Risperidone Grindeks

Leaflet attached to the packaging: information for the user

Risperidone Grindeks, 0.5 mg, coated tablets

Risperidone Grindeks, 1 mg, coated tablets

Risperidone Grindeks, 2 mg, coated tablets

Risperidone Grindeks, 3 mg, coated tablets

Risperidone Grindeks, 4 mg, coated tablets

Risperidone Grindeks, 6 mg, coated tablets

Risperidone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Risperidone Grindeks and what is it used for
• 2. Important information before taking Risperidone Grindeks
• 3. How to take Risperidone Grindeks
• 4. Possible side effects
• 5. How to store Risperidone Grindeks
• 6. Contents of the packaging and other information

1. What is Risperidone Grindeks and what is it used for

Risperidone Grindeks belongs to a group of medicines called antipsychotics.
Risperidone Grindeks is used to treat:

• Schizophrenia - a condition in which the patient may see, hear, or feel things that do not exist, believe in untrue things, or experience unusual suspicion or disorientation.
• Manic episodes - states in which the patient may feel strong excitement, agitation, irritation, enthusiasm, or be overly active. Manic episodes occur in the course of affective bipolar disorders.
• Short-term (up to 6 weeks) persistent aggression in patients with Alzheimer's disease, who harm themselves or others. Before using the medicine, alternative (non-pharmacological) treatment methods should be used.
• Short-term (up to 6 weeks) persistent aggression in intellectually disabled children (over 5 years old) and adolescents with behavioral disorders.

Risperidone Grindeks helps to alleviate the symptoms of the disease and prevent their recurrence.

2. Important information before taking Risperidone Grindeks

When not to take Risperidone Grindeks

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

If the patient is not sure whether the above information applies to them, they should consult a doctor or pharmacist before taking Risperidone Grindeks.

Warnings and precautions

Before starting to take Risperidone Grindeks, the patient should discuss it with their doctor or pharmacist:

• if the patient has heart rhythm disorders. Examples include irregular heartbeat or if the patient has a tendency to low blood pressure or is taking blood pressure regulating medicines. Risperidone Grindeks may cause a decrease in blood pressure. It may be necessary to adjust the dose of the medicine.
• if the patient knows of any factors that may contribute to their risk of stroke, such as high blood pressure, cardiovascular disease, or cerebral vessel disorders.
• if the patient has ever experienced involuntary movements of the tongue, lips, or face.
• if the patient has ever experienced a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as malignant neuroleptic syndrome).
• if the patient has Parkinson's disease or dementia.
• if the patient has had a low white blood cell count in the past (which may, but does not have to be, caused by the action of other medicines).
• if the patient has diabetes.
• if the patient has epilepsy.
• if the patient is a man and has experienced prolonged or painful erections.
• if the patient has body temperature regulation disorders or overheats.
• if the patient has kidney function disorders.
• if the patient has liver function disorders.
• if the patient has an abnormally high level of the hormone prolactin in the blood or suspected prolactin-dependent tumor.
• if the patient or any of their relatives have had blood clots in the past, as the use of antipsychotic medicines is associated with the formation of blood clots.

If the patient is not sure whether any of the above symptoms apply to them, they should consult a doctor or pharmacist before taking Risperidone Grindeks.
The attending doctor may order a white blood cell count test, as very rarely, patients taking Risperidone Grindeks have been observed to have a dangerously low number of a certain type of white blood cell necessary to fight infections.
Risperidone Grindeks may cause weight gain. Significant weight gain can have a negative impact on health. The attending doctor will regularly check the patient's weight.
The doctor should check if the patient has symptoms of high blood sugar levels, as patients taking Risperidone Grindeks have been observed to develop diabetes and exacerbate existing diabetes. In patients with existing diabetes, blood sugar levels should be regularly monitored.
Risperidone often increases the level of a hormone called "prolactin". This can cause side effects such as: menstrual disorders, fertility problems in women, breast swelling in men (see "Possible side effects"). If such side effects occur, it is recommended to perform a blood prolactin level test.
During cataract surgery, the pupil may not dilate sufficiently. The iris may also be floppy during the procedure, which can result in eye damage. If the patient has a planned eye surgery, they should inform their ophthalmologist about taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. Patients with dementia caused by stroke should not take risperidone.
During risperidone treatment, the patient should frequently consult their doctor.
Medical help should be sought immediately if the patient or their caregiver notices a sudden change in the patient's mental state or sudden weakness or numbness of the face, limbs, especially one-sided, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke.

