Package leaflet: Information for the patient

Risperidone Mylan Pharma 1 mg film-coated tablets, 2 mg film-coated tablets, 3 mg film-coated tablets, 4 mg film-coated tablets

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 other people, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Risperidone Mylan Pharma belongs to a group of medicines called "antipsychotics".
Risperidone Mylan Pharma is used to treat:

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.
Mania, a condition in which you may feel highly excited, euphoric, agitated, energized 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 are harming 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.

2. What you should know before taking Risperidone Mylan Pharma

Do not take Risperidone Mylan Pharma:

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 Pharma:

If you are taking furosemide (a diuretic used to reduce swelling and fluid retention caused by various medical conditions, including heart or liver problems).
If you have a heart condition. Examples include if you have weakness of the heart muscle (heart failure), have had a heart attack, tend to have low blood pressure, or are taking medicines for blood pressure. Risperidone Mylan Pharma may cause a drop in blood pressure. Your dose may need to be adjusted.
If you or someone in your family has a history of irregular heartbeat, as this medicine has been associated with potentially dangerous changes in heart rhythm.
If you are aware of any factors that may increase your risk of stroke, such as high blood pressure, cardiovascular disease, or cerebrovascular disorders.
If you are aware of any factors that may increase your risk of blood clots, such as if you smoke or have smoked, or if you are likely to remain immobile for a prolonged period (e.g. after surgery or illness).
If you or someone in your family has a history of blood clots, as medicines of this type have been associated with blood clot formation.
If you have or have had a low white blood cell count, especially if this occurred when taking other medicines.
If you have ever experienced involuntary rhythmic movements of the tongue, mouth, or face.
If you have ever had a condition involving symptoms such as high fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome").
If you have Parkinson’s disease (a brain disorder affecting movement, such as tremor, rigid posture, slow and shuffling movements) or dementia (a general decline in mental abilities such as memory loss and other cognitive functions), particularly dementia with Lewy bodies (abnormal aggregates of proteins developing within nerve cells in Parkinson’s disease).
If you have diabetes or are at risk of developing diabetes (you may have increased blood sugar levels).
If you have epilepsy.
If you are a man and have experienced prolonged or painful erections.
If you have difficulty regulating body temperature, are prone to overheating, or are or may be exposed to very high temperatures or physical exertion.
If you are or become dehydrated or have reduced blood volume (hypovolemia) during treatment.
If you have low levels of potassium or magnesium in your blood.
If you have kidney problems.
If you have liver problems.
If you have abnormally high levels of the hormone prolactin in your blood or have a tumour that may be dependent on prolactin.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before taking Risperidone Mylan Pharma.
During treatment
Risperidone Mylan Pharma 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 Pharma may cause weight gain. Significant weight gain may negatively affect your health. Your doctor should regularly monitor your body weight.
Since the development of diabetes or worsening of pre-existing diabetes has been observed in patients taking risperidone, your doctor should monitor for signs of high blood sugar levels. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Risperidone often increases levels of a hormone called "prolactin". This may cause unwanted effects such as menstrual disorders or fertility problems in women, breast enlargement in men, low sexual desire, impotence, and milky discharge from the breasts (see section 4 “Possible side effects”). If such side effects occur, assessment of prolactin levels in the blood is recommended.
If you are planning eye surgery, make sure to inform your doctor or hospital staff that you are taking this medicine. During cataract surgery (removal of clouded lens), this medicine may affect the pupil or iris (the coloured part of the eye), which could lead to eye damage.
Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke or “mini” strokes (also known as transient ischaemic attacks or TIAs). If your dementia is caused by stroke, you should 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—vision problems, or slurred speech, even if only briefly, 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.
Before starting treatment, your weight or your child’s weight should be measured and monitored regularly during treatment.
If fatigue 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 Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription and herbal products.
It is particularly 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 antimalarial medicines (e.g. quinine, mefloquine), medicines for heart rhythm disorders (e.g. quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), allergy medicines (antihistamines), certain antidepressants (e.g. paroxetine, fluoxetine, sertraline, fluvoxamine), tricyclic antidepressants (e.g. amitriptyline), tetracyclic antidepressants (e.g. maprotiline), or other medicines for mental health conditions (e.g. paliperidone or phenothiazines used to treat psychosis or as sedatives).
Medicines that slow heart rate, such as beta-blockers or verapamil (used to treat high blood pressure or angina).
Medicines that lower potassium or magnesium levels in the blood (e.g. certain diuretics).
Medicines for high blood pressure. Risperidone Mylan Pharma 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 for urination (diuretics), used for heart conditions or swelling of body parts due to fluid accumulation (e.g. furosemide or chlorothiazide). Risperidone Mylan Pharma, 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:

