Package Insert: Information for the User

Risperidona Stada 1 mg/ml Oral Solution EFG

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

• Keep this package insert, 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 package insert. See section 4.

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

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

3.How to take Risperidona Stada

4.Possible adverse effects

5.Storage of Risperidona Stada

6.Contents of the package and additional information

Risperidona belongs to a group of medicines called “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 Stada:

• If you are allergic to risperidone or any of the components of this medication (including those 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 taking risperidone if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you are using blood pressure medications. Risperidone may lower your blood pressure. You may need your dose adjusted.

• You know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular diseases, or problems with the blood vessels in your brain.

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

• You have ever had symptoms that include fever, muscle stiffness, sweating, or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome).

• You have Parkinson's disease or dementia.

• You have had low white blood cell counts in the past (which may or may not have been caused by other medications).

• You are diabetic.

• You have epilepsy.

• You are male and have ever had an erection that was prolonged or painful.

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

• You have kidney problems.

• You have liver problems.

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

• You or a family member has a history of blood clotting problems, as antipsychotics have been associated with blood clotting.

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 can cause eye damage. If you are planning eye surgery, make 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 having a 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 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 if you speak confusedly, even for a short time, seek medical treatment immediately. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for 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 the height of children who took risperidone, but it is unknown whether this is due to the medication or another reason.

Other medications and Risperidona Stada

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 heart rate.

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

• Medications for high blood pressure. Risperidone may lower your 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, 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).

• Phenobarbital.

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, and 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 (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 Stada 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 taking this medication..Your doctor will decide if you can take it.

• Symptoms may occur in newborn babies, from mothers who have been treated with risperidone in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

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

Driving and using machines

Risperidone may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention, until your doctor evaluates your response to this medication.

Risperidona Stada oral solution contains sodium

This medication contains 11.10 mg of sodium (main component of table salt/for cooking) in each ml of oral solution. This is equivalent to 0.55% of the maximum daily sodium intake recommended for an adult.

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 milligrams per day, which can be increased to 4 milligrams per day on the second day.

•Your doctor may adjust your dose based on your response to treatment.

•Most people find relief with daily doses of 4 to 6 milligrams.

•This total daily dose can be divided into one or two doses per day. Your doctor will indicate what is best for you.

Older adults

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

•Your doctor may increase your dose gradually to 1 to 2 milligrams twice a day.

•Your doctor will indicate what is best for you.

For the treatment of mania

Adults

•The initial dose will be 2 milligrams once a day, usually.

•Your doctor may adjust your dose gradually based on your response to treatment.

•Most people find relief with doses of 1 to 6 milligrams once a day.

Older adults

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

•Your doctor may adjust your dose gradually to 1 milligram to 2 milligrams twice a day based 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 be 0.25 milligrams twice a day, usually.

•Your doctor may adjust your dose gradually based on your response to treatment.

•Most people find relief with doses of 0.5 milligrams twice a day. Some patients may need 1 milligram 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 kilograms

•The initial dose will be 0.25 milligrams once a day, usually.

•The dose can be increased one day yes and one day no in increments of 0.25 milligrams per day.

•The usual maintenance dose is 0.25 milligrams to 0.75 milligrams once a day.

If they weigh 50 kilograms or more

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

•The dose can be increased one day yes and one day no in increments of 0.5 milligrams per day.

•The usual maintenance dose is 0.5 milligrams to 1.5 milligrams 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

Unless the disease being treated is considered, 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 administration

Risperidone Stada oral solution

The solution comes with a syringe (pipette). Use only the pipette provided with this medication to measure the prescribed dose. Measure the exact dose of medication needed. Be careful when measuring a small dose, for example, to 0.25 mg, it is necessary to measure 0.25 ml (a quarter of a milliliter); to 0.5 mg, it is necessary to measure 0.5 ml (half a milliliter).

Follow these steps:

1.Remove the child-resistant cap. Push the plastic cap down, turning it at the same time against the direction of the clock (Figure 1).

