Risperdal 6 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperdal 1, 3 and 6 mg film-coated tablets

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. It may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Risperdal is and what it is used for
What you need to know before taking Risperdal
How to take Risperdal
Possible adverse effects
How to store Risperdal
Contents of the pack and other information

1. What Risperdal is and what it is used for

Risperdal belongs to a group of medicines called "antipsychotics".

Risperdal is used to treat the following conditions:

Schizophrenia, in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused
Mania, in which you may feel extremely excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a condition called "bipolar disorder"
Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's type dementia who harm themselves or others. Alternative non-pharmacological treatments should have been tried previously
Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorders.

Risperdal may help reduce the symptoms of your illness and help prevent them from returning.

2. What you need to know before taking Risperdal

Do not take Risperdal

If you are allergic to risperidone or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure, consult your doctor or pharmacist before starting Risperdal.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperdal if:

You have any heart problems. Examples include irregular heart rhythm, low blood pressure, or if you are taking medications for blood pressure. Risperdal may lower blood pressure. You may need a dose adjustment.
You have any risk factors that may predispose you 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 symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
You have Parkinson's disease or dementia.
You have previously had low levels of white blood cells in your blood (whether or not caused by other medications).
You are diabetic.
You have epilepsy.
You are male and have previously experienced prolonged or painful erections.
You have problems regulating your body temperature or feel excessive heat.
You have kidney problems.
You have liver problems.
You have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
You or a family member has a history of blood clots, 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 Risperdal.

Rarely, patients treated with Risperdal have developed a dangerously low number of a type of white blood cell needed to fight infections. Your doctor may monitor your white blood cell count.

Risperdal may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

Cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking Risperdal. Your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar levels should be monitored regularly.

Risperdal frequently increases levels of a hormone called "prolactin." This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see Possible side effects). If these adverse effects occur, blood prolactin levels should be evaluated.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering 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. You should not take risperidone if your dementia is caused by a stroke.

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

If you or your caregiver notice a sudden change in your mental state, or sudden weakness or numbness in the face, arms, or legs—especially on one side—or if you experience confusion or slurred speech, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for behavioral disorders.

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

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

A small, inconclusive study reported increased height in children taking risperidone, but it is unknown whether this is a drug effect or due to other factors.

Other medicines and Risperdal

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

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

Medicines that act on the brain, such as those used to calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders, allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
Medicines that cause a slow heartbeat.
Medicines that cause low potassium levels in the blood (such as certain diuretics).
Medicines for high blood pressure. Risperdal may lower blood pressure.
Medicines for Parkinson's disease (such as levodopa).
Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperdal, 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 heart conditions).
Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.
Medicines known as beta-blockers (used to treat high blood pressure).
Phenothiazines (such as medicines used to treat psychosis or as sedatives).
Cimetidine, ranitidine (stomach acid blockers).
Itraconazole and ketoconazole (medicines used to treat fungal infections).
Some medicines used to treat HIV/AIDS, such as ritonavir.
Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
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 above applies to you, consult your doctor or pharmacist before taking Risperdal.

Risperdal with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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 of mothers treated with Risperdal during the last trimester of pregnancy (last three months): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.
Risperdal may increase levels of a hormone called "prolactin," which may affect fertility (see Possible side effects).

Driving and using machines

Dizziness, tiredness, and vision problems have been reported during treatment with Risperdal. Do not drive or operate tools or machinery without first consulting your doctor.

Risperdal film-coated tablets contain lactose and sodium

Film-coated tablets contain lactose, a type of sugar. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

Film-coated tablets contain less than 1 mmol of sodium (23 mg) per dose; i.e., essentially "sodium-free."

Risperdal 6 mg film-coated tablets contain Sunset Yellow FCF (E110), which may cause allergic reactions.

3. How to take Risperdal

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

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

The usual initial dose is 2 milligrams once daily; this may be increased to 4 milligrams once daily on the second day
Your doctor may adjust your dose depending on how you respond to treatment
Most people do best with daily doses of 4 to 6 milligrams
This total daily dose may be divided into one or two doses per day. Your doctor will advise you on what is best for you.

Elderly patients

The initial dose will usually be 0.5 milligrams twice daily
Your doctor may later gradually increase your dose to 1 to 2 milligrams twice daily
Your doctor will advise you on what is best for you.

For the treatment of mania

Adults

The initial dose will usually be 2 milligrams once daily
Your doctor may later gradually adjust your dose depending on your response to treatment
Most people do best with daily doses of 1 to 6 milligrams once daily.

Elderly patients

The initial dose will usually be 0.5 milligrams twice daily
Your doctor may later gradually adjust your dose to 1 to 2 milligrams twice daily depending on your response to treatment.

For the long-term treatment of aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

The initial dose will usually be 0.25 milligrams (0.25 ml of Risperdal oral solution 1 mg/ml) twice daily
Your doctor may later gradually adjust your dose depending on your response to treatment
Most people do best with doses of 0.5 milligrams twice daily. Some patients may require 1 milligram 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 Risperdal for schizophrenia or mania.

For the treatment of conduct disorders

The dose will depend on your child's weight:

If weight is less than 50 kilograms

The initial dose will usually be 0.25 milligrams (0.25 ml of Risperdal oral solution 1 mg/ml) once daily
The dose may be increased every other day in increments of 0.25 milligrams per day
The usual maintenance dose is 0.25 to 0.75 milligrams (0.25 ml to 0.75 ml of Risperdal oral solution 1 mg/ml) once daily.

If weight is 50 kilograms or more

The initial dose will usually be 0.5 milligrams once daily
The dose may be increased every other day in increments of 0.5 milligrams per day
The usual maintenance dose is 0.5 to 1.5 milligrams once daily.

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

Children under 5 years of age should not be treated with Risperdal for conduct disorders.

Patients with kidney or liver problems

Regardless of the condition being treated, all initial and subsequent doses of risperidone should be reduced by half. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this patient group.

Method of administration

FOR ORAL USE

Risperdal film-coated tablets

Swallow the tablet with a glass of water
The score line is intended solely for dividing the tablet if you have difficulty swallowing it whole.

If you take more Risperdal than you should

In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or experience abnormal heartbeats or seizures.
Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91.562.04.20, stating the medicine and the amount taken.

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Risperdal

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Risperdal

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to discontinue treatment, 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 adverse effects

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

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

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, or you have difficulty speaking even for a short period of time. These may be signs of a stroke
You develop tardive dyskinesia (involuntary spasms or twitching movements in the face, tongue or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of Risperdal may be necessary

Tell your doctor immediately if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 patients):

You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately
You develop fever, muscle stiffness, sweating or decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required
You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be required
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 side effects may also occur:

Very common adverse effects (may affect more than 1 in 10 people):
Difficulty falling or staying asleep
Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of "freezing" of movement which then restarts. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/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), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu
Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin occur rarely and may include in men, breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire or other sexual dysfunction. In women, symptoms may include breast discomfort, milk discharge from the breasts, missed periods 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 sustained muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
Dizziness
Dyskinesia: A condition involving involuntary muscle movements and may include repetitive, twitching or twisting movements, or spasms
Tremor (shakiness)
Blurred vision, eye infection or "red eye"
Rapid heartbeat, increased 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 (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 nail infection, skin infection, localized infection in a single area of the skin or body, viral infection, skin inflammation caused by mites
Decrease in a type of white blood cell that helps fight infections, decrease in white blood cell count, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in blood
Allergic reaction
Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake
Weight loss, loss of appetite leading to malnutrition and decreased body weight
Increased blood cholesterol
Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares
Lack of response to stimuli, loss of consciousness, decreased level of consciousness
Seizures (epileptic fits), fainting
Restlessness causing movement of body parts, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, pricking 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 upper and lower parts of the heart, abnormal electrical activity in the heart, QT interval prolongation in the heart, slow heartbeat, abnormal electrical conduction in the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
Decreased blood pressure, decreased blood pressure upon standing, as a result, some people taking Risperdal may feel weak, dizzy or lose consciousness when standing up or sitting up suddenly, flushing
Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, voice disorder, breathing difficulty
Stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excess gas or flatulence
Hives (or "urticaria"), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy scalp or skin, skin disorder, skin lesion
Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown
Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
Frequent urination, inability to urinate, pain when urinating
Erectile dysfunction, ejaculation disorder
Loss of menstruation, missed periods or other menstrual cycle problems (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
Thirst, feeling unwell, chest discomfort, feeling "under the weather", malaise
Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood
Procedure-related pain

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

Infection
Inappropriate secretion of a hormone that controls urine volume
Sleepwalking
Sleep-related eating disorder
Sugar in urine, decreased blood sugar, increased blood triglycerides (a type of fat)
Absence of emotions, inability to reach orgasm
Lack of movement or response while awake (catatonia)
Problems with blood vessels in the brain
Coma due to uncontrolled diabetes
Head agitation
Glaucoma (increased pressure in the eyeball), eye movement problems, eye rolling, crusts at the eyelid margin
Eye problems during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken Risperdal. If you need cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine
Dangerously low count of a type of white blood cell needed to fight infections in the blood
Dangerously excessive water intake
Irregular heartbeat
Breathing problems during sleep (sleep apnea), rapid, shallow breathing
Pancreatitis, intestinal obstruction
Swelling of the tongue, cracked lips, drug-related skin rash
Dandruff
Muscle fiber breakdown and muscle pain (rhabdomyolysis)
Delayed periods, increased mammary glands, breast enlargement, milk discharge from the breasts
Increased insulin (a hormone that controls blood sugar levels) in blood
Skin hardening
Decreased body temperature, coldness in arms and legs
Medication withdrawal syndrome
Yellowing of the skin and eyes (jaundice)

