RISPERIDONE AUROVITAS 1 mg/ml ORAL SOLUTION

2. What you need to know before taking Risperidona Aurovitas

Do not take Risperidona Aurovitas

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

If you are not sure, consult your doctor or pharmacist before starting to take risperidona.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risperidona Aurovitas:

• If you have any heart problems. Examples include heart rhythm disorders, or if you are prone to having low blood pressure or if you use medications for blood pressure. Risperidona may lower blood pressure. You may need to have your dose adjusted.
• If you know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with the blood vessels in the brain.
• If you have ever had involuntary movements of the tongue, mouth, and face.
• If you have ever had a disease whose symptoms include fever, muscle stiffness, sweating, or a decrease in the level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease or dementia.
• If you have had low white blood cell counts in the past (which may or may not have been caused by other medications).
• If you are diabetic.
• If you have epilepsy.
• If you are male and have ever had a prolonged or painful erection.
• If you have problems controlling body temperature or feel excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If you have an abnormally high level of the hormone prolactin in the blood or if you have a tumor that may be dependent on prolactin.
• If you or a family member have a history of blood clot formation, as antipsychotics have been associated with blood clot formation.

If you have doubts about whether what you have read affects you, consult your doctor or pharmacist before taking risperidona.

Because in very rare cases, a dangerously low number of a type of white blood cell necessary to fight infections in the blood has been observed in patients treated with risperidona, your doctor may check your white blood cell count.

Risperidona may cause you to gain weight. A significant weight gain can affect your health unfavorably. Your doctor will regularly monitor your weight.

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

Risperidona often increases the levels of a hormone called prolactin. This can cause side effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible side effects). If these side effects appear, it is recommended to evaluate prolactin levels in the blood.

During eye surgery for cataracts, the pupil (the black circle in the center of the eye) may not increase in size as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, which can cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medication.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of having a stroke. You should 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 notice 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 confused speech, even if only for a short time, seek medical attention immediately. It may be a sign of a stroke.

Children and adolescents

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

If during treatment with risperidona you suffer from fatigue, changing the administration hours may improve your difficulties in paying attention.

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

A small and inconclusive study has reported an increase in height in children who took risperidona, but it is not known if this is a drug effect or due to another reason.

Other medications and Risperidona Aurovitas

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

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

• Medications that act on your brain, such as those used to calm you down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidona may increase their sedative effect.
• Medications that can modify the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medications for mental problems.
• Medications that cause a slow heartbeat.
• Medications that produce low potassium levels in the blood (such as 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 (psychostimulants, such as methylphenidate).
• Diuretics, which are used for heart problems or to treat swelling of some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidona, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may decrease the effect of risperidona:

• 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 risperidona.

The following medications may increase the effect of risperidona:

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

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

If you have doubts about whether what you have read affects you, consult your doctor or pharmacist before taking risperidona.

Taking Risperidona Aurovitas with food, drinks, and alcohol

You can take this medication with or without food. 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.
• Newborns of mothers who have used risperidona in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.
• Risperidona may increase the levels of a hormone called "prolactin" that can affect fertility (see Possible side effects).

Driving and using machines

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

Risperidona Aurovitas oral solution contains benzoic acid (E210)

This medication 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 Risperidona Aurovitas

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you have any doubts, 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 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 is best for you.

Elderly patients

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

For the treatment of mania

Adults

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

Elderly patients

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

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

Adults (including elderly patients)

• The initial dose will be 0.25 mg (0.25 ml of risperidona 1 mg/ml oral solution), twice a day, usually.
• Later, your doctor may adjust your 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 of age should not receive treatment with risperidona for schizophrenia or mania.

For the treatment of behavioral disorders

The dose depends on your child's weight:

If they weigh less than 50 kg:

• The initial dose will be 0.25 mg (0.25 ml of risperidona 1 mg/ml oral solution) once a day, usually.
• The dose can 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 risperidona 1 mg/ml oral solution) once a day.

If they weigh 50 kg or more:

• The initial dose will be 0.5 mg, once a day, usually.
• The dose can 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 a day.

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

Children under 5 years of age should not receive treatment with risperidona for behavioral disorders.

Patients with kidney or liver problems

Regardless of the disease being treated, all initial doses and subsequent doses of risperidona should be reduced by half. Dose increases should be made more slowly in these patients.

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

Method of administration

Oral.

Risperidona Aurovitas oral solution

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

Remember that each milliliter (ml) of solution is equivalent 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 in the adapter opening (figure 2). Invert the bottle (figure 3).

• Fill the syringe with a small amount of solution by pulling the piston down (figure 3A), then push the piston up to eliminate any possible bubbles (figure 3B). Push the piston down to the mark that corresponds to the prescribed amount in milliliters (ml) by your doctor (figure 3C).

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

• Empty the syringe contents into a non-alcoholic beverage that is not tea, pushing the piston to the bottom of the syringe.
• Close the bottle
• Wash the syringe with water.

