Package Insert: Information for the User

Risperidone Cinfamed 2 mg Film-Coated Tablets

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

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

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

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

3. How to take risperidone cinfamed

4. Possible adverse effects

5. Storage of risperidone cinfamed

6. Contents of the package and additional information

Risperidona Cinfamed 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 condition 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 may help reduce the symptoms of your illness and prevent them from returning.

Do not take risperidona cinfamed

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

If you are unsure, consult your doctor or pharmacist before takingrisperidona cinfamed.

Warnings and precautions

Consult your doctor or pharmacist before starting to takerisperidona cinfamedif:

• You have any heart problems.The examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you are using blood pressure medications. Risperidona may lower your blood pressure. You may need to have your dose adjusted.
• You know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular diseases, or problems with the blood vessels in your brain.
• You have ever had involuntary movements of the tongue, mouth, and face.
• You have ever had symptoms that include fever, muscle stiffness, sweating, or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome).
• 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 medicines).
• You are diabetic.
• You have epilepsy.
• You are a male and have ever had an erection that lasted too long or was painful.
• You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• You or a family member has a history of blood clotting problems, as antipsychotics have been associated with blood clotting.

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before takingrisperidona.

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 risperidona, your doctor may check your white blood cell count.

Risperidona cinfamed may cause you to gain weight. A 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 risperidona, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Risperidonaincreases 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 Adverse Effects). If these adverse effects appear, it is recommended to evaluate the prolactin levels in the blood.

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, 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. Do not take risperidona if you have dementia caused by a stroke.

During treatment with risperidona, 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 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 behavior should be ruled out before starting treatment for behavioral disorders.

If during treatment with risperidona 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 this should be done regularly during treatment.

A small, inconclusive study has reported an increase in height in children who took risperidona, but it is unknown whether this is due to the medication or another reason.

Other medicines andrisperidona cinfamed

Inform your doctor or pharmacist if you are taking, have taken recently, ormayneed 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 medications (opioids), allergy medications (some antihistamines), as risperidona 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 heart rate.
• Medicines that cause low potassium levels in the blood (such as some diuretics).
• Medicines to treat high blood pressure. Risperidona may lower your blood pressure.
• Medicines to treat Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychoestimulants, 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). Risperidona, 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 risperidona:

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

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

The following medicines may increase the effect of risperidona

• 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).
• Phenothiazines(such as medicines usedto treat psychosis or as sedatives).
• Cimetidine, ranitidine (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 risperidona.

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before takingrisperidona cinfamed.

Use ofrisperidona cinfamedwith food, drinks, and alcohol

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

Pregnancy,breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can take it.
• The following symptoms may occur in newborn babies of mothers who were treated with risperidona in the last trimester of pregnancy (last three months of pregnancy): shivering, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, anddifficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.
• Risperidona cinfamedmay increase the levels of a hormone called “prolactin” that may affect fertility (see Possible Adverse Effects).

Driving and operating machines

Risperidona may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying illness, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Risperidona cinfamedcontains 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.

Risperidona cinfamedcontains the azo dyeyellow-orange S (E-110)

This medicine may cause allergic reactions because it contains yellow-orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Risperidona cinfamedcontains 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 your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The usual initial dose is 2 milligrams per day, which can be increased to 4 milligrams per day on the second day.
• Your doctor may adjust your dose based on your response to treatment.
• Most people feel better with daily doses of 4 to 6 milligrams.
• 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 be 0.5 milligrams twice a day, usually.
• Your doctor may later increase your dose gradually from 1 to 2 milligrams twice a day.
• Your doctor will tell you what is best for you.

For the treatment of mania

Adults

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

Older adults

• The initial dose will be 0.5 milligrams twice a day, usually.
• Your doctor may later adjust your dose gradually from 1 milligram to 2 milligrams 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 milligrams twice a day, usually.
• Your doctor may later adjust your dose gradually based on your response to treatment.
• Most people feel better with doses of 0.5 milligrams twice a day. Some patients may need 1 milligram 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 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 110 pounds:

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

If they weigh 110 pounds or more:

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

Patients with kidney or liver 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.

Administration form

For oral use

You should swallow the medication with a glass of water.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

Because the tablets are not divided into equal doses, there are other commercial presentations that are more suitable for some of the dosages described (e.g., 0.25 mg doses).