Children and adolescents

Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.
If the patient experiences fatigue during treatment, changing the time of risperidone administration may improve concentration.
The patient's weight may be measured before starting treatment and regularly during treatment.
In a small and inconclusive study, an increase in growth was found in children taking risperidone, but it is not known whether this is due to the action of the medicine or other factors.

Risperidone Grindeks and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Patients should especially inform their doctor or pharmacist if they are taking any of the following medicines:

• sedatives acting on the brain (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect.
• medicines that may cause a change in heart electrical activity, such as malaria medicines, anti-arrhythmic medicines, antihistamines, or certain antidepressants or other medicines used to treat mental disorders.
• medicines that slow down the heart rate.
• medicines that lower blood potassium levels (e.g., certain diuretics).
• medicines used to treat high blood pressure. Risperidone Grindeks may lower blood pressure.
• medicines used to treat Parkinson's disease (e.g., levodopa).
• medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• diuretics (used in heart disease or to relieve swelling in areas where there is excessive fluid accumulation, e.g., furosemide or chlorthiazide). Risperidone Grindeks taken alone or in combination with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may weaken the effect of risperidone:

• rifampicin (a medicine used to treat certain infections),
• carbamazepine, phenytoin (anti-epileptic medicines),
• phenobarbital. If the patient starts or stops taking these medicines, it may be necessary to adjust the dose of risperidone.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart diseases),
• antidepressants, such as paroxetine, fluoxetine, tricyclic antidepressants,
• beta-adrenergic blockers (used to treat high blood pressure),
• phenothiazines (e.g., used to treat psychoses or to sedate),
• cimetidine, ranitidine (reducing stomach acid),
• itraconazole and ketoconazole (used in fungal infections),
• certain medicines used to treat HIV/AIDS infection, such as ritonavir,
• verapamil, used to treat high blood pressure and/or heart rhythm disorders,
• sertraline and fluvoxamine, used to treat depression and other mental disorders. If the patient starts or stops taking these medicines, it may be necessary to adjust the dose of risperidone.

If the patient is not sure whether they have taken or are taking any of the above medicines, they should consult a doctor or pharmacist before taking Risperidone Grindeks.

Risperidone Grindeks with food, drink, and alcohol

This medicine can be taken with or without food.
During Risperidone Grindeks treatment, the patient should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take this medicine.
• In newborns whose mothers took Risperidone Grindeks in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If such symptoms are observed in the child, the patient should contact a doctor.
• Risperidone Grindeks may increase the level of a hormone called "prolactin", which can affect fertility (see "Possible side effects").

Driving and using machines

During Risperidone Grindeks treatment, the patient may experience dizziness, drowsiness, and/or vision disturbances. Therefore, without consulting a doctor, the patient should not drive vehicles, use any tools, or operate any machines.

Risperidone Grindeks contains lactose

Risperidone Grindeks contains lactose, a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.

Risperidone Grindeks, 2 mg, coated tablets contain orange yellow FCF (E110)

One of the ingredients of Risperidone Grindeks, 2 mg, coated tablets is orange yellow FCF (E110), which may cause allergic reactions.

Risperidone Grindeks, 4 mg, coated tablets contain tartrazine (E102)

One of the ingredients of Risperidone Grindeks, 4 mg, coated tablets is tartrazine (E102), which may cause allergic reactions.

3. How to take Risperidone Grindeks

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult a doctor or pharmacist.

Recommended doses are given below:

In the treatment of schizophrenia
Adults

• the initial dose is 2 mg per day, which may be increased to 4 mg per day on the second day.
• depending on the patient's response to treatment, the doctor may adjust the dose.
• for most patients, the daily dose is between 4 mg and 6 mg.
• this total daily dose may be given once or divided into two doses. The doctor will inform the patient which method of taking the medicine is best for them.

Elderly patients

• the initial dose is usually 0.5 mg twice a day.
• then the doctor may gradually increase the dose to 1 mg or 2 mg twice a day.
• the doctor will inform the patient which method of taking the medicine is best for them.

In the treatment of manic episodes
Adults

• the initial dose is usually 2 mg once a day.
• depending on the patient's response to treatment, the doctor may gradually adjust the dose.
• for most patients, the dose is between 1 mg and 6 mg once a day.

Elderly patients

• the initial dose is usually 0.5 mg twice a day.
• then the doctor may gradually adjust the dose to 1 mg or 2 mg twice a day, depending on the patient's response to treatment.