If you take more Risperidona Aurovitas than you should

Go to the doctor immediately. Take the medication package with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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, problems standing and walking, dizziness due to low blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidona Aurovitas

• If you forget to take a dose, take it as soon as you remember. But if it is close to the time of the next dose, skip the missed dose 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 missed doses.

If you interrupt treatment with Risperidona Aurovitas

Do not stop taking this medication unless your doctor tells you to. Symptoms may return. If your doctor decides to interrupt this treatment, they may gradually decrease your dose over a few days.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor ifyou experience any of the following rare 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 have difficulty speaking even for a short period. These can be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or twitching movements that cannot be controlled in the face, tongue, or other parts of the body). Report to your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to withdraw risperidone.

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

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

The following adverse effects may also appear:

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

• Difficulty staying or falling asleep.
• Parkinsonism: This disease may include slow or altered movement, feeling of stiffness or tension in the muscles (making jerky movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors at rest, increased saliva and/or drooling, and loss of facial expressiveness.
• Feeling drowsy or less attentive.
• 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 like you have the flu.
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may cause symptoms or not). Symptoms of increased prolactin occur rarely and may include, in men, breast swelling, difficulty having or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast tenderness, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle or fertility issues.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: It is a disease that involves slow or continuous involuntary contraction of the muscles. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness.
• Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremors (shakiness).
• Blurred vision, eye infection, or "red eye."
• Fast 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 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 infection of the nails, skin infection, localized infection in a single area of the skin or body part, 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 that causes malnutrition and weight loss.
• 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.
• A restlessness that causes movement of body parts, balance disorder, abnormal coordination, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, tingling, pinching, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes.
• Feeling of spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, anomaly in the electrical activity of the heart, prolonged QT interval in the heart, slow heartbeat, anomaly in the electrical conduction of the heart (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure, decreased blood pressure when standing up (as a consequence, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when getting up or sitting up suddenly), flushing.
• Aspiration pneumonia, pulmonary congestion, respiratory tract congestion, crackling sounds in the lungs, wheezing, voice disorder, breathing difficulty.
• Stomach or intestine 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 skin or scalp, skin disorder, skin injury.
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with 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 problems with the cycle (women).
• Development of breasts in men, milk secretion from the breasts, sexual dysfunction, breast pain, breast tenderness, vaginal discharge.
• Swelling of the face, mouth, eyes, or lips.
• Chills, increased body temperature.
• Change in gait.
• Feeling of thirst, feeling of discomfort, chest discomfort, feeling "unwell," discomfort.
• Increased liver transaminases in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood.
• Pain due to the procedure.

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

• Infection.
• Inadequate secretion of a hormone that controls urine volume.
• Sleepwalking.
• Sleep-related eating disorder.
• Sugar in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat).
• Lack of emotions, inability to reach orgasm.
• Not moving or responding while being awake (catatonia).
• Problems in the blood vessels of the brain.
• Coma due to uncontrolled diabetes.
• Head shaking.
• Glaucoma (increased pressure inside the eyeball), problems with eye movement, eye rotation, 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 necessary to fight infections in the blood.
• Dangerously excessive water intake.
• Irregular heartbeat.
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Tongue swelling, cracked lips, skin rash related to the medicine.
• Dandruff.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, breast enlargement, breast swelling, milk secretion from the breasts.
• Increased insulin (a hormone that controls blood sugar levels) in the 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

• Complications of uncontrolled diabetes, life-threatening.
• Severe allergic reaction with swelling, which can affect the throat, causing difficulty breathing.
• Lack of movement of the intestinal muscles that causes obstruction.

Frequency not known:cannot be estimated from the available data

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

The following adverse effect has appeared with the use of another medicine called paliperidone, which is very similar to risperidone, so it is also expected to appear with risperidone: Fast heartbeat when standing up.

Other adverse effects in children and adolescents

In general, it is expected that the adverse effects in children will be similar to those that appeared 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 attentive, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors (shakiness), diarrhea, and urinary incontinence (loss of control).

Reporting of adverse effects

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

5. Conservation of Risperidona Aurovitas

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

This medicine does not require special storage conditions.

Use within 3 months after the first opening.

Do not use this medicine after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the drains or into the trash. Deposit the containers and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Risperidona Aurovitas

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

Appearance of the product and package contents

Risperidona Aurovitas 1 mg/ml oral solution is a clear, colorless liquid.

30 ml: 30 ml amber glass bottle (type III), with a child-resistant closure made of opaque white polypropylene, in a cardboard box that also includes a 3 ml graduated syringe every 0.25 ml, with an adapter.

100 ml: 125 ml amber glass bottle (type III), with a child-resistant closure made of opaque white polypropylene, in a cardboard box that also includes a 3 ml graduated syringe every 0.25 ml, with an adapter.

It is possible that only some package sizes are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 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 medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this leaflet:January 2022

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