Leaflet: information for the user

Risperidone cinfa 1 mg/ml oral solution EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you and should not be given to others, even if they have the same symptomsas you, 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.

Risperidone cinfa belongs to a group of medicines called “antipsychotics”.

Risperidone cinfa 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 type dementia, who harm themselves or others. They must have tried alternative non-pharmacological treatments 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 may help reduce the symptoms of your illness and prevent them from coming back.

Do not take risperidone cinfa

• If you are allergic to risperidone or 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take risperidone cinfa.

• 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 taking blood pressure medicines. Risperidone may lower your blood pressure. You may need your dose adjusted.
• If 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 your brain.
• If you have ever had involuntary movements of the tongue, mouth and face.
• If you have ever had symptoms that include fever, muscle stiffness, sweating or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease or dementia.
• If you have had low white blood cell counts in the past (which may or may not have been caused by other medicines).
• If you are diabetic.
• If you have epilepsy.
• If you are a man and have ever had an erection that lasted for a long time or was painful.
• If you have problems controlling your body temperature or feel excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If you have an abnormally high level of prolactin in your blood or if you have a tumour that may be dependent on prolactin.
• If you or a member of your family has a history of blood clotting problems as antipsychotics have been associated with blood clotting in the blood.

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. A significant weight gain may affect your health unfavourably. 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 the levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible side effects). If these adverse effects appear, it is recommended that blood prolactin levels be evaluated.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the coloured part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning to have eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Patients with advanced age and dementia

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

You should see your doctor regularly during treatment with risperidone.

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 immediate medical treatment. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behaviour should be ruled out before starting treatment for conduct 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 regularly monitored 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 a side effect of the drug or due to another reason.

Other medicines and risperidone cinfa

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

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 down (benzodiazepines), or some pain medicines (opioids), allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental health problems.
• Medicines that cause a slow heartbeat.
• Medicines that cause a low potassium level in the blood (for example: some diuretics).
• Medicines for high blood pressure. Risperidone may lower your blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psycho-stimulants, such as methylphenidate).
• Diuretics, which are used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• Rifampicin (a medicine for treating some 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 types of heart disease).
• Antidepressants such as paroxetine, fluoxetine and tricyclic antidepressants.
• Medicines known as beta blockers (used to treat high blood pressure).
• Fenothiazines (such as medicines used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (gastric 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 mental health disorders.

If you start or stop taking these medicines, 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 risperidone cinfa with food, drink and alcohol

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

Risperidone oral solution should not be mixed with tea.

Pregnancy, breastfeeding and fertility

• If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will decide if you can take it.
• The following symptoms may occur in newborn babies of mothers who have been treated with risperidone in the last three months of pregnancy (last three months of pregnancy): trembling, stiffness and/or weakness of the muscles, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.
• Risperidone may increase the levels of a hormone called "prolactin" which may affect fertility (see Possible side effects).

Driving and operating machinery

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 machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Risperidone cinfa contains sodium

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

Follow exactly the administration instructions of this medication 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 usual 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 how you respond to treatment
• Most people find they do better with daily doses of 4 mg to 6 mg
• This total daily dose can be divided into one or two doses per day. Your doctor will tell you what is best for you

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day
• Your doctor may increase your dose gradually to 1 to 2 milligrams, taken twice a day
• Your doctor will tell you what is best for you

For the treatment of mania:

Adults

• The initial dose will usually be 2 mg, taken once a day
• Your doctor may adjust your dose gradually based on your response to treatment
• Most people find they do better 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 adjust your dose gradually from 1 mg to 2 mg, taken 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 usually be 0.25 mg, taken twice a day
• Your doctor may change your dose gradually based on your response to treatment
• Most people find they do better 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 risperidone for schizophrenia or mania

The dose will depend on your child's weight for the treatment of behavioral disorders:

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, by 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, by 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 risperidone 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 risperidone cinfa:

Oral administration

Risperidone oral solution

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

Follow these steps:

1. Shake the bottle well
2. Remove the cap from the bottle by pressing it down and turning it counterclockwise
3. Insert the syringe firmly into the port (hole) located at the neck of the bottle
4. To fill the syringe, invert the bottle. While holding the syringe, pull the plunger down slowly until the solution reaches the appropriate mark on the syringe
5. Replace the bottle in its normal position and remove the syringe from the hole by turning it gently
6. Empty the syringe into a non-alcoholic beverage that is not tea. Press the plunger slowly to release the solution gently. Replace the cap after use. Wash the syringe with warm water and let it air dry

If you take more risperidone cinfa than you should

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

• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication 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. 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 to make up for the missed ones

If you interrupt the treatment with risperidone cinfa

Do not stop taking this medication 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 using 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 your 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 tardive dyskinesia (involuntary spasms or movements that cannot be controlled in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary rhythmic movements of your tongue, mouth, and face. You may need to 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 your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You experience fever, muscle stiffness, sweating, or a decrease in your level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or a drop in blood pressure.