In the treatment of persistent aggression in patients with Alzheimer's disease
Adults (including elderly patients)

• the initial dose is usually 0.25 mg (0.25 mL of risperidone 1 mg/mL oral solution) twice a day.
• depending on the patient's response to treatment, the doctor may gradually adjust the dose.
• for most patients, the daily dose is 0.5 mg twice a day. Some patients may need a dose of 1 mg twice a day.
• the duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

Use in children and adolescents

• Risperidone Grindeks should not be used in children and adolescents under 18 years of age to treat schizophrenia or mania.

In the treatment of behavioral disorders
The dose depends on the child's weight:
In children with a body weight of less than 50 kg

• the initial dose is usually 0.25 mg (0.25 mL of risperidone 1 mg/mL oral solution) once a day.
• the dose may be increased every other day (gradually) by 0.25 mg per day.
• the usual maintenance dose is between 0.25 mg and 0.75 mg (0.25 mL to 0.75 mL of risperidone 1 mg/mL oral solution) once a day.

In children with a body weight of 50 kg or more

• the initial dose is usually 0.5 mg once a day.
• the dose may be increased every other day by 0.5 mg per day.
• the usual maintenance dose is between 0.5 mg and 1.5 mg once a day.

The duration of treatment in patients with behavioral disorders should not exceed 6 weeks.
Risperidone Grindeks should not be used in children under 5 years of age to treat behavioral disorders.

Patients with renal or hepatic impairment

Regardless of the disease being treated, all initial and subsequent doses of risperidone should be reduced by half. In these patients, doses should be increased more slowly.
Risperidone should be used with caution in this group of patients.

Method of administration

Oral administration

• The tablet should be swallowed with water.
• Risperidone Grindeks 2 mg and 6 mg coated tablets have a dividing line on one side, but Risperidone Grindeks 4 mg coated tablets have a double dividing line on one side. The tablet can be divided into equal doses.

Taking a higher dose of Risperidone Grindeks than recommended

• The patient should immediately consult a doctor. The patient should take the packaging of the medicine with them.
• After an overdose of the medicine, the patient may feel drowsy or tired, or they may experience abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, or irregular heartbeat, or they may have a seizure.

Missing a dose of Risperidone Grindeks

• If the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose as directed. If the patient forgets to take two or more doses, they should consult a doctor.
• The patient should not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Risperidone Grindeks treatment

The patient should not stop taking the medicine unless it is in agreement with their doctor. It is possible that the symptoms of the disease will recur. If the doctor decides to stop the treatment, the dose of the medicine may be gradually reduced over several days.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor if they experience any of the following, not very common side effects (may affect up to 1 in 100 people):

• in patients with dementia, a sudden change in mental state or sudden weakness or numbness of the face, limbs, especially one-sided, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke.
• late dyskinesia (involuntary, repetitive, spasmodic, or twitching movements). The patient should immediately inform their doctor if they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue risperidone.

The patient should immediately inform their doctor if they experience any of the following rare side effects (may affect up to 1 in 1,000 people):

• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), these clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, the patient should immediately seek medical help.
• fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary.
• a prolonged or painful erection in men. This condition is known as priapism. Immediate treatment may be necessary.
• a severe allergic reaction characterized by fever, swelling of the lips, face, or tongue, difficulty breathing, itching of the skin, rash, or low blood pressure.

Other side effects may also occur:

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

• difficulty sleeping or waking up.
• Parkinsonism: symptoms of this condition may include slow or abnormal movements, feeling of stiffness or tension in the muscles (which can cause the patient's movements to be uneven), and sometimes even a feeling of "freezing" of movements, followed by a release. Other symptoms of parkinsonism include a slow, shuffling gait, tremors, increased saliva production, and/or drooling, and a face without expression.
• feeling of drowsiness or decreased alertness.
• headache.

Common side effects (may affect up to 1 in 10 people):

• pneumonia, respiratory tract infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infection, flu-like symptoms.
• increased level of a hormone called "prolactin" in the blood (with or without symptoms). Symptoms of increased prolactin levels occur infrequently and may include in men: breast swelling, difficulty achieving or maintaining an erection, decreased sex drive, or other sexual disorders. In women, they may include breast discomfort, milk secretion from the breasts, absence of menstrual periods, or other menstrual cycle disorders, or fertility disorders.
• weight gain, increased appetite, decreased appetite.
• sleep disturbances, irritability, depression, anxiety, restlessness.
• dystonia: in this condition, there are slow or sustained involuntary muscle contractions. They can affect any part of the body (which can result in an abnormal posture), but dystonia most commonly affects the face, including abnormal eye movements, lip, tongue, or jaw movements.
• dizziness.
• dyskinesia: in this condition, there are involuntary muscle movements, including repetitive, spasmodic, or twitching movements.
• tremors (shaking).
• blurred vision, eye infection, or conjunctivitis.
• rapid heartbeat, high blood pressure, shortness of breath (dyspnea).
• sore throat, cough, nosebleed, stuffy nose.
• abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• rash, redness of the skin.
• muscle spasms, muscle or bone pain, back pain, joint pain.
• urinary incontinence.
• swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
• falls.

