
• Hives (or ‘nettle rash’), itching, hair loss, thickening of the skin, eczema, dry skin, skin discolouration, acne, flaky, itchy scalp or skin, skin disorder, skin lesion
• An increase of creatine phosphokinase (CPK) 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 disfunction, 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 gamma-GT (a liver enzyme called gamma-glutamyltransferase) in your blood, increased liver enzymes in your blood
• Procedural pain

Rare side effects (may affect up to 1 in 1,000 people):

• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sleep walking
• Sleep-related eating disorder
• Sugar in the urine, low blood sugar, high blood triglycerides (a type of fat)
• Lack of emotion, inability to reach orgasm
• Not moving or responding while awake (catatonia)
• Blood vessles problems in the brain
• Coma due to uncontrolled diabetes
• Shaking of the head
• Glaucoma (increased pressure within the eyeball), problems with movements 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 levels of a certain type of white blood cell needed to fight infection in your blood
• Dangerously excessive intake of water
• Irregular heartbeat
• Trouble breathing during sleep (sleep apnoea), fast, shallow breathing
• Inflammation of the pancreas, a blockage in the bowels
• Swollen tongue, chapped lips, rash on the skin related to medicine
• Dandruff
• Breakdown of muscle fibres 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
• Decreased body temperature, coldness in arms and legs
• Symptoms of drug withdrawal
• Yellowing of the skin and the eyes (jaundice).

Very rare side effects (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.

Not known (frequency cannot be estimated from the available data):

• Severe or life-threatening rash with blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

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 Grindeks: rapid heartbeat upon standing.

In general, the 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 of age) 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.

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is risperidone.

Each Risperidone Grindeks film-coated tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 6 mg risperidone.

The other ingredients are:

Risperidone Grindeks 0.5 mg film-coated tablet:

Tablet core: lactose, cellulose, microcrystalline (E460), maize starch, magnesium stearate (E572).

Film coating: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E471), poly(vinyl alcohol) (E1203), iron oxide red (E172), iron oxide yellow (E172).

Risperidone Grindeks 1 mg film-coated tablet:

Tablet core: lactose, cellulose, microcrystalline (E460), maize starch, magnesium stearate (E572).

Film coating: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E471), poly(vinyl alcohol) (E1203).

Risperidone Grindeks 2 mg film-coated tablet:

Tablet core: lactose, cellulose, microcrystalline (E460), maize starch, magnesium stearate (E572).

Film coating: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E471), poly(vinyl alcohol) (E1203), sunset yellow FCF aluminum lake (E110), quinoline yellow aluminum lake (E104).

Risperidone Grindeks 3 mg film-coated tablet:

Tablet core: lactose, cellulose, microcrystalline (E460), maize starch, magnesium stearate (E572).

Film coating: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E471), poly(vinyl alcohol) (E1203), iron oxide yellow (E172), iron oxide black (E172).

Risperidone Grindeks 4 mg film-coated tablet:

Tablet core: lactose, cellulose, microcrystalline (E460), maize starch, magnesium stearate (E572).

Film coating: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E471), poly(vinyl alcohol) (E1203), tartrazine aluminum lake (E102), indigo carmine aluminum lake (E132).

Risperidone Grindeks 6 mg film-coated tablet:

Tablet core: lactose, cellulose, microcrystalline (E460), maize starch, magnesium stearate (E572).

Film coating: macrogol poly(vinyl alcohol) grafted copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E471), poly(vinyl alcohol) (E1203), iron oxide yellow (E172), iron oxide red (E172).

Risperidone Grindeks 0.5 mg is pink, round biconvex film-coated tablet. Size of tablet is approximately 6 mm x 3 mm.

Risperidone Grindeks 1 mg is white, round biconvex film-coated tablet. Size of tablet is approximately 7 mm x 3 mm.

Risperidone Grindeks 2 mg is orange, round biconvex film-coated tablet with score line on one side. Size of tablet is approximately 8 mm x 4 mm.

Risperidone Grindeks 3 mg is beige, round biconvex film-coated tablet. Size of tablet is approximately 9 mm x 5 mm.

Risperidone Grindeks 4 mg is yellowish-green, round biconvex film-coated tablet with double score line on one side. Size of tablet is approximately 11 mm x 4 mm.

Risperidone Grindeks 6 mg is brownish, round biconvex film-coated tablet with score line on one side. Size of tablet is approximately 12 mm x 5 mm.

Risperidone Grindeks 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg are available in blisters of 20, 30, 60 or 100 film-coated tablets.

Not all pack sizes may be marketed.