Package leaflet: Information for the user

Risperidone Aurobindo 0.5 mg film-coated tablets, 1 mg film-coated tablets, 2 mg film-coated tablets, 3 mg film-coated tablets, 4 mg film-coated tablets, 6 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Risperidone Aurobindo is and what it is used for

Risperidone Aurobindo belongs to a group of medicines called "antipsychotics".
Risperidone Aurobindo is used for:

the treatment of schizophrenia, a condition in which you may see, hear or experience things that are not present, believe things that are not true, or feel unusually suspicious or confused.
the treatment of mania, a condition in which you may feel highly excited, euphoric, restless, enthusiastic or hyperactive. Mania occurs as part of an illness called "bipolar disorder".
short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who harm themselves or others. Non-pharmacological alternatives should have been tried before treatment.
short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged 5 years and older) and adolescents with conduct disorder.

Risperidone Aurobindo may help relieve the symptoms of your illness and prevent symptoms from recurring.

2. What you should know before taking Risperidone Aurobindo

Do not take Risperidone Aurobindo 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 conditions listed above apply to you, speak with your doctor or pharmacist before using Risperidone Aurobindo.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidone Aurobindo if:

You have a heart condition. Examples include irregular heartbeat, low blood pressure, or if you are taking medicines for blood pressure. Risperidone Aurobindo may cause a drop in blood pressure. A dose adjustment may be necessary.
You are aware of any risk factors for stroke, such as high blood pressure, cardiovascular disease, or cerebrovascular disorders.
You have ever experienced involuntary movements of the tongue, mouth, or face.
You have ever had a condition with symptoms such as high fever, muscle stiffness, sweating, or reduced level of consciousness (also known as neuroleptic malignant syndrome).
You have Parkinson’s disease or dementia.
You have diabetes.
You know you have previously had low levels of white blood cells (with or without being caused by other medicines).
You have epilepsy.
You are a man and have experienced prolonged or painful erections.
You have difficulty regulating body temperature or excessive overheating.
You have kidney problems.
You have liver problems.
You have abnormally high levels of the hormone prolactin in your blood or a possible prolactin-dependent tumour.
You or someone in your family has a history of blood clots (thrombosis), as antipsychotic medicines have been associated with blood clot formation.
If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Risperidone Aurobindo.

Very rarely, dangerously low levels of a certain type of white blood cells needed to fight infections have been observed in patients taking Risperidone Aurobindo. Your doctor may monitor your white blood cell count.

Risperidone Aurobindo may cause weight gain. Significant weight gain can negatively affect your health. Your doctor should regularly monitor your body weight.

Cases of new-onset diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking Risperidone Aurobindo. Your doctor should check for elevated blood glucose levels.

Blood glucose levels should be monitored regularly in patients with pre-existing diabetes mellitus.

Risperidone Aurobindo normally increases levels of a hormone called “prolactin”. This may cause side effects such as menstrual disorders and fertility problems in women, or breast enlargement in men (see “Possible side effects”). If such side effects occur, assessment of prolactin levels in the blood is recommended.

During eye surgery for clouding of the lens (cataract), the pupil (the black circle in the center of the eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become soft during surgery, which could lead to eye damage. If you are planning eye surgery, make sure to inform your doctor that you are taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You must not take risperidone if your dementia is caused by stroke.

During treatment with risperidone, you should see 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—or slurred speech, even if brief, seek immediate medical help. These may be signs of a stroke.

Children and adolescents

Before starting treatment for behavioural disorder, other causes of aggressive behaviour should be ruled out.

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

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

A small, inconclusive study reported increased height in children taking risperidone, but it is not known whether this is due to the medicine or another reason.

Other medicines and Risperidone Aurobindo

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

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

Medicines that act on the brain to help calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase the sedative effects of these medicines.
Medicines that may alter the electrical activity of your heart, such as medicines for malaria, heart rhythm disorders, allergies (antihistamines), certain antidepressants, or other medicines for mental disorders.
Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
Medicines that slow down the heart rate.
Medicines that cause low potassium levels in the blood (such as some diuretics).
Medicines for high blood pressure. Risperidone Aurobindo may cause a drop in blood pressure.
Medicines for Parkinson’s disease (such as levodopa).
Medicines for urination (diuretics), used for heart conditions or swelling of body parts due to excessive fluid accumulation (such as furosemide or chlorothiazide). Risperidone Aurobindo, alone or in combination 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 for fungal infections)
Certain medicines used in the treatment of 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 conditions listed above apply to you, speak with your doctor or pharmacist before using Risperidone Aurobindo.

Risperidone Aurobindo with food, drink, and alcohol

You may take this medicine with or without food. During treatment with Risperidone Aurobindo, you should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

The following symptoms may occur in newborns of mothers who have used risperidone during the third trimester (last three months of pregnancy): 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.
Risperidone Aurobindo may increase levels of a hormone called “prolactin”, which may affect fertility (see Possible side effects).

Driving and using machines

During treatment with Risperidone Aurobindo, dizziness, fatigue, and vision problems may occur. Do not drive or operate tools or machinery without first discussing it with your doctor.

Risperidone Aurobindo film-coated tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Risperidone Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:

For the treatment of schizophrenia

Adults

The usual starting dose is 2 mg per day, which may be increased to 4 mg daily from the second day.
Your doctor may then increase your dose depending on how you respond to treatment.
Most people feel better with daily doses between 4 mg and 6 mg.
The total daily dose may be taken as a single dose or divided into two doses. Your doctor will tell you which option is best for you.

Elderly patients

Your initial dose will usually be 0.5 mg twice daily.
Your doctor may gradually increase your dose up to 1–2 mg twice daily.
Your doctor will tell you which option is best for you.

For the treatment of mania

Adults

Your usual starting dose will be 2 mg once daily.
Your doctor may gradually adjust your dose depending on your response to treatment.
Most people feel better with doses between 1 mg and 6 mg once daily.

Elderly patients

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

For the treatment of long-standing aggression in patients with Alzheimer's dementia

Adults (including elderly patients)

Your usual starting dose will be 0.25 mg twice daily.
Your doctor may gradually adjust your dose depending on your response to treatment.
Most patients feel better with 0.5 mg twice daily. Some patients may require 1 mg twice daily.
The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks.

Use in children and adolescents

Children and adolescents under 18 years of age must not be treated with Risperidone Aurobindo for schizophrenia or mania.

For the treatment of conduct disorder in children and adolescents

The dose will depend on the child's body weight:

For children weighing less than 50 kg:

The usual starting dose is 0.25 mg once daily.
The dose may be increased every other day in increments of 0.25 mg per day.
The usual maintenance dose ranges between 0.25 mg and 0.75 mg once daily.

For children weighing 50 kg or more:

The usual starting dose is 0.5 mg once daily.
The dose may be increased every other day in increments of 0.5 mg per day.
The usual maintenance dose ranges between 0.5 mg and 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 must not be treated with Risperidone Aurobindo for conduct disorder.

Patients with kidney or liver problems

Regardless of the condition being treated, all initial and subsequent risperidone doses should be halved. Dose increases should be made more slowly in these patients. Risperidone must be used with caution in this patient group.

Instructions for administration

For oral use.
Swallow the tablet with a glass of water.

If you take more Risperidone Aurobindo than you should

Contact your doctor immediately. Take the medicine pack with you.
In case of overdose, you may feel drowsy or tired, experience unusual body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or develop an abnormal heartbeat or seizures.

If you forget to take Risperidone Aurobindo

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 together) to make up for a forgotten dose.

If you stop taking Risperidone Aurobindo

Do not stop taking this medicine unless your doctor tells you to do so. Your symptoms may return. If your doctor decides to discontinue this medicine, the dose may be gradually reduced over several days.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if:

You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult a doctor immediately.
You have dementia and experience a sudden change in your mental state or sudden weakness or sudden numbness of the face, arms or legs, particularly on one side, or difficulty speaking, even for a brief period of time. These may be signs of a stroke.
You have fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
You are a man and experience a prolonged or painful erection. This is called priapism. Immediate medical treatment may be required.
You develop involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of risperidone may be necessary.
You experience a severe allergic reaction characterised by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash or a drop in blood pressure.

The following side effects may occur:
Very common (may affect more than 1 in 10 people):

Difficulty falling asleep or staying asleep
Parkinsonism. This condition may include: slowed or impaired movements, feeling of muscle stiffness (making movements jerky), and sometimes a sensation of "freezing" followed by restarting. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased salivation and/or drooling, and loss of facial expression.
Feeling drowsy or less alert.
Headache.

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

Pneumonia, chest infection (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, feeling of having influenza.
Increased levels of a hormone called "prolactin" detected in a blood test (may or may not cause symptoms). Symptoms due to high prolactin levels are uncommon and in men may include breast enlargement, difficulty achieving or maintaining erections, decreased libido or other sexual dysfunctions. In women, they may include breast discomfort, milk leakage from the breasts, missed menstrual periods or other menstrual or fertility problems.
Weight gain, increased appetite, reduced appetite.
Sleep disturbances, irritability, depression, anxiety, restlessness.
Dystonia: this is a condition involving slow and prolonged involuntary muscle contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often affects facial muscles, including abnormal movements of the eyes, mouth, tongue or jaw.
Dizziness.
Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive spastic or twisting movements or spasms.
Tremor (shaking).
Blurred vision, eye infection or "pink eye" (conjunctivitis).
Rapid heartbeat, high blood pressure, shortness of breath.
Sore throat, cough, nosebleed, stuffy nose.
Pain or discomfort in the abdomen, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache.
Skin rash, redness of the skin.
Muscle spasms, bone or muscle pain, back pain, joint pain.
Urinary incontinence (lack of control).
Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
Falls.

