PATIENT INFORMATION LEAFLET

Risperidone Benel 1 mg/ml Oral Solution EFG

Risperidone

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

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

2.What you need to know before you start taking Risperidone Benel

3.How to take Risperidone Benel

4.Possible side effects

1. Storage of Risperidone Benel
2. Contents of the pack and additional information

Risperidona Benel 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 Benel may help reduce the symptoms of your disease and prevent them from returning.

Benel

Do not take Risperidona Benel if

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

If you are unsure, consult your doctor or pharmacist before taking Risperidona Benel.

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidona Benel if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to low blood pressure or if you are taking blood pressure medications. Risperidona 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 disease, or problems with blood vessels in the brain.
• You or a family member has a history of blood clots, as these medications may be associated with their formation.
• 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 a male and have had a prolonged or painful erection in the past. If you experience this while taking Risperidona, contact your doctor immediately.
• You have difficulty 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.

Consult your doctor immediately if you have:

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

If you are unsure whether the information above affects you, consult your doctor or pharmacist before using Risperidona Benel.

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

Risperidona may cause you to gain weight. Significant weight gain may 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 monitored.

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 taking 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.

You should see your doctor frequently during treatment with Risperidona.

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 are confused, even for a short time, seek immediate medical treatment. 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 in paying attention.

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

Other medications and Risperidona Benel

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

It is especially important to speak with 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 (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 (such as quinidine), 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 (for example: some diuretics).
• Medications for high blood pressure. Risperidone may lower your 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 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 (for example, used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (gastric acid blockers).

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

If you are unsure whether the information above affects you, consult your doctor or pharmacist before using Risperidona Benel.

Use of Risperidona Benel with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or if you think you may be 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 Benel in the last trimester of pregnancy (last three months of pregnancy) may experience the following symptoms: tremor, muscle stiffness, or weakness, drowsiness, agitation, breathing problems, or difficulty feeding. If your child experiences any of these symptoms, contact your doctor.
• Risperidone may increase prolactin levels, which can affect fertility (see section 4. Possible side effects).

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Risperidona Benel contains sodium

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

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 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 based on your response to treatment.
• Most people find relief 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 usually be 0.5 mg, taken twice a day.
• Your doctor will later increase your dose gradually to 1 mg - 2 mg, taken twice a day.
• Your doctor will tell you what is best for you.
  

Children and adolescents

• Children and adolescents under 18 years old should not receive treatment with Risperidona for schizophrenia.

For the treatment of mania

Adults

• The initial dose will usually be 2 mg, taken once a day.
• Your doctor may later adjust your dose gradually based on your response to treatment.
• Most people find relief with daily doses of 1 mg to 6 mg.

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor may later adjust your dose gradually to 1 mg - 2 mg, taken twice a day based on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years old should not receive treatment with Risperidona for mania.

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

Adults (including older adults)

• The initial dose will usually be 0.25 mg, taken twice a day.
• Your doctor may later change your dose gradually based on your response to treatment.
• Most people find relief with doses of 0.5 mg, taken twice a day. Some patients may need 1 mg, taken 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 treatment with Risperidona Benel for schizophrenia or mania.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If your child weighs less than 50 kg

• The initial dose will usually be 0.25 mg, taken once a day.
• The dose can be increased, one day yes and one day no, in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg, taken once a day.

If your child weighs 50 kg or more

• The initial dose will usually be 0.5 mg, taken once a day.
• The dose can be increased one day yes and one day no in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg, taken 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 treatment with Risperidona for behavioral disorders.

Patients with liver or kidney problems

Unless the disease being treated is taken into account, 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 Risperidona BenelBenel

Take Risperidona Benel exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Your doctor will tell you how much medicine you should take and for how long. This will depend on your illness and varies from person to person. The amount of medicine you should take is explained earlier in the "How much to take" heading.

Risperidona Benel oral solution

The solution comes with a syringe (pipette). Use only the syringe provided with this medication to measure the dose prescribed by your doctor. Measure the exact dose of medicine you need. Pay attention when measuring a small dose, for example, for 0.25 mg it is necessary to measure 0.25 ml (a quarter of a milliliter); for 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 syringe into the bottle
3. Hold the lower ring and pull the upper ring until it reaches the mark corresponding to the number of ml or mg you should administer (Figure 2)
4. Hold the lower ring and remove the syringe from the bottle (Figure 3)
5. Empty the syringe into a non-alcoholic drink that is not tea. Slide the upper ring down
6. Close the bottle
7. Wash the syringe with water and let it air dry.

If you take more Risperidona Benel than you should

• Go to your doctor immediately. Bring the medication packaging 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, difficulty standing and walking, a sensation of dizziness due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidona Benel

• If you forget to take a dose, take it as soon as you remember. But if it's almost 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 doses.

If you interrupt treatment with Risperidona Benel

You should not stop taking the treatment unless your doctor tells you to. Symptoms may reappear.If your doctor decides to stop 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 medications, Risperidone may cause side effects, although not everyone will experience them.

Very common:affect more than 1 in 10 people

Common:affect between 1 and 10 in every 100 people

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

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

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

Unknown:the frequency cannot be estimated from available data

Inform your doctor immediately if:

•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 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 it is difficult for you to speak even for a short period of time. These may be signs of a stroke

•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 involuntary rhythmic movements of the tongue, mouth, and face. You may need to discontinue Risperidone

•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

You may experience the following side effects:

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

• Difficulty staying or falling asleep
• Parkinsonism. This is a medical term that includes several symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement after it is restarted. Other signs of parkinsonism include walking slowly, tremors at rest, increased saliva secretion, or a very moist mouth, muscle stiffness, drooling, pain when bending the limbs, slower or altered body movements, reduced or difficult, lack of facial expression, muscle tension, torticollis, muscle stiffness, short and rapid steps, dragging the 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 (affect between 1 and 10 in every 100 people):

• Respiratory tract infection, chest infection (bronchitis), common cold symptoms, 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 in achieving or maintaining erections, or other sexual dysfunction. In women, they may include breast discomfort, milk secretion, loss of menstrual periods, or other menstrual cycle problems
• Weight gain, increased appetite, decreased appetite

• Sleep disorders, irritability, depression, anxiety, restlessness
• Dystonia: This is a disease that involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, 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 (loss of control)
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Falls

Uncommon (affect between 1 and 10 in every 1,000 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 (a type of white blood cell)
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar, excessive water intake
• Weight loss, loss of appetite leading to malnutrition and weight loss
• Increased cholesterol in the blood
• Euphoria (mania), confusion, decreased libido, nervousness, nightmares
• 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. You may need to discontinue Risperidone
• 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
• 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
• Light sensitivity of the eyes, dry eyes, increased tear production, eye redness
• Sensation 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), 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 lung sounds, 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 skin or scalp with itching, 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
• Urinating frequently, inability to urinate, painful urination
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods, loss of menstrual periods or other menstrual cycle problems (women)
• Male breast development, milk secretion, 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," feeling unwell
• 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 (affect between 1 and 10 in every 10,000 people):

• Infection
• Incorrect 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 achieve orgasm
• Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle stiffness)
• 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, 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 Zentiva. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication
• Very low count of a type of white blood cell necessary to fight infections in the blood
• Severe allergic reaction characterized by swelling, which may affect the throat causing difficulty breathing
• Lack of movement of the intestinal muscles causing obstruction

The following side 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: Rapid 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, tremors, diarrhea, and urinary incontinence (loss of control).

Reporting side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 out of 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 above30°C. Do not freeze.Keep in the original packaging.

Once the bottle is opened, discard any unused portion after 3 months.

Medicines should not be disposed of through drains or in the trash. Deposit empty containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

Composition of Risperidona Benel

The active ingredient is risperidone.

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

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

Appearance of Risperidona Benel and contents of the package

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

Each package 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Farmalider, S.A.

Aragoneses, 15

28108 Alcobendas Madrid,

Spain

Responsible for manufacturing:

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 leaflet has been reviewed in March 2025

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)www.aemps.gob.es