Product Information for the Patient

Risperidona Aurovitas 1 mg/ml Oral Solution EFG

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

-Keep this product information, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1.What is Risperidona Aurovitas and how is it used

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

3.How to take Risperidona Aurovitas

4.Possible adverse effects

5.Storage of Risperidona Aurovitas

6. Contents of the package and additional information

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

Risperidona 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. Alternative non-pharmacological treatments must have been tried 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 may help reduce the symptoms of your illness and prevent them from returning.

Do not take Risperidona Aurovitas

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

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

Warnings and precautions

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

•If you have any heart problems. Examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you use medications for high blood pressure. Risperidone 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 diseases, or problems with blood vessels in the brain.

•If you have ever had involuntary movements of the tongue, mouth, and face.

•If you have ever had a condition whose symptoms include fever, muscle stiffness, sweating, or a decrease in 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 an erection that lasted too long or was painful.

•If you have trouble controlling your body temperature or feel excessive heat.

•If you have kidney problems.

•If you have liver problems.

•If you have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.

•If you or a family member has a history of blood clot formation, as antipsychotics have been associated with blood clot formation.

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking risperidone.

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 risperidone, your doctor may check your white blood cell count.

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

Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen 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 regularly monitored.

Risperidone frequently increases levels of a hormone called prolactin. This can cause adverse effects such as menstrual disorders or fertility problems in women or breast enlargement in men (see Possible Adverse Effects). If these adverse effects appear, it is recommended to evaluate prolactin levels in the blood.

During cataract surgery, the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning eye surgery, be sure to inform your ophthalmologist that you are using this medication.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of stroke. Do not take risperidone if you have dementia caused by a stroke.

During treatment with risperidone, 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 confused speech, 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 behavioral disorders.

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

Before starting treatment, your weight or that of your child may be measured, and this should be done regularly during treatment.

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

Other medications and Risperidona Aurovitas

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:

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

•Medications capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medications for mental health problems.

•Medications that cause a slow heartbeat.

•Medications that produce a low level of potassium in the blood (such as some diuretics).

•Medications for high blood pressure. Risperidone 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 methylphenidate).

•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 chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may reduce the effect of risperidone:

•Rifampicin (a medication for treating some infections).

•Carbamazepine, phenytoin (medications for epilepsy).

•Fenobarbital.

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

The following medications may increase the effect of risperidone:

•Quinidine (used for certain types of heart disease).

•Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.

•Beta-blockers (used to treat high blood pressure).

•Phenothiazines (such as medications used to treat psychosis or as sedatives).

•Cimetidine, ranitidine (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 risperidone.

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking risperidone.

Taking Risperidona Aurovitas with food, drinks, and alcohol

You can take this medication 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 medication. Your doctor will decide if you can take it.

•Newborns of mothers who have usedrisperidonein the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn experiences any of these symptoms, contact your doctor.

•Risperidone may increase levels of a hormone called “prolactin” that may affect fertility (see Possible Adverse Effects).

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with risperidone. 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 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 or pharmacist. In case of 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.

Older adults

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

•Your doctor may later increase your dose gradually from 1 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 be 2 mg, once a day, usually.

•Your doctor may later 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.

Older adults

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

•Your doctor may later adjust your dose gradually from 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 older adults)

•The initial dose will be0.25mg (0.25 ml of risperidone 1 mg/ml oral solution), twice a day, usually.

•Your doctor may later 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 old should not receive risperidone treatment for schizophrenia or mania.

For the treatment of behavioral disorders

The dose will depend on your child's weight:

If they weigh less than 50 kg:

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

•The dose can be increased one day yes and one day no by 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 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 one day yes and one day no by 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 old should not receive risperidone treatment for behavioral disorders.

Patients with kidney or liver problems

Regardless of the disease being treated, all initial doses 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.

Administration form

Oral.

Risperidone 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 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 bubbles (figure 3B). Push the plunger down to the graduation mark corresponding to the amount in milliliters (ml) prescribed 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 contents of the syringe into a non-alcoholic beverage that is not tea, by pushing the plunger to the bottom of the syringe.

•Close the bottle

•Wash the syringe with water.

If you take more Risperidone Aurovitas than you should

Go to your doctor immediately. Bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

In case of overdose, you may feel drowsy or tired, have abnormal body movements, have trouble standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidone Aurovitas

•If you forget to take a dose, take it as soon as you remember. But if it's close to the 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 Risperidone Aurovitas

You should not stop taking this medication unless your doctor tells you to. Symptoms may reappear. If your doctor decides to stop this treatment, your 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.

Just like all medications,this medicationcan cause side effects, although not everyone will experience them.

Inform your doctor immediately ifyou experience any of the following rare side 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 in your face, arms, or legs, especially on one side, or it's hard for you to speak even for a short period of time. These may be signs of a stroke.

