RISPERIDONE 1 мг Фильм-coated таблетки

Содержание инструкции

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

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

Read this leaflet carefully before taking this medicine as 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 pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Risperidone Aurobindo belongs to a group of medicines called “antipsychotics”.
Risperidone Aurobindo 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 suspicious in an unusual way or confused.
• treatment of mania, a condition in which you may feel very excited, euphoric, agitated, enthusiastic or hyperactive. Mania occurs during an illness called “bipolar disorder”.
• short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, who harm themselves or others. Non-pharmacological alternatives must have been tried before treatment.
• short-term treatment (up to 6 weeks) of persistent aggression in children with intellectual disabilities (aged 5 years and over) and adolescents with conduct disorder.

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

2. What you need to 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 not sure whether the conditions mentioned above apply to you, talk to 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 problem. Examples include an irregular heartbeat, or if you tend to have low blood pressure or if you are taking medicines for blood pressure. Risperidone Aurobindo can cause a drop in blood pressure. Your dose may need to be adjusted.
• You are aware of any factors that could expose you to the risk of stroke, such as high blood pressure, cardiovascular disorders or circulatory disorders of the brain.
• You have ever experienced involuntary movements of the tongue, mouth and face.
• You have ever had a condition whose symptoms include high temperature, muscle rigidity, sweating or a reduced level of consciousness (also known as neuroleptic malignant syndrome).
• You suffer from Parkinson's disease or dementia.
• You are diabetic.
• You know you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• You suffer from epilepsy.
• You are a man and have experienced a prolonged or painful erection.
• You have difficulty controlling body temperature or excessive overheating.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of the hormone prolactin in your blood or have a possible prolactin-dependent tumor.
• If you or someone in your family has a history of blood clot formation (thrombosis), as antipsychotic drugs have been associated with blood clot formation. If you are not sure whether any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before using Risperidone Aurobindo.

Because dangerously low numbers of a certain type of white blood cells needed to fight infections in the blood have been observed very rarely in patients taking Risperidone Aurobindo, your doctor may check your white blood cell count.
Risperidone Aurobindo can cause an increase in your weight. Significant weight gain can negatively affect your health. Your doctor should measure your body weight regularly.
Since the onset or worsening of diabetes mellitus has been observed in patients taking Risperidone Aurobindo, your doctor should check for high blood glucose levels.
Blood glucose levels should be monitored regularly in patients with pre-existing diabetes mellitus.
Risperidone Aurobindo normally increases the levels of a hormone called “prolactin”. This can cause undesirable effects such as menstrual disorders and fertility problems in women, breast enlargement in men (see “Possible side effects”). If you experience such side effects, it is recommended to evaluate the level of prolactin in your blood.
During an eye operation for clouding of the lens (cataract), the pupil (the black circle in the center of the eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become soft during the operation and this can lead to eye damage. If you are planning an eye operation, be sure to tell your doctor that you are taking this medicine.

Elderly patients with dementia
Patients with dementia have an increased risk of stroke. Do not take risperidone if your dementia is caused by stroke.
During treatment with risperidone you should see your doctor frequently.
If you or the person assisting you notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or incomprehensible speech, even for a short period of time, you should seek immediate medical attention. These may be signs of a stroke.

Children and Adolescents
Before starting treatment for behavioral disorder, other causes for aggressive behavior must be excluded.
If fatigue occurs during treatment with risperidone, changing the time of administration of the medicine may improve attention difficulties.
Before starting treatment, your weight or your child's body weight may be measured and regularly checked during treatment.
A small and inconclusive study has recorded an increase in height in children who took risperidone, but it is not known whether this is an effect of the medicine or is due to some other 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 particularly important to inform your doctor or pharmacist if you are taking any of the following:
medicines for pain (opioids), medicines for allergies (some antihistamines), as risperidone can increase the sedative effects of all these medicines.

• medicines that can change the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm problems, for allergies (antihistamines), some antidepressants or other medicines for mental problems.
• medicines that increase the activity of the central nervous system (stimulants, such as methylphenidate).
• medicines that cause a slowing of the heartbeat.
• medicines that cause a decrease in potassium in the blood (such as some diuretics).
• medicines to treat high blood pressure. Risperidone Aurobindo can cause a drop in blood pressure.
• medicines for Parkinson's disease (such as levodopa).
• medicines for urination (diuretics), used for heart disorders or for swelling of parts of the body, due to excessive fluid accumulation (such as furosemide or chlorothiazide). Risperidone Aurobindo taken alone or with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines can reduce the effect of risperidone

• Rifampicin (a medicine to treat some 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 can increase the effect of risperidone

• Quinidine (used for some heart diseases).
• 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 the treatment of fungal infections)
• Some 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 not sure whether any of the conditions mentioned above may apply to you, talk to your doctor or pharmacist before using Risperidone Aurobindo.

