Package Leaflet: Information for the User

Risperidone Cinfa 6 mg Tablets 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as 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 cinfabelongs to a group of medicines called “antipsychotics”.

risperidone cinfais used totreat 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. 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 cinfa may help reduce the symptoms of your illness and prevent them from coming back.

Do not takerisperidone cinfa

• If you are allergic to risperidone or any of the other ingredients of this medicine (see 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:

• 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 medicines for high blood pressure. 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, have a history of blood clotting problems, as antipsychotics have been associated with the formation of blood clots.

If you are unsure about whether the information above 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 high 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 eye surgeon 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. Do not take risperidone if you have dementia caused by a stroke.

During treatment with risperidone, you should see your doctor regularly.

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 treatment immediately. 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 due to the drug or another reason.

Other medicines and risperidone cinfa

Inform your doctor or pharmacist if you are taking, have recently taken 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 (benzodiazepines), some pain medicines (opioids), allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can modify 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 heart rate.
• Medicines that cause low potassium levels in the blood (such as 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 for treating psychosis or as sedatives).
• Cimetidine, ranitidine (gastric acid blockers).
• Itraconazole and ketoconazole (medicines used for treating fungal infections).
• Some medicines used for treating HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used for treating high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used for treating 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 about whether the information above affects you, consult your doctor or pharmacist before taking risperidone.

Taking risperidone cinfa with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

• If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using 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 your pregnancy): trembling, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.
• Risperidone may increase 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 disease, may impair your ability 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 lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Risperidone cinfa contains sodium

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

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

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The initial recommended 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 (0.5 ml of risperidone oral solution), twice a day.
• Your doctor may later increase your dose gradually to 1 mg to 2 mg 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, once a day.
• Your doctor may later adjust your dose gradually based on your response to treatment.
• Most people find relief with doses of 1 mg to 6 mg once a day.

Older adults

• The initial dose will usually be 0.5 mg, twice a day.
• Your doctor may later adjust your dose gradually to 1 mg to 2 mg, 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 (0.25 ml of risperidone oral solution), twice a day.
• Your doctor may later adjust your dose gradually based on your response to treatment.
• Most people find relief 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 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.

For the treatment of behavioral disorders

The dose will depend on your child's weight:

If they weigh less than 50 kg:

• The initial dose will usually be 0.25 mg (0.25 ml of risperidone oral solution), 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 (0.25 ml to 0.75 ml of risperidone oral solution), once a day.

If they weigh 50 kg or more:

• The initial dose will usually be 0.5 mg, 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, 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 considered, all initial doses and subsequent doses of risperidone should be reduced by half. Dose increases should be made more slowly in these patients. Risperidone should be used with caution in this group of patients.

Administration form

Oral

You should swallow the medication with a glass of water.

If you take more risperidone cinfa than you should

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

You should 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 the use of this medication, ask your doctor or pharmacist.

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

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

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in 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 and other parts of your body). Inform your doctor immediately if you experience involuntary rhythmic movements of your tongue, mouth and face. It may be necessary to discontinue risperidone.

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

• You experience blood clots in 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 rigidity, 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 characterised by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash or a drop in blood pressure.

Also, the following side effects may occur:

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

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

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

• Pneumonia, chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infection, feeling like you have the flu.
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin occur rarely and may include in men, breast swelling, difficulty getting or maintaining erections, decreased libido and other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods and other problems with the cycle or fertility problems.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: 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: A condition that 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, laboured 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 people):

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal infection of the nails, 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) 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 pins and needles, numbness or tingling 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), feeling of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure, decreased blood pressure when standing up, as a result, some people who take risperidone may feel weakness, dizziness or loss of consciousness when getting 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 degradation
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Urinary frequency, inability to urinate, painful urination
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods, loss of menstrual periods or other cycle problems (women)
• Male breast development, milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes or lips
• Chills, increased body temperature
• Change in gait
• Feeling thirsty, 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 (may affect up to 1 in 1,000 people):

• 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, crusts on the edge of the eyelid
• 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
• Muscle fibre rupture and muscle pain (rhabdomyolysis)
• Delayed menstrual periods, breast enlargement, breast secretion
• Increased insulin (a hormone that controls blood sugar levels) in the blood
• Thickening of the skin
• Decreased body temperature, coldness in arms and legs
• Medication withdrawal syndrome
• Yellow skin and eyes (jaundice).

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

• Complications of uncontrolled diabetes, life-threatening
• Severe allergic reaction with swelling, which may affect the throat causing difficulty breathing
• Lack of movement of the muscles of the intestine 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: Fast 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, tremor (shaking), diarrhea and urinary incontinence.

Reporting of 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.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Risperidone cinfa composition

The active ingredient is risperidone. Each tablet contains 6 mg of risperidone.

The other components are: cornstarch, microcrystalline cellulose (E-460), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate, lactose monohydrate.

Product and packaging aspects and contents

Risperidone cinfa is presented in the form of cylindrical, slightly biconvex tablets, white in color, and marked with the code “R6”.

It is presented in PVC-PVDC/ALU blisters. Each package contains 30, 60, or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:June 2021

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/