Risperidone Aurovitas 3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Risperidone Aurovitas 3 mg film-coated tablets EFG

Read the 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Risperidona Aurovitas is and what it is used for

Risperidona Aurovitas belongs to a group of medicines called "antipsychotics".

Risperidone is used to treat the following:

• Schizophrenia, in which you may see, hear or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, in which you may feel overly excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in a condition called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer-type dementia who harm themselves or others. Alternative non-pharmacological treatments should have been tried previously.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorders.

Risperidone may help reduce the symptoms of your condition and help prevent them from returning.

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

Do not take Risperidone Aurovitas

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Risperidone Aurovitas if:

• You have any heart problems. Examples include irregular heartbeat, low blood pressure, or if you are taking medicines for blood pressure. Risperidone may reduce blood pressure. You may need a dose adjustment.
• You have any risk factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
• You have ever experienced involuntary movements of the tongue, mouth, or face.
• 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).
• You have Parkinson's disease or dementia.
• You have previously had low levels of white blood cells (with or without being caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are a man who has ever had a prolonged or painful erection.
• You have difficulty regulating body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood, or if you have a tumour that may be dependent on prolactin.
• You or a family member have a history of blood clots, as antipsychotics have been associated with blood clot formation.

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

Very rarely, patients treated with risperidone have developed a dangerously low number of a type of white blood cell needed to fight infections. Your doctor may monitor your white blood cell count.

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

Since diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking risperidone, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

During eye surgery for clouding of the lens (cataracts), the pupil (the black circle in the middle of the eye) may not dilate as needed. In addition, the iris (the coloured part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

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 Possible side effects). If these adverse effects occur, evaluation of blood prolactin levels is recommended.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You must not take risperidone if your dementia is caused by a stroke.

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

If you or your caregiver notice a sudden change in your mental state, or sudden weakness or numbness of the face, arms, or legs—especially on one side—or sudden confusion, even if brief, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

Other causes of aggressive behaviour should be ruled out before starting treatment for behavioural disorders.

If you experience fatigue during treatment with risperidone, changing the time of administration may help improve difficulties with concentration.

Before starting treatment, your weight or that of your child may be measured, and it may be monitored regularly during treatment.

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

Other medicines and Risperidone Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Medicines that act on your brain, such as those used to calm you (benzodiazepines), or some pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.

• Medicines capable of altering the electrical activity of your heart, such as those used for malaria, heart rhythm disorders, allergies (antihistamines), some antidepressants, or other medicines for mental disorders.

  • Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).

• Medicines that cause a slow heartbeat.

• Medicines that cause low potassium levels in the blood (such as some diuretics).

• Medicines for high blood pressure. Risperidone may lower blood pressure.

• Medicines for Parkinson’s disease (such as levodopa).

• Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

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

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

The following medicines may increase the effect of risperidone:

• Quinidine (used for certain types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.
• Medicines known as beta-blockers (used to treat high blood pressure).
• Phenothiazines (medicines used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Some medicines used to treat HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

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 apply to you, consult your doctor or pharmacist before taking risperidone.

Taking Risperidone Aurovitas with food, drinks and alcohol

You may take this medicine with or without food. You should avoid consuming alcohol while taking risperidone.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take it.

• Newborns of mothers who have used risperidone during the last trimester of pregnancy may experience symptoms such as tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor immediately.
• Risperidone may increase levels of a hormone called "prolactin" which may affect fertility (see Possible side effects).

Driving and using machines

Dizziness, tiredness, and vision problems have been reported during treatment with risperidone. Do not drive or operate tools or machinery without first consulting your doctor.

Risperidone Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Risperidone Aurovitas

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

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The usual initial dose is 2 mg per day, which may 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 tell you what is best for you.

Elderly patients

• The initial dose will usually be 0.5 mg twice daily.
• Your doctor may later gradually increase your dose to 1 to 2 mg twice daily.
• Your doctor will tell you what is best for you.

For the treatment of mania

Adults

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

Elderly patients

• The initial dose will usually be 0.5 mg twice daily.
• Your doctor may later gradually adjust your dose to 1 mg to 2 mg twice daily depending on your response to treatment.

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

Adults (including elderly patients)

• The initial dose will usually be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml), twice daily.
• Your doctor may later gradually adjust your dose depending on your response to treatment.
• Most people feel better with doses of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer-type dementia should not exceed 6 weeks.

Children and adolescents

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

For the treatment of conduct disorders

The dose will depend on your child's weight:

If weight is less than 50 kg:

• The initial dose will usually be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml) once daily.
• The dose may be increased every other day in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg (0.25 ml to 0.75 ml of risperidone oral solution 1 mg/ml) once daily.

If weight is 50 kg or more:

• The initial dose will usually be 0.5 mg once daily.
• The dose may be increased every other day in 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 condition being treated, all initial and subsequent doses of risperidone should be reduced by half. Dose increases should be made more slowly in these patients.

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

Method of administration

For oral use.

Swallow the tablet with water.

The score line is only intended to facilitate tablet splitting if you have difficulty swallowing the tablet whole.

If you take more Risperidone Aurovitas than you should

•

• In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing and walking, feel dizzy due to a drop in blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidone Aurovitas

• 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 to make up for forgotten doses.

If you stop taking Risperidone Aurovitas

You should not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to discontinue this treatment, they may gradually reduce your dose 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.

Tell your doctor immediately if you experience any of the following uncommon adverse effects: may affect up to 1 in 100 people

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or you have difficulty speaking, even for a short period of time. These may be signs of a stroke.
• You develop tardive dyskinesia (involuntary spasms or twitching movements of the face, tongue, or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

Tell your doctor immediately if you experience any of the following rare adverse effects: may affect up to 1 in 1,000 people

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be required.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

The following adverse effects may also occur:

Very common adverse effects: may affect more than 1 in 10 people

• Difficulty falling or staying asleep.
• Parkinsonism: This condition may include slow or impaired movement, a feeling of muscle stiffness or tightness (causing jerky movements), and sometimes a sensation of "freezing" of movement that then restarts. Other signs of parkinsonism include slow walking with shuffling steps, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Feeling drowsy or less alert.
• Headache.

Common adverse effects: may affect up to 1 in 10 people

• Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu.
• Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin occur infrequently and may include, in men, breast swelling, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast discomfort, milk discharge from the breasts, loss of menstrual periods, or other menstrual cycle problems or fertility issues.
• Weight gain, increased appetite, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, restlessness.
• Dystonia: A condition involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• Dizziness.
• Dyskinesia: A condition involving involuntary muscle movements and may include repetitive, twitching, or twisting movements, or spasms.
• Tremor (shakiness).
• Blurred vision, eye infection, or "red eye".
• Rapid heartbeat, increased blood pressure, shortness of breath.
• Sore throat, cough, nosebleeds, nasal congestion.
• 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 (tiredness), pain.
• Falls.

Uncommon adverse effects: may affect up to 1 in 100 people

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or body, viral infection, skin inflammation caused by mites.
• Decrease in a type of white blood cell that helps fight infections, decrease in the number of white blood cells, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in the number of eosinophils (a type of white blood cell) in the blood.
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake.
• Weight loss, loss of appetite leading to malnutrition and decreased body weight.
• Increased cholesterol in blood.
• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
• Seizures (epileptic fits), fainting.
• A restlessness causing movement of body parts, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin.
• Light sensitivity of the eyes, dry eyes, increased tearing, eye redness.
• Sensation of spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation in the heart, slow heartbeat, abnormal electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure, decreased blood pressure upon standing (as a result, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting up suddenly), flushing.
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, wheezing, voice disorder, breathing difficulty.
• Stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excess gas or flatulence.
• Hives (or "urticaria"), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy scalp or skin, skin disorder, skin lesion.
• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, inability to urinate, pain when urinating.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstruation, loss of menstrual periods, or other menstrual cycle problems (women).
• Breast development in men, milk discharge from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
• Swelling of the face, mouth, eyes, or lips.
• Chills, increased body temperature.
• Change in walking pattern.
• Thirst sensation, feeling unwell, chest discomfort, feeling "under the weather", malaise.
• Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood.
• Pain due to the procedure.

Rare adverse effects: may affect up to 1 in 1,000 people

• Infection.
• Inappropriate secretion of a hormone that controls urine volume.
• Sleepwalking.
• Sleep-related eating disorder.
• Sugar in urine, decreased blood sugar, increased triglycerides in blood (a type of fat).
• Absence of emotions, inability to achieve orgasm.
• Not moving or responding while awake (catatonia).
• Problems with blood vessels in the brain.
• Coma due to uncontrolled diabetes.
• Head agitation.
• Glaucoma (increased pressure inside the eyeball), problems with eye movement, eye rolling, crusts on the eyelid margin.
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.
• Dangerously low number of a type of white blood cell needed to fight infections in the blood.
• Dangerously excessive water intake.
• Irregular heartbeat.
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
• Inflammation of the pancreas, intestinal obstruction.
• Swelling of the tongue, cracked lips, drug-related skin rash.
• Dandruff.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, increased mammary glands, breast enlargement, milk discharge from the breasts.
• Increased insulin (a hormone that controls blood sugar levels) in blood.
• Skin hardening.
• Decreased body temperature, coldness in arms and legs.
• Medication withdrawal syndrome.
• Yellowing of the skin and eyes (jaundice).

Very rare adverse effects: may affect up to 1 in 10,000 people

• Life-threatening complications of uncontrolled diabetes.
• Severe allergic reaction with swelling, which may affect the throat causing difficulty breathing.
• Lack of movement in intestinal muscles causing obstruction.

Frequency not known: cannot be estimated from available data

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

The following adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with risperidone: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those observed 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, symptoms of common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (lack of bladder control).

Reporting of adverse effects

If you experience any adverse effect, talk to 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Aurovitas

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

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

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risperidone Aurovitas

• The active substance is risperidone. Each film-coated tablet contains 3 mg of risperidone.
• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica, magnesium stearate (E470b).

Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (PEG 400), quinoline yellow (E104).

Appearance of the product and contents of the pack

Your medicine consists of film-coated tablets.

The 3 mg tablets are yellow, capsule-shaped, biconvex, with the mark “A” on one side and “53” on the other. There is a score line between the “5” and the “3”. The tablet can be divided into equal halves.

Risperidone Aurovitas 3 mg film-coated tablets EFG is available in blister packs containing 20 and 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:	Risperidone AB 3 mg film-coated tablets
Cyprus:	Risperidone Aurobindo 3 mg film-coated tablets
Malta:	Risperidone Aurobindo 3 mg film-coated tablets
Spain:	Risperidone Aurovitas 3 mg film-coated tablets EFG
Portugal:	Risperidone Ritisca

Date of the most recent review of this leaflet: 04/2023

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