Risperidone Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE USER

RISPERIDONE MYLAN GENERICS 1 mg/ml oral solution

risperidone
Generic medicine
Read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Risperidone Mylan Generics is and what it is used for
2. What you need to know before taking Risperidone Mylan Generics
3. How to take Risperidone Mylan Generics
4. Possible side effects
5. How to store Risperidone Mylan Generics
6. Contents of the pack and other information

1. What Risperidone Mylan Generics is and what it is used for

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

• Treatment of schizophrenia, a condition in which you may see, hear or feel things that are not there, believe things that are not true, or feel unusually suspicious or confused.
• Treatment of mania, a condition in which you may feel extremely excited, euphoric, restless, elated or overactive. 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 are a danger to 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 Mylan Generics can help relieve the symptoms of the illness and help prevent their recurrence.

2. What you should know before taking Risperidone Mylan Generics

Do not take Risperidone Mylan Generics:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Mylan Generics if:

• You are taking furosemide (a diuretic used to reduce swelling and fluid retention caused by various medical conditions, including heart or liver problems).
• You have a heart condition. Examples include irregular heartbeat, weakness of the heart muscle (heart failure), history of heart attack, tendency to have low blood pressure, or if you are taking medicines for blood pressure. Risperidone may cause a drop in blood pressure. Your dose may need adjustment.
• You are aware of any factors that may increase your risk of stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular conditions.
• You are aware of any factors that may increase your risk of blood clots, such as smoking (current or past), or prolonged immobility (e.g., after surgery or illness).
• You or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
• You have or have had a low white blood cell count, especially if this occurred while taking other medicines.
• You have experienced involuntary movements of the tongue, mouth, or face.
• You have had a condition whose symptoms included fever, muscle stiffness, sweating, or reduced level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson’s disease (a brain disorder affecting movement, such as tremor, rigid posture, slow or shuffling movements) or dementia (a general decline in mental abilities such as memory loss and other cognitive functions), particularly dementia with Lewy bodies (abnormal protein aggregates developing within nerve cells in Parkinson’s disease).
• You have diabetes or are at risk of developing diabetes (you may experience increased blood sugar levels).
• You have epilepsy.
• You are a man and have experienced prolonged or painful erection.
• You have difficulty regulating body temperature or are prone to overheating.
• You are, or become, dehydrated or have reduced blood volume (hypovolemia) during treatment.
• You have low levels of potassium or magnesium in your blood.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood or have a tumour that may be prolactin-dependent.

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Risperidone Mylan Generics.
During treatment
Risperidone Mylan Generics may cause changes in white blood cell count, which help fight infections. Therefore, your doctor may request blood tests before and during treatment.
Risperidone Mylan Generics may cause weight gain. Significant weight gain may negatively affect your health. Your doctor should regularly monitor your body weight.
Since diabetes mellitus or worsening of pre-existing diabetes has been observed in patients taking Risperidone Mylan Generics, your doctor should check for signs of increased blood sugar levels. In patients with pre-existing diabetes, blood sugar levels should be monitored regularly.
Risperidone often increases levels of a hormone called "prolactin". This may cause unwanted effects such as menstrual disorders and fertility problems in women, or breast enlargement in men (see section 4 “Possible side effects”). If such side effects occur, assessment of blood prolactin levels is recommended.
If you are planning to undergo eye surgery, make sure to inform your doctor or hospital staff that you are taking this medicine. During cataract surgery (clouding of the eye's lens), this medicine may affect the pupil or iris (coloured part of the eye), which could cause eye damage.
Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke (also known as transient ischaemic attack or TIA). If your dementia is caused by stroke, you must not take risperidone.
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 attention. 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.
Before starting treatment, your child's body weight should be measured and monitored regularly during treatment.
If tiredness occurs during treatment with risperidone, changing the time of administration may improve attention difficulties.
A small, non-definitive study reported increased height in children taking risperidone, but it is not known whether this is a drug effect or due to other reasons.
Other medicines and Risperidone Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor or pharmacist if you are taking any of the following:

• Medicines acting 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 antimalarial drugs (e.g., quinine, mefloquine), medicines for heart rhythm disorders (e.g., quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), allergy medicines (antihistamines), certain tetracyclic antidepressants (e.g., maprotiline), or other medicines for mental disorders.
• Medicines that slow heart rate, such as beta-blockers or verapamil (used to treat high blood pressure or angina).
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines used to treat high blood pressure. Risperidone Mylan Generics may cause a drop in blood pressure.
• Medicines for Parkinson’s disease (e.g., levodopa).
• Medicines that increase central nervous system activity (psychostimulants such as methylphenidate).
• Medicines used to increase urine production (diuretics), used for heart conditions or swelling of body parts due to fluid accumulation (e.g., furosemide or chlorothiazide). Risperidone Mylan Generics, taken 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 any of 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, sertraline, fluvoxamine, tricyclic antidepressants (e.g., amitriptiline)
• Medicines known as beta-blockers and verapamil (used to treat high blood pressure)
• Phenothiazines, oral paliperidone (used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines used to treat fungal infections)
• Certain medicines used in the treatment of HIV/AIDS, such as ritonavir

If you start or stop taking any of these medicines, you may need a different dose of risperidone.
If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Risperidone Mylan Generics.
Taking Risperidone Mylan Generics with alcohol
During treatment with Risperidone Mylan Generics, you should avoid drinking alcohol.
Pregnancy, breastfeeding and fertility

• If you are pregnant, think you may be pregnant, are trying to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can use it.
• The following symptoms may occur in newborns whose mothers took Risperidone Mylan Generics during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
• Risperidone Mylan Generics may increase levels of a hormone called "prolactin", which may affect fertility in both female and male patients (see section 4 “Possible side effects”).

Driving and using machines
During treatment with Risperidone Mylan Generics, dizziness, tiredness, and vision problems may occur. Do not drive or operate tools or machinery without first discussing it with your doctor.
Risperidone Mylan Generics contains benzoic acid (E210)
This medicine contains less than 1.5 mg of benzoic acid per millilitre of oral solution.
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Risperidone Mylan Generics

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is as follows:
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 divided into one or two administrations. Your doctor will tell you what dose is best for you.

Elderly patients

• Your usual starting dose will generally be 0.5 mg twice daily.
• Your doctor may then gradually increase your dose up to 1–2 mg twice daily.
• Your doctor will tell you what dose is best for you.

For the treatment of mania
Adults

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

Elderly patients

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

For the treatment of persistent aggression in patients with Alzheimer’s dementia
Adults (including elderly patients)

• Your usual starting dose will generally be 0.25 mg twice daily.
• Your doctor may then gradually adjust your dose depending on your response to treatment.
• Most people 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 should not be treated with Risperidone Mylan Generics for schizophrenia and mania.

For the treatment of conduct disorder in children and adolescents
The dose will depend on your child’s weight:
For children weighing less than 50 kg:

• The usual starting dose will generally be 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 generally ranges between 0.25 mg and 0.75 mg once daily.

For children weighing 50 kg or more:

• The usual starting dose will generally be 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 generally 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 should not be treated with Risperidone Mylan Generics for
conduct disorder.
Patients with kidney or liver problems
Regardless of the condition being treated, all initial and subsequent risperidone doses must be halved. Dose increases should be made more slowly in these patients.
Risperidone should be used with caution in this patient group.
How to take Risperidone Mylan Generics
Your doctor has advised you on how much medicine to take and for how long. This depends on your condition and may vary from person to person.
The oral solution is supplied with a syringe (pipette). This should be used to help you measure the exact amount of medicine you need.
Follow these steps:

1. Remove the child-resistant cap. Press down on the screw cap while simultaneously turning it counterclockwise (Figure 1).
2. Insert the syringe into the bottle.
3. Holding the lower ring steady, pull the upper ring upwards to the mark corresponding to the required amount in millilitres or mg (Figure 2).
4. Holding the lower ring, remove the entire syringe from the bottle (Figure 3).
5. Empty the syringe contents into any non-alcoholic beverage, except tea. Slide the upper ring downwards.
6. Close the bottle.
7. Rinse the syringe with some water.

If you take more Risperidone Mylan Generics than you should

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

If you forget to take Risperidone Mylan Generics

• 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 missed dose.

If you stop taking Risperidone Mylan Generics
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return, or you may experience nausea, vomiting, sweating, difficulty sleeping, or involuntary movements. If your doctor decides to discontinue this medicine, your 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.
Contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the following side effects:

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

• Develops lung infections, including serious infections such as pneumonia – you may have high fever, cough and phlegm which may contain blood or be frothy, and you may feel very unwell

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

• Sudden weakness or numbness of the face, arms or legs, especially on one side, or vision problems or difficulty speaking lasting less than 24 hours. These may be signs of a mini-stroke (transient ischaemic attack), stroke, or reduced blood flow to the brain.
• An abnormal heart rhythm, such as palpitations (fibrillation) or a very slow or irregular heartbeat (heart block). These may be caused by abnormal electrical conduction in the heart and may be seen as an abnormal heart trace (ECG). In some cases, this may be life-threatening.
• If you do not respond to stimuli (changes in internal or external environment), are less conscious or lose consciousness, or have seizures.
• Involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of risperidone may be necessary.
• Development of diabetes – a condition in which the body is unable to properly regulate blood sugar levels. You may feel very thirsty and yet pass large amounts of urine, have increased appetite but feel tired and lethargic. If untreated, this may lead to coma or potentially life-threatening complications of uncontrolled diabetes.
• Infections with symptoms such as fever and severe deterioration in general condition, or fever with signs of local infection such as sore throat/mouth. Risperidone may cause a severe reduction in the number of white blood cells, reducing resistance to infections. A blood sample will be taken to check for a possible decrease in white blood cells. It is important to inform your doctor that you are taking this medicine.
• Inhalation of food into the airways, causing infection or lung congestion (e.g. due to mucus buildup).
• Skin infection, usually in the fatty layers of the thighs and buttocks (cellulitis).
• Inability to urinate or incomplete bladder emptying.
• Severe constipation, which may be due to intestinal obstruction or severe hardening and compaction of stools.

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

• Severe allergic reaction with difficulty breathing and shock, facial swelling, sudden swelling of the lips, eyes, tongue or throat, difficulty swallowing, hives, drop in blood pressure.
• Unexplained muscle pain, muscle cramps or muscle weakness (rhabdomyolysis).
• Formation of blood clots in veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical help.
• Fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• Prolonged and painful erection. This is called priapism. Immediate medical treatment may be required.
• Severe stomach pain radiating to the back. This may be a symptom of pancreas inflammation.
• Increased eye pressure (glaucoma), which may cause vision problems and, over time, serious visual impairment.
• Lower than normal sodium levels in the blood, which may cause weakness and confusion with muscle pain. This may be due to inappropriate secretion of a hormone (ADH) causing water retention in the body and dilution of the blood, thereby reducing sodium levels. This may be associated with dangerously excessive water intake (more than 2 litres per day).

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

• Loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heartbeat, unusual muscle pain or feeling of weakness, fatigue or discomfort. These may be signs of a rare, life-threatening complication of uncontrolled diabetes called diabetic ketoacidosis.

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

• Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may occur at a frequency of less than 1 in 10 people. Parkinsonism includes: increased salivation or watery mouth, musculoskeletal rigidity, drooling, jerking movements when bending limbs, slow, reduced or impaired body movements, expressionless face, muscle tension, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements during walking, persistent blinking in response to tapping on the forehead (as an abnormal reflex).

• Headache, difficulty falling asleep or staying asleep.

• Numbness, drowsiness.

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

• Fatigue, restlessness, inability to sit still, anxiety, numbness, depression, agitation, dizziness, feeling excessively tired, sleep disturbances.
• Vomiting, diarrhoea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache.
• Weight gain, increased body temperature, increased appetite, reduced appetite.
• Shortness of breath, flu, blurred vision, eye infection or allergic reactions of the eye which may produce sticky discharge, sinus infections, nasal congestion, nosebleeds, cough.
• Urinary tract infection, nocturnal emission of urine, inability to control urine (incontinence).
• Tremor, muscle spasm, involuntary movements of face, arms and legs, repetitive movements or abnormal postures associated with muscle contractions, muscle and joint pain, back pain, fluid retention in the body (e.g. swelling of arms and legs, pain in arms and legs).
• Skin rash, skin redness, ear infection.
• Increased heart rate, chest pain, hypertension.
• Falls.
• Increased level of the hormone prolactin in the blood.

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

• Excessive water consumption, thirst, faecal incontinence, thirst, flatulence, hoarseness or voice disturbances.

• High blood sugar levels.

• Bladder infection, viral infection and other infections, tonsillitis, stomach infection, fungal nail infection.

• Drop in blood pressure upon standing (orthostatic hypotension), low blood pressure, dizziness after changing position, awareness of heartbeat, decreased heart rate.

• Pain during urination, frequent need to urinate.

• Confusion, attention disturbance, excessive sleepiness, nightmares, nervousness, euphoric mood (mania).

• Increased liver enzymes, reduced haemoglobin or number of red blood cells (anaemia), increased eosinophils (a type of white blood cell), increased blood creatine phosphokinase, reduced platelets (blood cells that help stop bleeding), increased blood cholesterol.

• Muscle weakness, excessive restlessness associated with muscle spasms and tremor, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort.

• Skin lesion, skin disorders, dry skin, intense skin itching, acne, hair loss, eczema (skin inflammation) which may be caused by mites, skin discoloration, skin thickening, redness, tingling sensation, reduced skin sensitivity to pain or touch, inflammation of oily skin.

• Absence of menstrual periods, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, breast enlargement in men, breast pain or discomfort, reduced sexual drive, irregular or delayed menstrual cycle, vaginal discharge.

• Fainting, walking disturbance (gait), weakness, weight loss, reduced appetite leading to malnutrition and weight loss, feeling of "bad mood", balance problems, allergy, chills, abnormal coordination, altered taste.

• Painful oversensitivity to light, increased blood flow in the eye, dry eyes, increased tearing.

• Lung friction rub, difficulty speaking, difficulty swallowing, coarse/sibilant sound during breathing.

• Ringing in the ears, sensation of spinning and dizziness (vertigo), facial swelling.

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

• Inability to reach orgasm, breast enlargement or breasts swollen, warm and tender.
• Dandruff.
• Cold arms and legs, tongue swelling, inflammation of the lips, hardening of body parts, e.g. skin.
• Lack of movement or response while awake (catatonia).
• Sleepwalking.
• Sleep-related eating disorder.
• Crusting at the edge of the eyelids, rolling of the eyes, problems with eye movements, complications during cataract surgery.
• Absence of emotions.
• Drug withdrawal syndrome.
• Decreased body temperature.
• Rapid and shallow breathing, breathing problems during sleep, sinus arrhythmia (a normal variation in heart rhythm caused by breathing).
• Movement disorders.
• Head tremor.
• Yellowing of the skin and eyes (jaundice).
• Presence of sugar (glucose) in the urine, low blood sugar levels, increased levels of insulin or fats (triglycerides) in the blood.

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

• Intestinal obstruction (persistent constipation, with stomach bloating and vomiting).

The following side effects have been observed with the use of another medicine called paliperidone, which is very similar to risperidone, so these effects may also be expected with Risperidone Mylan Generics: 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 (aged 5 to 17 years) than in adults: drowsiness or reduced alertness, fatigue, headache, increased appetite, vomiting, cold-like symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhoea and urinary incontinence.

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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risperidone Mylan Generics

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze. Store in the original packaging.
After opening the bottle, any unused portion of Risperidone Mylan Generics oral solution must be discarded after 4 months.
Do not dispose of medicines 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 Mylan Generics contains

• The active substance is risperidone. 1 ml of oral solution contains 1 mg of risperidone.
• The other components are: tartaric acid (E334), benzoic acid (E210), hydrochloric acid and purified water.

Description of the appearance of Risperidone Mylan Generics and contents of the pack
Risperidone Mylan Generics oral solution: it is clear and colourless. The medicine is available in amber glass bottles with child-resistant cap containing 30 ml, 60 ml, 100 ml and 120 ml.
To facilitate accurate measurement, a syringe (pipette) is provided. A pipette cleaner and a protective sheath are also supplied.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 – 20124 Milano, Italy

Manufacturer responsible for batch release
Generics (UK) Ltd
Station Close, Potters Bar, Hertfordshire
EN6 1TL, United Kingdom
McDermott Laboratories Ltd (t/a Gerard Laboratories)
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13, Ireland
Chanelle Medical
Loughrea Industrial Estate, Co. Galway
Ireland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Risperidon Mylan 1mg/ml drank
Germany: Risperidon dura 1 mg/ml Lösung zum Einnehmen
Italy: Risperidone Mylan Generics
Netherlands: Risperidon drank Mylan 1mg/ml, drank
Portugal: Risperidona Mylan 1mg/ml, soluçaö oral
Slovenia: Risperidon Mylan
Spain: Risperidona Mylan 1mg/ml solución oral EFG
United Kingdom: Risperidone 1 mg/ml oral solution

This patient information leaflet was last approved on