Uncommon side effects (may affect up to 1 in 100 people):

• respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, skin infection limited to one area or one part of the body, viral infection, sepsis.
• decreased number of white blood cells, which help protect against infections, decreased number of platelets (blood cells that help stop bleeding), anemia, decreased number of red blood cells, increased number of eosinophils (a type of white blood cell) in the blood.
• allergic reaction.
• development of diabetes or worsening of existing diabetes, high blood sugar levels, excessive thirst.
• weight loss, loss of appetite leading to malnutrition and low body weight.
• increased cholesterol levels in the blood.
• elevated mood (mania), confusion, decreased libido, nervousness, nightmares.
• lack of reaction to stimuli, loss of consciousness, low level of consciousness.
• seizures, fainting.
• involuntary movements, balance disorders, lack of coordination, dizziness when changing position to standing, concentration disorders, speech difficulties, loss or abnormal taste, numbness or tingling sensation on the skin.
• increased sensitivity of the eyes to light, dry eye, excessive tearing, redness of the eyes.
• feeling of dizziness, ringing in the ears, ear pain.
• atrial fibrillation (irregular heart rhythm), conduction disorder between the heart chambers, abnormal conduction of electrical impulses in the heart, prolonged QT interval in the heart, slow heartbeat, abnormal electrocardiogram (ECG), feeling of palpitations.
• low blood pressure, low blood pressure when changing position to standing (which may cause some patients taking Risperidone Grindeks to faint, feel dizzy, or lose consciousness when they suddenly stand up or get up), flushing.
• aspiration pneumonia, pulmonary congestion, pulmonary edema, wheezing, rhonchi, speech difficulties, respiratory disorders.
• gastrointestinal infection, diarrhea, very hard stool, difficulty swallowing, excessive gas.
• hives, itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, flaky, itchy skin on the head or rest of the body, skin disorders, skin damage.
• increased activity of CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released from damaged muscles.
• abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• frequent urination, inability to urinate, painful urination.
• erectile dysfunction, ejaculation disorders.
• absence of menstrual periods, irregular menstrual periods, or other menstrual cycle disorders (in women).
• breast enlargement in men, milk secretion from the breasts, sexual disorders, breast pain, breast discomfort, vaginal discharge.
• swelling of the face, lips, eyes, or tongue.
• chills, increased body temperature.
• change in gait.
• feeling of thirst, malaise, chest discomfort, feeling unwell, discomfort.
• increased activity of aminotransferases in the blood, increased activity of the liver enzyme GGT (gamma-glutamyltransferase) in the blood, increased activity of liver enzymes in the blood.
• pain related to medical procedures.

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

• infection.
• abnormal secretion of the hormone that regulates the amount of urine.
• sleepwalking.
• sleep-related eating disorders.
• glucose in the urine, low blood sugar levels, high levels of triglycerides (fats) in the blood.
• lack of emotions, inability to achieve orgasm.
• decreased motor activity and lack of reaction in a patient with preserved consciousness (catatonia).
• cerebrovascular disorders.
• coma due to uncontrolled diabetes.
• tremors, nodding movements of the head.
• glaucoma (increased pressure in the eyeball), eye movement disorders, rotational eye movements, eyelid margin ulcers with crust formation.
• complications during cataract surgery. During this procedure, a condition known as Intraoperative Floppy Iris Syndrome (IFIS) may occur if the patient is taking or has taken risperidone. If the patient has a planned cataract surgery, they should inform their ophthalmologist about taking this medicine in the past or present.
• dangerously low number of certain white blood cells responsible for fighting infections.
• dangerously excessive thirst.
• irregular heart rhythm.
• sleep apnea (breathing disorders during sleep), rapid, shallow breathing.
• pancreatitis, intestinal obstruction.
• swelling of the tongue, chapped lips, drug rash.
• dandruff.
• muscle fiber breakdown and muscle pain (rhabdomyolysis).
• delayed menstrual periods, breast enlargement, breast engorgement, milk secretion from the breasts.
• increased insulin levels in the blood (a hormone that regulates blood sugar levels).
• skin thickening.
• low body temperature, cooling of the hands and feet.
• withdrawal symptoms.
• jaundice (yellowing of the skin and eyes).