The following side effects may also occur:

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

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

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

• 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 achieving or maintaining erections, decreased libido, or other sexual dysfunction. In women, they may include breast discomfort, milk secretion, missed periods, or other problems with the cycle or fertility.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: This is a condition 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 muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness.
• Dyskinesia: This is a condition that involves involuntary muscle movements and may include repetitive, spasmodic, or writhing movements, or spasms.
• Tremor (agitation).
• Blurred vision, eye infection, and "red eye."
• Fast heart rate, increased blood pressure, labored breathing.
• Throat pain, 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 patients):

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or part of the body, viral infection, skin inflammation caused by mites.
• Decreased white blood cell count, decreased white blood cell count, decreased platelet count, anemia, decreased red blood cell count, increased eosinophil count in the blood.
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar, excessive water intake.
• Weight loss, loss of appetite that causes malnutrition and weight loss.
• Increased cholesterol in the blood.
• Euphoria (mania), confusion, decreased libido, 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.
• 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 electrical activity, prolonged QT interval in the heart, slow heart rate, abnormal heart electrical 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 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, lung crepitus, 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 degradation.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, inability to urinate, painful urination.
• Erectile dysfunction, ejaculation disorder.
• Menstrual irregularities, menstrual irregularities, or other cycle problems (women)
• Male breast development, milk secretion, sexual dysfunction, breast pain, breast discomfort, vaginal secretion.
• Swelling of the face, mouth, eyes, or lips.
• Chills, increased body temperature.
• Change in gait.
• Sensation of thirst, feeling unwell, chest discomfort, feeling "off," discomfort.
• Increased liver 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 patients):

• Infection.
• Incorrect secretion of a hormone that controls urine volume.
• Somnambulism.
• Sleep-related eating disorder.
• High blood sugar, decreased blood sugar, increased triglycerides in the blood (a type of fat).
• Lack of emotions, inability to achieve orgasm.
• Catatonia (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, a condition 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 medication.
• Pelvicly low count of a type of white blood cell necessary to fight infections in the blood.
• Excessive water intake.
• Irregular heartbeat.
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Swelling of the tongue, cracked lips, skin rash related to the medication.
• Dandruff.
• Rhabdomyolysis (muscle fiber rupture and muscle pain).
• Delayed menstrual periods, breast enlargement, breast secretion.
• Increased insulin (a hormone that controls blood sugar levels) in the blood.
• Skin hardening.
• 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 patients):

• Complications of uncontrolled diabetes, life-threatening.
• Severe allergic reaction with swelling, which may affect the throat, causing difficulty breathing.
• Lack of movement of the intestinal muscles, causing obstruction.

The following side effect has occurred with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to occur 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 occurred 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 alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhea, and urinary incontinence.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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.

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

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

Once the bottle is opened, unused portions should be discarded after 3 months.

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

Composition of risperidone cinfa

• The active ingredient is risperidone. Each milliliter contains 1 mg of risperidone.
• The other components are: sodium chloride, domifen bromide, lemon aroma (which contains glucose in maltodextrin derived from corn), anhydrous citric acid, disodium dodecahydrogenophosphate, and purified water.

Appearance of the product and contents of the container:

Risperidone cinfa is a transparent and colorless, slightly yellowish solution with a lemon odor. It is presented in amber glass bottles with a child-resistant plastic closure of 30 or 100 ml with a 3 ml calibrated dosing syringe. 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

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10 - Areta Industrial Estate.

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

MEIJI PHARMA SPAIN, S.A.

Madrid Avenue, 94

28802 Alcalá de Henares (Madrid)

Spain

or

MEDINFAR MANUFACTURING, S.A.

Armando Martins Tavares Industrial Park

Rua Outeiro Da Armada, 5

Condeixa-a-Nova, 3150-194, Sebal

Portugal

Last review date of this leaflet:March 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/70047/P_70047.html

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