RISPERIDONE TEVA GENERICS

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Risperidone Teva Generics 1 mg film-coated tablets, 2 mg film-coated tablets, 3 mg film-coated tablets, 4 mg film-coated tablets

Generic medicine
Please 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 pass it on 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT RISPERIDONE TEVA GENERICS IS AND WHAT IT IS USED FOR

Risperidone Teva Generics belongs to a group of medicines called "antipsychotics".
Risperidone Teva Generics is used to treat the following conditions:

• Schizophrenia, a condition in which you may see, hear or feel things that are not present, believe things that are not true, or feel unusually suspicious or confused
• Mania, a condition in which you may feel highly excited, euphoric, restless, elated 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 measures should have been attempted 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 Teva Generics can help relieve the symptoms of the illness and prevent their recurrence.

2. WHAT YOU NEED TO KNOW BEFORE TAKING Risperidone Teva Generics

Do not take Risperidone Teva Generics

• 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 mentioned above apply to you, speak with your doctor or pharmacist before using Risperidone Teva Generics.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Teva Generics if:

• You have a heart condition, such as an irregular heartbeat, or if you tend to have low blood pressure, or if you are taking medicines for blood pressure. Risperidone Teva Generics 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 problems.
• You have ever experienced involuntary movements of the tongue, mouth, or face.
• You have ever had a condition whose symptoms include high body temperature, muscle stiffness, sweating, or decreased level of consciousness (also known as “Neuroleptic Malignant Syndrome”).
• You suffer from Parkinson’s disease or dementia.
• You know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
• You have diabetes.
• You suffer from epilepsy.
• You are a man and have experienced prolonged or painful erections.
• You have difficulty controlling your body temperature or are prone to overheating.
• You have kidney problems.
• You have liver problems.
• You have unusually high levels of the hormone prolactin in your blood or have a tumour that may be influenced by prolactin.
• You or someone in your family has a history of blood clots, as medicines like this 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 Teva Generics.
Since a dangerously low number of a certain type of white blood cells needed to fight infections has been observed very rarely in patients taking Risperidone Teva Generics, your doctor may monitor your white blood cell count.
Risperidone Teva Generics 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 mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking Risperidone Teva Generics, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood glucose should be monitored regularly.
Risperidone Teva Generics usually 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 prolactin levels in the blood is recommended.
During cataract surgery (removal of clouded lens), the pupil (the black circle in the centre of your eye) may fail to dilate as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery, which could lead to eye damage. If you are planning eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.
Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke. If your dementia is caused by stroke, you must not take risperidone.
During treatment with risperidone, you should see your doctor frequently.
If you, or someone caring for you, 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 only for a short time, seek immediate medical help. These may be signs of a stroke.
Risperidone Teva Generics, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.
Children and adolescents
Before starting treatment for behavioural disorder, other causes of aggressive behaviour should be ruled out.
If tiredness occurs during treatment with risperidone, changing the time of day when the medicine is taken may improve attention difficulties.
Before starting treatment, your body weight, or that of your child, should be measured and regularly monitored during treatment.
A small study with inconclusive results reported increased height in children taking risperidone, but it is not known whether this is due to the active substance or some other reason.
Other medicines and Risperidone Teva 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:

• Medicines acting on the brain to help you calm down (benzodiazepines), or certain painkillers (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 antimalarials, medicines for heart rhythm disorders, antiallergic medicines (antihistamines), certain antidepressants, or other medicines for mental disorders.
• Medicines that cause a slowing of the heart rate.
• Medicines that lower potassium levels in the blood (e.g. certain diuretics).
• Medicines for high blood pressure. Risperidone Teva Generics may cause a drop in blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Diuretics (medicines to increase urine production) used for heart conditions or swelling of body parts due to fluid accumulation (such as furosemide or chlorothiazide). Risperidone Teva 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 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 (used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines used to treat 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 any of these medicines, you may need a different dose of risperidone.
If you are unsure whether any of the conditions mentioned above apply to you, speak with your doctor or pharmacist before using Risperidone Teva Generics.
Risperidone Teva Generics and alcohol
During treatment with Risperidone Teva Generics, you should avoid drinking alcohol.
Pregnancy, breast-feeding and fertility

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

Driving and using machines
During treatment with Risperidone Teva Generics, dizziness, tiredness, and vision problems may occur. Do not drive or operate tools or machinery without first discussing it with your doctor.
Risperidone Teva Generics contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE RISPERIDONE TEVA GENERICS

Take this medicine exactly as prescribed by your doctor. 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 starting from the second day.
• Your doctor may then adjust your dose 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 per day. Your doctor will tell you which option is best for you.

Elderly patients

• Your starting 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 advise you on the best dosing regimen 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 daily 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 persistent 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 Teva Generics for schizophrenia or mania.

For the treatment of conduct disorder

The dose will depend on your child's 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 Teva Generics for conduct disorder.

Patients with kidney or liver problems

Regardless of the condition being treated, all initial and subsequent doses of risperidone 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.
You may take this medicine with or without food.
The tablets may be divided into equal doses.

If you take more Risperidone Teva Generics 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, difficulty standing or walking, dizziness due to low blood pressure, or have an irregular heartbeat or seizures.

If you forget to take Risperidone Teva 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 to make up for a forgotten dose.

If you stop taking Risperidone Teva Generics

Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. 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 everyone gets them.
Contact your doctor immediately if you

• have blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
  • have dementia and notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, particularly on one side, or slurred speech, even if only briefly. These may be signs of a stroke.
  • develop fever, muscle stiffness, sweating or reduced level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
  • are a man and have experienced a prolonged or painful erection. This condition is known as priapism. Immediate medical treatment may be required.
  • develop involuntary movements of the tongue, mouth or face. It may be necessary to stop taking risperidone.
  • experience a severe allergic reaction characterised by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash or low blood pressure.

The following side effects may occur:

Very common (may affect more than 1 in 10 people):

• Difficulty falling or staying asleep.
• Parkinsonism. This condition may include: slow or impaired body movements, a feeling of muscle stiffness or tension (causing jerky movements), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Drowsiness or reduced alertness.
• Headache.

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

• Pneumonia, chest infection (bronchitis), cold symptoms, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu.
• Increased levels of a hormone called "prolactin", detected by a blood test (which may or may not cause symptoms). Symptoms due to high prolactin levels are not common and, in men, may include breast swelling, difficulty achieving or maintaining erections, decreased sexual desire or other sexual dysfunction. In women, they may include breast tenderness, milk discharge from the breasts, missed periods or other menstrual problems, or fertility issues.
• Weight gain, increased appetite, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, agitation.
• Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it may affect any part of the body (and may result in abnormal posture), dystonia often involves facial muscles, including abnormal eye, mouth, tongue or jaw movements.
• Dizziness.
• Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or twisting movements or spasms.
• Tremor (shaking).
• Blurred vision, eye infection or conjunctivitis.
• Rapid heart rate, high blood pressure.
• Shortness of breath, sore throat, cough, nosebleed, blocked nose.
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache.
• Rash, skin redness.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence (lack of bladder 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, infection of a single skin area or body part, viral infection, skin inflammation caused by mites.
• Decrease in a type of white blood cell that helps protect the body from infections, reduced number of white blood cells, reduced platelets (blood cells that help stop bleeding), anaemia, reduced number of red blood cells, increased eosinophils (a type of white blood cell) in the blood.
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake.
• Weight loss, loss of appetite leading to malnutrition and low body weight.
• Increased cholesterol in the blood.
• Euphoria (mania), confusion, reduced sexual drive, nervousness, nightmares.
• Tardive dyskinesia (spasms or jerky movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience rhythmic involuntary movements of the tongue, mouth or face. Discontinuation of Risperidone Teva Generics may be necessary.
• Sudden loss of blood flow to the brain (stroke or "mini" stroke).
• Lack of response to stimuli, loss of consciousness, reduced level of consciousness.
• Seizures (fits), fainting.
• An urgent need to move part of the body, balance disorders, abnormal coordination, dizziness when standing up, attention disturbance, speech problems, loss or altered sense of taste, reduced skin sensitivity to pain and touch, a tingling, prickling or numb sensation of the skin.
• Light sensitivity of the eyes, dry eyes, increased tearing, eye redness.
• Sensation of spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (an abnormal heart rhythm), interruption of electrical conduction between upper and lower parts of the heart, abnormal heart electrical conduction, QT interval prolongation on ECG, slow heart rate, abnormal heart electrical tracing (electrocardiogram or ECG), sensation of rapid heartbeat or chest pulsations (palpitations).
• Low blood pressure, low blood pressure when standing up (as a result, some patients taking Risperidone Teva Generics may feel faint, dizzy or may faint when standing up or sitting down suddenly), hot flushes.
• Pneumonia caused by inhalation of food, pulmonary congestion, respiratory congestion, rattling sounds in the lungs, wheezing, voice disorders, respiratory disorders.
• Stomach or intestinal infection, faecal incontinence, hard stools, difficulty swallowing, excessive passing of gas or air.
• Hives, itching, hair loss, skin thickening, eczema, dry skin, skin discolouration, acne, scalp or skin flaking and itching, skin disorder, skin lesion.
• Increased levels of CPK (creatine phosphokinase) in the blood, an enzyme sometimes released when muscle damage occurs.
• 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 cycle, absence of menstruation or menstrual problems (females).
• Breast development in men, milk discharge from breasts, sexual dysfunction, breast pain, breast tenderness, vaginal discharge.
• Swelling of the face, mouth, eyes or lips.
• Chills, increased body temperature.
• Change in walking pattern.
• Thirst, feeling unwell, chest pain, feeling down.
• Increased liver transaminases in the blood, increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood.
• Procedural pain.

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

• Infection.
• Inappropriate secretion of the hormone that controls urine volume.
• Sugar in urine, low blood sugar levels, elevated triglyceride levels (a type of fat).
• Lack of emotion, inability to reach orgasm.
• Neuroleptic Malignant Syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity).
• Problems with cerebral blood vessels.
• Coma due to uncontrolled diabetes.
• Head shaking.
• Glaucoma (increased pressure within the eyeball). Eye movement problems, eye rolling, eyelid margin crusts.
• 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. If you are undergoing cataract surgery, make sure to inform your doctor if 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, lips or tongue, difficulty breathing, itching, rash and sometimes low blood pressure.
• Dangerously excessive water intake.
• Irregular heartbeat.
• Blood clots in the legs, blood clots in the lungs.
• Breathing problems during sleep (sleep apnoea), rapid and shallow breathing.
• Inflammation of the pancreas, colon obstruction.
• Swelling of the tongue, chapped lips, drug rash.
• Dandruff.
• Muscle fibre rupture and muscle pain (rhabdomyolysis).
• Delayed menstrual cycle, enlargement of mammary glands, breast enlargement, milk secretion from breasts.
• Increased insulin levels (a hormone that controls blood sugar levels).
• Priapism (a prolonged and painful erection that may require surgical treatment).
• Skin hardening.
• Very low body temperature, decreased body temperature, cold arms and legs.
• Drug withdrawal syndrome.
• Yellowing of the skin and eyes (jaundice).

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

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

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 Teva Generics: rapid heartbeat when standing up.
Additional side effects in children and adolescents
In general, the type of side effects expected in children is similar to that observed in adults.
The following side effects have been reported more frequently in children and adolescents (aged 5 to 17 years) than in adults: feeling sleepy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhoea and urinary incontinence (loss 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 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 TEVA GENERICS

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 blister/carton/labelling after
Exp. The expiry date refers to the last day of the month.
Do not store above 25°C.
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 Teva Generics contains
The active substance is risperidone.
Each film-coated tablet contains 1 mg, 2 mg, 3 mg or 4 mg of risperidone.
The other ingredients are:
Tablet core
monohydrate lactose, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose, pregelatinized starch, sodium glycolate starch (type A), magnesium stearate;
Risperidone Teva Generics 1 mg film-coated tablets
Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 6000, macrogol 400
Risperidone Teva Generics 2 mg film-coated tablets
Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 6000, iron oxide red (E 172), macrogol 400, iron oxide yellow (E 172).
Risperidone Teva Generics 3 mg film-coated tablets
Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 6000, macrogol 400,
quinoline yellow (E 104).
Risperidone Teva Generics 4 mg film-coated tablets
Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 6000, macrogol 400,
iron oxide yellow (E 172), quinoline yellow (E 104), indigo carmine (E 132).

Description of the appearance of Risperidone Teva Generics and package contents
Risperidone Teva Generics 1 mg film-coated tablets
White, round, slightly biconvex tablets, marked with “RIS 1” and a break line on one side and a break line on the other side.
The film-coated tablet can be divided into equal doses.
Risperidone Teva Generics 2 mg film-coated tablets
Beige, round, slightly biconvex tablets, marked with “RIS 2” and a break line on one side and a break line on the other side.
The film-coated tablet can be divided into equal doses.
Risperidone Teva Generics 3 mg film-coated tablets
Yellow, round, slightly biconvex tablets, marked with “RIS 3” and a break line on one side and a break line on the other side.
The film-coated tablet can be divided into equal doses.
Risperidone Teva Generics 4 mg film-coated tablets
Green, round, slightly biconvex tablets, marked with “RIS 4” and a break line on one side and a break line on the other side.
The film-coated tablet can be divided into equal doses.
Pack sizes of 6, 6x1, 10, 20, 20x1, 28, 28x1, 30, 30x1, 50, 50x1, 60, 60x1, 98, 98x1, 100, 100x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
ratiopharm GmbH, Graf-Arco Strasse 3 - 89079 Ulm (Germany)

Manufacturer responsible for batch release
Merckle GmbH, Ludwig-Merckle-Strasse 3 – 89143 Blaubeuren (Germany)
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, Debrecen H-4042 (Hungary)

This medicinal product is authorized in the European Economic Area countries under the following names:

Risperidone Teva Generics 1 mg film-coated tablets
Austria: Risperidon "ratiopharm" 1 mg-Filmtabletten
Belgium: Risperidone-Teva 1 mg comprimes pellicules
Czech Republic: Risperidon-ratiopharm 1 mg
Finland: Risperidon ratiopharm 1 mg tabletti, kalvopäällysteinen
Germany: Risperidon-ratiopharm 1 mg Filmtabletten
Italy: Risperidone Teva Generics 1 mg compresse rivestite con film
Portugal: Risperidona ratiopharm 1 mg comprimidos revestidos

Risperidone Teva Generics 2 mg film-coated tablets
Austria: Risperidon "ratiopharm" 2 mg-Filmtabletten
Belgium: Risperidone-Teva 2 mg comprimes pellicules
Finland: Risperidon ratiopharm 2 mg tabletti, kalvopäällysteinen
Germany: Risperidon-ratiopharm 2 mg Filmtabletten
Italy: Risperidone Teva Generics 2 mg compresse rivestite con film
Portugal: Risperidona ratiopharm 2 mg comprimidos revestidos

Risperidone Teva Generics 3 mg film-coated tablets
Austria: Risperidon "ratiopharm" 3 mg-Filmtabletten
Belgium: Risperidone-Teva 3 mg comprimes pellicules
Finland: Risperidon ratiopharm 3 mg tabletti, kalvopäällysteinen
Germany: Risperidon-ratiopharm 3 mg Filmtabletten
Italy: Risperidone Teva Generics 3 mg compresse rivestite con film
Portugal: Risperidona ratiopharm 3 mg comprimidos revestidos

Risperidone Teva Generics 4 mg film-coated tablets
Austria: Risperidon "ratiopharm" 4 mg-Filmtabletten
Finland: Risperidon ratiopharm 4 mg tabletti, kalvopäällysteinen
Germany: Risperidon-ratiopharm 4 mg Filmtabletten
Italy: Risperidone Teva Generics 4 mg compresse rivestite con film
Portugal: Risperidona ratiopharm 4 mg comprimidos revestidos