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

• life-threatening complications related to uncontrolled diabetes.
• a severe allergic reaction with swelling that can affect the throat and lead to breathing difficulties.
• intestinal obstruction due to lack of bowel movement.

Side effects with unknown frequency: frequency cannot be estimated from the available data

• a severe or life-threatening rash with blisters and peeling skin, which can occur in the mouth, nose, eyes, and genitals, as well as around these areas and can also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following side effects have been observed in patients taking another medicine called paliperidone, which is very similar to risperidone, so they can also be expected when taking Risperidone Grindeks: rapid heartbeat when changing position to standing.

Additional side effects in children and adolescents

Generally, side effects in children will be similar to those in adults.
The following side effects were more common in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or decreased alertness, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, runny nose, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and urinary incontinence.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Risperidone Grindeks

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Risperidone Grindeks contains

The active substance is risperidone.
Each Risperidone Grindeks tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 6 mg of risperidone.
The other ingredients are:
Risperidone Grindeks, 0.5 mg, coated tablets:
Core: lactose, microcrystalline cellulose (E460), corn starch, magnesium stearate (E572).
Coating: copolymer of methacrylic acid and ethyl acrylate (E1209), talc (E553b), titanium dioxide (E171), glycerol monostearate (E471), polyvinyl alcohol (E1203), iron oxide red (E172), iron oxide yellow (E172).
Risperidone Grindeks, 1 mg, coated tablets:
Core: lactose, microcrystalline cellulose (E460), corn starch, magnesium stearate (E572).
Coating: copolymer of methacrylic acid and ethyl acrylate (E1209), talc (E553b), titanium dioxide (E171), glycerol monostearate (E471), polyvinyl alcohol (E1203).
Risperidone Grindeks, 2 mg, coated tablets:
Core: lactose, microcrystalline cellulose (E460), corn starch, magnesium stearate (E572).
Coating: copolymer of methacrylic acid and ethyl acrylate (E1209), talc (E553b), titanium dioxide (E171), glycerol monostearate (E471), polyvinyl alcohol (E1203), orange yellow FCF, aluminum lake (E110), quinoline yellow, aluminum lake (E104).
Risperidone Grindeks, 3 mg, coated tablets:
Core: lactose, microcrystalline cellulose (E460), corn starch, magnesium stearate (E572).
Coating: copolymer of methacrylic acid and ethyl acrylate (E1209), talc (E553b), titanium dioxide (E171), glycerol monostearate (E471), polyvinyl alcohol (E1203), iron oxide yellow (E172), iron oxide black (E172).
Risperidone Grindeks, 4 mg, coated tablets:
Core: lactose, microcrystalline cellulose (E460), corn starch, magnesium stearate (E572).
Coating: copolymer of methacrylic acid and ethyl acrylate (E1209), talc (E553b), titanium dioxide (E171), glycerol monostearate (E471), polyvinyl alcohol (E1203), tartrazine, aluminum lake (E102), indigo carmine, aluminum lake (E132).
Risperidone Grindeks, 6 mg, coated tablets:
Core: lactose, microcrystalline cellulose (E460), corn starch, magnesium stearate (E572).
Coating: copolymer of methacrylic acid and ethyl acrylate (E1209), talc (E553b), titanium dioxide (E171), glycerol monostearate (E471), polyvinyl alcohol (E1203), iron oxide yellow (E172), iron oxide red (E172).

What Risperidone Grindeks looks like and contents of the pack

Risperidone Grindeks, 0.5 mg, are pink, round, biconvex coated tablets. The size of the tablet is approximately 6 mm x 3 mm.
Risperidone Grindeks, 1 mg, are white, round, biconvex coated tablets. The size of the tablet is approximately 7 mm x 3 mm.
Risperidone Grindeks, 2 mg, are orange, round, biconvex coated tablets with a dividing line on one side. The size of the tablet is approximately 8 mm x 4 mm.
Risperidone Grindeks, 3 mg, are beige, round, biconvex coated tablets. The size of the tablet is approximately 9 mm x 5 mm.
Risperidone Grindeks, 4 mg, are yellow-green, round, biconvex coated tablets with a double dividing line on one side. The size of the tablet is approximately 11 mm x 4 mm.
Risperidone Grindeks, 6 mg, are brown, round, biconvex coated tablets with a dividing line on one side. The size of the 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 containing 20, 30, 60, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
Email: grindeks@grindeks.lv

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: