Risperidone grindeks

Package leaflet: Information for the user

Risperidone Grindeks, 0.5 mg, film-coated tablets
Risperidone Grindeks, 1 mg, film-coated tablets
Risperidone Grindeks, 2 mg, film-coated tablets
Risperidone Grindeks, 3 mg, film-coated tablets
Risperidone Grindeks, 4 mg, film-coated tablets
Risperidone Grindeks, 6 mg, film-coated tablets
Risperidone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Risperidone Grindeks is and what it is 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 pack and other information

1. What Risperidone Grindeks is and what it is 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 things that are not true, or experience unusual suspiciousness or confusion.
• manic episodes – states in which the patient may feel intense excitement, agitation, restlessness, enthusiasm, or excessive activity. Manic episodes occur in disorders known as "bipolar affective disorders".
• short-term (up to 6 weeks) persistent aggression in patients with dementia of Alzheimer's type who are a danger to themselves or others. Before using this medicine, alternative (non-pharmacological) treatment methods should be considered.
• short-term (up to 6 weeks) persistent aggression in intellectually disabled children (over 5 years of age) and adolescents with behavioural disorders.

Risperidone Grindeks helps to relieve symptoms of the illness 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 to any of the other ingredients of this medicine (listed in section 6).

If the patient is unsure whether the above information applies to them, they should consult their doctor or
pharmacist before taking Risperidone Grindeks.
Warnings and precautions
Before starting treatment with Risperidone Grindeks, discuss the following with your doctor or
pharmacist:

• if the patient has heart function disorders. Examples include irregular heartbeat, or if the patient is prone to low blood pressure or is taking medications that regulate blood pressure. Risperidone Grindeks may cause a drop in blood pressure. Dose adjustment may be necessary.
• if the patient has any risk factors that may predispose them to stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disorders.
• if the patient has ever experienced involuntary movements of the tongue, mouth, or face.
• if the patient has ever had a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as neuroleptic malignant syndrome).
• if the patient has Parkinson's disease or dementia.
• if the patient has previously had a low white blood cell count (which may or may not have been caused by other medications).
• if the patient has diabetes.
• if the patient has epilepsy.
• if the patient is a man who has experienced prolonged or painful erection.
• if the patient has disorders of body temperature regulation or is prone to overheating.
• if the patient has kidney function disorders.
• if the patient has liver function disorders.
• if the patient has abnormally high levels of the hormone prolactin in the blood or suspected prolactin-dependent tumor.
• if the patient or any of their relatives have previously had blood clots, as antipsychotic medications are associated with an increased risk of thrombosis.