Risperidone Aurobindo with food and drink and alcohol.
You can take this medicine with or without food. During treatment with Risperidone Aurobindo you should avoid drinking alcohol.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• The following symptoms may occur in newborns of mothers who have used risperidone in the last trimester (last three months of pregnancy): tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.
• Risperidone Aurobindo can increase the levels of a hormone called “prolactin” which can impact fertility (see Possible side effects).

Driving and using machines
Dizziness, fatigue and vision problems may occur during treatment with Risperidone Aurobindo. Do not drive vehicles, or use tools or machines, until you have spoken to your doctor.

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

3. How to take Risperidone Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

The recommended dose is as follows:
For the treatment of schizophrenia
Adults

• The starting dose is usually 2 mg per day, which may be increased to 4 mg daily from the second day.
• Your dose may then be increased by your doctor depending on how you respond to treatment.
• Most people feel better with daily doses between 4 and 6 mg.
• The total daily dose may be divided into one or two administrations. Your doctor will tell you what is best for you.

Elderly

• Your starting dose will generally be 0.5 mg twice a day.
• Your dose may then be gradually increased by your doctor to 1-2 mg twice a day.
• Your doctor will tell you what is best for you.

For the treatment of mania
Adults

• Your starting dose will generally be 2 mg once a day.
• Your dose may then be gradually adjusted by your doctor, depending on your response to treatment.
• Most people will feel better with doses between 1 and 6 mg once a day.

Elderly

• Your starting dose will generally be 0.5 mg twice a day.
• Your dose may then be gradually adjusted by your doctor to 1 - 2 mg twice a day, depending on your response to treatment.

For the treatment of long-standing aggression in people with Alzheimer's dementia
Adults (including the elderly)

• Your starting dose will generally be 0.25 mg twice a day.
• Your dose may then be gradually adjusted by your doctor, depending on your response to treatment.
• Most people will feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day.
• The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under the age of 18 should 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 weight:
For children weighing less than 50 kg:

• The starting dose will generally be 0.25 mg once a day.
• The dose may be increased on alternate days with increments of 0.25 mg per day.
• The maintenance dose is generally between 0.25 mg and 0.75 mg once a day.

For children weighing 50 kg or more:

• The starting dose will generally be 0.5 mg once a day.
• The dose may be increased on alternate days with increments of 0.5 mg per day.
• The maintenance dose is generally between 0.5 mg and 1.5 mg once a day.

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 Aurobindo for conduct
disorder.

Patients with kidney or liver problems
Regardless of the condition to be treated, all initial doses and subsequent doses of risperidone
must be halved. Dose increases should occur more slowly in these patients.
Risperidone should be used with caution in this group of patients.

How to administer
For oral use.
You should swallow the tablet with a glass of water.

If you use more Risperidone Aurobindo than you should

• Consult your doctor immediately. Bring the medicine packaging with you.
• In case of overdose, you may feel sleepy or tired or have strange body movements, difficulty standing and walking, dizziness caused by low blood pressure, or abnormal heartbeat or convulsions.

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 the next dose, skip the missed dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for the forgottendose.

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 the doctor decides to stop this medicine, the dose may
be gradually reduced over a few days.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor immediately if:

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel to the lungs through the blood vessels 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 numbness on one side of the face, arms or legs, or difficulty speaking, even for a short period of time. These may be signs of a stroke.
• You have a fever, muscle rigidity, sweating or a reduced level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• You are a man and experience a prolonged or painful erection. This is called priapism. Immediate medical treatment may be necessary.
• You have involuntary, rhythmic movements of the tongue, mouth and face. Discontinuation of risperidone may be necessary.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, 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, a feeling of muscle stiffness (which makes movements jerky) and sometimes a feeling of “freezing” and then restarting. Other signs of parkinsonism include walking slowly with shuffling feet, resting tremor, increased salivation and/or drooling, and loss of facial expression.
• Feeling sleepy 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 like you have the flu.
• Increased levels of a hormone called “prolactin” found with a blood test (may or may not cause symptoms). Symptoms due to a high level of prolactin occur infrequently and in men may include breast enlargement, difficulty having or maintaining an erection, decreased desire or other sexual dysfunction. 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, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, restlessness.
• Dystonia: this is a condition involving slow and prolonged involuntary muscle contractions. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
• Dizziness.
• Dyskinesia: this is a condition involving involuntary muscle movements and can include repetitive, jerky or twisting movements or spasms.
• Tremor (shaking).
• Blurred vision, eye infection or “pink eye” (conjunctivitis).
• Rapid heart rate, high blood pressure, shortness of breath.
• Sore throat, cough, nosebleed, stuffy nose.
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Skin rash, skin redness.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Incontinence (loss of control) of urine.
• Swelling of the body, arms or legs, 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, an infection confined to a single area of the skin or part of the body, viral infection, skin infection caused by mites.
• Reduced number of white blood cells that help protect you from infections, decreased number of white blood cells, reduced platelets (blood cells that help stop bleeding), anemia, 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 thirst.
• 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 parts of the body that you cannot control). Tell your doctor immediately if you experience

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

• Sudden loss of blood supply to the brain (stroke or “mini” stroke).
• Unresponsiveness to stimuli, loss of consciousness, low level of consciousness.
• Convulsions (seizures), fainting.
• An irresistible urge to move parts of the body, balance problems, abnormal coordination, dizziness when standing up, attention problems, problems speaking, loss or abnormal sensation of taste, reduced sensitivity of the skin to pain or touch, a tingling or numb sensation of the skin.
• Excessive sensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes.
• Sensation of spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (an irregular heartbeat), an interruption in the conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, slow heartbeat, abnormal heart tracing (electrocardiogram or ECG), a sensation of palpitations (heart beating).
• 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 inhaling food, congestion of the lungs, congestion of the airways, crackles in the lungs, wheezing during breathing, speech disorders, airway disorders.
• Stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excessive passing of gas or air.
• Hives, itching, hair loss, thickening of the skin, dry skin, discoloration of the skin, acne, scaly and itchy skin, skin disorders, skin lesions.
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage.
• Abnormal posture, stiffness of the joints, swelling of the joints, muscle weakness, neck pain.
• Frequent urination, inability to urinate, pain when urinating
• Erectile dysfunction, ejaculation disorders.
• Loss of menstrual periods, skipped periods or other menstrual problems (women)
• Development of breast tissue 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 you walk
• Feeling thirsty, feeling unwell, chest discomfort, not feeling well, discomfort
• Increased liver transaminases in the blood, increased GGT (an enzyme called gammaglutamyltransferase) 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 the urine, low blood sugar levels, high levels of triglycerides (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 rigidity).
• Problems with blood vessels in the brain.
• Coma due to uncontrolled diabetes.
• Head tremor.
• Glaucoma (increased pressure inside the eyeball), problems with eye movement, rolling eyes, crusts on the eyelids.
• Problems with the eyes during cataract surgery. A condition called intraoperative floppy iris syndrome (IFIS) may occur during cataract surgery 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 needed to fight infections.
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes a drop in blood pressure.
• Dangerously excessive intake of water.
• Irregular heartbeat.
• Blood clot in the leg, blood clot in the lungs.
• Problems breathing during sleep (sleep apnea), rapid or shallow breathing.
• Inflammation of the pancreas, blockage of the intestine.
• Swollen tongue, cracked lips, drug-related skin rash.
• Scalp.
• Breakage of muscle fibers and muscle pain (rhabdomyolysis).
• Delay in the menstrual cycle, enlargement of the 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 that may require surgical treatment).
• Hardening of the skin.
• Reduced body temperature, cold arms and legs.
• Discontinuation symptoms of the drug.
• Jaundice (yellowing of the skin and eyes).

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

• Life-threatening complications of uncontrolled diabetes.
• Severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing.
• Lack of muscle movement in the intestine that causes it to block.

The following side effect has been observed with the use of another medicine called
paliperidone which is very similar to risperidone, therefore it can 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)
compared to adults: feeling sleepy or less alert, feeling tired, headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain,
dizziness, cough, fever, tremor, diarrhea and incontinence (loss of control) of
urine.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
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 which is stated on the package, blister and
bottle after EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Use within 3 months of first opening the HDPE container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Risperidone Aurobindo contains
The active ingredient is risperidone. Risperidone Aurobindo 0.5 mg, 1 mg, 2 mg, 3mg,
4 mg, and 6 mg tablets contain respectively 0.5 mg, 1 mg, 2mg, 3 mg, 4 mg, and 6 mg of risperidone.
The other ingredients are:

Tablets:
Lactose monohydrate
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)
indigo carmine (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’ imprinted on one side and ‘50’ on the other. Incision 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’ imprinted on one side and ‘51’ on the other. Incision 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’ imprinted on one side and ‘52’ on the other. Incision 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’ imprinted on one side and ‘53’ on the other. Incision 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’ imprinted on one side and ‘54’ on the other. Incision line between ‘5’ and ‘4’. The tablet can be divided into two equal doses.
• The 6 mg tablets are white, biconvex tablets, imprinted with ‘A’ 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 of: 6, 10, 20, 28, 30, 40, 50, 56, 60 or 100 tablets and Risperidone Aurobindo 6 mg film-coated tablets are available in blister packs of 6, 28, 30, 50, 56, 60 or 100 tablets.
Plastic bottles of Risperidone Aurobindo 0.5 mg, 1mg, 2mg, 3mg and 4mg film-coated tablets containing 100 or 250 tablets are also available.
Not all pack sizes may be marketed

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following denominations:
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