If you take morerisperidona cinfamedthan you should

In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have trouble standing and walking, feel dizzy due to decreased blood pressure, or have irregular 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 taken.

If you forget to take risperidona cinfamed

If you forget to take a dose, take it as soon as you remember. But if it's almost time for your next dose, do not take the missed dose 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 doses.

If you interrupt treatment withrisperidona cinfamed

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 side effects:

• 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's hard 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 you can't control in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary, rhythmic movements of your tongue, mouth, or face. You may need to stop takingrisperidona cinfamed.

Inform your doctor immediately if you experience any of the following rare side effects:

• You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which can travel through your 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.

You may also experience the following side effects::

Common side effects (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 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 attentive.
• Headache.

Frequent side effects (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 sex drive, or other sexual dysfunction. In women, they may include breast discomfort, milk secretion from the breasts, missed periods, or other problems with the cycle or fertility.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: A condition that involves involuntary, slow, or continuous muscle contractions.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 (shakiness).
• Blurred vision, eye infection, or "red eye."
• Fast heartbeat, 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 side effects (may affect up to 1 in 100 people)

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection in one area of the body 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, decreased appetite that causes malnutrition and weight loss.
• Increased cholesterol in the blood.
• Euphoria (mania), confusion, decreased sex drive, nervousness, nightmares.
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
• Seizures (epileptic crises), fainting.
• Restlessness 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 tearing, 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), 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 risperidona 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 sounds of the lungs, gasping, 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.
• Missed periods, missed menstrual periods, or other menstrual cycle problems (women).
• Male breast development, milk secretion from the breasts, 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 enzymes 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 side effects (may affect up to 1 in 1,000 people)

• Infection.
• Incorrect secretion of a hormone that controls urine volume.
• Somnambulism.
• Sleep-related eating disorder.
• Sugar in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat).
• Lack of emotions, inability to achieve orgasm.
• Lack of movement or response while awake (catatonia).
• Problems with blood vessels in the brain.
• Diabetes coma due to uncontrolled diabetes.
• Head agitation.
• Glaucoma (increased pressure in the eyeball), eye movement problems, eye rotation, crusts on the eyelid border.
• Eye problems during cataract surgery. During cataract surgery, you may experience a condition called intraoperative floppy iris syndrome (IFIS) if you are taking or have taken risperidona. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication.
• Low white blood cell count 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, chapped lips, skin rash related to the medication.
• Dandruff.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).
• 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 side effects (may affect up to 1 in 10,000 people)

• Complications of uncontrolled diabetes, life-threatening.
• Severe allergic reaction with swelling, which can affect the throat, causing difficulty breathing.
• Intestinal obstruction due to muscle paralysis.

Frequency not known: cannot be estimated from available data

• Severe skin rash or blistering that can start around the mouth, nose, eyes, genitals, and spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following side effect has appeared with the use of another medication called paliperidone, which is very similar to risperidona, so it is also expected to appear withrisperidona cinfamed: 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 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 (shakiness), diarrhea, 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 Pharmacovigilance 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.

This medication does not require special storage conditions.

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

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

Do not dispose of medications through the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at 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 film-coated risperidone Cinfa tablet contains 2 mg of risperidone.

- The other components are:

Tablet Core:

Maize pregelatinised starch, lactose, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate, and magnesium stearate.

Coating:

Partially hydrolysed polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171), talc, yellow orange S (E-110), yellow iron oxide (E-172), and quinoline yellow (E-104).

Appearance of the product and contents of the package

The 2 mg film-coated risperidone Cinfa tablets are oblong, biconvex, scored, and pale orange in color.

They are available in packages of 20 or 60 tablets.

Only some package sizes may be available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible Manufacturer

Meiji Pharma Spain, S.A.

Madrid Avenue, 94

28802 Alcalá de Henares (Madrid) - Spain

or

Farmalider S.A

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

or

Generis Farmacêutica S.A.

João de Deus Street, nº 19

Venda- Nova. Amadora 2700-487 - Portugal

or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of thisleaflet:September2022

Detailed information about this medicine 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 medicine 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/66805/P_66805.html

QR code to:https://cima.aemps.es/cima/dochtml/p/66805/P_66805.html