Risperdal 1 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperdal 1 mg/ml oral solution

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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Risperdal is and what it is used for
2. What you need to know before taking Risperdal
3. How to take Risperdal
4. Possible adverse effects
5. How to store Risperdal
6. 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:

• 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 overly 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-type dementia who harm themselves or others. Alternative non-pharmacological treatments should have been attempted 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 can 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 any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to 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 are taking medicines for blood pressure. Risperdal may reduce blood pressure. You may need your dose adjusted.
• You have 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 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 medicines).
• You are diabetic.
• You have epilepsy.
• You are a man who has 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 have 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.

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

Because diabetes mellitus or worsening of pre-existing diabetes mellitus has 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, evaluation of blood prolactin levels is recommended.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. In addition, 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 frequently.

If you or your caregiver notice a sudden change in your mental state or sudden onset of weakness or numbness in your face, arms, or legs—especially on one side—or if you speak unclearly, 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 may continue to be monitored regularly during treatment.

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

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 that you talk to your doctor or pharmacist if you are taking any of the following:

• Medicines that act on your 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 certain body parts 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 medicines may decrease 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.

Taking Risperdal with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

1. If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take it.
2. The following symptoms may occur in newborns whose mothers were treated with Risperdal during the third trimester of pregnancy (last three months): tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.
3. Risperdal may increase levels of a hormone called "prolactin," which may 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 machinery without first consulting your doctor.

Risperdal oral solution contains benzoic acid (E210) and sodium

This medicine contains 2 mg of benzoic acid in each 1 ml of oral solution. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free."

3. How to take Risperdal

Follow exactly the instructions for using this medicine 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 per day; this 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 improve with daily doses of 4 to 6 milligrams
• This total daily dose can be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

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

For the treatment of mania

Adults

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

Elderly patients

• The initial dose will usually be 0.5 milligrams twice daily
• Your doctor may gradually adjust your dose later 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 gradually adjust your dose depending on your response to treatment
• Most people improve 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 weighing 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 weighing 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 risperidone doses 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

FOR ORAL USE

Risperdal oral solution

The solution comes with a syringe (pipette). Use only the syringe (pipette) supplied with this medicine to measure the dose prescribed by your doctor.

Follow these steps:

1. Remove the child-resistant cap. Push down the plastic cap while turning it counterclockwise (Figure 1)

2. Insert the syringe into the bottle (Figure 2)

3. Holding the lower ring (Figure 3a), pull the upper ring up to the mark corresponding to the number of milliliters or milligrams to be administered. Always read the mark aligned with the lower ring (see examples in Figure 3b)

• Measure the exact dose of medicine you need. Pay close attention when measuring a small dose; for example, for 0.25 mg, measure 0.25 ml (a quarter of a milliliter); for 0.5 mg, measure 0.5 ml (half a milliliter).

• 1 ml of Risperdal oral solution contains 1 mg of risperidone. The volume measured is marked every 0.25 ml / 0.25 mg on the syringe.

• Figure 3b shows examples of prescribed doses and the corresponding marks on the syringe.

4. Holding the lower ring, remove the entire syringe from the bottle (Figure 4)

5. Empty the syringe into a non-alcoholic drink (not tea). Slide the upper ring downward.
6. Close the bottle.
7. Wash the syringe with water and allow it to air dry.

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 have abnormal heartbeats or seizures.
• Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91.562.04.20, indicating the medicine and the amount taken.

It is recommended to bring the medicine’s 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 your 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 once) to make up for a missed dose.

If you stop taking Risperdal

You should not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop 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 produce adverse effects, although not everyone experiences 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 have difficulty speaking, even for a short period of time. These may be signs of a stroke
• You experience 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 of 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 experience 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 (resulting in jerky movements), and sometimes a feeling of "freezing" of movement that 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 elevated prolactin occur rarely and may include, in men, breast swelling, difficulty achieving 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 menstrual cycle problems or fertility issues
• Weight gain, increased appetite, decreased appetite
• Sleep disorders, 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 result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements
• Dizziness
• Dyskinesia: A condition involving involuntary muscle movements, which may include repetitive, spasmodic, or twisting movements, or 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, stomach 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 the blood
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake
• Weight loss, loss of appetite leading to malnutrition and reduced body weight
• Increased cholesterol in blood
• 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, prickling, or numbness of the skin
• Light sensitivity of the eyes, dry eyes, increased tearing, eye redness
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity in the heart, QT interval prolongation on ECG, 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 down suddenly, flushing
• Pneumonia due to aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, wheezing, 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, absence of menstrual periods, or other menstrual cycle problems (women)
• Breast development 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
• Change in walking pattern
• Thirst sensation, 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, low blood sugar, increased blood triglycerides (a type of fat)
• Absence of emotions, inability to achieve 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 eye), eye movement problems, eye rolling, crusts on 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
• Tongue swelling, cracked lips, drug-related skin rash
• Dandruff
• Muscle fiber breakdown and muscle pain (rhabdomyolysis)
• Delayed menstrual periods, enlarged mammary glands, breast enlargement, breast discharge
• 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 leading to obstruction

Frequency not known: cannot be estimated from available data

• Severe or life-threatening skin rash with blisters and peeling of the skin, which 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 a common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (loss 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 Risperdal

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

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

Do not store above 30°C.

Do not refrigerate or freeze.

Once the bottle has been opened, any unused portion of Risperdal oral solution should be discarded after 3 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines 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.

1 ml of Risperdal oral solution contains 1 milligram of risperidone.

The other components (excipients) are:

Tartaric acid (E334), Benzoic acid (E210), Sodium hydroxide, Distilled water.

Appearance of Risperdal and contents of the pack

Risperdal oral solution is supplied in an amber glass bottle with a child-resistant cap containing 30 ml, 60 ml, 100 ml or 120 ml of a clear, colourless liquid. A dosing pipette is also provided.

The pipette supplied with the 30 ml, 60 ml and 100 ml bottles is graduated in milligrams and millilitres, with a minimum volume of 0.25 ml and a maximum volume of 3 ml. Graduation marks in 0.25 ml increments (equivalent to 0.25 mg of oral solution) up to 3 ml (equivalent to 3 mg of oral solution) are printed on this pipette. The pipette supplied with the 120 ml bottle is graduated in milligrams and millilitres, with a minimum volume of 0.25 ml and a maximum volume of 4 ml. Graduation marks in 0.25 ml increments (equivalent to 0.25 mg of oral solution) up to 4 ml (equivalent to 4 mg of oral solution) are printed on this pipette.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Batch Release Responsibility

JANSSEN PHARMACEUTICA NV
Turnhoutseweg, 30 (Beerse) – B-2340 – Belgium.

Lusomedicamenta Sociedade Técnica Farmacêutica S.A.
Estrada Consiglieri Pedroso 66, 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal

This medicinal product is authorised in the European Economic Area member states 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 0.5mg; 6mg / 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

Date of the most recent revision of this leaflet: February 2026.

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