RISPERIDONE GRINDEKS 3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Risperidone Grindeks 0.5 mg film-coated tablets EFG

Risperidone Grindeks 1 mg film-coated tablets EFG

Risperidone Grindeks 2 mg film-coated tablets EFG

Risperidone Grindeks 3 mg film-coated tablets EFG

Risperidone Grindeks 4 mg film-coated tablets EFG

Risperidone Grindeks 6 mg film-coated tablets EFG

risperidone

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the package leaflet

1. What is Risperidone Grindeks and what is it used for
2. What you need to know before you take Risperidone Grindeks
3. How to take Risperidone Grindeks
4. Possible side effects
5. Storing Risperidone Grindeks
6. Contents of the pack 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 is indicated for the treatment of the following conditions:

• Schizophrenia, in which you may see, hear or feel things that are not real, believe things that are not true or feel unusually suspicious or confused.
• Mania, in which you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in a disease called bipolar disorder.
• Short-term treatment (up to a maximum of 6 weeks) of persistent aggression in people with Alzheimer's dementia, who may harm themselves or others. Alternative treatment (without medication) should have been used before.
• Short-term treatment (up to a maximum of 6 weeks) of persistent aggression in children with intellectual disability (from at least 5 years of age) and adolescents with behavioral disorders.

Risperidone may help to alleviate the symptoms of your illness and prevent the symptoms from returning.

2. What you need to know before you take Risperidone Grindeks

Do not take Risperidone Grindeks:

• 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 any of the above applies to you, talk to your doctor or pharmacist before taking risperidone.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take risperidone if:

• You have heart problems. Some examples include an irregular heartbeat, if you are prone to low blood pressure or if you are taking medicines for blood pressure. Risperidone may lower your blood pressure. You may need to have your dose adjusted.
• You know of any factor that may make you prone to having a stroke, such as high blood pressure, a heart condition or problems with the blood vessels in the brain.
• You have ever had involuntary movements of the tongue, mouth and face.
• You have ever had a disease whose symptoms include fever, muscle stiffness, sweating or decreased consciousness (also known as neuroleptic malignant syndrome).
• You have Parkinson's disease or dementia.
• If you have had low white blood cell counts 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 have ever had a prolonged or painful erection.
• You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high blood level of a hormone called prolactinor if you have a tumor that may depend on prolactin.
• You or a family member have a history of blood clotting problems, as antipsychotics have been associated with the 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.

Since very rare cases of low and dangerous white blood cell counts have been observed in patients taking risperidone, your doctor may check your white blood cell count.

Risperidone may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will check your body weight regularly.

Since cases of diabetes mellitusor worsening of pre-existing diabetes mellitushave been reported in patients taking risperidone, your doctor should perform tests to detect signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Risperidone often increases the levels of a hormone called prolactin. This increase can cause side effects such as menstrual disorders or fertility problems in women or breast swelling in men (see the section on possible side effects). If such side effects occur, it is recommended to evaluate the level of prolactin in the blood.

It is possible that, during eye surgery for retinal opacity (cataracts), the pupil (the black circle in the center of the eye) may not dilate as it should. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, which could cause eye damage. If you are scheduled to have eye surgery, be sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia

Elderly patients with dementia have a higher risk of stroke. If you have dementia caused by a stroke, you should not take risperidone.

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

If you or your caregiver notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side of the body, or slurred speech, even if only for a short period, you should seek medical attention immediately, as these may be signs of a stroke.

Children and adolescents

Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.

If during treatment with risperidone you experience fatigue, a change in the time of administration may improve attention problems.

Before starting treatment, your weight or your child's weight should be measured, and it may be measured regularly during treatment.

In a small study where no clear conclusions were drawn, an increase in height was reported in children taking risperidone, but it is not known if this is an effect of the medicine or due to another cause.

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 tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines that act on the brain, such as those used to help you calm down (benzodiazepines), some pain medications (opioids) or allergy medications (some antihistamines), as risperidone may increase the sedative effect of all of them.
• Medicines that can change the electrical activity of the heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental problems.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (such as certain diuretics).
• Medicines used to treat high blood pressure. Risperidone may 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).
• Diuretic medicines used for heart problems or swelling of some parts of the body due to excessive fluid accumulation (such as furosemide or chlorthiazide). When taking risperidone alone or with furosemide, the risk of stroke or death may increase in elderly patients with dementia.

The following medicines may reduce the effects of risperidone:

• Rifampicin (a medicine used to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital

If you start taking these medicines or stop taking them, you may need a different dose of risperidone.

The following medicines may increase the effects of risperidone:

• Quinidine (used to treat certain heart conditions)
• 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 sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines used to treat fungal infections)
• Certain medicines used to treat HIV/AIDS, such as ritonavir
• Verapamil, a medicine used to treat high blood pressure or abnormal heart rhythm
• Sertraline and fluvoxamine, which are medicines used to treat depression and other psychiatric disorders

If you start taking these medicines or stop taking them, 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.

Taking Risperidone Grindeks with food, drinks and alcohol

You can take this medicine with or without food. You should avoid consuming alcohol while taking risperidone.

Pregnancy, breastfeeding and fertility

• If you are pregnant or breastfeeding, 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 whether you can take it.
• The following symptoms may occur in newborn babies of mothers who have been treated with risperidone during the last trimester of pregnancy (the last three months of pregnancy): trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and feeding problems. If your child has any of these symptoms, you should contact your doctor.
• Risperidone may increase the levels of a hormone called prolactinthat can affect fertility (see the section on possible side effects).

Driving and using machines

Risperidone acts on the central nervous system and may cause symptoms such as drowsiness, dizziness or changes in vision, and may decrease your reaction ability. These effects, as well as the disease itself, make it advisable to be cautious when driving vehicles or operating hazardous machinery, especially while your particular sensitivity to the medicine has not been established.

Risperidone Grindeks contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Risperidone Grindeks 2 mg film-coated tablets contain orange yellow FCF (E-110)

This medicine may cause allergic reactions.

Risperidone Grindeks 4 mg film-coated tablets contain tartrazine (E-102)

This medicine may cause allergic reactions.

3. How to take Risperidone Grindeks

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is as follows:

Treatment of schizophrenia

Adults

• The usual starting dose is 2 mg per day, which can be increased to 4 mg per day on the second day of treatment.
• After that, your doctor may adjust the dose based on your response to treatment.
• Most people feel better with daily doses of 4-6 mg.
• This daily total dose can be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

• The starting dose will usually be 0.5 mg twice a day.
• After that, your doctor may gradually increase the dose to 1 or 2 mg twice a day.
• Your doctor will tell you what is best for you.

Treatment of mania

Adults

• The starting dose will usually be 2 mg once a day.
• After that, your doctor may gradually adjust the dose based on your response to treatment.
• Most people feel better with doses of 1-6 mg once a day.

Elderly patients

• The starting dose will usually be 0.5 mg twice a day.
• After that, your doctor may gradually adjust the dose to 1-2 mg twice a day, based on your response to treatment.

Treatment of persistent aggression in people with Alzheimer's dementia

Adults (including elderly patients)

• The starting dose will usually be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml) twice a day.
• After that, your doctor may gradually adjust the dose based on your response to treatment.
• Most people feel better with doses of 0.5 mg twice a day. Some patients may need 1 mg twice a day.
• Treatment duration in patients with Alzheimer's dementia should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years of age should not be treated with risperidone for schizophrenia or mania.

Treatment of behavioral disorders

The dose will depend on your child's weight:

Children weighing less than 50 kg

• The starting dose will usually be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml) once a day.
• The dose can be increased every other day with increments of 0.25 mg per day.
• The usual maintenance dose is 0.25-0.75 mg (0.25-0.75 ml of risperidone oral solution 1 mg/ml) once a day.

Children weighing 50 kg or more

• The starting dose will usually be 0.5 mg once a day.
• The dose can be increased every other day with increments of 0.5 mg per day.
• The usual maintenance dose is 0.5-1.5 mg once a day.

Treatment duration in patients with behavioral disorders should not exceed 6 weeks.

Children under 5 years of age should not be treated with risperidone for behavioral disorders.

Patients with kidney or liver problems

Regardless of the disease being treated, all starting doses and subsequent doses of risperidone should be halved. Dose increases should be slower in these patients.

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

Method of administration

Oral use.

• You should swallow the 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 line on one side. The tablet can be divided into equal doses.

If you take more Risperidone Grindeks than you should

• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.
• In the event of an overdose, you may feel drowsy or tired, have abnormal body movements or problems standing or walking, feel dizzy due to low blood pressure or experience abnormal heartbeats or epileptic seizures.

If you forgot to take Risperidona Grindeks

• If you forgot to take a dose, take it as soon as possible when you remember it. However, if it's almost time for your next dose, skip the missed dose and take only one dose at the usual time. If you forget to take two or more doses, consult your doctor.
• Do not take a double dose to make up for missed doses (twice the dose recommended by your doctor).

If you interrupt treatment with Risperidona Grindeks

You should not stop taking this medication unless your doctor tells you to, as symptoms may reappear. If your doctor decides to interrupt treatment with this medication, they may gradually reduce the dose over a few days.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Inform your doctor immediately if you experience any of the following rare adverse effects (may affect up to 1 in 100 people):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side of the body, or slurred speech, even if only for a short period, as these could be signs of a stroke.
• You have tardive dyskinesia (involuntary movements or spasms that you cannot control in the face, tongue, or other parts of the body). If you experience rhythmic involuntary movements of the tongue, mouth, and face, inform your doctor immediately. It may be necessary to withdraw treatment with risperidone.

Inform your doctor immediately if you experience any of the following very rare adverse effects (may affect up to 1 in 1000 people):

• You have the formation of blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, see your doctor immediately.
• You have fever, muscle stiffness, sweating, or decreased consciousness (a disorder called neuroleptic malignant syndrome). You may need immediate medical treatment.
• If you are a man and experience prolonged and painful erections. This effect is called priapism. You may need immediate medical treatment.
• If you have a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, rash, or low blood pressure.

Other adverse effects may also occur:

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

• Difficulty staying asleep or maintaining sleep.
• Parkinsonism: this disease can include slow movement or deterioration of movement, feeling of stiffness or tightness of the muscles (movements become spasmodic) and, occasionally, even a feeling of movement blockage that resumes shortly after. Other signs of parkinsonism include a slow gait, tremors while at rest, increased salivation or drooling, and loss of facial expression.
• Feeling of drowsiness or decreased alertness.
• Headache.

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

• Pneumonia, chest infection (bronchitis), common cold symptoms, nasal sinus infection, urinary tract infection, ear infection, pseudo-flu symptoms (like having the flu)
• Increased levels of a hormone called prolactinin the blood test (which can cause symptoms or not). Symptoms of elevated prolactin occur infrequently and may include, in men, breast swelling, difficulty having or maintaining erections, decreased sexual desire, or other sexual dysfunction. In women, they may include breast pain, milk secretion from the breasts, absence of menstruation, or other problems with the menstrual cycle or fertility problems.
• Weight gain, increased appetite, decreased appetite
• Sleep disorders, irritability, depression, anxiety, restlessness
• Dystonia: this disorder involves involuntary and sustained muscle contraction. Although it can affect any part of the body (and can cause an abnormal posture), dystonia usually involves the muscles of the face, including abnormal eye muscles, mouth, tongue, or jaw.
• Feeling of dizziness
• Dyskinesia: this condition involves involuntary muscle movements and may include repetitive, spasmodic, or contorted movements or twitches.
• Tremors (agitation)
• Blurred vision, eye infection, or "conjunctivitis"
• Fast heart rate, high blood pressure, shortness of breath
• Sore throat, cough, nosebleed, nasal congestion
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Rash, skin redness
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence (loss of bladder control)
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Falls.

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

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, a localized infection in one area of the skin or body part, viral infection, skin inflammation caused by mites
• Decreased count of the type of white blood cells that help protect us against infections, low white blood cell count, decreased platelet count (blood cells that help stop bleeding), anemia, decreased red blood cell count, increased number of eosinophils (a type of white blood cell) in the blood
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar, excessive water consumption
• Weight loss, loss of appetite that causes malnutrition and weight loss
• Increased cholesterol in the blood
• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares
• Unresponsiveness, loss of consciousness, low level of consciousness
• Seizures (epileptic fits), fainting
• An uncontrollable urge to move parts of the body, balance disorder, lack of coordination, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensation to pain and touch, a feeling of tingling, numbness, or prickling of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tearing, eye redness
• Feeling of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (an abnormal heart rhythm), an interruption of conduction between the upper and lower parts of the heart, abnormal heart electrical conduction, prolonged QT interval of the heart, slow heart rate, abnormal heart tracing (electrocardiogram or ECG), feeling of fluttering or strong heartbeat (palpitations)
• Low blood pressure, low blood pressure when standing up (so some people taking risperidone may feel dizzy, faint, or lose consciousness when getting up or sitting down quickly), flushing
• Pneumonia caused by inhaling food, pulmonary congestion, respiratory tract congestion, crackling sounds in the lungs, wheezing, voice disorder, respiratory tract disorder
• Stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, flatulence
• Hives (urticarial rash), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, exfoliation, itching of the scalp or skin, skin disorder, skin injury
• An increase in creatine phosphokinase (CPK) in the blood, which is an enzyme that is sometimes released with muscle breakdown
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, painful urination
• Erectile dysfunction, ejaculation disorder
• Absence of menstruation, menstrual disorders, or other problems with the menstrual cycle (women)
• Development of breasts in men, milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, increased body temperature
• A change in the way of walking
• Feeling of thirst, general discomfort, chest pain, feeling of discomfort, general malaise
• Increased liver transaminases in the blood, increased gamma-GT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood
• Pain associated with a therapeutic procedure

Rare adverse effects (may affect up to 1 in 1000 people):

• Infection
• Abnormal secretion of a hormone that controls urine volume
• Sleepwalking
• Sleep-related eating disorders
• Sugar in the urine, low blood sugar, high triglycerides in the blood (a type of fat)
• Lack of emotion, inability to reach orgasm
• Absence of movement or response while awake (catatonia)
• Problems in the blood vessels of the brain
• Coma due to uncontrolled diabetes
• Head tremors
• Glaucoma (increased pressure inside the eye), problems with eye movements, slow eye movements, crust on the eyelid margin
• Problems in the eyes during cataract surgery. During cataract surgery, a disorder called intraoperative floppy iris syndrome (IFIS)may occur if you are taking or have taken risperidone. If you are going to have cataract surgery, be sure to inform your ophthalmologist that you are taking or have taken this medication.
• Dangerously low levels of a certain type of white blood cell necessary to fight blood infections
• Excessive and dangerous water intake
• Irregular heartbeat
• Difficulty breathing during sleep (sleep apnea), rapid shallow breathing
• Pancreatitis, intestinal obstruction
• Tongue swelling, cracked lips, drug-related skin rash
• Dandruff
• Rupture of muscle fibers and muscle pain (rhabdomyolysis)
• A delay in menstrual periods, breast enlargement, breast growth, milk secretion from the breasts
• Increased insulin (a hormone that controls blood sugar levels) in the blood
• Hardening of the skin
• Decreased body temperature, coldness in the arms and legs
• Drug withdrawal symptoms
• Yellowing of the skin and eyes (jaundice).

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

• Potentially fatal complications of uncontrolled diabetes
• Severe allergic reaction, accompanied by swelling that can affect the throat and cause difficulty breathing
• Absence of movement of the intestinal muscles that causes obstruction

Frequency not known (cannot be estimated from available data):

• A severe or life-threatening rash, accompanied by blisters and peeling of the skin, which can start in the mouth or around it, the nose, eyes, and genitals, and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following adverse effects have been observed with the use of another medication called paliperidone, which is very similar to risperidone, so their occurrence can also be expected with this medication: rapid heartbeat when standing up.

Other adverse effects in children and adolescents

In general, it is expected that adverse effects in children will be similar to those in adults.

The following adverse effects have been reported more frequently in children and adolescents (5 to 17 years old) than in adults: feeling of drowsiness or decreased alertness, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors (agitation), diarrhea, and urinary incontinence (loss of bladder control).

Reporting adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Risperidona Grindeks

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Risperidone Grindeks

The active ingredient is risperidone.

Each Risperidone Grindeks film-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 0.5mg film-coated tablets EFG:

Tablet core: lactose, microcrystalline cellulose (E-460), corn starch, magnesium stearate (E-572).

Coating: macrogol and poly (vinyl alcohol) graft copolymer (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly (vinyl alcohol) (E-1203), red iron oxide (E-172), yellow iron oxide (E-172).

Risperidone Grindeks 1mg film-coated tablets EFG:

Tablet core: lactose, microcrystalline cellulose (E-460), corn starch, magnesium stearate (E-572).

Coating: macrogol and poly (vinyl alcohol) graft copolymer (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly (vinyl alcohol) (E-1203).

Risperidone Grindeks 2mg film-coated tablets:

Tablet core: lactose, microcrystalline cellulose (E-460), corn starch, magnesium stearate (E-572).

Coating: macrogol and poly (vinyl alcohol) graft copolymer (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly (vinyl alcohol) (E-1203), orange-yellow aluminum lake (E-110), quinoline yellow aluminum lake (E-104).

Risperidone Grindeks 3mg film-coated tablets:

Tablet core: lactose, microcrystalline cellulose (E-460), corn starch, magnesium stearate (E-572).

Coating: macrogol and poly (vinyl alcohol) graft copolymer (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly (vinyl alcohol) (E-1203), yellow iron oxide (E-172), black iron oxide (E-172).

Risperidone Grindeks 4mg film-coated tablets:

Tablet core: lactose, microcrystalline cellulose (E-460), corn starch, magnesium stearate (E-572).

Coating: macrogol and poly (vinyl alcohol) graft copolymer (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly (vinyl alcohol) (E-1203), tartrazine aluminum lake (E-102), carmine indigo aluminum lake (E-132).

Risperidone Grindeks 6mg film-coated tablets:

Tablet core: lactose, microcrystalline cellulose (E-460), corn starch, magnesium stearate (E-572).

Coating: macrogol and poly (vinyl alcohol) graft copolymer (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly (vinyl alcohol) (E-1203), yellow iron oxide (E-172), red iron oxide (E-172).

Product Appearance and Package Contents

Risperidone Grindeks 0.5 mg are pink, round, and biconvex film-coated tablets. The tablet size is approximately 6 mm × 3 mm.

Risperidone Grindeks 1 mg are white, round, and biconvex film-coated tablets. The tablet size is approximately 7 mm × 3 mm.

Risperidone Grindeks 2 mg are orange, round, biconvex film-coated tablets with a score line on one side. The tablet size is approximately 8 mm × 4 mm.

Risperidone Grindeks 3 mg are beige, round, and biconvex film-coated tablets. The tablet size is approximately 9 mm × 5 mm.

Risperidone Grindeks 4 mg are greenish-yellow, round, biconvex film-coated tablets with a double score line on one side. The tablet size is approximately 11 mm × 4 mm.

Risperidone Grindeks 6 mg are brown, round, biconvex film-coated tablets with a score line on one side. The tablet size is approximately 12 mm × 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.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS.

Krustpils iela 53, Riga, LV‑1057, Latvia

Phone: +371 67083205

e-mail: grindeks@grindeks.lv

For further information about this medicinal product, please contact the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

28003, Madrid, Spain

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

Date of last revision of this leaflet:12/2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/