RISPERIDONE BENEL 1 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone Benel 1 mg/ml oral solution EFG

Risperidone

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in the package leaflet. See section 4.

Contents of the package leaflet

1. What is Risperidone Benel and what is it used for
2. What you need to know before taking Risperidone Benel
3. How to take Risperidone Benel
4. Possible side effects
   1. Storage of Risperidone Benel
   2. Package contents and additional information

1. What is Risperidone Benel and what is it used for

Risperidone Benel belongs to a group of medications called "antipsychotics".

Risperidone 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 occurs in a disease called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's-type dementia, who harm themselves or others. Other alternative treatments (non-pharmacological) should 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.

Risperidone Benel may help reduce the symptoms of your illness and prevent them from coming back.

Benel

2. What you need to know before taking Risperidone Benel

Do not take Risperidone Benel if

• You are allergic (hypersensitive) to the active ingredient or any of the components of Risperidone Benel (listed in section 6).

If you are not sure, consult your doctor or pharmacist before taking Risperidone Benel.

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidone Benel 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. Risperidone may lower blood pressure. You may need to have your dose adjusted.
• 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 or a family member has a history of blood clots, these medications may be associated with the formation of clots.
• 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).
• You are diabetic.
• You have epilepsy.
• You are male and have had a prolonged or painful erection in the past. If you experience this while taking Risperidone, contact your doctor immediately.
• You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.

Consult your doctor immediately if you have:

• Involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Risperidone.
• Fever, severe muscle stiffness, sweating, or a low level of consciousness (a disease called "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.

If you have doubts about whether what you have read affects you, consult your doctor or pharmacist before using Risperidone Benel.

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. 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 risperidone, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored.

During eye surgery for cataracts, the pupil (the black circle in the middle 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 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 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 risperidone you experience fatigue, changing the administration hours may improve your attention difficulties.

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

Other medications and Risperidone Benel

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 products

• 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 risperidone may increase their sedative effect.
• Medications that can modify the electrical activity of your heart, such as those used for malaria, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants, or other medications for mental problems.
• Medications that cause a slow heartbeat.
• Medications that cause low potassium levels 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).
• 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 chlorthiazide). Risperidone, 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 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 (e.g., used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).

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

If you have doubts about whether what you have read affects you, consult your doctor or pharmacist before using Risperidone Benel.

Using Risperidone Benel with food, drinks, and alcohol

You can take this medication with or without food. You should avoid consuming alcohol while taking Risperidone.

Risperidone Benel 1 mg/ml oral solution should not be mixed with tea.

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 Risperidone Benel in the last trimester of pregnancy (last three months of pregnancy) may present with the following symptoms: tremors, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your child presents with any of these symptoms, contact your doctor.
• Risperidone may increase the levels of a hormone called "prolactin" that can affect fertility (see section 4. Possible side effects).

Consult your doctor or pharmacist before using any medication.

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.

Risperidone Benel contains sodium

Risperidone Benel contains approximately 11.14 mg of sodium per milliliter of solution, which should be taken into account in patients with low-sodium diets.

3. How to take Risperidone Benel

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

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

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperidone for schizophrenia.

For the treatment of mania

Adults

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

Elderly patients

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

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperidone for bipolar mania.

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

Adults (including elderly patients)

• The initial dose will normally be 0.25 mg, twice a day.
• Later, your doctor may adjust the 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-type dementia should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperidone Benel for schizophrenia or mania.

For the treatment of behavioral disorders in children and adolescents

The dose depends on your child's weight:

If they weigh less than 50 kg

• The initial dose will normally be 0.25 mg, once a day.
• The dose may be increased, one day yes and one day no, in increments of 0.25 mg per day.
• The normal maintenance dose is 0.25 mg to 0.75 mg, once a day.

If they weigh 50 kg or more

• The initial dose will normally be 0.5 mg, once a day.
• The dose may be increased, one day yes and one day no, in increments of 0.5 mg per day.
• The normal 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 Risperidone for behavioral disorders.

Patients with liver or kidney 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.

How to take Risperidone Benel

Always take Risperidone Benel exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will indicate how much medication you should take and for how long. This will depend on your illness and may vary from person to person. The amount of medication you should take is explained above in the "How much to take" section.

Risperidone Benel oral solution

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

Follow these steps:

1. Remove the child-resistant cap. Push the plastic cap down, turning it counterclockwise (Figure 1)
2. Insert the syringe into the bottle
3. Holding the lower ring, pull the upper ring up to the mark that corresponds to the number of ml or mg you should administer (Figure 2)
4. Holding the lower ring, remove the entire syringe from the bottle (Figure 3)
5. Empty the syringe into a non-alcoholic beverage that is not tea. Slide the upper ring down
6. Close the bottle
7. Rinse the syringe with water and let it air dry.

If you take more Risperidone Benel than you should

• Go to the doctor immediately. Bring the medication package with you. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.
• 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 Risperidone Benel

• If you forget to take a dose, take it as soon as you remember. But if it's 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 stop treatment with Risperidone Benel

Do not stop taking the treatment unless your doctor tells you to. The symptoms may come back. If your doctor decides to stop the treatment, your dose may be gradually decreased over a few days.

