Risperidone CINFA 1 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

risperidone cinfa 1 mg/ml oral solution EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What risperidone cinfa is and what it is used for
2. What you need to know before taking risperidone cinfa
3. How to take risperidone cinfa
4. Possible adverse effects
5. How to store risperidone cinfa
6. Contents of the pack and other information

1. What risperidone cinfa is and what it is used for

Risperidone cinfa belongs to a group of medicines called "antipsychotics".

Risperidone cinfa is used to treat the following conditions:

• Schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, a condition in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in an illness called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who are harming themselves or others. Alternative non-pharmacological treatments should have been tried first.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorders.

Risperidone may help reduce the symptoms of your illness and help prevent them from returning.

2. What you need to know before starting to take risperidone cinfa

Do not take risperidona cinfa

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take risperidona cinfa.

• If you have any heart problems. Examples include irregular heartbeat, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone may lower blood pressure. You may need your dose adjusted.
• If you have any risk factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• If you have ever experienced involuntary movements of the tongue, mouth, or face.
• If you have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease or dementia.
• If you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
• If you are diabetic.
• If you have epilepsy.
• If you are male and have ever had a prolonged or painful erection.
• If you have difficulty regulating your body temperature or feel excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If you have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
• If you or a family member has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking risperidone.

Very rarely, patients treated with risperidone have developed a dangerously low number of a type of white blood cells needed to fight infections. Your doctor may monitor your white blood cell count.

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

Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking risperidone, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar levels should be monitored regularly.

Risperidone frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see Possible side effects). If these adverse effects occur, evaluation of prolactin levels in the blood is recommended.

During cataract surgery (removal of clouded lens), the pupil (the black circle in the center of the eye) may fail to dilate as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You must not take risperidona if your dementia is caused by 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 sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or if you experience confusion, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

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

If you experience fatigue during treatment with risperidona, changing the time of administration may improve difficulties with attention.

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

A small, inconclusive study reported increased height in children taking risperidona, but it is unknown whether this is a drug effect or due to other factors.

Other medicines and risperidona cinfa

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

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

• Medicines that act on your brain, such as those used to calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders, allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (e.g., some diuretics).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics used for heart problems or to treat swelling in 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 medicines may reduce the effect of risperidone:

• Rifampicin (a medicine used to treat certain infections).
• Carbamazepine, phenytoin (medicines for epilepsy).
• Phenobarbital.

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

The following medicines may increase the effect of risperidone:

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

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

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using risperidone.

Taking risperidona cinfa with food, drinks, and alcohol

You may take this medicine with or without food. You should avoid consuming alcohol while taking risperidone.

Risperidone oral solution must not be mixed with tea.

Pregnancy, breastfeeding, and fertility

• If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take it.
• The following symptoms may occur in newborn babies whose mothers have been treated with risperidone during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
• Risperidone may increase levels of a hormone called “prolactin,” which may affect fertility (see “Possible side effects”).

Driving and using machines

Risperidone may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

risperidona cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; hence, it is essentially “sodium-free.”

3. How to take risperidone cinfa

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dosage:

For the treatment of schizophrenia

Adults

• The usual initial dose is 2 mg once daily; this may be increased to 4 mg once daily on the second day.
• Your doctor may adjust your dose depending on your response to treatment.
• Most people respond well to daily doses of 4 mg to 6 mg.
• This total daily dose may be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Your doctor may gradually increase your dose later to 1–2 mg twice daily.
• Your doctor will tell you what is best for you.

For the treatment of mania:

Adults

• The initial dose is usually 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people respond well to daily doses ranging from 1 mg to 6 mg.

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Your doctor may gradually adjust your dose later to 1 mg to 2 mg twice daily, depending on your response to treatment.

For the long-term treatment of aggression in patients with Alzheimer-type dementia:

Adults (including elderly patients)

• The initial dose is usually 0.25 mg twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most patients respond well to a dose of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer-type dementia should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years of age should not be treated with risperidone for schizophrenia or mania.

For the treatment of conduct disorders, the dose will depend on your child's weight:

If weight is less than 50 kg

• The initial dose is usually 0.25 mg once daily.
• The dose may be increased every other day in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once daily.

If weight is 50 kg or more

• The initial dose is usually 0.5 mg once daily.
• The dose may be increased every other day in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once daily.

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

Children under 5 years of age should not be treated with risperidone for conduct disorders.

Patients with liver or kidney problems

Regardless of the condition being treated, all initial 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 patient group.

How to take risperidone cinfa:

For oral use.

Risperidone oral solution

The solution comes with a syringe (pipette). Use only the syringe (pipette) supplied with this medicine to measure the prescribed dose. Measure the exact dose of medication needed. Pay attention when measuring a small dose; for example, 0.25 mg requires measuring 0.25 ml (a quarter of a millilitre); 0.5 mg requires measuring 0.5 ml (half a millilitre).

Follow these steps:

1. Shake the bottle well.
2. Remove the cap by pressing down and turning counterclockwise.
3. Firmly insert the syringe into the port (opening) in the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe, gently pull the plunger down until the solution reaches the appropriate mark on the syringe.
5. Return the bottle to an upright position and gently remove the syringe by rotating it slightly.
6. Empty the syringe into a non-alcoholic beverage (not tea). Press the plunger slowly to release the solution gently. Replace the cap after use. Wash the syringe with lukewarm water and allow it to air dry.

If you take more risperidone cinfa than you should

• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to a drop in blood pressure, or have irregular heartbeat or seizures.

• In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take risperidone cinfa

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.
• Do not take a double dose to make up for a missed dose.

If you stop taking risperidone cinfa

You should not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop treatment, your dose may be gradually reduced over several days.

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

4. Possible adverse effects

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

Contact your doctor immediately if you experience any of the following uncommon adverse 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 of the face, arms, or legs, especially on one side of the body, or difficulty speaking, even for a short period of time. These may be signs of a stroke.
• You develop tardive dyskinesia (involuntary spasms or spasmodic movements of the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

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

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You develop a high fever, muscle rigidity, sweating, or decreased level of consciousness (a condition known as “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be required.
• You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• 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.

The following side effects may also occur:

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

• Difficulty falling or staying asleep.
• Parkinsonism: this condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of “freezing” of movement that later restarts. Other signs of parkinsonism include shuffling slow gait, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness.
• Feeling drowsy or less alert.
• Headache.

Common (may affect up to 1 in 10 patients):

• Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu.
• Increased levels of a hormone called “prolactin” detected in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin occur rarely and may include, in men, breast swelling, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, missed menstrual periods, or other menstrual cycle or fertility problems.
• Weight gain, increased appetite, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, restlessness.
• Dystonia: a condition involving involuntary, sustained muscle contractions. Although any part of the body may be affected (leading to abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• Dizziness.
• Dyskinesia: a condition involving involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremor (shakiness).
• Blurred vision, eye infection, and “red eye.”
• Rapid heartbeat, increased blood pressure, shortness of breath.
• Sore throat, cough, nosebleeds, nasal congestion.
• Abdominal pain, stomach discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Skin rash, redness of the skin.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence (loss of bladder control).
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
• Falls.

Uncommon (may affect up to 1 in 100 patients):

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

• Decreased levels of a type of white blood cell that helps fight infections, decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), anemia, decreased red blood cells, increased number of eosinophils (a type of white blood cell) in the blood.

• Allergic reaction.

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

• Weight loss, loss of appetite leading to malnutrition and reduced body weight.

• Increased cholesterol levels in the blood.

• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.

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

• Seizures (epileptic fits), fainting.

• A restlessness causing movement of body parts, balance disorder, abnormal coordination, dizziness upon standing, attention disturbances, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin.

• Light sensitivity of the eyes, dry eyes, increased tearing, eye redness.

• Sensation of spinning (vertigo), ringing in the ears, ear pain.

• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation on the electrocardiogram (ECG), slow heartbeat, abnormal electrical conduction of the heart (ECG), sensation of fluttering or pounding in the chest (palpitations).

• Decreased blood pressure, decreased blood pressure upon standing; as a result, some people taking risperidone may feel weak, dizzy, or lose consciousness when standing up or sitting up suddenly, flushing.

• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, wheezing, voice disorder, breathing difficulty.

• Stomach or intestinal infection, fecal incontin 1.000 patients):**

• Infection.

• Inappropriate secretion of a hormone that controls urine volume.

• Sleepwalking.

• Sleep-related eating disorder.

• Sugar in urine, low blood sugar, increased blood triglycerides (a type of fat).

• Absence of emotions, inability to reach orgasm.

• Lack of movement or response while awake (catatonia).

• Problems with blood vessels in the brain.

• Coma due to uncontrolled diabetes.

• Head rocking.

• Glaucoma (increased pressure in the eyeball), eye movement problems, eye rolling, crusts on the eyelid margin.

• Eye problems during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.

• Dangerously low number of a type of white blood cell needed to fight infections in the blood.

• Dangerously excessive water intake.

• Irregular heartbeat.

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

• Inflammation of the pancreas, intestinal obstruction.

• Swelling of the tongue, cracked lips, drug-related skin rash.

• Dandruff.

• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

• Delayed menstrual periods, enlarged mammary glands, breast enlargement, milk secretion from the breasts.

• 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.

• Yellowing of the skin and eyes (jaundice).

Very rare (may affect up to 1 in 10,000 patients):

• Life-threatening complications of uncontrolled diabetes.
• Severe allergic reaction with swelling, which may affect the throat and cause breathing difficulties.
• Lack of movement in the intestinal muscles causing obstruction.

The following adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with risperidone: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those seen in adults. The following adverse effects were reported more frequently in children and adolescents (5 to 17 years of age) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, symptoms of a common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (lack of bladder control).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Risperidone cinfa storage

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

Store below 30 °C. Do not freeze. Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Once the bottle has been opened, any unused portion should be discarded after 3 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of risperidone cinfa

• The active substance is risperidone. Each millilitre contains 1 mg of risperidone.
• The other components are: sodium chloride, domiphen bromide, lemon flavour (containing glucose in maltodextrin derived from maize), anhydrous citric acid, disodium hydrogen phosphate dodecahydrate and purified water.

Appearance of the medicine and contents of the pack

Risperidone cinfa is a clear, colourless and slightly yellowish solution with a lemon odour. It is supplied in amber glass bottles with a child-resistant plastic closure of 30 or 100 ml, together with a 3 ml dosing syringe calibrated in ml. The minimum volume is 0.25 ml. The maximum volume is 3 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10 - Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain

Manufacturer

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 Outeiro Da Armada, 5
Condeixa-a-Nova, 3150-194, Sebal
Portugal

Date of the most recent revision of this leaflet: March 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70047/P_70047.html

QR code link: https://cima.aemps.es/cima/dochtml/p/70047/P_70047.html