Risperidone Grindex 3 mg film-coated tablets EFG: detailed information

Brand name Risperidone Grindex 3 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

RISPERIDONE · 3 mg

Prescription type Prescription Only Medicine

ATC code

N05A N05AX N05AX08

Registration number 89041

Manufacturer Grindeks As

Risperidone Grindex 3 mg film-coated tablets EFG tablets, film-coated

Table of Contents

Package leaflet: Information for the user
Introduction
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 adverse effects
5. Storage of Risperidone Grindeks
6. Package contents and other information

Package leaflet: Information for the user

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

Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Risperidone Grindeks is and what it is used for
What you need to know before taking Risperidone Grindeks
How to take Risperidone Grindeks
Possible side effects
How to store Risperidone Grindeks
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 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 excessively excited, euphoric, agitated, enthusiastic, or hyperactive. Mania occurs in a condition known as bipolar disorder.
Short-term treatment (up to a maximum of 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who harm themselves or others. A non-drug treatment should have been tried previously.
Short-term treatment (up to a maximum of 6 weeks) of persistent aggression in children with intellectual disability (at least 5 years of age) and adolescents with conduct disorders.

Risperidone may help relieve the symptoms of your condition and help prevent symptoms from returning.

2. What you need to 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 any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Warnings and precautions

Talk to your doctor or pharmacist before starting risperidone if:

You have heart problems. Examples include irregular heartbeat, a tendency to low blood pressure, or if you are taking medicines for blood pressure. Risperidone may lower blood pressure. You may need a dose adjustment.
You are aware of any risk factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
You have ever experienced involuntary movements of the tongue, mouth, or face.
You have ever had an illness with symptoms such as fever, muscle stiffness, sweating, or decreased level of consciousness (also known as neuroleptic malignant syndrome).
You suffer from Parkinson’s disease or dementia.
You have previously had low levels of white blood cells in the blood (whether or not caused by other medicines).
You are diabetic.
You have epilepsy.
You are a man and have ever experienced prolonged or painful erection.
You have difficulty regulating body temperature or feel excessive heat.
You have kidney problems.
You have liver problems.
You have abnormally high blood levels of the hormone prolactin or suffer from a tumor that may be prolactin-dependent.
You or a family member have a history of blood clotting disorders, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Since very rare cases of dangerously low counts of certain types of white blood cells essential for fighting blood infections 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 periodically monitor your body weight.

Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking risperidone, your doctor should perform tests to detect signs of increased blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

Risperidone frequently increases levels of a hormone called prolactin. This increase may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see section Possible side effects). If such adverse effects occur, evaluation of prolactin blood levels is recommended.

During cataract surgery (cataract removal due to lens opacity), the pupil (the black circle in the center of the eye) may not dilate as expected. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could lead to 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

Elderly patients with dementia have an increased risk of stroke. If your dementia is caused by stroke, you must not take risperidone.

During treatment with risperidone, you should visit your doctor regularly.

If you or your caregiver notice a sudden change in your mental state, 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 time, seek immediate medical attention, as these could be signs of a stroke.

Children and adolescents

Before starting treatment for conduct disorder, other causes of aggressive behavior should be ruled out.

If you experience tiredness during treatment with risperidone, changing the time of administration may improve attention problems.

Before starting treatment, your body weight or that of your child should be measured and may be monitored regularly during treatment.

In a small study with inconclusive results, increased height has been reported in children taking risperidone, but it is unknown whether this is a direct effect of the medicine or due to other causes.

Other medicines and Risperidone Grindeks

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important to inform your doctor or pharmacist if you are taking any of the following medicines:

Medicines acting on the brain, for example, those used to calm you down (benzodiazepines), certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase the sedative effect of all these.
Medicines capable of altering the heart's electrical activity, such as medicines for malaria, heart rhythm disorders, allergies (antihistamines), some antidepressants, or other medicines used to treat mental disorders.
Medicines that cause slow heart rate.
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 central nervous system activity (psychostimulants, such as methylphenidate).
Diuretic medicines used for heart problems or swelling in parts of the body due to fluid accumulation (such as furosemide or chlorothiazide). Taking risperidone alone or together with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effects 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 effects of risperidone:

Quinidine (used to treat certain types of heart disease)
Antidepressants, such as paroxetine, fluoxetine, and tricyclic antidepressants
Medicines known as beta-blockers (used to treat high blood pressure)
Phenothiazines (such as medicines used to treat psychosis or sedatives)
Cimetidine, ranitidine (stomach acid blockers)
Itraconazole and ketoconazole (medicines used to treat fungal infections)
Certain medicines used in the treatment of HIV/AIDS infection, 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 or stop taking these medicines, you may need a different dose of risperidone.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Taking Risperidona Grindeks with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you may take it.
The following symptoms may occur in newborn babies whose mothers have been treated with risperidone during the last trimester of pregnancy (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 must contact your doctor.
Risperidone may increase the levels of a hormone called prolactin, which may affect fertility (see section Possible side effects).

Driving and using machines

Risperidone acts on the central nervous system and may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. These effects, as well as the underlying illness itself, mean that caution is advised when driving vehicles or operating dangerous machinery, especially until the individual patient's response to the medicine has been established.

Risperidona Grindeks contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Risperidona Grindeks 2 mg film-coated tablets contain Sunset Yellow FCF (E-110)

This medicine may cause allergic-type reactions.

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

This medicine may cause allergic-type reactions.

3. How to take Risperidone Grindeks

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

Treatment of schizophrenia

Adults

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

Elderly patients

The starting dose will usually be 0.5 mg twice daily.
Thereafter, your doctor may gradually increase the dose up to 1 or 2 mg twice daily.
Your doctor will inform you what is best for you.

Treatment of mania

Adults

The starting dose will usually be 2 mg once daily.
Thereafter, your doctor may gradually adjust the dose according to your response to treatment.
Most people feel better with doses of 1–6 mg once daily.

Elderly patients

The starting dose will usually be 0.5 mg twice daily.
Thereafter, your doctor may gradually adjust the dose up to 1–2 mg twice daily, depending on your response to treatment.

Treatment of persistent aggression in patients with Alzheimer-type 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 daily.
Thereafter, your doctor may gradually adjust the dose according to your response to treatment.
Most people feel better with doses of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
The duration of treatment in patients with Alzheimer-type 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 conduct disorder

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 daily.
The dose may be increased on alternate days in 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 daily.

Children weighing 50 kg or more

The starting dose will usually be 0.5 mg once daily.
The dose may be increased on alternate days in increments of 0.5 mg per day.
The usual maintenance dose is 0.5–1.5 mg once daily.

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

Children under 5 years of age should not be treated with risperidone for conduct disorder.

Patients with kidney or liver problems

Regardless of the condition 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 patient group.

Method of administration

Oral use.

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

If you take more Risperidone Grindeks than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.
In the case of overdose, you may feel drowsy or tired, have abnormal body movements, difficulty standing or walking, feel dizzy due to low blood pressure, or experience abnormal heartbeats or epileptic seizures.

If you forget to take Risperidona 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 take only your next 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 a forgotten dose (do not take twice the dose prescribed by your doctor).

If you stop taking Risperidona Grindeks

You should not stop taking this medicine unless your doctor tells you to, as your symptoms may return. If your doctor decides to discontinue treatment with this medicine, they may gradually reduce the dose over several days.

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

4. Possible adverse effects

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

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

You have dementia and experience a sudden change in your mental state, 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 brief period, as these could be signs of a stroke.
You have tardive dyskinesia (uncontrollable shaking or spasmodic movements of the face, tongue or other body parts). If you experience involuntary rhythmic movements of the tongue, mouth or face, inform your doctor immediately. It may be necessary to discontinue treatment with risperidone.

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

You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
You develop fever, muscle rigidity, sweating, or decreased consciousness (a disorder known as neuroleptic malignant syndrome). You may require immediate medical treatment.
You are a man and experience prolonged, painful erections. This effect is called priapism. You may require immediate medical treatment.
You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

Other adverse effects that may occur are listed below:

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

Difficulty falling asleep or staying asleep.
Parkinsonism: this condition may include slow or impaired movement, a sensation of muscle stiffness or tightness (movements become spasmodic), and sometimes even a feeling of movement "freezing" that resumes shortly afterward. Other signs of parkinsonism include shuffling gait, resting tremor, increased salivation or drooling, and loss of facial expression.
Feeling drowsy or less alert.
Headache.

