Risperidone vipharm

Poland
Brand name Risperidone vipharm
Form tablets, film-coated
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 100175216
Manufacturer PharmaPath S.A.
Risperidone vipharm tablets, film-coated

Package leaflet: Information for the patient

Risperidon Vipharm, 1 mg, film-coated tablets
Risperidon Vipharm, 2 mg, film-coated tablets
Risperidon Vipharm, 3 mg, film-coated tablets
Risperidon Vipharm, 4 mg, film-coated tablets
Risperidone
Please 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 further questions, please ask your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Risperidon Vipharm is and what it is used for

Risperidon Vipharm belongs to a group of medicines called antipsychotics.
Risperidon Vipharm is used for:

  • Treating schizophrenia – a condition in which the patient may see, hear, or feel things that do not exist, believe in untrue things, or experience unusual suspicion or disorientation.
  • Treating manic episodes – a condition in which the patient may experience intense excitement, agitation, enthusiasm, or excessive activity. Manic episodes occur in bipolar affective disorder.
  • Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's type dementia who are a danger to themselves or others. Before starting treatment, alternative non-pharmacological treatment methods should be considered.
  • Short-term treatment (up to 6 weeks) of severe aggression in intellectually disabled children (over 5 years of age) and adolescents with behavioural disorders.

2. Information before using Risperidon Vipharm

When not to use Risperidon Vipharm:

  • if the patient is allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Risperidon Vipharm, discuss this with your doctor or
pharmacist:

  • if the patient has heart function disorders, for example irregular heartbeat, or if the patient has a tendency to low blood pressure, or if the patient is taking medicines
    to regulate blood pressure. Risperidon Vipharm may cause a drop in blood pressure.
    Dose adjustment may be necessary.

  • if the patient has any risk factors that may predispose to stroke, such as high blood pressure, cardiovascular disorders or cerebrovascular disorders.

  • if the patient has ever experienced uncontrolled movements, mainly of the face and tongue.

  • if the patient has ever had symptoms including high fever, muscle stiffness, sweating or decreased level of consciousness (a condition known as "neuroleptic malignant syndrome").

  • in patients with Parkinson's disease or dementia.

  • if the patient has previously had low white blood cell count (which may have been related, but not necessarily, to taking other medicines).

  • in patients with diabetes.

  • in patients with epilepsy.

  • if the patient is a man and has experienced prolonged or painful erection. If such symptoms occur during treatment with Risperidon Vipharm, contact a doctor immediately.

  • if the patient has disorders of body temperature regulation or overheating.

  • if the patient has kidney function disorders.

  • if the patient has liver function disorders.

  • if the patient has been diagnosed with abnormally high levels of the hormone prolactin in the blood or a tumour likely to be prolactin-dependent.

  • if the patient or a family member has previously had blood clots, as treatment with medicines such as Risperidon Vipharm is associated with an increased risk of thrombosis.

The doctor may order a white blood cell count, as very rarely, patients taking
Risperidon Vipharm have developed a dangerously low level of a certain type of
white blood cells needed to fight infections.
Risperidon Vipharm may cause weight gain. Significant weight gain
may negatively affect health. The doctor should regularly monitor the patient's body weight.
Since diabetes or worsening of pre-existing diabetes has been observed in patients taking Risperidon Vipharm, the doctor should order a blood sugar test.
In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
During eye surgery to remove lens clouding (cataract), the pupil (black circle
in the middle of the eye) may fail to dilate when required. Also, the iris
(coloured part of the eye) may become soft during surgery, which may lead to
visual damage. If the patient knows they will undergo eye surgery in the future, they should inform the ophthalmologist about taking this medicine.
Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke. Patients with dementia
caused by stroke should not take risperidone.
During treatment with Risperidon Vipharm, the patient should consult the doctor frequently.
Seek immediate medical help if the patient or caregiver observes sudden change in mental status or sudden weakness or numbness
of facial muscles, arms or legs, especially on one side, or speech disturbances, even
if they occur briefly. These symptoms may indicate a stroke.
Children and adolescents
Before starting treatment for behavioural disorders, other causes of aggressive behaviour should be ruled out.
If the patient experiences fatigue during treatment, concentration may improve by changing the time of administration of risperidone.
Before starting treatment, the patient's body weight (including in children)
may be measured and should be regularly monitored during treatment.
Risperidon Vipharm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients should especially inform the doctor or pharmacist if they are taking any of the
following medicines:

  • medicines acting on the brain, such as medicines to help calm down (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect,
  • medicines that may cause changes in the electrical activity of the heart, such as antimalarial drugs, antiarrhythmics (e.g. quinidine, propafenone), antihistamines, certain antidepressants or other medicines used to treat psychiatric disorders,
  • medicines that slow down heart rate,
  • medicines that reduce potassium levels in the blood (e.g.: certain diuretics),
  • medicines used for high blood pressure. Risperidon Vipharm may lower blood pressure,
  • medicines used in Parkinson's disease, e.g. levodopa,
  • diuretics, used in patients with heart disease or to relieve swelling in areas where excess fluid has accumulated (e.g. furosemide or chlorothiazide). Risperidon Vipharm, taken alone or together with furosemide, may increase the risk of stroke or death in elderly patients with dementia,
  • medicines stimulating the central nervous system (psychostimulants, such as methylphenidate).

The following medicines may reduce the effect of risperidone:

  • rifampicin (a medicine used to treat certain infections),
  • carbamazepine, phenytoin (medicines for epilepsy),
  • phenobarbital. When starting or stopping these medicines, a change in risperidone dose may be necessary.

The following medicines may enhance the effect of risperidone:

  • quinidine (used in 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 to calm),
  • cimetidine, ranitidine (reducing gastric acid secretion). When starting or stopping these medicines, a change in risperidone dose may be necessary.

If the patient is unsure whether they have taken or are taking any of the medicines described above,
they should consult a doctor or pharmacist before using Risperidon Vipharm.
Taking Risperidon Vipharm with food and drink
This medicine can be taken with food or independently of meals. During treatment with Risperidon
Vipharm, alcohol consumption should be avoided.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before using this medicine.
Newborns whose mothers took Risperidon Vipharm during the last trimester of pregnancy
(last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, feeding difficulties. If the child develops any of these symptoms, contact a doctor.
Risperidon Vipharm may increase levels of a hormone called "prolactin", which may affect fertility (see: Possible side effects).
Driving and operating machinery
During treatment with Risperidon Vipharm, dizziness, tiredness and
visual disturbances may occur. Therefore, without consulting a doctor, do not drive or
operate any machinery.
Important information about certain ingredients of Risperidon Vipharm
Risperidon Vipharm contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Risperidon Vipharm contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Risperidon Vipharm 2 mg contains sunset yellow (E 110), which may cause allergic reactions.

3. How to take Risperidon Vipharm

This medicine should always be taken as directed by the physician or pharmacist. If in
doubt, consult the doctor or pharmacist.
The doctor will determine the dose and duration of treatment, which depends on the individual patient's condition.
The tablet should be taken with water.
Other pharmaceutical companies offer medicinal products containing risperidone in lower strengths, in the form of an oral solution 1 mg/ml, allowing dosing in increments of 0.25 mg. If in doubt, consult the doctor.

In the treatment of schizophrenia
Adults

  • The recommended initial dose is 2 mg per day; this dose may be increased on the second day to 4 mg per day.
  • Depending on the patient's response to treatment, the doctor may adjust the dose.
  • For most patients, the optimal daily dose ranges from 4 mg to 6 mg.
  • Risperidon Vipharm may increase the level of a hormone called "prolactin", which may affect fertility (see: Possible side effects).
  • This total daily dose may be taken once daily or divided into two doses. The doctor will inform the patient which dosing regimen is best.

Elderly patients

  • The initial dose is usually 0.5 mg twice daily.
  • The doctor may then gradually increase the dose to 1 mg – 2 mg twice daily.
  • The doctor will inform the patient which dosing regimen is best.

In the treatment of manic episodes
Adults

  • The initial dose is usually 2 mg once daily.
  • Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
  • For most patients, the optimal dose ranges from 1 mg to 6 mg once daily.

Elderly patients

  • The initial dose is usually 0.5 mg twice daily.
  • The doctor may then gradually adjust the dose to 1 mg to 2 mg twice daily, depending on the patient's response to treatment.

In the treatment of persistent aggression in patients with Alzheimer's type dementia
Adults (including elderly patients)

  • The initial dose is usually 0.25 mg twice daily.
  • Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
  • For most patients, the optimal daily dose is 0.5 mg twice daily. Some patients may require a dose of 1 mg twice daily.
  • The duration of treatment in patients with Alzheimer's type dementia should not exceed 6 weeks.

Use in children and adolescents
Risperidon Vipharm should not be used in children and adolescents under 18 years of age for the treatment of mania in bipolar affective disorder.
In the treatment of behavioural disorders in children and adolescents
The dose depends on the child's body weight:
In children weighing less than 50 kg

  • The initial dose is usually 0.25 mg once daily.
  • The dose may be increased every other day (gradually) by 0.25 mg per day.
  • The usual maintenance dose is usually 0.25 mg to 0.75 mg once daily.

In children weighing 50 kg or more

  • The initial dose is usually 0.5 mg once daily.
  • The dose may be increased every other day by 0.5 mg per day.
  • The usual maintenance dose is usually 0.5 mg to 1.5 mg once daily.

The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.
Risperidon Vipharm should not be used in children under 5 years of age for the treatment of behavioural disorders.

Patients with renal or hepatic impairment
Regardless of the disease being treated, all initial and subsequent doses should be reduced by half. In these patients, doses should be increased more slowly.
Risperidone should be used with caution in this patient group.

Taking more Risperidon Vipharm than prescribed
Seek medical advice immediately. Take the medicine package with you.
In case of overdose, the patient may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, irregular heart rhythm, or seizures may occur.

If a dose of Risperidon Vipharm is missed
If the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken as prescribed. If the patient forgets two or more doses, they should contact the doctor.
Do not take a double dose to make up for a missed dose.

Stopping Risperidon Vipharm
Do not stop taking this medicine unless advised by the doctor. Symptoms of the illness may recur. If the doctor decides to discontinue treatment, the dose may be gradually reduced over several days.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor if:

  • The patient develops blood clots in the veins, especially in the legs (symptoms include leg pain and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. In such cases, immediate medical help should be sought.
  • In patients with dementia, there is a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, particularly on one side, or slurred speech, even if brief. These may be symptoms of stroke.
  • The patient develops fever, severe muscle stiffness, sweating or reduced level of consciousness (a condition known as "neuroleptic malignant syndrome"). Immediate medical help may be required.
  • The male patient experiences prolonged or painful erection. This is called priapism. Immediate medical help may be required.
  • The patient develops involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of Risperidon Vipharm may be necessary.

The following adverse reactions may occur.
Very common adverse reactions (may occur in more than 1 in 10 patients)

  • Difficulty falling asleep or staying asleep
  • Parkinsonism: this condition may include: slow or disturbed body movements, feeling of stiffness or muscle tension (causing jerky movements) and sometimes even a sensation of "freezing" in movement, followed by restarting. Other symptoms of parkinsonism include slow, shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face.
  • Feeling of drowsiness or reduced attention.
  • Headache.

Common adverse reactions (may occur in 1 to 10 in 100 patients)

  • Pneumonia, chest infection (bronchitis), common cold symptoms, sinus infections, urinary tract infection, ear infections, flu-like symptoms
  • Risperidone may increase blood levels of a hormone called "prolactin" (which may, but does not necessarily, cause symptoms). When symptoms of high prolactin levels occur, they may cause in men breast swelling, difficulty achieving or maintaining erection, or other sexual disturbances. In women, they may cause breast discomfort, milk discharge from the breasts, absence of menstruation, or other menstrual cycle problems.
  • Weight gain, increased appetite, decreased appetite.
  • Sleep disturbances, irritability, depression, anxiety, restlessness.
  • Dystonia: this is a condition involving slow or sustained involuntary muscle contractions. Although it may affect any part of the body (and may cause abnormal posture), dystonia often involves facial muscles, including abnormal eye, mouth, tongue and jaw movements.
  • Dizziness.
  • Dyskinesia: this is a condition involving involuntary muscle movements, and may include repetitive, spasmodic or writhing movements or muscle twitching.
  • Tremor (shaking).
  • Blurred vision, eye infections or "red eye".
  • Rapid heartbeat, high blood pressure, shortness of breath.
  • Sore throat, cough, nosebleeds, nasal congestion.
  • Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache.
  • Rash, skin redness.
  • Muscle cramps, bone or muscle pain, back pain, joint pain.
  • Urinary incontinence (lack of control over urination).
  • Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue, pain.
  • Falls.

Uncommon adverse reactions (may occur in 1 to 10 in 1000 patients)

  • Respiratory tract infection, cystitis, eye infection, tonsillitis, fungal nail infection, skin infections, localized skin or body part infections, viral infections, dermatitis caused by mites.
  • Decrease in type of white blood cells that help protect against infection, drop in white blood cell count, reduced platelet count (blood cells that help stop bleeding), anaemia, reduced red blood cell count, increased number of eosinophils (a type of white blood cell) in blood.
  • Allergic reaction.
  • Diabetes or worsening of diabetes, high blood sugar levels, excessive water drinking.
  • Weight loss, appetite loss due to malnutrition and low body weight.
  • Increased blood cholesterol levels.
  • Elevated mood (mania), confusion, reduced sexual drive, nervousness, nightmares.
  • Late dyskinesia (involuntary muscle twitching or jerky movements of the face, tongue or other body parts). You should immediately inform your doctor if involuntary rhythmic movements of the tongue, mouth or face occur. Discontinuation of Risperidon Vipharm 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.
  • Irresistible urge to move body parts, imbalance, coordination disturbances, dizziness upon standing, attention disturbances, speech disturbances, loss or disturbances of taste, reduced skin sensitivity to pain and touch, tingling, pricking or numbness sensations in the skin.
  • Light sensitivity of the eyes, dry eyes, excessive tearing, eye redness.
  • Sensation of spinning (dizziness), ringing in the ears, ear pain.
  • Atrial fibrillation (irregular heartbeat), conduction block between upper and lower heart chambers, disturbances in heart's electrical conduction, QT interval prolongation, slow heartbeat, disturbances in monitoring heart's electrical activity (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).
  • Low blood pressure, low blood pressure upon standing (as a result, some patients taking Risperidon Vipharm may experience fainting, dizziness or fainting upon sudden sitting or standing), sudden flushing of the face.
  • Pneumonia caused by food entering the airways, lung congestion, congestion of the airways, crackling sounds in the lungs, wheezing, voice disturbances, breathing disturbances.
  • Stomach or intestinal infection, faecal incontinence, very hard stools, difficulty swallowing, excessive passing of gas or flatulence.
  • Hives (or "red rash on the skin"), itching, hair loss, skin thickening, skin rash, dry skin, skin discoloration, acne, skin peeling, scalp or skin itching, skin disorders, skin changes.
  • Increased levels of CPK (creatine kinase) in blood, an enzyme sometimes released due to muscle breakdown.
  • Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
  • Frequent urination, urine retention, pain during urination.
  • Erectile dysfunction, ejaculation disorders.
  • Loss of menstruation, absence of menstruation or other menstrual cycle problems (in women).
  • Breast development in men, milk discharge from breasts, sexual disturbances, breast pain, breast discomfort, vaginal discharge.
  • Swelling of the face, lips, eyes or eyelids.
  • Chills, increased body temperature.
  • Change in walking pattern.
  • Thirst, malaise, chest discomfort, feeling of "being unwell", discomfort.
  • Increased liver aminotransferase activity in blood, increased GGT (liver enzyme called gamma-glutamyl transferase) activity in blood, increased liver enzyme activity in blood.
  • Pain during procedures.

Rare adverse reactions (may occur in 1 to 10 in 10,000 patients)

  • Infection.
  • Inappropriate secretion of a hormone regulating urine volume.
  • Sugar in urine, low blood sugar levels, high blood triglyceride levels (a type of fat).
  • Lack of emotion, inability to achieve orgasm.
  • Neuroleptic malignant syndrome (disorientation, reduced or loss of consciousness, high fever, severe muscle rigidity).
  • Problems with blood vessels in the brain.
  • Coma due to uncontrolled diabetes.
  • Dizziness.
  • Glaucoma (increased pressure in the eyeball), eye movement problems, eye protrusion, crusts on eyelid margins.
  • Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur when the patient is taking or has taken Risperidon Vipharm. If the patient is to undergo cataract surgery, the ophthalmologist should be informed about current or past use of this medicine.
  • Dangerously low levels of certain white blood cells needed to fight infections in blood.
  • Severe allergic reaction characterized by: fever, swelling of lips, face, mouth or tongue, breathing difficulties, itching, rash and sometimes low blood pressure.
  • Dangerously excessive water intake.
  • Irregular heartbeat.
  • Blood clots in legs, blood clots in lungs.
  • Breathing problems during sleep (sleep apnoea), rapid, shallow breathing.
  • Pancreatitis, intestinal obstruction.
  • Tongue swelling, cracked lips, drug-related skin rash.
  • Pityriasis.
  • Muscle fiber breakdown and muscle pain (rhabdomyolysis).
  • Delayed menstruation, enlarged breast glands, breast enlargement, breast discharge.
  • Increased insulin levels (a hormone regulating blood sugar) in blood.
  • Priapism (prolonged penile erection which may require surgical treatment).
  • Skin induration.
  • Low body temperature, drop in body temperature, cold sensation in hands and feet.
  • Withdrawal symptoms.
  • Yellowing of the skin and eyes (jaundice).

Very rare (may occur in less than 1 in 10,000 patients)

  • Life-threatening complications related to uncontrolled diabetes.
  • Severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties.
  • Intestinal obstruction.

The following adverse reactions have been observed with use of another medicine called paliperidone, which is very similar to risperidone, and therefore they may also occur during use of Risperidon Vipharm: rapid heartbeat after discontinuation.

Additional adverse reactions in children and adolescents
Generally, adverse reactions in children are expected to be similar to those in adults.
The following adverse reactions have been reported more frequently in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or reduced attention, fatigue (tiredness), headache, increased appetite, vomiting, cold symptoms, nasal mucosal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhoea and urinary incontinence (lack of control over urination).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Risperidon Vipharm

  • Keep the medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
  • No special storage instructions are required.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Risperidon Vipharm contains
Risperidon Vipharm, 1 mg coated tablets.
The active substance in Risperidon Vipharm 1 mg is risperidone at a dose of 1 mg.
The other ingredients are:
Tablet core
monohydrate lactose, maize starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Tablet coating
Opadry White 02H28525:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, talc.

Risperidon Vipharm, 2 mg coated tablets.
The active substance in Risperidon Vipharm 2 mg is risperidone at a dose of 2 mg.
The other ingredients are:
Tablet core
monohydrate lactose, maize starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Tablet coating
Opadry Orange 02H23363:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, orange yellow (E110), talc.

Risperidon Vipharm, 3 mg coated tablets.
The active substance in Risperidon Vipharm 3 mg is risperidone at a dose of 3 mg.
The other ingredients are:
Tablet core
monohydrate lactose, maize starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Tablet coating
Opadry Yellow 02H22051:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, quinoline yellow (E104), talc.

Risperidon Vipharm, 4 mg coated tablets.
The active substance in Risperidon Vipharm 4 mg is risperidone at a dose of 4 mg.
The other ingredients are:
Tablet core
monohydrate lactose, maize starch, sodium lauryl sulfate, microcrystalline cellulose,
hypromellose, colloidal anhydrous silica, magnesium stearate.
Tablet coating
Opadry Green 02H21429:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, indigo carmine (E132), quinoline yellow (E104), talc.

What Risperidon Vipharm looks like and contents of the pack
Coated tablets
1 mg: White, oblong coated tablet measuring 11 x 5.5 mm, with a score line on both sides.
2 mg: Orange, oblong coated tablet measuring 11 x 5.5 mm, with a score line on both sides.
3 mg: Yellow, oblong coated tablet measuring 11 x 5.5 mm, with a score line on both sides.
4 mg: Green, oblong coated tablet measuring 11 x 5.5 mm, with a score line on both sides.

The tablets are packed in PVC/PE/PVDC//Al blisters containing 10 tablets, in a cardboard box.
Pack sizes:
1 mg: 6, 20, 50, 60 or 100 coated tablets
2 mg: 20, 50, 60 or 100 coated tablets
3 mg: 20, 50, 60 or 100 coated tablets
4 mg: 6, 20, 28, 30, 50, 60 or 100 coated tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: (+4822) 679 5135
fax: (+4822) 678 92 87
e-mail: [email protected]

Manufacturer
PharmaPath S.A.
1, 28 Octovriou str., Ag. Varvara
123 51 Athens
Greece