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

4. Possible Adverse Effects

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

Very common: affects more than 1 in 10 people

Common: affects between 1 and 10 in every 100 people

Uncommon: affects between 1 and 10 in every 1,000 people

Rare: affects between 1 and 10 in every 10,000 people

Very rare: affects less than 1 in 10,000 people

Unknown: frequency cannot be estimated from available data

Report immediately to your doctor if:

• Presents 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
• Has dementia and presents a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or has difficulty speaking, even for a short period. They can be signs of a stroke
• Presents fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). May require immediate medical treatment
• Is a man and presents a prolonged or painful erection. It is known as priapism. May require immediate medical treatment
• Presents rhythmic involuntary movements of the tongue, mouth, and face. May require withdrawal of risperidone
• Presents 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 side effects may appear:

Very common (affects more than 1 in 10 people)

• Difficulty staying or falling asleep
• Parkinsonism. It is a medical term that includes several symptoms. Each individual symptom may occur with less frequency than 1 in 10 people. Parkinsonism includes: feeling of stiffness or tension in the muscles (making jerky movements) and sometimes a feeling of "freezing" of movement after restarting. Other signs of parkinsonism include walking slowly, resting tremor, increased saliva secretion or very moist mouth, musculoskeletal stiffness, drooling, pain when bending limbs, slower or altered body movements, reduced or difficult, lack of facial expression, muscle tension, torticollis, muscle stiffness, short and rapid steps when walking, dragging feet, and absence of normal arm movements, persistent blinking as a response to forehead tapping (an abnormal reflex)
• Feeling drowsy or less attentive
• Headache.

Common (affects between 1 and 10 in every 100 people):

• Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling like having the flu
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). When symptoms of increased prolactin appear, they may include in men, breast swelling, difficulty having or maintaining erections, or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle
• 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
• Discinesia: 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 heartbeat, increased blood pressure, shortness of breath
• 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 (loss of control)
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Falls.

Uncommon (affects between 1 and 10 in every 1,000 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 cells that help 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)
• 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
• Late discinesia (spasms or uncontrolled muscle movements in the face, tongue, or other parts of the body). Report to your doctor immediately if you experience rhythmic involuntary movements of the tongue, mouth, and face. Withdrawal of Risperidone may be necessary
• Sudden loss of blood flow to the brain (stroke or "mini" stroke)
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness
• Seizures (epileptic crises), fainting
• A restlessness that causes movement of body parts, balance disorder, abnormal coordination, dizziness when standing up, attention alteration, 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 tearing, eye redness
• Feeling that everything spins (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, prolongation of the 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 down 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 degradation
• 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 discomfort, vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, an increase in 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 (affects between 1 and 10 in every 10,000 people):

• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sugar in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat)
• Lack of emotions, inability to reach orgasm
• Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness)
• Problems in the blood vessels of the brain
• Coma due to uncontrolled diabetes
• Head agitation
• Glaucoma (increased eye pressure), 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 Zentiva. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication
• Dangerously low number of a type of white blood cells necessary to fight infections in the blood
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, shortness of breath, itching, skin rash, and sometimes a drop in blood pressure
• Excessive and dangerous water intake
• Irregular heartbeat
• Blood clots in the legs, blood clots in the lungs
• Breathing problems during sleep (sleep apnea), rapid and shallow breathing
• Pancreatitis, intestinal obstruction
• Tongue swelling, cracked lips, skin rash related to the medication
• Dandruff
• Rupture of muscle fibers 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
• Priapism (a prolonged erection that may require surgical treatment)
• Skin hardening
• Decreased body temperature, coldness in arms and legs
• Drug withdrawal syndrome
• Yellowing of the skin and eyes (jaundice).

Very rare (affects less than 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.

The following adverse effects have 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 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, tremor (shaking), diarrhea, and urinary incontinence (loss of control).

Reporting of adverse effects:

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

5. Conservation of Risperidone Benel

Keep out of the reach and sight of children.

Do not use after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Do not freeze. Keep in the original packaging.

Once the bottle is opened, what has not been used must be discarded after 3 months.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Risperidone Benel

The active principle is risperidone.

Each milliliter of Risperidone Benel oral solution contains 1 mg of risperidone.

The other components are: sodium chloride, anhydrous citric acid, disodium phosphate dodecahydrate, lemon flavor, bromide domiphen, and purified water.

Appearance of Risperidone Benel and packaging content

Risperidone Benel 1 mg/ml is presented in the form of an oral solution, transparent and slightly yellowish.

Each packaging contains 30 ml or 100 ml of oral solution, with a 3 ml syringe, calibrated in milliliters. The minimum volume is 0.25 ml. The maximum volume is 3 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Farmalider, S.A.

Aragoneses, 15

28108 Alcobendas Madrid,

Spain

Manufacturer:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802-Alcalá de Henares, Madrid

Spain

O

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, 5

Condeixa-a-Nova, 3150-194, Sebal

Portugal

This prospectus was revised in March 2025

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