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

Life-threatening complications of uncontrolled diabetes
Severe allergic reaction with swelling, which may affect the throat causing breathing difficulty
Lack of movement in intestinal muscles causing obstruction

Frequency not known: cannot be estimated from available data

Severe or life-threatening blistering and peeling skin rash that may start around the mouth, nose, eyes, genitals and spread to other parts of the body (Stevens-Johnson Syndrome or toxic epidermal necrolysis)

The following adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with Risperdal: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

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

The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, symptoms of common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea and urinary incontinence (lack of bladder control).

Reporting of adverse effects

If you experience any adverse effect, talk to 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 Risperdal

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Blister packs: Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risperdal

The active substance is risperidone.

Each Risperdal film-coated tablet contains 1, 3, or 6 milligrams of risperidone.

The other components are:

Risperdal 1 mg film-coated tablets:

Tablet core: Lactose monohydrate, maize starch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate.

Coating: Hypromellose (E464), propylene glycol (E490).

Risperdal 3 mg film-coated tablets:

Tablet core: Lactose monohydrate, maize starch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate.

Coating: Hypromellose (E464), propylene glycol (E490), titanium dioxide (E171), talc (E553B), quinoline yellow (E104).

Risperdal 6 mg film-coated tablets:

Tablet core: Lactose monohydrate, maize starch, microcrystalline cellulose (E460), magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate.

Coating: Hypromellose (E464), propylene glycol (E490), titanium dioxide (E171), talc (E553B), quinoline yellow (E104), orange yellow S (E110).

Appearance of Risperdal and contents of the pack

Risperdal film-coated tablets are packed in PVC/LDPE/PVDC/aluminum blisters and in HDPE bottles with child-resistant plastic screw caps.

Film-coated tablets

The 1 mg risperidone film-coated tablets are biconvex, oblong, scored, white tablets measuring 10.5 mm x 5 mm.
The 3 mg risperidone film-coated tablets are biconvex, oblong, scored, yellow tablets measuring 13.5 mm x 6.5 mm.
The 6 mg risperidone film-coated tablets are biconvex, circular, yellow tablets measuring 8 mm.

The film-coated tablets are engraved on one side with RIS 1, RIS 3, and RIS 6 respectively. Additionally, JANSSEN may be engraved on the other side.

Pack sizes

Risperdal film-coated tablets are available in the following pack sizes:

1 mg: blister packs containing 6, 20, 50, 60 or 100 tablets and bottles containing 500 tablets.
3 mg: blister packs containing 20, 50, 60 or 100 tablets.
6 mg: blister packs containing 28, 30 or 60 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Janssen-Cilag, S.A.
Paseo del Club Deportivo 1, Edificio 16
28223 Pozuelo de Alarcón (Madrid)
Spain

Responsible for Batch Release

Janssen Cilag S.P.A.
Via C. Janssen (Borgo San Michele, Latina) - I 04100 – Italy

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Risperdal
Belgium: RISPERDAL
Cyprus: RISPERDAL
Czech Republic: RISPERDAL
Denmark: RISPERDAL
Estonia: RISPOLEPT
Finland: RISPERDAL
France: RISPERDAL
Germany: RISPERDAL 1 mg; 2 mg; 3 mg; 4 mg / Risperdal 0.5 mg; 6 mg / Risperdal Lösung 1 mg/ml
Greece: RISPERDAL
Hungary: RISPERDAL
Iceland: RISPERDAL
Ireland: RISPERDAL
Italy: RISPERDAL
Lithuania: RISPOLEPT
Latvia: RISPOLEPT
Luxembourg: RISPERDAL
Malta: RISPERDAL
Netherlands: RISPERDAL
Norway: RISPERDAL
Poland: RISPOLEPT
Portugal: RISPERDAL
Romania: RISPOLEPT
Slovenia: RISPERDAL
Spain: RISPERDAL
Sweden: RISPERDAL
United Kingdom (Northern Ireland): RISPERDAL

Date of the most recent revision of this leaflet: August 2022.

Detailed and up-to-date 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).