Risperidone Grindeks

Patient Information Leaflet

Risperidone Grindeks 0.5 mg film-coated tablets, 1 mg film-coated tablets, 2 mg film-coated tablets, 3 mg film-coated tablets, 4 mg film-coated tablets, 6 mg film-coated tablets

risperidone
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Risperidone Grindeks is and what it is used for
2. What you need to know 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 for the treatment of:

• Schizophrenia, a condition in which you may see, hear or experience things that are not real, believe things that are not true, or feel unusually suspicious or confused.
• Mania, a condition in which you may feel highly excited, euphoric, restless, energized or hyperactive. Mania occurs as part of an illness called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who are harming themselves or others. Non-pharmacological alternatives should have been considered before treatment.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged 5 years and older) and adolescents with conduct disorder.

Risperidone Grindeks may help relieve the symptoms of the illness and prevent their recurrence.

2. What you should know before taking Risperidone Grindeks

Do not take Risperidone Grindeks if

• You are allergic to risperidone or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether the above applies to you, speak with your doctor or pharmacist before taking Risperidone Grindeks.

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

• You have a heart problem. Examples include if you have weakness of the heart muscle (heart failure), have had a heart attack, tend to have low blood pressure, or are taking medicines for blood pressure. Risperidone Grindeks may cause a drop in blood pressure. Your dose may need to be adjusted.
• You are aware of any factors that may put you at risk of stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disorders.
• You have experienced involuntary rhythmic movements of the tongue, mouth, or face.
• You have had a condition in which symptoms include high fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder called "neuroleptic malignant syndrome").
• You have Parkinson's disease or dementia.
• You have or have had a low white blood cell count in the blood, especially if this occurred when taking other medicines.
• You are diabetic.
• You suffer from epilepsy.
• You are a man and have experienced prolonged or painful erections.
• You have difficulty regulating body temperature or are prone to overheating.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of the hormone prolactin in the blood or have a tumour that may be dependent on prolactin.
• You or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before taking Risperidone Grindeks.
Since a dangerously low number of a certain type of white blood cells, necessary to fight infections in the blood, has been observed very rarely in patients taking Risperidone Grindeks, your doctor may monitor your white blood cell count.
Risperidone Grindeks may cause weight gain. Significant weight gain can negatively affect health. Your doctor should regularly monitor body weight.
Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed 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 increases levels of a hormone called "prolactin". This may cause side effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see section 4 "Possible side effects"). If these side effects occur, it is recommended to assess prolactin levels in the blood.
During eye surgery for lens clouding (cataract), the pupil (the black circle in the center of the eye) may not dilate as required. Additionally, the iris (the coloured part of the eye) may become floppy during surgery, potentially causing eye damage. If you are scheduled for eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke. If your dementia is caused by stroke, you must not take risperidone.
During treatment with risperidone, you must see your doctor frequently.
If you or someone caring for you notices a sudden change in your mental state, sudden weakness or numbness of the face, arms, or legs—especially on one side—visual problems, or slurred speech, even if only briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents
Before starting treatment for behavioural disorder, other causes of aggressive behaviour should be ruled out.
If tiredness occurs during treatment with risperidone, changing the time of administration may improve attention difficulties.
Before starting treatment, your weight or your child's weight must be measured and monitored regularly during treatment.
A small, non-definitive study reported increased height in children who took risperidone, but it is not known whether this is a drug effect or due to another reason.

Other medicines and Risperidone Grindeks
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor or pharmacist if you are taking any of the following:

• Medicines that act on your brain to help calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), since risperidone may increase the sedative effects of all these medicines.
• Medicines that may alter the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm disorders, for allergies (antihistamines), some antidepressants, or other medicines for mental health conditions.
• Medicines that cause a slowing of the heartbeat.
• Medicines that cause low potassium or magnesium levels in the blood (e.g. certain diuretics).
• Medicines for high blood pressure. Risperidone Grindeks may cause a drop in blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Medicines used to treat fluid retention (diuretics), used for heart problems or swelling of body parts due to fluid accumulation (such as furosemide or chlorothiazide). Risperidone Grindeks, taken alone or 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. If you start or stop taking these 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 hypertension).
• Phenothiazines (such as medicines used to treat psychosis or for calming).
• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Certain medicines used in the treatment of HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat hypertension and/or heart rhythm abnormalities.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders. If you start or stop taking these medicines, you may need a different dose of risperidone. If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Risperidone Grindeks.

Risperidone Grindeks with food, drinks, and alcohol
This medicine can be taken with or without food. You should avoid drinking alcohol while taking Risperidone Grindeks.

Pregnancy, breastfeeding, and fertility

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take it.
• The following symptoms may occur in newborns whose mothers have used Risperidone Grindeks during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
• Risperidone Grindeks may increase levels of a hormone called "prolactin", which may affect fertility (see section 4 "Possible side effects").

Driving and using machines
While being treated with Risperidone Grindeks, dizziness, tiredness, and vision problems may occur. Do not drive or operate tools or machinery without first discussing it with your doctor.

Risperidone Grindeks contains lactose
Risperidone Grindeks contains lactose, a type of sugar.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:

For 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.
• Your doctor may then adjust the dose according to your response to treatment.
• Most people feel better with daily doses between 4 and 6 mg.
• The total daily dose may be divided into one or two doses per day. Your doctor will tell you which dose is best for you.

Elderly patients

• Your recommended starting dose will generally be 0.5 mg twice daily.
• Your doctor may then gradually increase your dose up to 1–2 mg twice daily.
• Your doctor will tell you which dose is most suitable for you.

For the treatment of mania

Adults

• Your recommended starting dose will generally be 2 mg once daily.
• Your doctor may then gradually adjust your dose depending on your response to treatment.
• Most people feel better with doses between 1 and 6 mg once daily.

Elderly patients

• Your recommended starting dose will generally be 0.5 mg twice daily.
• Your doctor may then gradually adjust your dose up to 1–2 mg twice daily, depending on your response to treatment.

For the treatment of persistent aggression in patients with Alzheimer’s dementia

Adults (including elderly patients)

• Your recommended starting dose will generally be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml) twice daily.
• Your doctor may then gradually adjust your dose depending on your response to treatment.
• Most people feel better with 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer’s dementia should not exceed 6 weeks.

Use in children and adolescents
Children and adolescents under 18 years of age must 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 weighing less than 50 kg:

• The recommended initial dose will generally be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml) once daily.
• The dose may be increased every other day in increments of 0.25 mg per day.
• The maintenance dose is generally between 0.25 mg and 0.75 mg (from 0.25 to 0.75 ml of risperidone oral solution 1 mg/ml) once daily.

For children weighing 50 kg or more:

• The recommended initial dose will generally be 0.5 mg once daily.
• The dose may be increased every other day in increments of 0.5 mg per day.
• The maintenance dose is generally between 0.5 mg and 1.5 mg once daily.

The duration of treatment in patients with conduct disorder should not exceed 6 weeks.

Children under 5 years of age must not be treated with Risperidone Grindeks for conduct disorder.

Patients with kidney or liver problems
Regardless of the reason for taking this medicine, all initial and subsequent doses of risperidone must be halved. Dose increases should be made more slowly in these patients.

Risperidone must be used with caution in this group of patients.

How to take Risperidone Grindeks
For oral use

• Swallow the tablets with a glass of water.
• Risperidone Grindeks 2 mg and 6 mg film-coated tablets have a breakline on one side, while Risperidone Grindeks 4 mg film-coated tablets have a double breakline on one side. The tablet may be divided into equal doses.

If you take more Risperidone Grindeks than you should

• Contact your doctor immediately. Take the medicine package with you.
• In case of overdose, you may feel drowsy or tired, experience unusual body movements, have difficulty standing or walking, dizziness due to low blood pressure, or abnormal heartbeat or seizures.

If you forget to take Risperidone Grindeks

• If you forget to take a dose, take it as soon as you remember. 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 together) to make up for a forgotten dose.

If you stop taking Risperidone Grindeks
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to discontinue this medicine, your dose may be gradually reduced over several days.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you experience any of the following uncommon side effects (may affect up to 1 in 100 users):

• Dementia and a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs, especially on one side of the body, difficulty speaking, even for a brief period of time. These may be signs of a stroke.
• Tardive dyskinesia (rhythmic movements or twitching of the face, tongue or other parts of the body). Inform your doctor if you experience involuntary rhythmic movements of the tongue, mouth or face. It may be necessary to discontinue risperidone.

Contact your doctor immediately if you experience any of the following uncommon side effects (may affect up to 1 in 1,000 users):

• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
• Fever, muscle stiffness, sweating or reduced level of consciousness (a disorder called "Neuroleptic Malignant Syndrome"). Immediate medical intervention may be required.
• You are a man and experience a prolonged or painful erection. This is called priapism. Immediate medical intervention may be required.
• Severe allergic reactions characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash or low blood pressure.

Other side effects that may occur:
Very common (affect more than 1 in 10 users):

• Difficulty falling asleep or staying asleep.
• Parkinsonism: this condition may include slow or altered movements, a feeling of stiffness or tension in the muscles (causing jerky movements), and sometimes a sensation of "freezing" in movement that then resumes. Other signs of parkinsonism include slow, shuffling gait, resting tremor, increased salivation and/or drooling, and loss of facial expression.
• Drowsiness or lethargy.
• Headache.

Common (may affect up to 1 in 10 users):

• Pneumonia, chest infection (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, feeling of flu.
• Elevated levels of a hormone called "prolactin" detected in a blood test (which may or may not cause symptoms). Symptoms of high prolactin occur rarely and may include, in men, breast enlargement, difficulty achieving or maintaining an erection, reduced sexual desire or other sexual dysfunction. In women, symptoms may include breast tenderness, milk leakage from the breasts, absence of menstruation or other menstrual cycle problems, or fertility issues.
• Weight gain, increased appetite, decreased appetite
• Sleep disturbances, irritability, depression, anxiety, restlessness
• Dystonia: a condition involving involuntary slow or prolonged muscle contractions. Although it may affect any part of the body (and may result in abnormal posture), dystonia often affects facial muscles, including abnormal eye, mouth, tongue or jaw movements.
• Dizziness
• Dyskinesia: a condition involving involuntary muscle movements, which may include repetitive, spasmodic or twisting movements, or contractions
• Tremor
• Blurred vision, eye infection or "pink eye".
• Rapid heartbeat, high blood pressure, shortness of breath
• Sore throat, cough, nosebleed, nasal congestion
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Skin rash, skin redness
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence (lack of control)
• 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 users):

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection or infection in a single body area, viral infection, skin inflammation caused by mites.
• Decrease in the type of white blood cells that help protect against infections, low white blood cell count, decreased platelets (blood cells that help stop bleeding), anaemia, decreased red blood cells, increased eosinophils (a type of white blood cells) in the blood
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar, excessive water consumption
• Weight loss, loss of appetite leading to malnutrition and low body weight
• Increased cholesterol in the blood
• Euphoric mood (mania), confusion, decreased sexual desire, nervousness, nightmares
• Lack of response to stimuli, loss of consciousness, low level of consciousness
• Seizures (convulsive fits), fainting
• Restless urge to move parts of the body, balance disorders, abnormal coordination, dizziness upon standing, attention disorders, language problems, loss or alteration of taste sensation, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin
• Light sensitivity of the eyes, dry eyes, increased tearing, eye redness
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, QT interval prolongation of the heart, slowed heart rate, abnormal heart electrical tracing (electrocardiogram or ECG), sensation of pounding or pulsation in the chest (palpitations)
• Low blood pressure, low blood pressure upon standing (as a result, some people taking risperidone may feel faint, dizzy or faint upon standing or sitting up suddenly), hot flushes
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, wheezing, voice disorders, respiratory disorders
• Stomach or intestinal infection, faecal incontinence, very hard stools, difficulty swallowing, excessive passing of gas or air
• Hives (or "nettle rash"), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy scalp or skin, skin disorders, skin lesion
• Increased creatine phosphokinase (CPK) in the blood, an enzyme sometimes released during muscle breakdown.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, pain during urination
• Erectile dysfunction, ejaculation disorder
• Loss of menstruation, absence of menstruation or other menstrual cycle problems (women)
• Breast development in men, milk leakage from the breasts, sexual dysfunction, breast pain, breast tenderness, vaginal discharge
• Swelling of the face, mouth, eyes or lips
• Chills, increased body temperature
• Change in walking pattern
• Thirst, feeling of discomfort, chest discomfort, feeling of "malaise", discomfort
• Increased liver transaminases in the blood, increased gamma-GT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood
• Procedural pain.

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

• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sleepwalking
• Sleep-related eating disorders
• Sugar in urine, low blood sugar, high triglycerides in the blood (a type of fat)
• Lack of emotions, inability to reach orgasm
• Lack of movement or response during wakefulness (catatonia)
• Blood circulation problems in the brain
• Coma due to uncontrolled diabetes
• Head shaking
• Glaucoma (increased pressure inside the eyeball), eye movement problems, eye rolling, eyelid margin crusting
• Eye problems during cataract surgery. During cataract surgery, if you are taking or have taken risperidone, a condition called "Intraoperative Floppy Iris Syndrome" (IFIS) may occur. If you are undergoing cataract surgery, inform your ophthalmologist if you are taking or have taken this medicine.
• Dangerously low levels of a certain type of white blood cells needed to fight infections in the blood
• Dangerously excessive water intake
• Irregular heartbeat
• Breathing problems during sleep (sleep apnoea), rapid and shallow breathing
• Pancreatitis, intestinal obstruction
• Swollen tongue, chapped lips, drug-related skin rashes
• Dandruff
• Muscle fibre rupture and muscle pain (rhabdomyolysis)
• Delayed menstrual cycle, enlargement of breast glands, breast enlargement, mammary secretions
• Increased insulin (a hormone that controls blood sugar levels) in the blood
• Skin hardening
• Decreased body temperature, coldness in arms and legs.
• Drug withdrawal symptoms
• Yellowing of the skin and eyes (jaundice).

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

• Life-threatening complications due to uncontrolled diabetes
• Severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
• Lack of movement in intestinal muscles causing a blockage.

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

• Severe or life-threatening skin rash, with blisters and peeling skin, which may start inside 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 observed with the use of another medicine called paliperidone, which is very similar to risperidone, and therefore may also be expected with Risperidone Grindeks: rapid heartbeat upon standing.

Additional side effects in children and adolescents
In general, side effects in children are similar to those in adults.
The following side effects have been reported more frequently in children and adolescents (aged between 5 and 17 years) compared to adults: drowsiness or lack of attention, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhoea and urinary incontinence (lack of control).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risperidone Grindeks

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

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

The excipients are:

Risperidone Grindeks 0.5 mg film-coated tablets:
Tablet core: Lactose, Microcrystalline cellulose (E460), Maize starch, Magnesium stearate (E572).
Coating: Grafted poly(vinyl alcohol) copolymer with macrogol (E1209), Talc (E553b), Titanium dioxide (E171), Glycerol monocaprylocaprate (E471), Poly(vinyl alcohol) (E1203), Red iron oxide (E172), Yellow iron oxide (E172).

Risperidone Grindeks 1 mg film-coated tablets:
Tablet core: Lactose, Microcrystalline cellulose (E460), Maize starch, Magnesium stearate (E572).
Coating: Grafted macrogol copolymer of poly(vinyl alcohol) (E1209), Talc (E553b), Titanium dioxide (E171), Glycerol monocaprylocaprate (E471), Poly(vinyl alcohol) (E1203).

Risperidone Grindeks 2 mg film-coated tablets:
Tablet core: Lactose, Microcrystalline cellulose (E460), Maize starch, Magnesium stearate (E572).
Coating: Grafted macrogol copolymer of poly(vinyl alcohol) (E1209), Talc (E553b), Titanium dioxide (E171), Glycerol monocaprylocaprate (E471), Poly(vinyl alcohol) (E1203), Sunset yellow FCF aluminium lake (E110), Quinoline yellow aluminium lake (E104).

Risperidone Grindeks 3 mg film-coated tablets:
Tablet core: Lactose, Microcrystalline cellulose (E460), Maize starch, Magnesium stearate (E572).
Coating: Grafted macrogol copolymer of poly(vinyl alcohol) (E1209), Talc (E553b), Titanium dioxide (E171), Glycerol monocaprylocaprate (E471), Poly(vinyl alcohol) (E1203), Red iron oxide (E172), Black iron oxide (E172).

Risperidone Grindeks 4 mg film-coated tablets:
Tablet core: Lactose, Microcrystalline cellulose (E460), Maize starch, Magnesium stearate (E572).
Coating: Grafted macrogol copolymer of poly(vinyl alcohol) (E1209), Talc (E553b), Titanium dioxide (E171), Glycerol monocaprylocaprate (E471), Poly(vinyl alcohol) (E1203), Tartrazine aluminium lake (E102), Indigo carmine aluminium lake (E132).

Risperidone Grindeks 6 mg film-coated tablets:
Tablet core: Lactose, Microcrystalline cellulose (E460), Maize starch, Magnesium stearate (E572).
Coating: Grafted macrogol copolymer of poly(vinyl alcohol) (E1209), Talc (E553b), Titanium dioxide (E171), Glycerol monocaprylocaprate (E471), Poly(vinyl alcohol) (E1203), Yellow iron oxide (E172), Red iron oxide (E172).

Description of the Appearance of Risperidone Grindeks and Contents of the Pack
Risperidone Grindeks 0.5 mg: Pink, round, biconvex, film-coated tablet. Tablet size: approximately 6 mm x 3 mm.
Risperidone Grindeks 1 mg: White, round, biconvex, film-coated tablet. Tablet size: approximately 7 mm x 3 mm.
Risperidone Grindeks 2 mg: Orange, round, biconvex, film-coated tablet, with a break line on one side. Tablet size: approximately 8 mm x 4 mm.
Risperidone Grindeks 3 mg: Beige, round, biconvex, film-coated tablet. Tablet size: approximately 9 mm x 5 mm.
Risperidone Grindeks 4 mg: Yellowish-green, round, biconvex, film-coated tablet, with a double break line on one side. Tablet size: approximately 11 mm x 4 mm.
Risperidone Grindeks 6 mg: Brownish, round, biconvex, film-coated tablet, with a break line on one side. Tablet size: 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 blister packs containing 20, 30, 60, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: +371 67083205
E-mail: [email protected]

This medicinal product is authorized in the Member States of the European Union under the following names:

This leaflet was last reviewed in 01/2024