Risperidon Vipharm

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

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Risperidon Vipharm and what is it used for
• 2. Important information 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 is Risperidon Vipharm and what is it used for

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

• treatment of schizophrenia - a condition where the patient may see, hear or feel things that do not exist, believe in untrue things or feel unusual suspicion or disorientation.
• treatment of manic episodes - a condition where the patient may feel strong excitement, agitation, irritability, enthusiasm or be overly active. Manic episodes occur in the course of bipolar affective disorder.
• short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who harm themselves or others. Before taking the medicine, alternative non-pharmacological treatment methods should be used.
• short-term treatment (up to 6 weeks) of persistent aggression in mentally retarded children (over 5 years old) and adolescents with behavioral disorders.

2. Important information before taking Risperidon Vipharm

When not to take 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 with your doctor or pharmacist:

• if the patient has heart rhythm disorders, such as irregular heartbeat, or if the patient has a tendency to low blood pressure, or if the patient is taking blood pressure-lowering medicines. Risperidon Vipharm may cause a decrease in blood pressure.

It may be necessary to adjust the dose of the medicine.

• if the patient knows of any factors that may increase the risk of stroke, such as high blood pressure, cardiovascular disease or cerebrovascular disorders.
• if the patient has ever had 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 called "malignant neuroleptic syndrome").
• in patients with Parkinson's disease or dementia.
• if the patient has a history of low white blood cell count (which may have been related to, but not necessarily, the use of other medicines).
• in patients with diabetes.
• in patients with epilepsy.
• if the patient is a man and has experienced prolonged or painful erections. If such symptoms occur during treatment with Risperidon Vipharm, contact your doctor immediately.
• if the patient has disorders of body temperature regulation or if the patient overheats.
• if the patient has kidney function disorders.
• if the patient has liver function disorders.
• if the patient has an abnormally high level of the hormone prolactin in the blood or a prolactin-dependent tumor.
• if the patient or any of their relatives have had blood clots in the past, as the use of such medicines as Risperidon Vipharm is associated with the formation of blood clots.

The doctor may order a white blood cell count test, as very rarely, patients taking Risperidon Vipharm have developed a dangerously low level of a certain type of white blood cell needed to fight infections in the blood.
Risperidon Vipharm may cause weight gain. Significant weight gain can have a negative impact on health. The doctor should regularly measure the patient's weight.
As diabetes or worsening of existing diabetes has been observed in patients taking Risperidon Vipharm, the doctor should order a blood sugar test.
In patients with existing diabetes, blood glucose levels should be regularly monitored.
During eye surgery to remove cataracts, the pupil (the black circle in the center of the eye) may not dilate as required, and the iris (the colored part of the eye) may become flaccid during surgery, which can lead to vision damage. If the patient knows that they will undergo eye surgery in the future, they should inform their 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 frequently consult their doctor.
Medical help should be sought immediately if the patient or their caregiver notices a sudden change in the patient's mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke.

Children and adolescents

Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.
If the patient experiences fatigue during treatment, changing the time of risperidone administration may improve concentration.
Before starting treatment, the patient's weight (also in the case of a child patient) may be measured and regularly monitored during treatment.

Risperidon Vipharm and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Patients should especially inform their doctor or pharmacist if they are taking any of the following medicines:

• medicines that act on the brain, such as sedatives (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect,
• medicines that can cause changes in heart rhythm, such as anti-malarial medicines, anti-arrhythmic medicines (e.g., quinidine, propafenone), antihistamines, or certain antidepressants or other medicines used to treat mental disorders,
• medicines that slow down heart rate,
• medicines that lower blood potassium levels (e.g., certain diuretics),
• medicines used to treat high blood pressure. Risperidon Vipharm may lower blood pressure,
• medicines used to treat Parkinson's disease, such as levodopa,
• diuretics (used in heart disease or to relieve swelling in areas where there is excessive fluid accumulation, 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 that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)

The following medicines may weaken the effect of risperidone:

• rifampicin (a medicine used to treat certain infections),
• carbamazepine, phenytoin (anti-epileptic medicines),
• phenobarbital. If you start or stop taking these medicines, it may be necessary to adjust the dose of risperidone.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart diseases),
• antidepressants, such as paroxetine, fluoxetine, tricyclic antidepressants,
• beta-adrenergic blockers (used to treat high blood pressure),
• phenothiazines (used to treat psychoses or to sedate),
• cimetidine, ranitidine (reducing stomach acid), if you start or stop taking these medicines, it may be necessary to adjust the dose of risperidone.

If you are not sure whether you have taken or are taking any of the above medicines, you should consult your doctor or pharmacist before taking Risperidon Vipharm.

Taking Risperidon Vipharm with food and drink

This medicine can be taken with or without food. During treatment with Risperidon Vipharm, you should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
In newborns whose mothers took Risperidon Vipharm during the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur: trembling, muscle stiffness and/or weakness, sleepiness, agitation, breathing difficulties, feeding difficulties. If your child experiences any of these symptoms, contact your doctor.
Risperidon Vipharm may increase the level of a hormone called "prolactin", which may affect fertility (see: Possible side effects).

Driving and using machines

During treatment with Risperidon Vipharm, dizziness, fatigue, and vision disturbances may occur. Therefore, do not drive or operate any machines without consulting your doctor.

Important information about some ingredients of Risperidon Vipharm

Risperidon Vipharm contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
Risperidon Vipharm contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".
Risperidon Vipharm 2 mg contains orange yellow S (E 110), which may cause allergic reactions.

3. How to take Risperidon Vipharm

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist.
The doctor will determine the dose of the medicine and the duration of treatment. This depends on the individual patient's condition.
Swallow the tablet with water.
There are other medicinal products from other pharmaceutical companies that contain risperidone in smaller strengths in the form of an oral solution 1 mg/ml with the possibility of dosing in increments of 0.25 mg. If you have any doubts, consult your doctor.

In the treatment of schizophrenia

Adults

• The recommended initial dose is 2 mg per day, which may be increased to 4 mg per day on the second day.
• Depending on the patient's response to treatment, the doctor may adjust the dose.
• For most patients, the optimal daily dose is between 4 mg and 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 or divided into two doses. The doctor will inform you which method of taking the medicine is best for you.

Elderly patients

• The initial dose is usually 0.5 mg twice a day.
• Then the doctor may gradually increase the dose to 1 mg to 2 mg twice a day.
• The doctor will inform you which method of taking the medicine is best for you.

In the treatment of manic episodes

Adults

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

Elderly patients

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

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

Adults (including elderly patients)

• The initial dose is usually 0.25 mg twice a day.
• 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 a day. Some patients may need a dose of 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

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 behavioral disorders in children and adolescents

The dose depends on the child's weight:
In children with a body weight of less than 50 kg

• The initial dose is usually 0.25 mg once a day.
• The dose may be increased every other day (gradually) by 0.25 mg per day.
• Usually, the maintenance dose is between 0.25 mg and 0.75 mg once a day.

In children with a body weight of 50 kg or more

• The initial dose is usually 0.5 mg once a day.
• The dose may be increased every other day by 0.5 mg per day.
• Usually, the maintenance dose is between 0.5 mg and 1.5 mg once a day.

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

Overdose of Risperidon Vipharm

Seek medical attention immediately. Take the medicine packaging with you.
In case of overdose, the patient may experience drowsiness or fatigue, or may have abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, or irregular heartbeat.

Missed dose of Risperidon Vipharm

If you miss a dose, take the next dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose as directed. If you miss two or more doses, consult your doctor.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Risperidon Vipharm

Do not stop taking the medicine unless your doctor tells you to. It is possible that the symptoms of the disease will recur. If the doctor decides to stop treatment, the dose of the medicine may be gradually reduced over several days.
If you have any further questions about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor immediately if:

• The patient develops blood clots in the veins, especially in the legs (symptoms include pain and redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. Seek medical attention immediately if such symptoms occur.
• In patients with dementia, there is a sudden change in their mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke.
• The patient develops a fever, severe muscle stiffness, sweating or decreased level of consciousness (a condition called "malignant neuroleptic syndrome"). Immediate medical attention may be necessary.
• A man develops a prolonged or painful erection. This is called priapism. Immediate medical attention may be necessary.
• The patient experiences involuntary rhythmic movements of the tongue, lips and face. It may be necessary to discontinue Risperidon Vipharm.

The following side effects may occur.

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

• Difficulty falling or staying asleep.
• Parkinsonism: this condition may include: slow or impaired body movements, feeling of stiffness or tension in the muscles (which can cause jerky movements) and sometimes even a feeling of "freezing" of movement, followed by resumption of movement. Other symptoms of parkinsonism include slow, shuffling gait, tremors at rest, increased salivation and/or drooling, and a mask-like face.
• Feeling drowsy or weak.
• Headache.

Common side effects (may affect up to 1 in 10 people)

• Pneumonia, chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infection, flu-like symptoms
• Risperidon Vipharm may increase the level of a hormone called "prolactin" in the blood (which may, but not necessarily, cause symptoms). When symptoms of high prolactin levels occur, they may cause men to experience breast swelling, difficulty getting or maintaining an erection, or other sexual problems. In women, they may cause breast discomfort, breast milk secretion, absence of menstruation, or other problems related to the menstrual cycle.
• Weight gain, increased appetite, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, restlessness.
• Dystonia: this is a condition characterized by slow or sustained involuntary muscle contractions. Although it can affect any part of the body (and may cause an abnormal posture), dystonia most often affects the muscles of the face, including abnormal movements of the eyes, lips, tongue, and jaw.
• Dizziness.
• Dyskinesia: this is a condition characterized by involuntary muscle movements, and may include repetitive, spasmodic, or writhing movements or muscle stiffness.
• Tremor (shaking).
• Blurred vision, eye infections, or "red eye".
• Rapid heartbeat, high blood pressure, shortness of breath.
• Sore throat, cough, nosebleeds, stuffy nose.
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Rash, skin redness.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence (loss of bladder control).
• Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue, pain.
• Falls.

Uncommon side effects (may affect up to 1 in 100 people)

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal infection of the nails, skin infections, infections limited to one area of the skin or part of the body, viral infections, skin inflammation caused by mites.
• Decrease in a type of white blood cell that helps protect against infection, decrease in white blood cell count, decrease in platelet count (blood cells that help stop bleeding), anemia, decrease in red blood cell count, increase in eosinophils (a type of white blood cell) in the blood.
• Allergic reaction.
• Diabetes or worsening of existing diabetes, high blood sugar, excessive thirst.
• Weight loss, loss of appetite due to malnutrition and low body weight.
• Increased cholesterol levels in the blood.
• Mood elevation (mania), confusion, decreased sex drive, nervousness, nightmares.
• Late dyskinesia (muscle stiffness or jerky movements that cannot be controlled on the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, lips, and face. It may be necessary to discontinue Risperidon Vipharm.
• Sudden loss of blood supply to the brain (stroke or "mini" stroke)
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
• Seizures (convulsions), fainting.
• Uncontrollable need to move a body part, balance disturbances, coordination disturbances, dizziness when standing up, attention disturbances, speech disturbances, loss or disturbance of taste, decreased skin sensitivity to pain and touch, tingling, numbness, or prickling sensation of the skin.
• Excessive sensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes.
• Feeling of spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (irregular heart rhythm), conduction disorder between the upper and lower parts of the heart, heart conduction disorders, prolonged QT interval, slow heartbeat, disturbances in the tracing of the heart's electrical activity (electrocardiogram or EKG), feeling of pounding or fluttering in the chest (palpitations).
• Low blood pressure, low blood pressure when standing up (which may cause fainting, dizziness, or flushing of the face in some patients taking Risperidon Vipharm).
• Pneumonia caused by food entering the airways, pulmonary congestion, bronchial congestion, crackling in the lungs, wheezing, voice disturbances, breathing difficulties.
• Gastrointestinal infection, diarrhea, very hard stools, difficulty swallowing, excessive gas or bloating
• Hives (or "red rash on the skin"), itching, hair loss, skin thickening, rash, dry skin, skin discoloration, acne, skin peeling, itching of the scalp and skin, skin disorders, skin changes.
• Increased CPK (creatine kinase) levels in the blood, an enzyme that is sometimes released due to muscle breakdown.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, urinary retention, painful urination.
• Erectile dysfunction, ejaculation disorders.
• Amenorrhea (loss of menstruation) or other problems with the menstrual cycle (in women).
• Breast development in men, breast milk secretion, sexual disorders, breast pain, breast discomfort, vaginal discharge.
• Facial swelling, lip swelling, eye swelling, or mouth swelling.
• Chills, elevated body temperature.
• Change in gait.
• Feeling of thirst, malaise, chest discomfort, feeling of "being out of sorts", discomfort.
• Increased liver enzyme activity in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) activity in the blood, increased liver enzyme activity in the blood.
• Pain during procedures.

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

• Infection.
• Inappropriate secretion of the hormone that regulates urine volume.
• Sugar in the urine, low blood sugar, high triglyceride levels in the blood (a type of fat).
• Lack of emotions, inability to achieve orgasm.
• Malignant neuroleptic syndrome (disorientation, decreased or lost consciousness, high fever, severe muscle stiffness).
• Vascular problems in the brain.
• Coma due to uncontrolled diabetes.
• Head shaking.
• Glaucoma (increased pressure in the eyeball), eye movement problems, eye deviation, eyelid problems.
• 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 you need to undergo cataract surgery, inform your ophthalmologist about taking this medicine.
• Dangerously low level of a certain type of white blood cell needed to fight infections in the blood.
• Severe allergic reaction characterized by: fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, rash, and sometimes a drop in blood pressure.
• Severe excessive water intake.
• Irregular heartbeat.
• Blood clots in the legs, blood clots in the lungs.
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, bowel obstruction.
• Tongue swelling, cracked lips, skin rash related to taking the medicine.
• Dandruff.
• Muscle breakdown and muscle pain (rhabdomyolysis).
• Delayed menstruation, breast enlargement, breast engorgement, breast secretion.
• Increased insulin levels (a hormone that regulates blood sugar levels) in the blood.
• Priapism (prolonged erection of the penis, which may require surgical treatment).
• Skin thickening.
• Low body temperature, decreased body temperature, feeling of cold hands and feet.
• Withdrawal symptoms.
• Jaundice (yellowing of the skin and eyes).

Very rare side effects (may affect less than 1 in 10,000 people)

• Life-threatening complications related to uncontrolled diabetes.
• Severe allergic reaction with swelling that can involve the throat and lead to breathing difficulties.
• Bowel obstruction.

The following side effects have been observed with the use of another medicine called paliperidone, which is very similar to risperidone, so they may also occur with Risperidon Vipharm: rapid heartbeat after discontinuation.

Additional side effects in children and adolescents

It is expected that side effects in children will be similar to those in adults.
The following side effects were reported more frequently in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or weakness, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, stuffy nose, abdominal pain, dizziness, cough, fever, tremors (shaking), diarrhea, and urinary incontinence (loss of bladder control).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 month.
• There are no special precautions for storage.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Risperidon Vipharm contains

Risperidon Vipharm, 1 mg, film-coated tablets.
The active substance of Risperidon Vipharm 1 mg is risperidone in a dose of 1 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate.
Tablet coating
Opadry White 02H28525:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, talc.
Risperidon Vipharm, 2 mg, film-coated tablets.
The active substance of Risperidon Vipharm 2 mg is risperidone in a dose of 2 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate.
Tablet coating
Opadry Orange 02H23363:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, orange yellow S (E110), talc.
Risperidon Vipharm, 3 mg, film-coated tablets.
The active substance of Risperidon Vipharm 3 mg is risperidone in a dose of 3 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, magnesium stearate.
Tablet coating
Opadry Yellow 02H22051:
hypromellose 5cP, titanium dioxide (E171), propylene glycol, quinoline yellow (E104), talc.
Risperidon Vipharm, 4 mg, film-coated tablets.
The active substance of Risperidon Vipharm 4 mg is risperidone in a dose of 4 mg.
The other ingredients are:
Tablet core
lactose monohydrate, corn starch, sodium lauryl sulfate, microcrystalline cellulose, hypromellose, anhydrous colloidal 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

Film-coated tablets
1 mg: White, oval tablet with a length of 11 mm and a width of 5.5 mm, with a score line on both sides.
2 mg: Orange, oval tablet with a length of 11 mm and a width of 5.5 mm, with a score line on both sides.
3 mg: Yellow, oval tablet with a length of 11 mm and a width of 5.5 mm, with a score line on both sides.
4 mg: Green, oval tablet with a length of 11 mm and a width of 5.5 mm, with a score line on both sides.
The tablets are packaged in PVC/PE/PVDC//Al blisters containing 10 tablets, in a cardboard box.
Pack sizes:
1 mg:
6, 20, 50, 60, or 100 film-coated tablets
2 mg:
20, 50, 60, or 100 film-coated tablets
3 mg:
20, 50, 60, or 100 film-coated tablets
4 mg:
6, 20, 28, 30, 50, 60, or 100 film-coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A.
Radziwiłłów 9
05-850 Ożarów Mazowiecki
phone: (+48 22) 679 5135
fax: (+48 22) 678 92 87
e-mail: vipharm@vipharm.com.pl
Manufacturer
PharmaPath S.A.
28 Octovriou 1, Ag. Varvara
123 51 Athens
Greece
Date of last revision of the leaflet:01.03.2022