Risperidone ViatriS 6 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidone Viatris 6 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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 and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Risperidone belongs to a group of medicines called "antipsychotics".

Risperidone is used to treat the following:

• Schizophrenia, which is characterized by hearing, seeing, or feeling things that are not present, believing things that are not true, unusual distrust, or confusion.
• Mania, which is characterized by feeling excessively excited, euphoric, agitated, enthusiastic, or hyperactive. Mania occurs in a condition called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of severe aggression in patients with Alzheimer's dementia who harm themselves or others. Alternative treatments (non-pharmacological) should have been tried previously.

Short-term treatment (up to 6 weeks) of severe aggression in intellectually disabled children (over 5 years of age) and adolescents with conduct disorders.

2. What you need to know before taking Risperidone Viatris

Do not take Risperidone Viatris:

• If you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidone Viatris:

• If you are taking furosemide (a 'diuretic' used to reduce swelling and fluid retention caused by various medical conditions, including heart or liver disease).
• If you have any heart disease. For example, if you have weakness in the heart muscle (heart failure), have had a heart attack, are prone to low blood pressure, or are taking medicines for blood pressure. Risperidone may cause low blood pressure, and your dose may need to be adjusted.
• If you or a family member has a history of irregular heartbeat, as this medicine has been associated with potentially serious changes in heart rhythm.
• If you have any factor that may increase the risk of embolism, such as high blood pressure, cardiovascular disorders, or problems with cerebral blood vessels.
• If you have any factor that may increase the risk of blood clots, such as being a smoker or having smoked in the past, or if you are likely to be immobile for a long period (e.g., after surgery or illness).
• If you or a family member has a history of blood clots, as these medicines have been associated with blood clot formation.
• If you have, or have had, low levels of white blood cells in the blood, especially if this occurred while taking other medicines.
• If you have ever experienced involuntary movements of the tongue, mouth, or face.
• If you have ever had an illness with symptoms such as fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson’s disease (a brain disorder affecting movement, such as tremors, postural rigidity, slow movements, and gait disturbances) or dementia (a general decline in all areas of mental ability, such as memory loss and other cognitive impairments), particularly dementia with Lewy bodies (abnormal protein aggregates that develop within nerve cells in Parkinson’s disease).
• If you have diabetes or are at risk of developing diabetes (you may have elevated blood sugar levels).
• If you have epilepsy.
• If you are a man and have ever had a prolonged or painful erection.
• If you have difficulty regulating your body temperature, are prone to overheating, or are or may be exposed to very high temperatures or extreme physical exertion.
• If you are or become dehydrated or have low blood volume (hypovolemia) during treatment.
• If you have low levels of potassium or magnesium in the blood.
• If you have kidney problems.
• If you have liver problems.
• If you have abnormally high levels of the hormone prolactin in the blood or have a tumor that may be prolactin-dependent.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

During treatment

Risperidone may cause changes in the number of white blood cells, which help fight infections. Therefore, your doctor may perform blood tests before and during treatment.

Risperidone may cause weight gain. Significant weight gain may negatively affect your health. Your doctor should monitor your body weight regularly.

Since diabetes or worsening of pre-existing diabetes has been observed in patients taking risperidone, your doctor should check your blood sugar levels. Patients with pre-existing diabetes should regularly monitor their blood glucose levels.

Risperidone frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see section 4, "Possible side effects"). If these adverse effects occur, evaluation of prolactin levels in the blood is recommended.

If you are undergoing eye surgery, inform your doctor or hospital staff that you are taking this medicine. During cataract surgery (clouding of the eye's lens), this medicine may affect the pupil or iris (the colored part of the eye), which could lead to eye damage.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of embolism or mini-embolism (also known as transient ischemic attack or TIA). You should not take risperidone if your dementia is caused by embolism.

During treatment with risperidone, you should visit your doctor regularly.

Seek immediate medical attention if you or your caregiver notice a sudden change in mental status, sudden weakness, numbness in the face, arms, or legs—especially on one side—vision problems, or difficulty speaking, even if only for a short time. These may be signs of a stroke.

Children and adolescents

Before starting treatment for conduct disorder, other possible causes of aggressive behavior should be ruled out.

Before starting treatment, your body weight or your child’s body weight may be measured and monitored regularly during treatment.

If fatigue occurs during treatment, changing the time of dosing may improve attention difficulties.

A small, inconclusive study reported increased height in children taking risperidone, but it is unknown whether this is a drug effect or due to other reasons.

Taking Risperidone Viatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal medicines.

It is especially important to inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines that act on the brain, such as those used to calm you (benzodiazepines), certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effects.
• Medicines that can alter the electrical activity of your heart, such as those used for malaria (quinine, mefloquine), heart rhythm disorders (such as quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), allergies (antihistamines), certain antidepressants (such as paroxetine, fluoxetine, sertraline, fluvoxamine, tricyclic antidepressants like amitriptyline), tetracyclic antidepressants (such as maprotiline), or other medicines for mental health conditions (such as paliperidone or phenothiazines used to treat psychosis or for sedation).
• Medicines that slow the heart rate, such as beta-blockers or verapamil (used to treat high blood pressure or angina).
• Medicines that may reduce potassium or magnesium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidone may cause a decrease in blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretic tablets used to treat heart problems or swelling in parts of the body due to fluid accumulation (such as furosemide or chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of embolism or death in elderly patients with dementia.

The following medicines reduce the effect of risperidone:

• Rifampicin (a medicine used to treat certain infections).
• Carbamazepine, phenytoin (medicines used for epilepsy).
• Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines increase the effect of risperidone:

• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Some medicines used to treat HIV/AIDS, such as ritonavir.

If you start or stop taking these medicines, you may need a different dose of risperidone.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Taking Risperidone Viatris with food, drinks, and alcohol

You should avoid consuming alcoholic beverages during treatment with risperidone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before you or your partner use this medicine. Your doctor will decide whether you can take it.

The following symptoms may occur in newborns of mothers who have taken risperidone during the third trimester (the last three months of pregnancy): tremors, muscle stiffness, restlessness, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to 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, dizziness, fatigue, and vision problems may occur. Do not drive or operate tools or machinery without first consulting your doctor.

Risperidone Viatris contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free."

Risperidone Viatris 2 mg and 6 mg contains sunset yellow (E110)

This medicine may cause allergic reactions because it contains sunset yellow (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Risperidone Viatris

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how much to take and for how long. This depends on your condition and may vary from person to person.

The recommended dose is as follows:

For 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 of treatment.
• Depending on your response to treatment, your doctor may adjust your dose.
• Most people experience improvement with daily doses of 4 to 6 mg.
• The total daily dose may be divided into one or two doses per day. Your doctor will inform you which dose is most suitable for you.

Elderly patients

• The recommended initial dose is usually 0.5 mg twice daily.
• The dose may be gradually increased by your doctor to 1 mg or 2 mg twice daily.
• Your doctor will inform you of the most suitable dose for you.

Use in children and adolescents

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

For the treatment of mania

Adults

• The recommended initial dose is usually 2 mg once daily.
• The dose may be gradually adjusted by your doctor depending on your response to treatment.
• Most people feel better with doses of 1 to 6 mg once daily.

Elderly patients

• The recommended initial dose is usually 0.5 mg twice daily.
• The dose may be gradually adjusted by your doctor to 1 mg or 2 mg twice daily, depending on your response to treatment.

Use in children and adolescents

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

For the treatment of persistent aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

• The recommended initial dose is usually 0.25 mg twice daily.
• The dose may be gradually adjusted by your doctor depending on your response to treatment.
• Most people feel better with 0.5 mg twice daily. Some patients require a dose of 1 mg twice daily.
• Treatment in patients with Alzheimer-type dementia should not last longer than 6 weeks.

For the treatment of conduct disorders in children and adolescents

The dose depends on the child's weight:

For children weighing less than 50 kg:

• The recommended initial dose is usually 0.25 mg once daily.
• The dose may be increased every other day by increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once daily.

For children weighing 50 kg or more:

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

The duration of treatment in patients with conduct disorders should not exceed 6 weeks.

Children under 5 years of age should not be treated with risperidone for conduct disorders.

Patients with kidney or liver problems

Regardless of the reason for taking this medicine, all initial and subsequent doses should be reduced by half. Dose increases should be slower in these patients.

Risperidone should be used with caution in this patient group.

How to take Risperidone

• Swallow the tablet with plenty of water.
• Risperidone may be taken with or without food.

The tablet may be divided into equal doses.

If you take more Risperidone Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, you may feel drowsy or tired, have abnormal body movements, difficulty standing or walking, feel dizzy due to low blood pressure, or experience a fast or irregular heartbeat or seizures.

If you forget to take Risperidone Viatris

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for missed doses.

If you stop taking Risperidone Viatris

Do not stop taking this medicine unless your doctor has instructed you to do so. Your symptoms may return. If your doctor decides to discontinue treatment, the dose should be gradually reduced over several days.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Consult your doctor or go to a hospital emergency department immediately if:

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

• You develop lung infections, including severe lung infections such as pneumonia – you may have a very high temperature, cough with phlegm that may be bloody or frothy, and feel unwell.

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

• You experience a sudden change in mental state, sudden fatigue, or numbness in the face, arms, or legs, especially on one side, vision problems, or difficulty speaking, even for a short period. These may be signs of a stroke, mini-stroke (TIA, transient ischaemic attack), or reduced blood flow to the brain.
• You experience an abnormal heart rhythm, such as fluttering of the heart (fibrillation) or very slow or irregular heartbeat (heart block). This may be caused by abnormal electrical conduction in the heart and may appear as an abnormal tracing of the heart's electrical activity (ECG). In some cases, it may be potentially life-threatening.
• You do not respond to stimuli (changes in internal or external environment), have a low level of consciousness or lose consciousness, or suffer seizures (fits).
• You develop involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.
• You develop diabetes – a condition where the body is unable to properly regulate blood sugar levels. You may feel very thirsty, pass large amounts of urine, and have increased appetite despite feeling tired and lethargic. If untreated, this may lead to coma or potentially fatal complications from uncontrolled diabetes.
• You experience a higher number of infections, such as sore throat, mouth ulcers, etc., which may be caused by a decrease in white blood cells, including those that help protect you against bacterial infections.
• You develop a lung infection caused by inhaling food into the airways or have lung congestion (e.g., due to mucus buildup).
• You develop a skin infection (usually in the fatty layers of the thighs and buttocks) (cellulitis).
• You are unable to urinate or experience incomplete bladder emptying.
• You have severe constipation, which may be due to intestinal obstruction or severe hardening or compaction of stools.

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

• You develop a severe rash, itching, or hives on the skin, swelling of the face, lips, tongue, or throat, shortness of breath, difficulty breathing, dizziness, or shock. These may be signs of a severe allergic reaction or angioedema.
• You develop blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
• You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
• You experience a prolonged or painful erection. This is called priapism. Immediate medical treatment may be necessary.
• You have severe stomach pain radiating to your back. This may be a symptom of pancreas inflammation.
• You develop increased eye pressure (glaucoma), which may cause vision problems and, over time, serious vision damage.
• Lower-than-normal sodium levels in the blood, which may cause weakness, confusion, and muscle pain. This may be due to inappropriate secretion of the hormone (ADH), leading to water retention by the body and dilution of the blood, thereby reducing sodium levels. This may be associated with dangerously excessive water intake (more than 2 litres of water per day).
• You experience severe fatigue or muscle pain, which may be due to breakdown of muscle tissue (rhabdomyolysis).

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

• You experience loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heartbeat, unusual muscle pain, or feel weak, tired, or unwell. These may be signs of a rare, potentially fatal complication of uncontrolled diabetes called diabetic ketoacidosis.

Seek immediate medical advice if you experience any of the adverse effects listed above.

The following adverse effects may also occur:

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

• Parkinsonism. A medical term encompassing many symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: increased salivation or drooling, musculoskeletal rigidity, drooling, jerking movements when bending joints, slow, reduced, or impaired body movements, expressionless face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, rapid steps, lack of normal arm swing when walking, persistent blinking in response to tapping the forehead (an abnormal reflex).
• Headaches, difficulty falling or staying asleep.
• Drowsiness, sleepiness.

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

• Fatigue, unusual weakness (asthenia), feeling tired, drowsiness or lack of energy (lethargy), restlessness, inability to sit still, anxiety, depression, agitation, dizziness, feeling tired, sleep disturbances.
• Vomiting, diarrhoea, constipation, nausea, heartburn or indigestion, stomach pain or discomfort, sore throat, dry mouth, toothache.
• Weight gain, increased body temperature (high fever), increased appetite, loss of appetite.
• Shortness of breath, flu, blurred vision, eye infection or allergic reaction causing sticky discharge, sinus infection, nasal or sinus congestion, nosebleeds, cough.
• Urinary tract infection, bedwetting, inability to control urine (incontinence), inability to control when to urinate.
• Tremor, muscle spasms, involuntary movements of the face, arms, or legs, repetitive movements or abnormal postures associated with muscle contractions, joint and muscle pain, back pain.
• Fluid retention in the body (e.g., swelling of arms and legs), limb pain.
• Skin rashes, redness of the skin, ear infections.
• Fast heartbeat, chest pain, high blood pressure.
• Falls.
• Increased level of the hormone prolactin in the blood.

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

• Excessive water intake, thirst, faecal incontinence, flatulence, hoarse voice, and voice disorders.
• High blood sugar.
• Bladder infection, viral infection and other infections, tonsil infection, stomach infection, fungal nail infection.
• Drop in blood pressure upon standing, low blood pressure, dizziness when changing position, awareness of heartbeat, slow heart rate.
• Pain when urinating, increased frequency of urination.
• Confusion, attention disturbance, excessive sleepiness, nightmares, nervousness, euphoria (mania).
• Increased liver enzymes, low haemoglobin or red blood cell count (anaemia), increased eosinophils (a type of white blood cell), increased blood creatine phosphokinase, decreased platelet count (blood cells that stop bleeding), increased blood cholesterol.
• Muscle weakness, excessive restlessness associated with muscle spasms and tremors, ear pain, neck pain, joint swelling, abnormal postures, joint stiffness, chest discomfort.
• Skin lesions, skin disorders, dry skin, severe itching, acne, hair loss, eczema (skin inflammation) possibly caused by mites, skin discolouration, thickened skin, flushing, sensations like pins and needles, reduced skin sensitivity to touch or pain, inflammation of oily skin.
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorders, milk secretion from the breasts, breast enlargement in men, breast pain or discomfort, decreased sex drive, irregular or delayed menstruation, vaginal discharge.
• Fainting, gait disturbances (walking problems), slowness, weight loss, decreased appetite leading to malnutrition and weight loss, feeling depressed, balance disorders, allergy, chills, abnormal coordination, altered taste.
• Painful sensitivity to light, increased ocular blood flow, dry eyes, increased tearing.
• Crackling sounds in the lungs, speech problems, difficulty swallowing, harsh or wheezing sounds when breathing.
• Ringing in the ears, sensation of spinning and dizziness (vertigo), facial swelling.

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

• Inability to achieve orgasm, breast enlargement or swelling, warmth, tender breasts.
• Dandruff.
• Coldness in the limbs, tongue swelling, lip swelling, hardening of certain body parts such as the skin.
• Lack of movement or response while awake (catatonia).
• Sleepwalking.
• Sleep-related eating disorder.
• Crusts on the eyelids, eye rolling, eye movement problems, complications during cataract surgery.
• Absence of emotion.
• Withdrawal syndrome.
• Decreased body temperature.
• Rapid and shallow breathing, breathing problems during sleep, sinus arrhythmia (a normal variation in heart rhythm caused by breathing).
• Head tremor.
• Yellowing of the skin and eyes (jaundice).
• Sugar (glucose) in the urine, low blood sugar, increased blood triglycerides (a type of fat).

Cases of low blood pressure upon standing have also been reported with medicines like risperidone, which is associated with a very high increase in heart rate.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those seen in adults.

The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy 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 (lack of control).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Risperidone Viatris

The active substance is risperidone. Each film-coated tablet contains 6 mg of risperidone.

The other components are:

Tablet core: Lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose (E-460), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.

Coating: Hypromellose (E-464), propylene glycol (E-490), titanium dioxide (E-171), talc (E-553B), quinoline yellow (E-104) and sunset yellow (E-110).

Appearance of the product and contents of the container

Yellow, round, biconvex, film-coated tablet marked with a "6" on one side and a score line on the other side.

Pack sizes

Blister packs containing 20, 28, 30, 50, 56, 60 or 100 film-coated tablets.

Single-dose perforated blisters containing (28 × 1), (30 × 1), (56 × 1), (60 × 1) or (100 × 1) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13.
Ireland

or

Mylan Hungary Kft.
Mylan utca 1
H-2900 Komárom
Hungary

or

Mylan Dublin
Newenham Court
Northern Cross
Malahide Road
Dublin 17
Ireland

or

Logiters, Logistica Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050-306
Portugal

or

Mylan Germany GmbH
Zweigniederlassung Bad Homburg Benzstrasse 1,
61352 Bad Homburg v. d. Höhe,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Spain: Risperidona Viatris 6 mg film-coated tablets EFG
Italy: Risperidone Mylan Pharma
Netherlands: Risperidon Mylan 6 mg, filmomhulde tabletten
Portugal: Risperidona Mylan 6 mg comprimido revestido por película

Date of latest review of this leaflet: July 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/