If the patient is unsure whether any of the symptoms described above apply to them, they should
consult their doctor or pharmacist before taking Risperidone Grindeks.
The treating physician may order a white blood cell count test, as very rarely, a dangerously low number of
certain types of white blood cells necessary to fight infections has been observed in patients taking Risperidone Grindeks.
Risperidone Grindeks may cause weight gain. Significant weight gain may negatively affect health. The treating physician will regularly monitor the patient's body weight.
The doctor should check whether the patient has symptoms of high blood glucose levels,
as diabetes and worsening of pre-existing diabetes have been observed in patients taking Risperidone Grindeks. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Risperidone frequently increases the level of a hormone called "prolactin". This may cause adverse effects such as: menstrual disorders, fertility problems in women, breast swelling in men (see section "Possible side effects"). If such adverse effects occur, blood prolactin level testing is recommended.
During cataract surgery, the pupil may not dilate sufficiently. Also, the iris may be flaccid during the procedure, which may lead to eye damage. If the patient has planned eye surgery, they should inform the 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 treatment with risperidone, the patient should frequently consult their doctor.
Seek immediate medical help if the patient or caregiver observes sudden change in mental status, sudden weakness or numbness of facial muscles or limbs, especially on one side, or speech disturbances, even if they occur briefly. These symptoms may indicate a stroke.
Children and adolescents
Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.
If fatigue occurs during treatment, changing the time of risperidone administration may improve concentration.
The patient's body weight may be measured before starting treatment and regularly during treatment.
In a small and inconclusive study, increased growth was observed in children taking risperidone, but it is not known whether this is due to the drug or other causes.
Risperidone Grindeks and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 changes in the electrical activity of the heart, such as antimalarial drugs, antiarrhythmics, antihistamines, certain antidepressants, or other medicines used to treat psychiatric disorders.
• medicines that cause slowing of the heart rate.
• medicines that reduce potassium levels in the blood (e.g., certain diuretics).
• medicines used for hypertension. Risperidone Grindeks may lower blood pressure.
• medicines used to treat Parkinson's disease (e.g., levodopa).
• medicines that increase central nervous system activity (psychostimulants such as methylphenidate).
• diuretics (used in patients with heart disease or to reduce swelling in areas with excessive fluid accumulation (e.g., furosemide or hydrochlorothiazide). Risperidone Grindeks, taken alone or together with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• rifampicin (a medicine used to treat certain infections),
• carbamazepine, phenytoin (medicines for epilepsy),
• phenobarbital. When starting or stopping these medicines, a change in risperidone dose may be necessary.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart conditions),
• antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants,
• beta-blockers (used to treat hypertension),
• phenothiazines (e.g., used to treat psychosis or for sedation),
• cimetidine, ranitidine (reducing gastric acid secretion),
• itraconazole and ketoconazole (used in fungal infections),
• certain medicines used to treat HIV/AIDS infection, such as ritonavir,
• verapamil, used to treat hypertension and (or) heart rhythm disorders,
• sertraline and fluvoxamine, used to treat depression and other psychiatric disorders. When starting or stopping these medicines, a change in risperidone dose may be necessary.

If the patient is unsure whether they have taken or are taking any of the medicines listed above,
they should consult their doctor or pharmacist before taking Risperidone Grindeks.
Risperidone Grindeks with food, drink, and alcohol
This medicine can be taken with or without food. During treatment with Risperidone Grindeks, alcohol consumption should be avoided.
Pregnancy, breastfeeding, and effect on fertility

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take this medicine.
• Newborns whose mothers took Risperidone Grindeks during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the baby, contact a doctor.
• Risperidone Grindeks may increase blood levels of a hormone called "prolactin", which may affect fertility (see section "Possible side effects").

Driving and using machines
During treatment with Risperidone Grindeks, dizziness, fatigue, and visual disturbances may occur. Therefore, do not drive, use tools, or operate machinery without consulting your doctor.
Risperidone Grindeks contains lactose
Risperidone Grindeks contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Risperidone Grindeks 2 mg film-coated tablets contain sunset yellow FCF (E110)
One of the ingredients of Risperidone Grindeks 2 mg film-coated tablets is sunset yellow FCF (E110), which may cause allergic reactions.
Risperidone Grindeks 4 mg film-coated tablets contain tartrazine (E102)
One of the ingredients of Risperidone Grindeks 4 mg film-coated tablets is tartrazine (E102),
which may cause allergic reactions.

3. How to take Risperidone Grindeks

This medicine should always be taken exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The recommended doses are given below:

Treatment of schizophrenia
Adults

• The initial dose is 2 mg per day; this dose may be increased on the second day to 4 mg per day.
• Depending on the patient's response to treatment, the doctor may adjust the dose.
• For most patients, the daily dose ranges from 4 mg to 6 mg.
• This total daily dose may be taken as a single dose or divided into two doses. Your doctor will inform you which dosing schedule is best for you.

Elderly patients

• The usual initial dose is 0.5 mg twice daily.
• The doctor may then gradually increase the dose to 1 mg or 2 mg twice daily.
• Your doctor will inform you which dosing schedule is best for you.

Treatment of manic episodes
Adults

• The usual initial dose is 2 mg once daily.
• Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
• For most patients, the dose ranges from 1 mg to 6 mg once daily.