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

Pneumonia, chest infection (bronchitis), frequent cold symptoms, sinus infection, urinary tract infection, ear infection, pseudoinfluenza symptoms (feeling as if you have the flu)
Increased levels of a hormone called prolactin in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin occur infrequently and may include, in men, breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunction. In women, they may include breast pain, milk discharge 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: this disorder involves involuntary and sustained muscle contractions. Although it can affect any part of the body (and may cause abnormal posture), dystonia often involves facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
Dizziness
Dyskinesia: this condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements or jerking.
Tremor (agitation)
Blurred vision, eye infection, or "conjunctivitis"
Rapid heartbeat, elevated blood pressure, shortness of breath
Sore throat, cough, nosebleeds, 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 (lack 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 nail infection, skin infection, a localized skin infection or infection in a single body area, viral infection, skin inflammation caused by mites
Decreased count of the type of white blood cells that help protect us from 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 drinking
Weight loss, loss of appetite leading to malnutrition and reduced body weight
Increased cholesterol in the blood
Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares
Lack of response to stimuli, loss of consciousness, low level of consciousness
Seizures (epileptic fits), fainting
Uncontrollable urge to move body parts, balance disorder, lack of coordination, dizziness upon standing, attention disorder, speech problems, loss or changes in 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 (an abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical conduction of the heart, prolonged QT interval on the heart, slow heart rate, abnormal heart electrical pattern (electrocardiogram or ECG), sensation of fluttering or strong heartbeat (palpitations)
Low blood pressure, low blood pressure upon standing (thus, some people taking risperidone may feel dizzy, faint, or lose consciousness when standing up or sitting up 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, skin peeling, scalp or skin itching, skin disorder, skin lesion
Increased creatine phosphokinase (CPK) in the blood, an enzyme sometimes released when muscles break down
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 irregularities, or other menstrual cycle problems (in women)
Breast development in men, milk discharge from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
Swelling of the face, mouth, eyes, or lips
Chills, increased body temperature
Change in walking pattern
Feeling thirsty, general discomfort, chest pain, feeling unwell, 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, elevated blood triglycerides (a type of fat)
Lack of emotion, inability to reach orgasm
Absence of movement or response while awake (catatonia)
Problems with blood vessels in the brain
Coma due to uncontrolled diabetes
Head tremor
Glaucoma (increased pressure inside the eye), problems with eye movements, slow eye movements, crusting at the eyelid margin
Eye problems during cataract surgery. A disorder called intraoperative floppy iris syndrome (IFIS) may occur during cataract surgery if you are taking or have taken risperidone. If you are scheduled for cataract surgery, make sure to inform your ophthalmologist that you are taking or have taken this medicine.
Dangerously low levels of a certain type of white blood cell needed to fight blood infections
Excessively dangerous water intake
Irregular heartbeat
Difficulty breathing during sleep (sleep apnea), rapid shallow breathing
Pancreatitis, intestinal obstruction
Swelling of the tongue, cracked lips, drug-related skin rash
Dandruff
Rupture of muscle fibers and muscle pain (rhabdomyolysis)
Delayed menstrual periods, increased breast glands, breast growth, breast discharge
Increased insulin (a hormone that controls blood sugar levels) in the blood
Skin hardening
Decreased body temperature, coldness in arms and legs
Medication withdrawal symptoms
Yellowing of the skin and eyes (jaundice)

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

Potentially life-threatening complications of uncontrolled diabetes
Severe allergic reaction, accompanied by swelling that may affect the throat and cause difficulty breathing
Absence of movement in intestinal muscles leading to obstruction

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

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

The following adverse effects have been observed with the use of another medicine called paliperidone, which is very similar to risperidone, so they may also be expected with this medicine: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those in adults.

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

Reporting of 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Grindeks

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Risperidone Grindeks

The active substance is risperidone.

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

The other components are:

Risperidone Grindeks 0.5 mg film-coated tablets EFG: