Risperidone Aurovitas 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risperidone Aurovitas 1 mg/ml oral solution 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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, a condition 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, a condition in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in an illness called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's type dementia who are a danger to themselves or others. Alternative non-pharmacological treatments should have been tried first.
• 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 illness and prevent them from returning.

2. What you need to know before taking Risperidona Aurovitas

Do not take Risperidona Aurovitas

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidona Aurovitas:

• If you have any heart problems. Examples include irregular heartbeat, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone may lower blood pressure. You may need a dose adjustment.
• If you have any risk factors that may make you more likely to have a stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
• 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 or dementia.
• If you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• If you are diabetic.
• If you have epilepsy.
• If you are male and have ever had a prolonged or painful erection.
• If you have difficulty regulating body temperature or feel excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If you have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
• If you or a family member has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the above applies 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 cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have 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.

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.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. Additionally, the iris (the colored 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.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should 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 if you speak in a confused manner, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

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

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

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

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.

Other medicines and Risperidona Aurovitas

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

It is especially important to 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 that can alter 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 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).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, taken 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 (such as 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 applies to you, consult your doctor or pharmacist before taking risperidone.

Taking Risperidona 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 or breastfeeding, think you may be pregnant, or plan 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.
• 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 observed during treatment with risperidone. Do not drive or operate tools or machinery without first consulting your doctor.

Risperidona Aurovitas oral solution contains benzoic acid (E210)

This medicine contains 2 mg of benzoic acid per ml of oral solution. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Risperidone Aurovitas

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

Recommended dosage:

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 a day.
• Your doctor may gradually increase your dose later to 1 mg to 2 mg twice a day.
• 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 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 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 1 mg/ml oral solution) twice daily.
• Your doctor may 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.

Use in 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 1 mg/ml oral solution) 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 1 mg/ml oral solution) 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

Oral use.

Risperidone Aurovitas oral solution

The solution comes with a syringe. Use only the syringe provided with this medicine to measure the dose prescribed by your doctor. Measure the exact dose of medication you need. Pay attention when measuring a small dose; for example, for 0.25 mg measure 0.25 ml (a quarter of a millilitre); for 0.5 mg measure 0.5 ml (half a millilitre).

Remember that each millilitre (ml) of solution corresponds to 1 mg.

Follow these steps:

• Open the bottle: press the cap down and turn it counterclockwise (figure 1).

• Take the syringe and place it into the opening of the adapter (figure 2). Invert the bottle (figure 3).

• Fill the syringe with a small amount of solution by pulling the plunger down (figure 3A), then push the plunger up to remove any possible air bubble (figure 3B). Push the plunger down to the graduation mark corresponding to the amount in millilitres (ml) prescribed by your doctor (figure 3C). Each graduation on the syringe corresponds to 0.05 ml of solution (Figure 3D).

• Turn the bottle back to its correct upright position (figure 4A). Remove the syringe from the adapter (figure 4B).

• Empty the contents of the syringe into a non-alcoholic drink (not tea), pushing the plunger to the bottom of the syringe.
• Close the bottle.
• Wash the syringe with water and allow it to air dry.

If you take more Risperidone Aurovitas than you should

Seek medical help immediately. Take the medicine packaging with you.

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 decreased 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 your regular dosing schedule. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for a missed dose.

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 stop 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 gets 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 parts of the body). 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 disorder 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 needed.
• 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 altered movement, sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a "freezing" sensation in movement that then restarts. Other signs of parkinsonism include slow shuffling walk, 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 rarely and may include, in men, breast swelling, difficulty achieving or maintaining erections, decreased sexual desire or other sexual dysfunctions. In women, symptoms 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 disorders, irritability, depression, anxiety, restlessness.
• Dystonia: A condition involving involuntary, slow or continuous muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia often 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, stomach 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 part, viral infection, skin inflammation caused by mites.
• Decreased levels of a type of white blood cell that helps fight infections, decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), anemia, decreased red blood cells, increased 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 reduced body weight.
• Increased cholesterol in the 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.
• Restlessness causing body movements, 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 on the electrocardiogram (ECG), slow heartbeat, abnormal electrical conduction of the heart (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 weak, dizzy or lose consciousness when standing up or sitting up suddenly), flushing.
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory congestion, crackling lung sounds, 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, painful urination.
• 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, malaise, chest discomfort, feeling "unwell", general discomfort.
• Increased liver transaminases in blood, increased GGT (an enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood.
• Procedure-related pain.

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, low 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 eye), eye movement problems, eye rolling, crusts at the edge of the eyelid.
• Eye problems during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need 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.
• Drug 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 breathing difficulty.
• Lack of movement in intestinal muscles leading to obstruction.

Frequency not known: cannot be estimated from available data

• Severe or potentially life-threatening skin 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 use of another medicine called paliperidone, which is very similar to risperidone, and therefore may also be expected 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 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, 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, 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: 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.

This medicine does not require any special storage conditions.

Use within 3 months after first opening.

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

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

6. Contents of the container and other information

Composition of Risperidone Aurovitas

• The active substance is risperidone. Each ml contains 1 mg of risperidone.
• The other components are: benzoic acid, concentrated hydrochloric acid (for pH adjustment), purified water.

Appearance of the product and contents of the container

Risperidone Aurovitas 1 mg/ml oral solution is a clear, colourless liquid.

30 ml: amber glass bottle (type III) of 630 ml, with a white opaque polypropylene child-resistant closure, in a cardboard box which also includes a 3 ml graduated syringe, graduated every 0.025 ml, with an adapter.

100 ml: amber glass bottle (type III) of 125 ml, with a white opaque polypropylene child-resistant closure, in a cardboard box which also includes a 3 ml graduated syringe, graduated every 0.205 ml, with an adapter.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Spain:	Risperidone Aurovitas 1 mg/ml oral solution EFG
Portugal:	Risperidone Aurovitas

Date of the most recent review of this leaflet: January 2022March 2026

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