2.Insert the pipette into the bottle.

3.Hold the lower ring and pull the upper ring until it reaches the mark corresponding to the number of milliliters or milligrams to be administered (Figure 2).

4.Hold the lower ring and remove the pipette from the bottle (Figure 3).

5.Empty the pipette into a non-alcoholic beverage that is not tea. Slide the upper ring down.

6.Close the bottle.

7.Wash the pipette with water and let it air dry.

If you take more Risperidone Stada than you should

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.

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Risperidone Stada

•If you forget to take a dose, take it as soon as you remember. But if it is almost time for your 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 compensate for the missed dose.

If you interrupt treatment with Risperidone Stada

Do 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 100 patients):

•You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in the face, arms, or legs, especially on one side, or it is difficult for you to speak even for a short period of time.This may be a sign of a stroke.

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

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

•You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel 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 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.

You may also experience the following side effects:

Very common (may affect more than 1 in 10 people):

•Difficulty staying or falling asleep.

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

•You feel drowsy or less attentive.

•Headache.

Common (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 or may not cause symptoms). Symptoms of increased prolactin occur rarely and may include in men, breast swelling, difficulty having or maintaining erections, decreased sexual desire, 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.

•Weight gain, increased appetite, decreased appetite.

•Sleep disorders, irritability, depression, anxiety, restlessness.

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

•Tremor (agitation).

•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.

Rare (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, decreased 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 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, feeling of tingling, pinching, or numbness of the skin.

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

•Feeling of spinning (vertigo), buzzing 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), feeling of fluttering or pounding in the chest (palpitations).

•Decreased blood pressure, decreased blood pressure when standing up (as a result, some people who take 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, respiratory difficulty.

•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 degradation.

•Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.

•Frequent urination, 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.

•Feeling of thirst, feeling of discomfort, chest discomfort, feeling unwell, discomfort.

•Increased 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 (may affect up to 1 in 1,000 people):

•Infection.

•Incorrect secretion of a hormone that controls urine volume.

•Somnambulism.

•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 achieve orgasm.

•Catatonia (lack of movement or response while awake).

•Problems with blood vessels in the brain.

•Diabetic coma due to uncontrolled diabetes.

•Head agitation.

•Glaucoma (increased pressure in the eyeball), eye movement problems, eye rotation, corneal ulcers.

•Eye problems during cataract surgery. During cataract surgery, there may be a condition 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.

•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.

•Thickening of the skin.

•Decreased body temperature, coldness in arms and legs.

•Medication withdrawal syndrome.

•Yellow skin and eyes (jaundice).

Very rare (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 respiratory difficulty.

•Paralysis of the muscles of the intestines, causing obstruction.

Unknown frequency: cannot be estimated from available data

•Severe or fatal skin rash with blisters and skin peeling that may start around the mouth, nose, eyes, 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: rapid heartbeat 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 (shaking), diarrhea, 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:https://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.

Do not use this medication after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Do not freeze.

Storein theoriginal packaging to protect it from light.

Once the bottle is opened, any unused Risperidona Stada oral solution should be discarded after 3 months.

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

Composition of Risperidona Stada

The active ingredient is risperidone.

Each milliliter of oral solution of Risperidona Stada contains 1 mg of risperidone.

The other components (excipients) are: sodium chloride, domifen bromide, citric acid, sodium dodecahydrate hydrogen phosphate, lemon aroma, and purified water.

Appearance of Risperidona Stada and contents of the packaging

Risperidona Stada oral solution is presented in the form of a transparent and colorless to slightly yellowish solution.

Each package contains 30 ml or 100 ml of oral solution and a dosing syringe. The smallest amount that this syringe can dose is 0.25 ml and the maximum is 3 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares (Madrid)

Spain

or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares,

Rua Oteiro de Armada, 5

Condeixa-a-Nova, 3150-194, Sebal

Portugal

Last review date of this prospectus:March 2025

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es