Elderly patients

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

Treatment of persistent aggression in patients with Alzheimer's dementia
Adults (including elderly patients)

• The usual initial dose is 0.25 mg (0.25 mL of risperidone oral solution 1 mg/mL) twice daily.
• 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 daily. Some patients may require a dose of 1 mg twice daily.
• The duration of treatment in patients with Alzheimer's dementia 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 for the treatment of schizophrenia or mania.

Treatment of behavioural disorders
The dose depends on the child's body weight:
In children weighing less than 50 kg

• The usual initial dose is 0.25 mg (0.25 mL of risperidone oral solution 1 mg/mL) once daily.
• The dose may be increased every other day (gradually) by 0.25 mg per day.
• The usual maintenance dose is typically 0.25 mg to 0.75 mg (0.25 mL to 0.75 mL of risperidone oral solution 1 mg/mL) once daily.

In children weighing 50 kg or more

• The usual initial dose is 0.5 mg once daily.
• The dose may be increased every other day by 0.5 mg per day.
• The usual maintenance dose is typically 0.5 mg to 1.5 mg once daily.

The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.
Risperidone Grindeks should not be used in children under 5 years of age for the treatment of behavioural disorders.

Patients with renal or hepatic impairment
Regardless of the disease being treated, all initial doses and subsequent doses of risperidone should be halved. Doses should be increased more slowly in these patients. Risperidone should be used with caution in this patient group.

Method of administration
Oral use

• Swallow the tablet with water.
• Risperidone Grindeks 2 mg and 6 mg coated tablets have a single break line on one side, while Risperidone Grindeks 4 mg coated tablets have a double break line on one side. The tablet may be divided into equal doses.

If you take more Risperidone Grindeks than you should

• Seek medical advice immediately. Take the medicine package with you.
• After an overdose, the patient may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, irregular heartbeat, or seizures may occur.

If you forget to take 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 missed dose should be skipped and the next dose taken as prescribed. If the patient forgets two or more doses, they should contact their doctor.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Risperidone Grindeks
Do not stop taking this medicine unless instructed by your doctor. Symptoms of the illness may return. If your doctor decides to discontinue treatment, the dose may be gradually reduced over several days.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Contact the doctor immediately if the patient experiences any of the following
uncommon side effects (may affect fewer than 1 in 100 people):

• sudden change in mental state or sudden weakness or numbness of the face, limbs, particularly on one side, or speech disturbances, even if brief. These symptoms may indicate a stroke.
• tardive dyskinesia (twitching or jerking involuntary movements of the face, tongue, or other body parts). Inform the doctor immediately if rhythmic involuntary movements of the tongue, mouth, or face occur. Discontinuation of risperidone may be necessary.

Contact the doctor immediately if the patient experiences any of the following
rare side effects (may affect fewer than 1 in 1000 people):

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

Other side effects may also occur:

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

• difficulty falling asleep or waking up.
• parkinsonism: symptoms of this condition may include slow or abnormal movements, feeling of stiffness or muscle tension (causing uneven movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include slow shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face.
• feeling of drowsiness or reduced alertness.
• headache.

Common side effects (may affect fewer than 1 in 10 people):

• pneumonia, respiratory tract infection (bronchitis), cold symptoms, sinus infection, urinary tract infection, ear infection, flu-like symptoms.
• increased blood levels of a hormone called "prolactin" (with or without symptoms). Symptoms of elevated prolactin levels are uncommon and may include in men: breast swelling, difficulty achieving or maintaining erection, decreased sexual desire, or other sexual disorders. In women, symptoms may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding, or other menstrual cycle disorders, or fertility problems.
• weight gain, increased appetite, decreased appetite.
• sleep disturbances, irritability, depression, anxiety, restlessness.
• dystonia: in this condition, slow or sustained involuntary muscle contractions occur. They may affect any part of the body (possibly resulting in abnormal posture), but dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• dizziness.
• dyskinesia: in this condition, involuntary muscle movements occur, including repetitive, spasmodic, or twisting movements or jerks.
• tremor (shaking).
• blurred vision, eye infection, or conjunctivitis.
• rapid heartbeat, high blood pressure, shortness of breath (dyspnea).
• sore throat, cough, nosebleed, nasal congestion.
• abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• rash, skin redness.
• muscle cramps, bone or muscle pain, back pain, joint pain.
• urinary incontinence.
• body swelling, swelling of upper or lower limbs, fever, chest pain, weakness, fatigue (tiredness), pain.
• fall.