•You experience tardive dyskinesia (involuntary spasms or movements that cannot be controlled in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary rhythmic movements of your tongue, mouth, and face. You may need to stop taking risperidone.

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

•You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which can travel through your blood vessels to your 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 your 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. This 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 low blood pressure.

Other side effects may also occur:

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

•Difficulty staying or falling asleep.

•Parkinsonism: This condition may include: slow or altered movement, feeling of stiffness or tension in your muscles (making sudden movements), and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly while dragging your feet, resting tremor, increased saliva and/or drooling, and loss of facial expression.

•Feeling drowsy or less attentive.

•Headache.

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

•Pneumonia, chest infection (bronchitis), common cold symptoms, 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). The symptoms of increased prolactin occur rarely and may include in men: breast swelling, difficulty getting or maintaining erections, decreased sex drive, or other sexual dysfunction. In women, they may include breast discomfort, 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: This is a condition that involves involuntary slow or continuous muscle contractions. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.

•Dizziness.

•Dyskinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.

•Tremor (shakiness).

•Blurred vision, eye infection, or "red eye."

•Fast heart rate, increased blood pressure, labored breathing.

•Sore throat, cough, nasal bleeding, 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.

•Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.

•Falls.

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

•Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or part of the body, viral infection, skin inflammation caused by mites.

•Decreased white blood cell count, decreased white blood cell count, decreased platelet count, anemia, decreased red blood cell count, increased eosinophil count in the blood.

•Allergic reaction.

•Diabetes or worsening of diabetes, high blood sugar, excessive water intake.

•Weight loss, loss of appetite that causes malnutrition and weight loss.

•Increased cholesterol in the blood.

•Euphoria (mania), confusion, decreased sex drive, nervousness, nightmares.

•Lack of response to stimuli, loss of consciousness, decreased level of consciousness.

•Seizures (epileptic crises), fainting.

•Anxiety that causes movement of parts of the body, balance disorder, abnormal coordination, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of tingling, pinching, or numbness of the skin.

•Increased sensitivity of the eyes to light, dry eyes, increased tear production, eye redness.

•Sensation 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, abnormal heart activity, prolonged QT interval in the heart, slow heart rate, abnormal heart conduction (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).

•Decreased blood pressure, decreased blood pressure when standing up (as a result, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly), flushing.

•Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crepitant sounds of the lungs, wheezing, voice disorder, difficulty breathing.

•Stomach or intestinal infection, fecal incontinence, hard stools, difficulty swallowing, excessive gas or flatulence.

•Hives (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.

•Urination frequency, inability to urinate, painful urination.

•Erectile dysfunction, ejaculation disorder.

•Loss of menstrual periods, loss of menstrual periods or other problems with the cycle (women).

•Male breast development, milk secretion 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 gait.

•Sensation of thirst, feeling unwell, chest discomfort, feeling "off," discomfort.

•Increased liver enzymes 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 side effects:may affect up to 1 in 1,000 people

•Infection.

•Inadequate secretion of a hormone that controls urine volume.

•Somnambulism.

•Sleep-related eating disorder.

•High blood sugar, decreased blood sugar, increased triglycerides in the blood (a type of fat).

•Lack of emotions, inability to achieve orgasm.

•Catatonia (not moving or responding while awake).

•Problems with blood vessels in the brain.

•Diabetic coma due to uncontrolled diabetes.

•Head agitation.

•Glaucoma (increased pressure within the eyeball), eye movement problems, eye rotation, crusts on the edge of the eyelid.

•Eye problems during cataract surgery. During cataract surgery, there may be an alteration called intraoperative floppy iris syndrome (IFIS) 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 medication.

•Low white blood cell count, a type of white blood cell necessary to fight infections in the blood.

•Excessive water intake.

•Irregular heartbeat.

•Respiratory problems during sleep (sleep apnea), rapid, shallow breathing.

•Pancreatitis, intestinal obstruction.

•Swelling of the tongue, chapped lips, skin rash related to the medication.

•Dandruff.

•Muscle fiber rupture and muscle pain (rhabdomyolysis).

•Delayed menstrual periods, breast enlargement, breast secretion.

•Increased insulin (a hormone that controls blood sugar levels) in the blood.

•Hardening of the skin.

•Decreased body temperature, coldness in arms and legs.

•Medication withdrawal syndrome.

•Yellow skin and eyes (jaundice).

Very rare side 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.

•Intestinal muscle paralysis causing obstruction.

Unknown frequency: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 side effect has appeared with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to appear with risperidone: Fast heart rate when standing up.

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 (shakiness), diarrhea, and urinary incontinence.

Reporting side effects

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

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

This medication does not require special storage conditions.

Use within 3 months after the first opening.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Risperidona Aurovitas

-The active ingredient 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

Risperidona Aurovitas 1 mg/ml oral solution is a transparent and colorless liquid.

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

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

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible 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:

Last review date of this leaflet:January 2022

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