RISPERDAL 6 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Risperdal 1, 3, and 6 mg Film-Coated Tablets

Risperidone

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What is Risperdal and what is it used for
2. What you need to know before taking Risperdal
3. How to take Risperdal
4. Possible side effects
5. Storing Risperdal
6. Package Contents and Additional Information

1. What is Risperdal and what is it used for

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

Risperdal is used to treat the following:

• Schizophrenia, where you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused.
• Mania, where you may feel very 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 people with Alzheimer's disease, who may harm themselves or others. Other alternative treatments (non-pharmacological) should have been tried previously.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children and adolescents with behavioral disorders.

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

2. What you need to know before taking Risperdal

Do not take Risperdal

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

If you are not sure, consult your doctor or pharmacist before taking Risperdal.

Warnings and Precautions

Consult your doctor or pharmacist before taking Risperdal if:

• You have any heart problems. Examples include irregular heartbeat or if you are prone to low blood pressure or if you use medications for blood pressure. Risperdal may lower 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, cardiovascular disease, 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 symptoms that include fever, muscle stiffness, sweating, or a decrease in consciousness level (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 medications).
• You are diabetic.
• You have epilepsy.
• You are male and have had a prolonged or painful erection in the past.
• You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of the hormone prolactin in your blood or if you have a tumor that may be dependent 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 unsure about any of the above, consult your doctor or pharmacist before taking Risperdal.

Because very rarely, patients treated with Risperdal have been observed to have a dangerously low number of a type of white blood cell necessary to fight infections in the blood, your doctor may check your white blood cell count.

Risperdal may cause you to gain weight. Significant weight gain can affect your health unfavorably. Your doctor will regularly monitor your weight.

Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen in patients taking Risperdal, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Risperdal often increases the levels of a hormone called "prolactin". This can cause side effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible Side Effects). If these side effects occur, it is recommended to evaluate prolactin levels in the blood.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not increase in size as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, which can cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medication.

Elderly Patients with Dementia

In elderly patients with dementia, there is an increased risk of having a stroke. You should not take risperidone if you have dementia caused by a stroke.

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

If you or your caregiver notice a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or confused speech, even if only for a short time, seek medical attention immediately. It may be a sign of a stroke.

Children and Adolescents

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

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

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

A small, inconclusive study has reported an increase in height in children who took risperidone, but it is unknown whether this is a drug effect or due to another reason.

Other Medications and Risperdal

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

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

• Medications that act on your brain, such as those used to calm you down (benzodiazepines) or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase their sedative effect.
• Medications that can modify the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medications for mental problems.
• Medications that cause a slow heartbeat.
• Medications that cause low potassium levels in the blood (such as some diuretics).
• Medications for high blood pressure. Risperdal may lower blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Medications that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Diuretics, which are used for heart problems or to treat swelling of some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperdal, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may decrease the effect of risperidone

• Rifampicin (a medication for treating some infections).
• Carbamazepine, phenytoin (medications for epilepsy).
• Phenobarbital.

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

The following medications may increase the effect of risperidone

• Quinidine (used for certain types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.
• Medications known as beta-blockers (used to treat high blood pressure).
• Phenothiazines (such as medications used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medications used to treat fungal infections).
• Some medications used to treat HIV/AIDS, such as ritonavir.
• Verapamil, a medication used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medications used to treat depression and other psychiatric disorders.

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

If you are unsure about any of the above, consult your doctor or pharmacist before taking Risperdal.

Using Risperdal with Food, Drinks, and Alcohol

You can take this medication with or without food. You should avoid consuming alcohol while taking Risperdal.

Pregnancy, Breastfeeding, and Fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will decide if you can take it.
• The following symptoms may occur in newborn babies of mothers who have been treated with Risperdal in the last trimester of pregnancy (last three months of pregnancy): trembling, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.
• Risperdal may increase the levels of a hormone called "prolactin" that can affect fertility (see Possible Side Effects).

Driving and Using Machines

Dizziness, fatigue, and vision problems have been observed during treatment with Risperdal. Do not drive or operate tools or machines without consulting your doctor first.

Risperdal Film-Coated Tablets Contain Lactose and Sodium

The film-coated tablets contain lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

The film-coated tablets contain less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

Risperdal 6 mg Film-Coated Tablets Contain Orange Yellow S (E110)which may cause allergic reactions.

3. How to Take Risperdal

Follow the administration instructions of this medication exactly as indicated 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 per day, which may be increased to 4 milligrams per day on the second day.
• Your doctor may adjust your dose depending on how you respond to treatment.
• Most people feel better with daily doses of 4 to 6 milligrams.
• This daily total dose can be divided into one or two doses per day. Your doctor will indicate what is best for you.

Elderly Patients

• The initial dose will be 0.5 milligrams twice a day, usually.
• Later, your doctor may gradually increase your dose to 1 to 2 milligrams twice a day.
• Your doctor will indicate what is best for you.

For the treatment of mania

Adults

• The initial dose will be 2 milligrams once a day, usually.
• Later, your doctor may adjust your dose gradually depending on your response to treatment.
• Most people feel better with doses of 1 to 6 milligrams once a day.

Elderly Patients

• The initial dose will be 0.5 milligrams twice a day, usually.
• Later, your doctor may adjust your dose gradually to 1 milligram to 2 milligrams twice a day depending on your response to treatment.

For the treatment of long-term aggression in people with Alzheimer's disease

Adults (including elderly patients)

• The initial dose will be 0.25 milligrams (0.25 ml of Risperdal oral solution 1 mg/ml) twice a day, usually.
• Later, your doctor may adjust your dose gradually depending on your response to treatment.
• Most people feel better with doses of 0.5 milligrams twice a day. Some patients may need 1 milligram twice a day.
• Treatment duration in patients with Alzheimer's disease should not exceed 6 weeks.

Use in Children and Adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperdal for schizophrenia or mania.

For the treatment of behavioral disorders

The dose depends on your child's weight:

If they weigh less than50 kilograms

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

If they weigh50 kilogramsor more

• The initial dose will be 0.5 milligrams once a day, usually.
• The dose can be increased every other day in increments of 0.5 milligrams per day.
• The usual maintenance dose is 0.5 milligrams to 1.5 milligrams once a day.

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

Children under 5 years of age should not receive treatment with Risperdal for behavioral disorders.

Patients with Kidney or Liver Problems

Regardless of the disease 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 group of patients.

Method of Administration

ORAL ROUTE

Risperdal Film-Coated Tablets

• You should swallow the medication with a drink of water.
• The score line is only for breaking the tablet if you find it difficult to swallow it whole.

If you take more Risperdal than you should

• In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing and walking, dizziness due to low blood pressure, or have abnormal heartbeats or seizures.
• Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to take the package and package leaflet of the medication to the healthcare professional.

If you forget to take Risperdal

• If you forget to take a dose, take it as soon as you remember. But if it's close to the time for your next dose, skip the missed dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for the missed dose.

If you stop taking Risperdal

Do not stop taking this medication unless your doctor tells you to. Symptoms may come back. If your doctor decides to stop this treatment, your dose may be gradually decreased over a few days.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor if you experience any of the following rare 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 have difficulty speaking even for a short period. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or twitching movements that cannot be controlled in the face, tongue, or other parts of the body). Report to your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to withdraw Risperdal.

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

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You experience fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. It is known as priapism. You may need 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 a drop in blood pressure.

The following side effects may also appear:

• Very common adverse effects (may affect more than 1 in 10 people):
• Dificulty staying or falling asleep.
• Parkinsonism: This disease may include slow or altered movement, feeling of stiffness or muscle tension (making sudden movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors at rest, increased saliva and/or drooling, and loss of facial expressiveness.
• Feeling drowsy or less attentive.
• 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 like having the flu.
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). The symptoms of increased prolactin occur rarely and may include, in men, breast swelling, difficulty having or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle or fertility issues.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: It is a disease that involves slow or continuous involuntary contraction of the muscles. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness.
• Discinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremors (shaking).
• Blurred vision, eye infections, or "red eye".
• Rapid heartbeat, increased blood pressure, shortness of breath.
• Sore throat, cough, nasal bleeding, 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 control).
• Body swelling, arm or leg swelling, 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, localized infection in a single area of the skin or body part, viral infection, skin inflammation caused by mites.
• Decrease in a type of white blood cell that helps fight infections, decrease in the number of white blood cells, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in the number of eosinophils (a type of white blood cell) in the blood.
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake.
• Weight loss, loss of appetite that causes malnutrition and weight loss.
• Increased cholesterol in the blood.
• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.
• Absence of response to stimuli, loss of consciousness, decreased level of consciousness.
• Seizures (epileptic crises), fainting.
• A restlessness that causes movement of body parts, balance disorder, abnormal coordination, dizziness when standing up, attention alteration, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of tingling, pinching, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tearing, eye redness.
• Feeling that everything is 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, anomaly in the electrical activity of the heart, prolongation of the QT interval in the heart, slow heartbeat, anomaly in the electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure, decreased blood pressure when standing up, as a consequence, some people taking Risperdal may feel weakness, dizziness, or loss of consciousness when getting up or sitting down suddenly, flushing.
• Aspiration pneumonia, pulmonary congestion, respiratory tract congestion, lung crepitus, wheezing, voice disorder, breathing difficulty.
• Stomach or intestine 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 skin or scalp, skin disorder, skin injury.
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle degradation.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, inability to urinate, painful urination.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstruation, loss of menstrual periods, or other problems with the cycle (women).
• Development of breasts in men, milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
• Facial swelling, mouth, eye, or lip swelling.
• Chills, increased body temperature.
• Change in gait.
• Feeling of thirst, feeling of discomfort, chest discomfort, feeling "unwell", discomfort.
• Increased liver transaminases in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood.
• Pain due to the procedure.

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 the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat).
• Absence of emotions, inability to reach orgasm.
• Lack of movement or response while awake (catatonia).
• Problems in the blood vessels of the brain.
• Diabetic coma due to uncontrolled diabetes.
• Head shaking.
• Glaucoma (increased eye pressure), eye movement problems, eye rotation, crusts on the eyelid margin.
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken Risperdal. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication.
• Dangerously low number of a type of white blood cell necessary to fight infections in the blood.
• Dangerously excessive water intake.
• Irregular heartbeat.
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Tongue swelling, cracked lips, skin rash related to the medication.
• Dandruff.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, breast enlargement, breast swelling, milk secretion from the breasts.
• Increased insulin (a hormone that controls blood sugar levels) in the blood.
• Skin hardening.
• Decreased body temperature, coldness in arms and legs.
• Drug withdrawal syndrome.
• Yellowing of the skin and eyes (jaundice).

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

• Complications of uncontrolled diabetes, life-threatening.
• Severe allergic reaction with swelling, which can affect the throat, causing difficulty breathing.
• Lack of movement of the intestinal muscles that causes obstruction.

Frequency not known: cannot be estimated from the available data

• Severe rash with blisters and peeling of the skin that can start around the mouth, nose, eyes, genitals, and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following adverse effect has appeared with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to appear with Risperdal: Rapid heartbeat when standing up.

Other adverse effects in children and adolescents

In general, it is expected that the adverse effects in children will be similar to those that appeared 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 attentive, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors (shaking), diarrhea, and urinary incontinence (loss of control).

Reporting of adverse effects

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

5. Storage of Risperdal

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

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Risperdal

The active ingredient is risperidone.

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

The other components are:

Risperdal 1 mg film-coated tablets:

Core of the tablet:Lactose monohydrate, cornstarch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.

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

Risperdal 3 mg film-coated tablets:

Core of the tablet:Lactose monohydrate, cornstarch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.

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

Risperdal 6 mg film-coated tablets:

Core of the tablet:Lactose monohydrate, cornstarch, microcrystalline cellulose (E460), magnesium stearate, anhydrous colloidal 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 package contents

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

Film-coated tablets

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

The film-coated tablets have the following markings on one side: RIS 1, RIS 3, and RIS 6, respectively. Additionally, they may have the marking JANSSEN on the other side.

Package sizes

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

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

Not all package sizes may be marketed.

Marketing authorization holder

Janssen-Cilag, S.A.

Paseo del Club Deportivo 1, Edificio 16.

28223 Pozuelo de Alarcón (Madrid).

Spain.

Batch release responsible

Janssen Cilag S.P.A.

Via C. Janssen (Borgo San Michelle, Latina) - I 04100 – Italy.

This medicine 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 last revision of this prospectus:August 2022.

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