Uncommon side effects (may affect fewer than 1 in 100 people):

• respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection, viral infection, skin inflammation caused by mites.
• 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 cells) in the blood.
• allergic reaction.
• onset 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 response to stimuli, loss of consciousness, low level of consciousness.
• seizures, fainting.
• compulsion to move body parts, balance disorders, abnormal coordination, dizziness upon changing to upright position, concentration difficulties, speech difficulties, loss or abnormal sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking, or numbness of the skin.
• light sensitivity of the eyes, dry eye, increased tearing, eye redness.
• dizziness, ringing in the ears, ear pain.
• atrial fibrillation (irregular heartbeat), conduction block between heart chambers, abnormal conduction of electrical impulses in the heart, QT interval prolongation in the heart, slow heartbeat, abnormal electrocardiogram (ECG), palpitations.
• low blood pressure, low blood pressure upon standing (as a result of which some patients taking Risperidone Grindeks may faint, feel dizzy, or lose consciousness when standing up suddenly or rising quickly), sudden flushing.
• aspiration pneumonia caused by food entering the airways, pulmonary congestion, congestion of the respiratory tract, crackles, rales, speech difficulties, respiratory tract disorders.
• stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excessive passing of gas.
• urticaria, itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, scaly and itchy scalp or skin elsewhere on the body, skin disorders, skin damage.
• increased CPK (creatine phosphokinase) activity in the blood, an enzyme 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 bleeding, lack of menstrual periods, or other menstrual cycle disorders (in women).
• breast enlargement in men, milk discharge from the breasts, sexual disorders, breast pain, breast discomfort, vaginal discharge.
• swelling of the face, lips, eyes, or mouth.
• chills, increased body temperature.
• change in walking pattern.
• feeling of thirst, general malaise, chest discomfort, feeling unwell, discomfort.
• increased aminotransferase activity in the blood, increased GGT enzyme activity (liver enzyme - gamma-glutamyltransferase) in the blood, increased liver enzyme activity in the blood.
• pain related to medical procedures.

Rare side effects (may affect fewer than 1 in 1000 people):

• infection.
• abnormal secretion of a hormone regulating urine output.
• sleepwalking.
• eating disorders related to sleep.
• glucose in urine, low blood sugar, high triglyceride (fat) levels in the blood.
• lack of emotion, inability to achieve orgasm.
• reduced motor activity and lack of response in a patient with preserved consciousness (catatonia).
• cerebral vascular disorders.
• coma due to uncontrolled diabetes.
• tremulous, nodding head movements.
• glaucoma (increased pressure in the eyeball), eye movement disorders, rotary eye movements, eyelid margin ulcers with crust formation.
• eye-related complications during cataract surgery. During this procedure, floppy iris syndrome (Intraoperative Floppy Iris Syndrome, IFIS) may occur if the patient is currently or has previously taken risperidone. If cataract surgery is planned, inform the ophthalmologist about current or past use of this medicine.
• dangerously low number of specific white blood cells responsible for fighting infections.
• dangerously excessive water intake.
• irregular heartbeat.
• breathing disorders during sleep (sleep apnea), rapid, shallow breathing.
• pancreatitis, intestinal obstruction.
• tongue swelling, dry lips, drug rash.
• psoriasis.
• muscle fiber breakdown and muscle pain (rhabdomyolysis).
• delayed menstrual periods, enlargement of mammary glands, breast enlargement, breast discharge.
• increased insulin levels in the blood (hormone regulating blood sugar).
• skin hardening.
• low body temperature, cold hands and feet.
• withdrawal symptoms.
• yellowing of the skin and eyes (jaundice).

