Label: information for the user

Risperidone Viatris 4 mg film-coated tablets EFG

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Risperidone Viatris and how it is used

2. What you need to know before starting to take Risperidone Viatris

3. How to take Risperidone Viatris

4. Possible adverse effects

5. Storage of Risperidone Viatris

6. Contents of the package and additional information

Risperidona belongs to a group of medications called “anti-psychotics”.

Risperidona is used to treat the following:

• Schizophrenia, which is characterized by hearing, seeing, or feeling things that are not present, believing something that is not true, or feeling suspicious in an unusual way, or confusion.
• Mania, which is characterized by feeling extremely excited, euphoric, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer's dementia, who self-harm or harm others. Previously, alternative treatments (non-pharmacological) must have been used.

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

Do not take Risperidona Viatris:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidona 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 a weakened heart muscle (heart failure), have had a heart attack, are prone to low blood pressure, or are taking medications for high blood pressure. Risperidone may cause low blood pressure and it may be necessary to adjust your dose.
• If you, or a family member, have a history of irregular heart rhythm, as this medication has been associated with potentially serious changes in heart rhythm.
• If you have any factor that may increase the risk of a blood clot, such as high blood pressure, cardiovascular disease, or problems with cerebral blood vessels.
• If you have any factor that may increase the risk of a blood clot, such as smoking, or have smoked, or are likely to be immobile for a long period of time (for example, after surgery or illness).
• If you, or a family member, have a history of blood clots, as these medications have been associated with the formation of blood clots.
• If you have low levels of white blood cells in your blood, especially if these have appeared while taking other medications.
• If you have ever experienced involuntary movements of the tongue, mouth, and face.
• If you have ever had a condition with the following symptoms: fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease (a brain disorder that affects movement, such as tremors, postural rigidity, slow movements, and displacement) or dementia (a general decline in all areas of mental ability, such as memory loss and other mental abilities), especially Lewy body dementia (abnormal protein aggregates that develop within nerve cells in Parkinson's disease).
• If you are diabetic or at risk of developing diabetes (you may have high 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 controlling your body temperature, are prone to excessive heat, or are exposed to very high temperatures or extreme exercise.
• If you are, or become, dehydrated or have low blood volume (hypovolemia) during treatment.
• If you have low levels of potassium or magnesium in your blood.
• If you have kidney problems.
• If you have liver problems.
• If you have an abnormally high level of prolactin hormone in your blood or have a tumor that may be dependent on prolactin.

If you are unsure whether this 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, so your doctor may perform blood tests before and after treatment.

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

Risperidone has been associated with diabetes or worsening of pre-existing diabetes in patients taking risperidone, so your doctor should check your blood sugar levels. Patients with pre-existing diabetes should regularly control their blood sugar (glucose) levels.

Risperidone increases prolactin hormone levels, which can cause adverse effects such as menstrual disorders or fertility problems in women or breast enlargement in men (see Possible Adverse Reactions). If these adverse effects appear, it is recommended to evaluate your prolactin blood levels.

If you are undergoing eye surgery, inform your doctor or hospital staff that you are taking this medication. During cataract surgery (a clouding of the lens in the eye), this medication may affect the pupil or iris (colored part of the eye), which could cause eye damage.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of embolism or mini-embolism (also known as transient ischemic attack or TIA). Do not take risperidone if you have dementia caused by an embolism.

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

You should seek immediate medical attention if you or your caregiver notice a sudden change in your mental state, sudden weakness, numbness in the face, arms, or legs, especially on one side, vision problems, or difficulty speaking, even if only for a short period. These may be signs of an embolism.

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 regularly monitored during treatment.

If during treatment you experience fatigue, a change in dosage time may improve attention difficulties.

A small, inconclusive study has reported an increase in height in children taking risperidone, but it is unknown whether this is a medication effect or due to another reason.

Taking Risperidona Viatris with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications and herbal remedies.

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

• Medications that act on your brain to, for example, help you relax (benzodiazepines) or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase the sedative effect of all of them.
• Medications capable of modifying the electrical activity of your heart, such as those used for malaria (quinine, mefloquine), heart rhythm problems (such as quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), allergies (antihistamines), some antidepressants (such as paroxetine, fluoxetine, sertraline, fluvoxamine, tricyclic antidepressants (such as amitriptyline), tetracyclic antidepressants (such as maprotiline) or other medications for mental health conditions (such as paliperidone or phenothiazines, used to treat psychosis or to calm down).
• Medications that cause a decrease in heart rate, such as beta-blockers or verapamil (used to treat high blood pressure or angina).
• Medications that may cause a decrease in potassium or magnesium levels in the blood (for example, certain diuretics).
• Medications for high blood pressure. Risperidone may cause a decrease in blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Medications that increase the activity of the central nervous system (psychoestimulants, such as methylphenidate).
• Tablets for fluid retention (diuretics) used to treat heart problems or swelling in some parts of your body, due to fluid accumulation (such as furosemide or chlorothiazide). Risperidone taken alone or in combination with furosemide may increase the risk of embolism or death in patients with advanced age and dementia.

The following medications reduce the effect of risperidone:

• Rifampicin (a medication for treating some infections).
• Carbamazepine, phenytoin (medications for epilepsy).
• Phenobarbital.

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

The following medications increase the effect of risperidone:

• Cimetidine, ranitidine (gastric acid blockers).
• Itraconazole and ketoconazole (medications used for treating fungal infections).
• Some medications used for treating HIV/AIDS, such as ritonavir.

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

If you are unsure whether this applies to you, consult your doctor or pharmacist before taking risperidone.

Taking Risperidona 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take it.

The following symptoms may appear in newborns of mothers who have taken risperidone in the last trimester (the last three months of pregnancy): tremors, muscle stiffness, agitation, difficulty breathing, and difficulty feeding. If your baby shows any of these symptoms, you may need to contact your doctor.

Risperidone may increase prolactin hormone levels, which can affect fertility (see section 4, "Possible Adverse Reactions").

Driving and using machines

During treatment with risperidone, you may experience dizziness, fatigue, and vision problems. Do not drive or operate tools or machines without consulting your doctor first.

Risperidona Viatris contains lactose

If your doctor has told you that you have intolerance to certain sugars, consult with them before taking this medication.

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

Risperidona Viatris 2 mg and 6 mgcontainsyellow orange

This medication may cause allergic reactions because it contains yellow orange (E110). It may cause asthma, especially in patients allergic to aspirin.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 varies from person to person.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The initial recommended dose is 2 mg per day, which can be increased to 4 mg per day on the second day of treatment.
• Depending on how you respond to treatment, your doctor may adjust your dose.
• Most people feel improvement with daily doses of 4 to 6 mg.
• The total daily dose can be divided between one or two doses per day. Your doctor will inform you which dose is most suitable for you.

Older adults

• The initial recommended dose is usually 0.5 mg twice a day.
• The dose can be gradually increased by your doctor to 1 mg or 2 mg twice a day.
• Your doctor will inform you which dose is most suitable for you.

Use in children and adolescents

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

For the treatment of mania

Adults

• The initial recommended dose is usually 2 mg once a day.
• The dose can be gradually adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with doses of 1 to 6 mg once a day.

Older adults

• The initial recommended dose is usually 0.5 mg twice a day.

• The dose can be gradually adjusted by your doctor to 1 mg or 2 mg twice a day depending on how you respond to treatment.

Use in children and adolescents

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

For the treatment of prolonged aggression in patients with Alzheimer's disease

Adults (including older adults)

• The initial recommended dose is usually 0.25 mg twice a day.
• The dose can be gradually adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with 0.5 mg twice a day. Some patients require a dose of 1 mg twice a day.
• Treatment in patients with Alzheimer's disease should not be prolonged for more than 6 weeks.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on the child's weight:

For children weighing less than 50 kg:

• The initial recommended dose is usually 0.25 mg once a day.
• The dose can be increased on alternate days by amounts of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once a day.

For children weighing 50 kg or more:

• The initial recommended dose is usually 0.5 mg once a day.
• The dose can be increased on alternate days by amounts of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once a day.

Treatment in patients with behavioral disorders should not be prolonged for more than 6 weeks.

Children under 5 years old should not be treated with risperidone for behavioral disorders.

Patients with kidney or liver problems

Regardless of why you are taking this medication, all initial and subsequent doses should be reduced by half. The increase in dose should be slower in these patients.

Risperidone should be used with caution in this group of patients.

How to take risperidone

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

The tablet can be divided into equal doses.

If you take more Risperidona Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

In case of overdose, you may feel drowsy or tired, have abnormal body movements, have trouble standing or walking, feel dizzy due to low blood pressure, or experience a rapid or abnormal heart rate or seizures.

If you forget to take Risperidona 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 usual dosing schedule. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to compensate for the missed doses.

If you interrupt treatment with Risperidona Viatris

You should not stop taking this medication unless your doctor tells you to. It is possible that symptoms will reappear. If your doctor decides to stop treatment, the dose should be gradually reduced over a few days.

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

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

Consult your doctoror go to the emergency department of a hospitalimmediately if:

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

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

Infrequent (can affect up to 1 in 100 people):

• You experience a sudden change in your 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 of time. These may be signs of a blood clot, mini-stroke (TIA, transient ischemic attack) or decreased blood flow to the brain.
• You experience an abnormal heart rhythm, such as fluttering of the heart (fibrillation) or a very slow or abnormal heart rate (heart block). This can be caused by an abnormal electrical conduction of the heart and may be seen as an abnormal tracing of the heart's electrical activity (ECG). In some cases, it can be potentially fatal.
• You do not respond to stimuli (change in internal or external environment), have a low level of consciousness or become unconscious, or experience seizures (convulsions).
• You develop involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue risperidone.
• You develop diabetes – a condition where the body is unable to control blood sugar levels properly. You may feel very thirsty, but with increased urine output, have an increased appetite despite feeling tired and lethargic. If left untreated, it can cause a coma, or potentially fatal complications of uncontrolled diabetes.
• You experience an increased 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 respiratory tract or have a lung congestion (e.g., due to a buildup of mucus).
• You develop a skin infection (usually in the fatty layers of the thigh and buttocks (cellulitis).
• You are unable to urinate or have incomplete emptying of the bladder.
• You experience severe constipation, which may be due to intestinal obstruction or severe hardening or compaction of stool.

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

• You develop a severe rash, itching or urticaria on the skin, swelling of the face, lips, tongue or throat, shortness of breath, difficulty breathing, dizziness and 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 swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• You develop fever, muscle rigidity, sweating or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• If you experience a prolonged or painful erection. This is called priapism. Immediate medical treatment may be necessary.
• You develop severe stomach pain that reaches the back. This may be a symptom of pancreatitis.
• You develop increased eye pressure (glaucoma), which can cause vision problems and, in the long term, serious vision problems.
• You have lower-than-normal sodium levels in your blood, which can cause weakness and confusion with muscle pain. This may be due to an inappropriate secretion of the hormone (ADH) that causes water retention in the body and dilutes the blood, reducing the amount of sodium. This may be associated with excessive water intake (more than 2 liters of water per day).
• You experience severe fatigue or muscle pain, which may be due to muscle tissue rupture (rhabdomyolysis).

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

• You develop loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, unusual muscle pain or feeling weak, tired or uncomfortable. These may be signs of a rare complication, potentially fatal, of uncontrolled diabetes called diabetic ketoacidosis.

Consult your doctor immediately if you experience any of the side effects described above.

The following side effects may also occur:

Very frequent (can affect more than 1 in 10 people):

• Parkinsonism. A medical term that includes many symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: increased salivation or water in the mouth, muscular rigidity, drooling, joint stiffness, slow, reduced or abnormal movement, facial expressionlessness, muscle tension, stiff neck, muscle rigidity, small, rapid and shuffling gait, lack of habitual arm movement while walking, persistent blinking in response to forehead slapping (an abnormal reflex).
• Headaches, difficulty falling asleep or staying asleep.
• Drowsiness, sleep.

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

• Fatigue, unusual weakness (asthenia), feeling tired, drowsiness or lack of energy (lethargy), restlessness, inability to remain seated, anxiety, depression, agitation, dizziness, feeling tired, sleep disorders.
• Vomiting, diarrhea, 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.
• Lack of air, common cold, blurred vision, eye infection or allergic reaction that can produce a sticky secretion, sinus infection, nasal or sinus congestion, nosebleeds, cough.
• Urinary tract infection, bedwetting, inability to control urination (incontinence), inability to control when urinating.
• Tremor, muscle spasms, involuntary movements of the face, arms or legs, repetitive movements or abnormal postures associated with muscle contractions, joint pain and muscle pain, back pain.
• Fluid retention (e.g., swelling of arms and legs), pain in the extremities.
• Hives, redness of the skin, ear infections.
• Accelerated heart rate, chest pain, high blood pressure.
• Falls.
• Increased prolactin hormone levels in the blood.

Infrequent (can affect up to 1 in 100 people):

• Excessive water intake, thirst, incontinence, gas, hoarse voice and voice disorders.
• High blood sugar.
• Urinary tract infection, viral infection and other infections, tonsillitis, stomach infection, fungal infection in the nails.
• Low blood pressure when standing up, low blood pressure, dizziness when changing position, awareness of heartbeats, decreased heart rate.
• Difficulty urinating, increased frequency of urination.
• Confusion, attention disorder, excessive sleep, nightmares, nervousness, euphoria (mania).
• Increased liver enzymes, low hemoglobin or red blood cell count (anemia), increased eosinophils (special white blood cells), increased creatine phosphokinase in the blood, decreased platelet count (blood cells that stop bleeding), increased cholesterol in the blood.
• Weakness, excessive agitation associated with muscle spasms and tremors, ear pain, neck pain, joint inflammation, abnormal postures, joint stiffness, chest discomfort.
• Skin lesions, skin disorders, dry skin, intense itching on the skin, acne, hair loss, eczema (skin inflammation) that may be caused by mites, skin discoloration, increased skin thickness, redness, sensations like pins and needles, decreased skin sensitivity to touch or pain, skin inflammation.
• Menstrual cessation, sexual dysfunction, erectile dysfunction, disorders in ejaculation, breast secretion, male breast enlargement, breast pain or discomfort, decreased libido, irregular or delayed menstruation, vaginal discharge.
• Fainting, gait disorders, slowness, weight loss, decreased appetite leading to malnutrition and weight loss, feeling depressed, balance disorders, allergy, chills, abnormal coordination, altered taste.
• Increased sensitivity to light, increased blood flow to the eyes, dry eyes, increased tearing.
• Crackling sounds in the lungs, speech disorders, difficulty swallowing, harsh or whistling sounds while breathing.
• Tinnitus in the ears, feeling of spinning and dizziness (vertigo), facial edema.

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

• Inability to achieve orgasm, breast enlargement or inflammation, heat, sensitive breasts.
• Dandruff.
• Coldness in the extremities, tongue swelling, lip inflammation, hardening of some parts of the body such as the skin.
• Absence of movement or response while awake (catatonia).
• Somnambulism.
• Sleep-related eating disorder.
• Crusts on the eyelids, eye movements, eye movement disorders, complications during cataract surgery.
• Lack of emotion.
• Withdrawal syndrome.
• Decreased body temperature.
• Shallow and rapid breathing, difficulty breathing while sleeping, sinus arrhythmia (a normal variation in heart rate caused by breathing).
• Head tremor.
• Yellow skin and eyes (jaundice).
• Sugar (glucose) in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat).

There have also been reports of low blood pressure when standing up with risperidone, which is associated with a very high increase in heart rate.

Other side effects in children and adolescents

In general, it is expected that side effects in children will be similar to those that appeared in adults.

The following side effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less attentive, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhea and urinary incontinence.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the blister pack and on the container after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.Once the bottle is opened, use within 180 days.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risperidona Viatris

The active ingredient is risperidone. Each film-coated tablet contains 4 mg of risperidone.

The other components are:

Core tablet:Lactose monohydrate, pregelatinized cornstarch, 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), yellow quinoline (E-104), indigo carmine (E-132).

Appearance of the product and contents of the package

Green, round, biconvex, film-coated tablet, marked with a “4”on one face and a notch on the other face.

Packaging sizes

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

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

Bottles containing 30, 60, 100 or 250 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder andmanufacturer

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany: Risperidon Mylan 4 mg filmtabletten

Spain: Risperidona Viatris 4 mg film-coated tablets EFG

France: Risperidone Viatris 4 mgfilm-coated tablet

Italy: Risperidone Mylan Pharma

Portugal: Risperidona Mylan 4 mg film-coated tablet

Last review date of this leaflet:July 2019

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/