Cimetidine, ranitidine (stomach acid blockers).
Itraconazole, ketoconazole (medicines for 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 conditions listed above apply to you, talk to your doctor or pharmacist before using Risperidone Mylan Pharma.
Risperidone Mylan Pharma and alcohol
During treatment with Risperidone Mylan Pharma, you should avoid drinking alcohol.
Pregnancy, breastfeeding and fertility

The following symptoms may occur in newborns whose mothers have used Risperidone Mylan Pharma 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 shows any of these symptoms, you may need to contact your doctor.

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before you or your partner take this medicine. Your doctor will decide whether you can take it.
Risperidone 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 Pharma, dizziness, fatigue, and vision problems may occur. Do not drive or operate tools or machinery without first discussing this with your doctor.
Risperidone Mylan Pharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The 2 mg film-coated tablets of Risperidone Mylan Pharma also contain a colouring agent called sunset yellow (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Risperidone Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how much medicine to take and for how long. This will depend on your condition and may vary from person to person.

Dosage

For the treatment of schizophrenia

Adults

The recommended starting dose is 2 mg per day, which may be increased to 4 mg daily from the second day onwards.
Your dose may then be adjusted by your doctor depending on your response 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 dosage is best for you.

Elderly patients

The recommended starting dose is generally 0.5 mg twice daily.
The dose may then be gradually increased by your doctor up to 1–2 mg twice daily.
Your doctor will tell you which dose is best for you.

Use in children and adolescents

Children and adolescents under 18 years of age should not be treated with Risperidone Mylan Pharma for schizophrenia.

For the treatment of mania

Adults

The recommended starting dose is generally 2 mg once daily.
The dose may then be gradually adjusted by your doctor, depending on your response to treatment.
Most people feel better with doses between 1 mg and 6 mg once daily.

Elderly patients

The recommended starting dose is generally 0.5 mg twice daily.
The dose may then be gradually adjusted by your doctor up to 1–2 mg twice daily, depending on your response to treatment.

Use in children and adolescents

Children and adolescents under 18 years of age should not be treated with risperidone for mania.

For the treatment of persistent aggression in patients with Alzheimer's dementia

Adults (including elderly patients)

The recommended starting dose is generally 0.25 mg twice daily.
The dose may then be gradually adjusted by your doctor, 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.

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

For children weighing 50 kg or more:

The recommended starting dose is generally 0.5 mg once daily.
The dose may be increased every other day in increments of 0.5 mg per day.
The maintenance dose is generally 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 Pharma for conduct disorder.

Patients with kidney or liver problems

Regardless of the reason for taking this medicine, all initial and subsequent doses of risperidone 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 Pharma

Swallow the tablets with a glass of water.
Risperidone Mylan Pharma may be taken with or without food.

The tablets may be divided into two equal doses.

If you take more Risperidone Mylan Pharma than you should

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

If you forget to take Risperidone Mylan Pharma

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 Mylan Pharma

Do not stop taking this medicine unless your doctor tells you to. 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.
Contact your doctor immediately or go to the Emergency Department if you:
Common (may affect up to 1 in 10 people):

Develop lung infections, including severe lung infections such as pneumonia – you may have a very high temperature, cough with phlegm that may contain blood or be frothy, and you may feel very unwell.

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

Experience a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs (especially on one side), visual problems, or difficulty speaking, even for a brief period. These may be signs of a stroke, “mini” stroke (transient ischaemic attack) or reduced blood flow to the brain.
Have an abnormal heart rhythm, for example, irregular heartbeats (fibrillation) or a heartbeat that is too slow or irregular (heart block). These may be caused by abnormal electrical conduction in the heart and may result in an abnormal recording of the heart's electrical activity (ECG). In some cases, this may be life-threatening.
Become unresponsive to stimuli (changes in your internal or external environment), have a reduced level of consciousness or lose consciousness, or have epileptic seizures (fits).
Experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of risperidone may be necessary.
Develop diabetes – a condition in which the body is unable to properly control blood sugar levels. You may feel very thirsty, urinate frequently, have increased appetite and feel tired or drowsy. If untreated, this condition may lead to coma or potentially life-threatening complications of uncontrolled diabetes.
Experience an increased number of infections you contract, such as sore throat or mouth ulcers, which may be caused by a decrease in white blood cells, including those that help protect against bacterial infections.
Develop a lung infection caused by inhaling food into the airways or have lung congestion (e.g. due to mucus buildup).
Notice a skin infection, usually in the fatty tissue of the thigh or buttock (cellulitis).
Have difficulty urinating or incomplete emptying of the bladder.
Have severe constipation, which may be due to intestinal obstruction or very hard, compacted stools.

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

Experience a severe skin rash, itching or blisters on the skin; swelling of the face, lips, tongue or throat; shortness of breath, difficulty breathing, dizziness or shock. These may be signs of a severe allergic reaction or angioedema.
Develop blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
Have fever, muscle stiffness, sweating or decreased level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”). Immediate medical intervention may be required.
Are a man and experience a prolonged or painful erection. This is called priapism. Immediate medical intervention may be required.
Feel severe stomach pain radiating to your back. This may be a sign of inflammation of the pancreas.
Develop increased pressure inside the eye (glaucoma), which may cause vision problems and, over time, serious vision impairment.
Have lower than normal sodium levels in the blood, which may make you feel weak, confused and experience muscle pain. This may be due to inappropriate secretion of an hormone (ADH) causing the body to retain water and dilute the blood, thereby reducing sodium levels. This may be associated with dangerously high water intake (more than 2 litres of water per day).
Notice severe muscle weakness or pain, which may indicate breakdown of muscle tissue (rhabdomyolysis).

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

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

Contact your doctor immediately if you experience any of the side effects listed above.
The following side effects may also occur:
Very common (affect more than 1 in 10 people):

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

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

Fatigue, habitual weakness (asthenia), feeling tired, drowsiness, or lack of energy (lethargy), restlessness, inability to sit still, anxiety, depression, agitation, dizziness, feeling excessively exhausted, sleep disturbances.
Vomiting, diarrhoea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache.
Weight gain, increased body temperature (high temperature), increased appetite, reduced appetite.
Shortness of breath, flu-like symptoms, blurred vision, eye infection or allergic reactions of the eye which may cause sticky discharge, sinus infection, nasal or sinus congestion, nosebleeds, cough.
Urinary tract infection, nighttime urination, inability to hold urine (incontinence), inability to urinate.
Tremor, muscle spasm, involuntary movements of the face or limbs, repetitive movements or abnormal postures associated with muscle contractions, joint and muscle 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 infections.
Increased heart rate, chest pain, elevated blood pressure.
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, flatulence, hoarseness or voice disturbances.
High blood sugar levels.
Bladder infection, viral or other infections, tonsil infection, stomach infection, fungal nail infection.
Drop in blood pressure upon standing (orthostatic hypotension), low blood pressure, dizziness after changing position, awareness of heartbeat (palpitations), decreased heart rate.
Pain when passing urine, frequent need to urinate.
Confusion, attention disturbance, excessive sleepiness, nightmares, nervousness, euphoric mood (mania).
Elevated liver enzymes, reduced haemoglobin or red blood cell count (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 injury, skin disorders, dry skin, intense skin itching, acne, hair loss, eczema (skin inflammation) possibly caused by mites, skin discolouration, skin thickening, redness, pins and needles 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 desire, irregular or delayed menstrual cycle, vaginal discharge.
Fainting, walking difficulty (gait disturbance), slowness, weight loss, reduced appetite leading to malnutrition and weight loss, feeling “bad-tempered”, balance problems, allergy, chills, abnormal coordination, taste disturbances.
Painful sensitivity to light, increased blood flow in the eye, dry eyes, increased tearing.
Lung friction sound, difficulty speaking, difficulty swallowing, coarse/sibilant breathing sounds.
Ringing in the ears, dizziness and spinning sensations (vertigo), facial swelling.

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

Inability to reach orgasm, breast enlargement or breast tenderness with swollen, warm breasts.
Dandruff.
Cold arms and legs, tongue swelling, lip inflammation, hardening of body parts, e.g. skin.
Absence of movement or response while awake (catatonia).
Sleepwalking.
Sleep-related eating disorders.
Crusting at the edge of the eyelids, rolling of the eyes, eye movement problems, complications during cataract surgery.
Absence of emotions.
Drug withdrawal syndrome, reduced body temperature.
Rapid and shallow breathing, breathing problems during sleep, sinus arrhythmia (a normal variation in heart rhythm caused by breathing).
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.

It has been observed that medicines such as risperidone may cause a drop in blood pressure upon changing from a lying to a standing position, which is associated with a marked increase in heart rate once the body has recovered.
Additional side effects in children and adolescents
In general, the expected side effects in children are 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, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhoea and urinary incontinence (lack of bladder 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Risperidone Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp". The expiry date refers to the last day of the month.
Blister 1 mg: do not store above 30°C.
For blister 2 mg, 3 mg, 4 mg: no special storage conditions are required.
For plastic bottle 1 mg: do not store above 30°C. After first opening, use within 180 days.
For plastic bottle 2 mg, 4 mg: after first opening, use within 180 days.
Medicines must not be disposed of 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 Pharma contains
The active substance is risperidone.
Each film-coated tablet of Risperidone Mylan Pharma contains 1 mg, 2 mg, 3 mg or 4 mg of
risperidone.
The excipients are:
Risperidone Mylan Pharma 1 mg film-coated tablets:
Tablet core: monohydrate lactose, pregelatinized maize starch, microcrystalline cellulose (E460),
magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
Coating: hypromellose (E464), propylene glycol (E490), titanium dioxide (E171), talc (E553B).
Risperidone Mylan Pharma 2 mg film-coated tablets:
Tablet core: monohydrate lactose, pregelatinized maize starch, microcrystalline cellulose (E460),
magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
Coating: hypromellose (E464), propylene glycol (E490), titanium dioxide (E171), talc (E553B) and
sunset yellow (E110).
Risperidone Mylan Pharma 3 mg film-coated tablets:
Tablet core: monohydrate lactose, pregelatinized maize starch, microcrystalline cellulose (E460),
magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
Coating: hypromellose (E464), propylene glycol (E490), titanium dioxide (E171), talc (E553B) and
quinoline yellow (E104).
Risperidone Mylan Pharma 4 mg film-coated tablets:
Tablet core: monohydrate lactose, pregelatinized maize starch, microcrystalline cellulose (E460),
magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
Coating: hypromellose (E464), titanium dioxide (E171), propylene glycol (E490), talc (E553B),
quinoline yellow (E104) and indigo carmine (E132).

Description of the appearance of Risperidone Mylan Pharma and package contents
Risperidone Mylan Pharma 1 mg: White, round, biconvex, film-coated tablet, marked with "1" on one side and a break line on the other side.
Risperidone Mylan Pharma 2 mg: Orange, round, biconvex, film-coated tablet, marked with "2" on one side and a break line on the other side.
Risperidone Mylan Pharma 3 mg: Yellow, round, biconvex, film-coated tablet, marked with "3" on one side and a break line on the other side.
Risperidone Mylan Pharma 4 mg: Green, round, biconvex, film-coated tablet, marked with "4" on one side and a break line on the other side.

Packaging:
Risperidone Mylan Pharma 1 mg, 2 mg, 3 mg, 4 mg are available in blister packs containing 20, 28, 30, 50, 56, 60 or 100 film-coated tablets.
Risperidone Mylan Pharma 1 mg, 2 mg, 3 mg, 4 mg are available in perforated unit dose blister packs in packages of (28 x 1), (30 x 1), (56 x 1), (60 x 1) or (100 x 1).
Risperidone Mylan Pharma 1 mg, 2 mg, 4 mg are available in bottles containing 60, 100 or 250 film-coated tablets.
Only Risperidone Mylan Pharma 4 mg is available in bottles containing 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13,
Ireland
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary
Mylan Dublin
Newenham Court
Northern Cross
Malahide Road
Dublin 17
Ireland
Logiters, Logistica Portugal, S.A
Estrada dos Arneiros, 4,
Azambuja, 2050-306
Portugal
Mylan Germany GmbH
Zweigniederlassung Bad Homburg Benzstrasse 1,
61352 Bad Homburg v. d. Höhe,
Germany

This medicinal product is authorized in the European Economic Area member states under the following names:
Denmark Rispemyl 0.5 mg, 1 mg, 2 mg film-coated tablets
Finland Rismyl 0.5 mg, 1 mg, 2 mg film-coated tablets
France Risperidone Viatris 1 mg, 2 mg, 4 mg, comprimé pelliculé sécable
Germany Risperidon Mylan 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, Filmtabletten
Italy Risperidone Mylan Pharma
Spain Risperidona Viatris 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg comprimidos recubiertos con película EFG
Portugal Risperidona Mylan
Sweden Rispemyl, 0.5 mg, 1 mg, 2 mg film-coated tablets

This leaflet was last revised on