Very rare side effects (may affect fewer than 1 in 10,000 people):

• life-threatening complications associated with uncontrolled diabetes.
• severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties.
• loss of intestinal function leading to obstruction.

Side effects with unknown frequency: frequency cannot be determined from available data

• severe or life-threatening rash with blisters and peeling skin, which may appear in the mouth, nose, eyes, genital organs, and around these areas, and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following side effects have been observed with another medicine called paliperidone, which is very similar to risperidone, so they may also be expected with Risperidone Grindeks: rapid heartbeat upon standing.

Additional side effects in children and adolescents
Generally, side effects in children are similar to those in adults.
The following side effects have been observed more frequently in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or reduced alertness, fatigue (tiredness), headache, increased appetite, vomiting, frequent cold symptoms, nasal mucosa congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhea, and urinary incontinence.

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 helps to provide more information on the safety of the medicine.

5. How to store Risperidone Grindeks

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Risperidone Grindeks contains
The active substance is risperidone.
Each Risperidone Grindeks coated 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:
Tablet core: lactose, cellulose microcrystalline (E460), maize starch, magnesium stearate (E572).
Coating: polyethylene glycol and poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocapronate (E471), polyvinyl alcohol (E1203), iron oxide red (E172), iron oxide yellow (E172).
Risperidone Grindeks, 1 mg, coated tablets:
Tablet core: lactose, cellulose microcrystalline (E460), maize starch, magnesium stearate (E572).
Coating: polyethylene glycol and poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocapronate (E471), polyvinyl alcohol (E1203).
Risperidone Grindeks, 2 mg, coated tablets:
Tablet core: lactose, cellulose microcrystalline (E460), maize starch, magnesium stearate (E572).
Coating: polyethylene glycol and poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocapronate (E471), polyvinyl alcohol (E1203), orange yellow S, aluminium lake (E110), quinoline yellow, aluminium lake (E104).
Risperidone Grindeks, 3 mg, coated tablets:
Tablet core: lactose, cellulose microcrystalline (E460), maize starch, magnesium stearate (E572).
Coating: polyethylene glycol and poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocapronate (E471), polyvinyl alcohol (E1203), iron oxide yellow (E172), iron oxide black (E172).
Risperidone Grindeks, 4 mg, coated tablets:
Tablet core: lactose, cellulose microcrystalline (E460), maize starch, magnesium stearate (E572).
Coating: polyethylene glycol and poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocapronate (E471), polyvinyl alcohol (E1203), tartrazine, aluminium lake (E102), indigo carmine, aluminium lake (E132).
Risperidone Grindeks, 6 mg, coated tablets:
Tablet core: lactose, cellulose microcrystalline (E460), maize starch, magnesium stearate (E572).
Coating: polyethylene glycol and poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171), glycerol monocaprylocapronate (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 is a pink, round, biconvex coated tablet. The tablet size is approximately 6 mm by 3 mm.
Risperidone Grindeks 1 mg is a white, round, biconvex coated tablet. The tablet size is approximately 7 mm by 3 mm.
Risperidone Grindeks 2 mg is an orange, round, biconvex coated tablet with a single breakline on one side. The tablet size is approximately 8 mm by 4 mm.
Risperidone Grindeks 3 mg is a beige, round, biconvex coated tablet. The tablet size is approximately 9 mm by 5 mm.
Risperidone Grindeks 4 mg is a yellowish-green, round, biconvex coated tablet with a double breakline on one side. The tablet size is approximately 11 mm by 4 mm.
Risperidone Grindeks 6 mg is a brownish, round, biconvex coated tablet with a single breakline on one side. The tablet size is approximately 12 mm by 5 mm.
Risperidone Grindeks 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg are available in blister packs containing 20, 30, 60 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names: