Label: Information for the Patient

Risperidone Viatris 1 mg/ml Oral Solution EFG

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you 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 side effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

6. Contents of the pack and additional information

Risperidona Viatris belongs to a group of medications known as “antipsychotics”.

Risperidona Viatris is used to treat the following:

• Schizophrenia, with which you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused.
• Mania, with which you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. They must have tried alternative non-pharmacological treatments previously.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years old) and adolescents with behavioral disorders.

Risperidona Viatris may help reduce the symptoms of your disease and prevent them from returning.

Do not take Risperidona Viatris

-If you are allergic to risperidona or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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).
• You have any heart problems. Examples include irregular heart rhythm if you experience weakness of the heart muscle (heart failure), have had a heart attack, or are prone to having low blood pressure or if you use medications for high blood pressure. Risperidona may lower blood pressure. You may need to have your dose adjusted.
• You know of any factor that may make you prone to having a heart attack, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• You know of any factor that may make you prone to developing blood clots, such as smoking in the present or past, or if you are likely to be immobile for a prolonged period (for example, after surgery or illness).
• You or a family member has a history of blood clots, as this medication has been associated with their formation.
• You have or have had a low white blood cell count in the blood, particularly if this has occurred while taking other medications.
• You have ever experienced involuntary movements of the tongue, mouth, and face.
• You have ever experienced symptoms that include fever, muscle stiffness, sweating, or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease (a brain disorder that affects movement, such as tremors, rigid posture, slow movements, and dragging the feet) or dementia (a general decline in intellectual ability, such as memory loss and other mental faculties), particularly Lewy body dementia (a collection of abnormal proteins that appear inside brain cells in Parkinson's disease).
• You are diabetic or at risk of developing diabetes (you may have high blood sugar levels).
• You have epilepsy.
• You are male and have ever experienced prolonged or painful erections.
• You have difficulty controlling your body temperature or feel excessive heat.
• You have dehydration or low blood volume (hypovolemia) during treatment.
• You have low levels of potassium or magnesium in the blood.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of prolactin in the blood or if you have a tumor that may be dependent on prolactin.

If you are unsure whether the information above affects you, consult your doctor or pharmacist before starting to take risperidona.

During treatment

Risperidona may cause changes in white blood cell count, which help fight infections, so your doctor may perform blood tests before and during treatment.

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

Because an increase in the appearance of diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking risperidona, your doctor should determine if there are signs of high blood sugar levels. In patients with a history of diabetes mellitus, blood sugar levels should be regularly controlled.

It is common for risperidona to increase levels of a hormone called "prolactin." This could cause adverse effects, such as menstrual disorders or fertility problems in women, breast swelling in men, decreased libido, impotence, and spontaneous milk secretion from the mammary glands (see "Possible adverse effects"). If such adverse effects occur, it is recommended to evaluate prolactin levels in the blood.

If you are scheduled to undergo 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 (the colored part of the eye) and cause eye injury.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of having a stroke (also known as transient ischemic attack or TIA). Do not take risperidona if you have dementia caused by a stroke. During treatment with risperidona, you should see your doctor frequently.

If you or your caregiver observe a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or speak confusedly, even for a short time, seek medical treatment immediately. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for conduct disorders.

Before starting treatment, your child's body weight should be measured and monitored periodically.

If during treatment with risperidona you experience fatigue, changing the administration times may improve your difficulties with attention.

A small, inconclusive study has shown an increase in height in children who received risperidona, but it is unknown whether this is due to the effect of the medication or other reasons.

Other medications and Risperidona Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Medications that act on your brain, such as those used to calm down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidona may increase their sedative effect.
• Medications capable of modifying the electrical activity of your heart, such as those used for malaria (quinine, mefloquine), heart rhythm problems (such as quinidina, disopiramida, procainamida, propafenona, amiodarona, sotalol), allergies (antihistamines), some antidepressants, antidepressants tricyclic (such as maprotilina), or other medications for mental health problems.
• Medications that cause slow heart rate, such as beta-blockers or verapamilo (used to treat high blood pressure or angina pectoris).
• Medications that cause low potassium levels in the blood (for example: some diuretics).
• Medications for high blood pressure. Risperidona may lower blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Medications that increase the activity of the central nervous system (psychoestimulants, such as metilfenidato).
• Diuretics, which are used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or hidroclorotiazida). Risperidona, taken alone or with furosemide, may increase the risk of stroke or death in patients with advanced age and dementia.

The following medications may reduce the effect of risperidona:

• Rifampicina (a medication used to treat some infections).
• Carbamazepina, fenitoína (medications used to treat epilepsy).
• Fenobarbital.

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

The following medications may increase the effect of risperidona:

• Quinidina (used to treat certain types of heart disease).
• Antidepressants such as paroxetina, fluoxetina, sertralina, fluvoxamina, and tricyclic antidepressants (such as amitriptilina).
• Medications known as beta-blockers and verapamilo (used to treat high blood pressure).
• Fenotiazinas, paliperidona oral (for example, used to treat psychosis or as sedatives).
• Cimetidina, ranitidina (gastric acid blockers).
• Itraconazol and ketoconazol (medications used to treat fungal infections).
• Certain medications used to treat HIV/AIDS, such as ritonavir.

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

If you are unsure whether the information above affects you, consult your doctor or pharmacist before using risperidona.

Taking Risperidona Viatris with alcohol

You should avoid consuming alcohol while taking risperidona.

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 took risperidona in the last trimester of pregnancy (last three months): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby experiences any of these symptoms, contact your doctor.
• Risperidona may increase levels of a hormone called "prolactin" that may affect fertility in women or men (see section 4 Possible adverse effects).

Driving and operating machinery

Dizziness, fatigue, and vision problems have been observed during treatment with risperidona. Do not drive or operate tools or machinery without consulting your doctor first.

Risperidona Viatris contains benzoic acid (E-210)

This medication contains 1.5 mg of benzoic acid in each ml of oral solution. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day, which can be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose depending on how you respond to treatment.
• Most people feel better with daily doses of 4 mg to 6 mg.
• This total daily dose can be divided into one or two doses per day. Your doctor will indicate what dose is best for you.

Patients with advanced age

• The initial dose will normally be 0.5 mg, twice a day.
• Later, your doctor will gradually increase the dose to 1 mg to 2 mg, twice a day.
• Your doctor will indicate what dose is best for you.

For the treatment of mania

Adults

• The initial dose will normally be 2 mg, once a day.
• Your doctor may later adjust the dose gradually depending on your response to treatment.
• Most people feel better with daily doses of 1 mg to 6 mg.

Patients with advanced age

• The initial dose will normally be 0.5 mg, twice a day.
• Your doctor may later adjust the dose gradually to 1 mg to 2 mg, twice a day, depending on your response to treatment.

For the treatment of long-term aggression in people with Alzheimer's disease

Adults (including patients with advanced age)

• The initial dose will normally be 0.25 mg, twice a day.
• Your doctor may later change the dose gradually depending on your response to treatment.
• Most people feel better with doses of 0.5 mg twice a day. Some patients may need 1 mg twice a day.
• The duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years should not receive treatment with Risperidona Viatris for schizophrenia or mania.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than50 kg

• The initial dose will normally be 0.25 mg, once a day.
• The dose can be increased, one day yes and one day no, in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg, once a day.

If they weigh50 kgor more

• The initial dose will normally be 0.5 mg, once a day.
• The dose can be increased, one day yes and one day no, in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg, once a day.

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

Children under 5 years should not receive treatment with risperidone for behavioral disorders.

People with liver or kidney problems

Unless the disease being treated is taken into account, all initial doses and subsequent doses of risperidone should be reduced to half. Dose increases should be made more slowly in these patients.

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

How to take Risperidona Viatris

Your doctor will indicate how much medication you should take and for how long. This will depend on your disease and varies from person to person.

The solution comes with a syringe. You should use it to measure the exact amount of medication you need.

Follow these steps:

1. Remove the child-resistant cap. Push the plastic cap down, turning it at the same time against the direction of the clock (Figure 1).
2. Insert the syringe into the bottle.
3. Holding the lower ring, pull the upper ring up to the mark corresponding to the number of ml or mg you should administer (Figure 2).
4. Holding the lower ring, remove the syringe from the bottle (Figure 3).
5. Empty the pipette into a non-alcoholic drink that is not tea. Slide the upper ring down.
6. Close the bottle.
7. Wash the syringe with water.

If you take more Risperidona Viatris than you should

• Go to your doctor immediately. Bring the medication packaging with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidona Viatris

• If you forget to take a dose, take it as soon as you remember. But if it's almost time for your next dose, skip the missed one and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for the missed ones.

If you interrupt treatment with Risperidona Viatris

You should not stop taking the treatment unless your doctor tells you to. Symptoms may reappear, or you may experience nausea, vomiting, sweating, difficulty sleeping, and involuntary movement disorders. If your doctor decides to stop treatment, the dose may 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.

Contact your doctor immediately orgo to the emergency department of a hospitalif you experience any of the following side effects:

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

• Development of lung infections, including severe lung infections such as pneumonia – may present with an increase in body temperature, cough with mucus, which may be bloody or frothy, and feeling very unwell.

Less frequent (can affect up to 1 in 100 people):

• Weakness or sudden numbness of the face, arms, or legs, especially on one side, cases of vision problems or difficulty speaking that last less than 24 hours. These may be signs of a mini-stroke (TIA), stroke, or reduced blood flow to the brain.
• Abnormal heart rhythm, such as palpitations (fibrillation), very slow or abnormal heart rhythm (heart block). These may be caused by abnormal heart electrical conduction and may be detected as an abnormality of heart electrical activity (electrocardiogram or ECG). In some cases, this may be potentially fatal.
• Lack of response to stimuli (change in internal or external environment),decreased consciousness or loss of consciousness, or seizures.
• Involuntary rhythmic movements of the tongue, mouth, and face. May require discontinuation of risperidone.
• Development of diabetes – occurs when the body is unable to control blood sugar levels correctly. May have excessive thirst, frequent need to urinate, increased appetite, fatigue, and drowsiness. If not treated, may fall into a coma or have complications resulting from uncontrolled diabetes.
• Infections with symptoms such as fever and severe deterioration of general condition, or fever with symptoms of local infection such as sore throat or mouth. Risperidone may cause a significant decrease in the number of white blood cells in the blood and, as a result, decrease resistance to infections. Blood tests will be performed to check if there is a possible reduction in white blood cells in the blood. It is essential to inform your doctor that you are taking this medicine.
• Pulmonary infection caused by the passage of food into the respiratory tract, pulmonary congestion (e.g., due to accumulation of mucus).
• Cellulitis, usually in the thighs and buttocks.
• Inability to urinate or incomplete emptying of the bladder.
• Severe constipation, which may be due to intestinal obstruction or hardening and compaction of feces.

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

• Severe allergic reaction causing difficulty breathing and shock, swollen face, sudden swelling of the lips and eyes, tongue or throat, difficulty swallowing, urticaria, and decreased blood pressure.
• Unexplained muscle pain, muscle cramps, or muscle weakness (rhabdomyolysis).
• Thrombosis in veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels of the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, go to the doctor immediately.
• Fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). May require immediate medical treatment.
• Prolonged or painful erection, called priapism. May require immediate medical treatment.
• Abdominal pain radiating to the back. This may be a symptom of pancreatitis inflammation.
• Increased eye pressure (glaucoma), which may cause vision problems and serious vision problems over time.
• Decreased normal sodium levels in the blood, which may make you feel weak, confused, and have muscle pain. This may be due to inadequate secretion of the hormone (ADH), which makes the body retain water and dilute the blood, reducing the amount of sodium. May be associated with excessive intake of large amounts of water (more than 2 liters of water per day).

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

• 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 potentially fatal, rare complication of uncontrolled diabetes, called diabetic ketoacidosis.

Other side effects may also appear:

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

•Parkinsonism. A medical term that includes several symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: increased salivation or very moist mouth, muscle stiffness, drooling, pain when bending the limbs, slower, reduced, or difficult body movements, lack of facial expression, muscle tension, torticollis, muscle stiffness, short and rapid steps, dragging the feet, and absence of normal arm, parpadeo persistent as a response to forehead taps (an abnormal reflex).

•Headache, difficulty falling or staying asleep.

•Drowsiness, somnolence.

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

•Fatigue, tiredness, inability to remain calm, anxiety, somnolence, depression, agitation, dizziness, feeling of exhaustion, sleep disturbance.

•Vomiting, diarrhea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache.

•Weight gain, increased body temperature, increased appetite, decreased appetite.

•Lack of breath, flu, blurred vision, eye infection or allergic reactions that may produce a sticky secretion, nasal congestion, nosebleed, cough.

•Urinary tract infection, urinating in bed, inability to control urine flow (incontinence).

•Tremor, muscle cramps, involuntary movements of the face or arms and legs, repetitive movements or abnormal postures associated with muscle contractions, muscle pain and joint pain, back pain.

• Fluid retention in the body (e.g., swelling of arms and legs), pain in arms and legs.

•Rash, skin redness, ear infections.

•Fast heart rate, chest pain, increased blood pressure.

•Falls.

•Increased concentration of prolactin hormone in the blood.

Less frequent (can affect up to 1 in 100 people):

•Excessive water intake, thirst, incontinence, gas, snoring or voice disorder.

• High blood sugar levels.

•Urinary tract infection, viral infection, and other infections, tonsillitis, stomach infection, eye secretion, fungal nail infection.

•Low blood pressure when standing up, decreased blood pressure, feeling of dizziness when changing position, feeling heartbeats, slow heart rate.

•Difficulty urinating, frequent urination.

•Confusion, attention disorder, excessive sleep, nightmares, nervousness, manic state.

•Increased liver enzymes, decreased hemoglobin or red blood cell count (anemia), increased eosinophils (special white blood cells), increased creatine phosphokinase, decreased platelet count (blood cells that help stop bleeding), increased cholesterol in the blood.

•Weakness, excessive restlessness associated with muscle spasms and tremor, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort.

•Skin lesion, skin disorder, dry skin, intense itching, acne, hair loss, eczema (skin inflammation), which may be due to mites, skin discoloration, skin thickening, blush, feeling of pinpricks, reduced skin sensitivity to pain or touch, skin inflammation, skin fat inflammation.

•Amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in men, breast pain or discomfort, irregular or delayed menstruation, vaginal secretion.

•Loss of consciousness, gait disorder (walking style), inactivity, weight loss, reduced appetite with malnutrition and weight loss, feeling of "indisposition", balance disorder, allergy, chills, coordination anomaly, taste disturbances.

•Increased sensitivity to light, increased blood flow to the eye, dry eyes, increased tear production.

•Crackling sounds from the lungs, speech difficulties, difficulty swallowing, hoarse or hissing sound when breathing.

•Tinnitus, feeling of movement and dizziness (vertigo), facial edema.

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

•Inability to achieve orgasm, breast enlargement, breast sensitivity and swelling.

•Dandruff.

•Coldness in arms and legs, tongue swelling, lip inflammation, hardening of body parts such as skin.

• Lack of movement or response while awake (catatonia).
• Somnambulism.
• Sleep-related eating disorder.

•Formation of crusts on the eyelid edge, eye movement,eye movement problems,complications during cataract surgery.

•Lack of emotions.

•Medication withdrawal syndrome.

• Decreased body temperature.

•Fast and shallow breathing, respiratory problems during sleep, sinus arrhythmia (a normal variability of heart rhythm caused by breathing).

•Movement disorder.

•Tremor of the head.

•Yellow skin and eyes (jaundice).

•Presence of sugar in the urine, low blood sugar levels, high insulin and triglyceride levels in the blood.

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

•Intestinal obstruction (persistent constipation accompanied by stomach swelling and vomiting).

The following side effects have appeared with the use of another medicine called paliperidone, which is very similar to risperidone, so it is also expected to appear with risperidone: Rapid heart rate when standing up.

Unknown: Cannot be estimated from available data

• Severe skin rash or potentially fatal with blisters and skin peeling that may start in the mouth and around, nose, eyes, and genitals and spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)

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

Ifyou experience any typeof 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 Pharmacovigilance of Medicines for Human Use:https://www.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 medication after the expiration date that appears on the packaging or in the bottle, after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C). Do not refrigerate or freeze. Store in the original packaging.

Once the bottle is opened, discard any unused portion after 4 months.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Risperidone Viatris Composition

The active ingredient is risperidone. Each milliliter of oral solution contains 1 mg of risperidone.

The other components are tartaric acid (E334), benzoic acid (E210), hydrochloric acid, and purified water.

Appearance of the product and contents of the package

The oral solution is transparent and colorless. It is available in amber glass bottles with a child-resistant cap, containing 30 ml, 60 ml, 100 ml, and 120 ml.

A syringe (pipette) is included to facilitate exact measurement. A pipette cleaner is also included.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, County Galway

Ireland

or

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate,Grange Road,Dublin 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

For more information about this medication, please contact 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 European Economic Area member states with the following names:

Germany:Risperidon dura 1 mg/ml Lösung zum Einnehmen

Spain:Risperidona Viatris 1 mg/ml oral solution EFG

Italy:Risperidone Mylan Generics

Netherlands:Risperidon drank Mylan 1 mg/ml, drank

Portugal:Risperidona Mylan 1 mg/ml, solução oral

United Kingdom:Risperidone 1 mg/ml oral solution

Last review date of this leaflet:August 2024

More 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/