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

Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, a skin infection confined to a single area of the skin or part of the body, viral infection, skin infection caused by mites.
Reduction in the type of white blood cells that help protect you from infections, reduced number of white blood cells, reduced platelets (blood cells that help stop bleeding), anaemia, reduced red blood cells, increased eosinophils (a type of white blood cells) in the blood.
Allergic reaction.
Diabetes or worsening of diabetes, high blood sugar levels, excessive water drinking.
Weight loss, loss of appetite leading to malnutrition and low body weight.
Increased cholesterol in the blood.
Euphoria (mania), confusion, reduced sexual drive, nervousness, nightmares.
Tardive dyskinesia (spasms or jerky movements of the face, tongue or other body parts that cannot be controlled). Inform your doctor immediately if you experience

involuntary rhythmic movements of the tongue, mouth or face. It may be necessary
to discontinue Risperidone Aurobindo.

Sudden reduction in blood supply to the brain (stroke or "mini" stroke).
Lack of response to stimuli, loss of consciousness, low level of consciousness.
Seizures (epileptic fits), fainting.
An uncontrollable urge to move parts of the body, balance disorders, abnormal coordination, dizziness when standing up, attention disorders, speech problems, loss or abnormal sensation of taste, reduced skin sensitivity to pain or touch, tingling or numbness of the skin.
Excessive sensitivity of the eyes to light, dry eyes, increased tearing, eye redness.
Sensation of spinning (vertigo), ringing in the ears, earache.
Atrial fibrillation (an abnormal heart rhythm), interruption in conduction between upper and lower parts of the heart, abnormal electrical conduction of the heart, QT interval prolongation of the heart, slow heartbeat, abnormal electrical tracing of the heart (electrocardiogram or ECG), sensation of heartbeat in the chest (palpitations).
Low blood pressure, low blood pressure when standing up (as a result, many people taking Risperidone Aurobindo may feel faint, dizzy or may fall when standing or getting up suddenly), flushing.
Pneumonia caused by inhalation of food, lung congestion, respiratory congestion, crackling sounds in the lungs, wheezing, voice disorders, airway disorders.
Stomach or intestinal infection, faecal incontinence, very hard stools, difficulty swallowing, excessive passing of gas or air.
Hives, itching, hair loss, thickening of the skin, eczema, dry skin, skin discolouration, acne, scaly and itchy scalp or skin, skin disorders, skin lesions.
Increased CPK (creatine phosphokinase) in the blood, an enzyme sometimes released when there is muscle damage.
Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
Frequent urination, inability to urinate, pain during urination.
Erectile dysfunction, ejaculation disorders.
Loss of menstrual periods, skipped menstrual periods or other menstrual problems (women).
Breast development in men, milk leakage from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
Swelling of the face, mouth, eyes or lips.
Chills, increased body temperature.
A change in the way of walking.
Feeling thirsty, feeling unwell, chest discomfort, not feeling well, discomfort.
Increased liver transaminases in the blood, increased GGT (a liver enzyme called gamma-glutamyl transferase) in the blood, increases in liver enzymes in the blood.
Procedural pain.

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

Infection.
Inappropriate secretion of a hormone that controls urine volume.
Sugar in urine, low blood sugar levels, high triglyceride levels (a fat) in the blood.
Lack of emotions, inability to reach orgasm.
Neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle stiffness).
Problems with blood vessels in the brain.
Coma due to uncontrolled diabetes.
Head tremor.
Glaucoma (increased pressure inside the eyeball), problems with eye movements, eye rolling, crusts at the edges of the eyelids.
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 Risperidone Aurobindo. Make sure your doctor knows that you are taking or have taken this medicine.
Dangerously low number of a certain type of white blood cells in the blood needed to fight infections.
Severe allergic reaction characterised by fever, swelling of the mouth, face, tongue or lips, shortness of breath, itching, skin rash and sometimes drop in blood pressure.
Dangerously excessive water intake.
Irregular heartbeat.
Blood clot in the legs, blood clot in the lungs.
Breathing problems during sleep (sleep apnoea), rapid or shallow breathing.
Inflammation of the pancreas, intestinal blockage.
Swollen tongue, chapped lips, drug-related skin rash.
Dandruff.
Muscle fibre breakdown and muscle pain (rhabdomyolysis).
Delay in menstrual cycle, enlargement of breast glands, breast enlargement, secretion from the breasts.
Increased insulin in the blood (a hormone that controls blood sugar levels).
Priapism (a prolonged and painful erection of the penis which may require surgical treatment).
Skin hardening.
Reduced body temperature, cold arms and legs.
Drug withdrawal symptoms.
Yellowing of the skin and eyes (jaundice).

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

Life-threatening complications of uncontrolled diabetes.
Severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties.
Lack of muscle movement in the intestine causing blockage.

The following side effect has been observed with the use of another medicine called
paliperidone, which is very similar to risperidone, and therefore may also be expected with Risperidone
Aurobindo: rapid heartbeat when standing up.
Additional side effects in children and adolescents
In general, side effects in children are expected to be similar to those in adults.
The following side effects have been reported more frequently in children and adolescents (5-17 years)
than in adults: feeling drowsy or less alert, feeling of fatigue (tiredness),
headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal
pain, dizziness, cough, fever, tremor, diarrhoea and urinary incontinence (lack of control).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risperidone Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and HDPE bottle after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Use within 3 months of first opening the HDPE container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Risperidone Aurobindo contains
The active substance is risperidone. Risperidone Aurobindo tablets of 0.5 mg, 1 mg, 2 mg, 3 mg,
4 mg, and 6 mg contain respectively 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 6 mg of risperidone.
The other components are:
Tablets:
Monohydrate lactose
Microcrystalline cellulose (E460)
Anhydrous colloidal silica
Magnesium stearate (E470b).
Coating:
0.5 mg and 4 mg film-coated tablets
hypromellose (E464)
titanium dioxide (E171)
macrogol (PEG 400)
quinoline yellow (E104)
indigotine (E132).
1 mg and 6 mg film-coated tablets
hypromellose (E464)
titanium dioxide (E171)
macrogol (PEG 400)
2 mg film-coated tablets
hypromellose (E464)
titanium dioxide (E171)
macrogol (PEG 400)
yellow iron oxide (E172)
red iron oxide (E172)
black iron oxide (E172)
3 mg film-coated tablets
hypromellose (E464)
titanium dioxide (E171)
macrogol (PEG 400)
quinoline yellow (E104)

Description of the appearance of Risperidone Aurobindo and contents of the pack
Film-coated tablets

The 0.5 mg tablets are green, biconvex, capsule-shaped tablets, with 'A' engraved on one side and '50' on the other. Score line between '5' and '0'. The tablet can be divided into two equal doses.
The 1 mg tablets are white, biconvex, capsule-shaped tablets, with 'A' engraved on one side and '51' on the other. Score line between '5' and '1'. The tablet can be divided into two equal doses.
The 2 mg tablets are light orange, biconvex, capsule-shaped tablets, with 'A' engraved on one side and '52' on the other. Score line between '5' and '2'. The tablet can be divided into two equal doses.
The 3 mg tablets are yellow, biconvex, capsule-shaped tablets, with 'A' engraved on one side and '53' on the other. Score line between '5' and '3'. The tablet can be divided into two equal doses.
The 4 mg tablets are green, biconvex, capsule-shaped tablets, with 'A' engraved on one side and '54' on the other. Score line between '5' and '4'. The tablet can be divided into two equal doses.
The 6 mg tablets are white, biconvex, with 'A' engraved on one side and '55' on the other.

Risperidone Aurobindo 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg film-coated tablets are available in blister packs containing: 6, 10, 20, 28, 30, 40, 50, 56, 60 or 100 tablets.
Risperidone Aurobindo 6 mg film-coated tablets are available in blister packs containing 6, 28, 30, 50, 56, 60 or 100 tablets.
Plastic bottles of Risperidone Aurobindo 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg film-coated tablets are also available, containing 100 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany Risperidon Aurobindo 0.5 mg/ 1 mg/ 2 mg/ 3 mg/ 4 mg/ 6 mg Filmtabletten
Italy Risperidone Aurobindo
Netherlands Risperidon Aurobindo 0.5 mg/ 1 mg/ 2 mg/ 3 mg/ 4 mg/ 6 mg, filmomhulde tabletten
Portugal Risperidona Aurobindo 0.5 mg/ 1 mg/ 2 mg/ 3 mg/ 4 mg/ 6 mg Comprimido revestido por película
United Kingdom Risperidone 0.5 mg/ 1 mg/ 2 mg/ 3 mg/ 4 mg/ 6 mg film-coated tablets