Leaflet: information for the user

Risperidona Teva-ratio 1 mg film-coated tablets EFG

1.What is Risperidona Teva-ratio and what it is used for

2.What you need to know before taking Risperidona Teva-ratio

3.How to take Risperidona Teva-ratio

4.Possible side effects

1. Storage of Risperidona Teva-ratio

6.Contents of the pack and additional information

Risperidona Teva 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. 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.

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

Do not take Risperidona Teva:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

If you are unsure, consult your doctor or pharmacist before using Risperidona Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risperidona 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 using medications for high blood pressure. 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 heart attack, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the 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 medications).
• You are diabetic.
• You have epilepsy.
• You are a male and have ever had a prolonged or painful erection. If you experience this while taking Risperidona, contact your doctor immediately.
• You have difficulty controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• If 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 using Risperidona Teva.

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 may cause you to gain weight. Significant weight gain can 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.

Risperidona frequently increases levels of a hormone called prolactin. This can cause adverse effects such as menstrual disturbances or fertility problems in women or breast enlargement in men (see "Possible adverse effects"). If these adverse effects appear, it is recommended to evaluate prolactin levels in the blood.

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 colored part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning to have eye surgery, be sure to inform your ophthalmologist that you are using this medication.

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 frequently.

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 speak confusedly, even for a short time, seek medical treatment immediately. 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 in paying attention.

Before starting treatment, your weight or that of your child may be measured, and this should be regularly monitored 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 medications and Risperidona Teva

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

• Medications that act on your brain, such as those used to calm down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidona may increase their sedative effect.
• Medications capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medications for mental health problems.
• Medications that cause a slow heart rate.
• Medications that cause low potassium levels in the blood (for example: some diuretics).
• Medications for high blood pressure. Risperidona may lower blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Medications 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 medications may reduce the effect of risperidona:

• Rifampicin (a medication for treating some infections).
• Carbamazepine, phenytoin (medications for epilepsy).
• Phenobarbital.

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

The following medications may increase the effect of risperidona:

• Quinidine (used for certain types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
• Medications known as beta blockers (used to treat high blood pressure).

• Fenothiazines (such as medications used to treat psychosis or as sedatives).

• Cimetidine, ranitidine (gastric acid blockers).

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

• Itraconazole and ketoconazole (medications used to treat fungal infections)
• Some medications used to treat HIV/AIDS, such as ritonavir
• Verapamil, a medication used to treat high blood pressure and/or abnormal heart rhythm
• Sertraline and fluvoxamine, medications used to treat depression and other psychiatric disorders

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

Taking Risperidona Teva with food, drinks, and alcohol

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

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 medication.Your doctor will decide if you can take it.

• The following symptoms may occur in newborn babies, from mothers who have been treated with risperidona in the last trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your newborn baby develops any of these symptoms, contact your doctor.
• Risperidona may increase levels of a hormone called "prolactin" that may affect fertility (see Possible adverse effects).

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Risperidona Teva 1 mg film-coated tablets contain lactose

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

Risperidona Teva 1 mg film-coated tablets contain sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; 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 starting 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 feel better with daily doses of 4 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 starting dose will usually be 0.5 mg, taken twice a day.
• Your doctor will later increase your dose gradually to 1 mg - 2 mg, taken twice a day.
• Your doctor will tell you what is best for you.

Children and adolescents

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

For the treatment of mania

Adults

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

Older adults

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

Children and adolescents

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

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

Adults (including older adults)

• The starting dose will be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml (there are other presentations of risperidone, in oral solution)) taken twice a day, usually.
• Your doctor may later change your dose gradually based on your response to treatment.
• Most people feel 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.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than 50 kg

• The starting dose will usually be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml (there are other presentations of risperidone, in oral solution)) taken once a day, usually.
• The dose can be increased, one day yes and one day no, in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg (0.25 ml to 0.75 ml of risperidone oral solution 1 mg/ml (there are other presentations of risperidone, in oral solution)) taken once a day.

If they weigh 50 kg or more

• The starting dose will usually be 0.5 mg taken once a day, usually.
• The dose can be increased one day yes and one day no in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg, taken once a day.

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

Children under 5 years old should not receive treatment with risperidone for behavioral disorders.

Patients with liver or kidney problems

Unless the disease being treated is taken into account, all starting doses and subsequent doses of risperidone should be reduced to 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.

How to take Risperidone Teva

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

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

Risperidone Teva coated tablets with film

You should swallow the medication with a glass of water.

If you take more Risperidone Teva than you should

• Go to the doctor immediately. Bring the medication packaging with you. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidone Teva

If you forget to take a dose, take it as soon as you remember. But if it's almost time for your next dose, skip the missed one and continue as usual. If you forget two or more doses, contact your doctor.Do not take a double dose (two doses at once) to make up for the missed dose.

If you interrupt treatment with Risperidone Teva

You should not stop taking the 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 (which may affect up to 1 in 100 patients):

• It has dementia and presents a sudden change in your mental state or sudden weakness or numbness in the 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 (spasms or involuntary movements that cannot be controlled in the face, tongue or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. You may need to discontinue risperidone.

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

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You experience fever, muscle stiffness, sweating or a decrease in 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 low blood pressure.

The following side effects may also occur:

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

• Parkinsonism: This condition may include slow movement 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 the feet, tremor at rest, increased saliva and/or drooling and loss of facial expression.
• Difficulty staying or falling asleep.
• Feeling drowsy or less alert.
• Headache.

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

• Fatigue, tiredness, restlessness, irritability, anxiety, dizziness, feeling of exhaustion, sleep disorders, depression.
• Vomiting, diarrhea, constipation, nausea, abdominal pain or discomfort, sore throat, dry mouth, toothache, indigestion.
• Dyskinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic or twisting movements, or spasms.
• 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 facial muscles, including abnormal movements of the eyes, mouth, tongue or jaw.
• Tremor (agitation)
• Weight gain, increased appetite, decreased appetite

You experience sinusitis, lung infection (pneumonia), common cold symptoms, feeling like you have the flu, chest infection (bronchitis), nasal congestion, nosebleeds, cough, ear infection.

• Urinary tract infection, urinary incontinence.
• Muscle spasms, bone or muscle pain, joint pain, back pain, swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain.

• Skin rash, skin redness.
• Fast heart rate, increased blood pressure, labored breathing.
• Increased concentration of the prolactin hormone in the blood (which may or may not cause symptoms). Prolactin symptoms occur rarely and may include in men, breast swelling, difficulty getting or maintaining erections or other sexual dysfunction. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods or other problems with the cycle or fertility problems.
• Blurred vision, eye infection or "red eye".
• Falls.

Rare side effects (which may affect up to 1 in 100 people):

• Urinary incontinence, feeling thirsty, hard stools, excessive gas or flatulence.
• Lung infection, bladder infection, eye redness, viral infection, tonsillitis, skin infection, eye infection, stomach or intestinal infection, nail fungus infection.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, abnormal heart conduction, low blood pressure when standing up, as a result, some people taking risperidone may feel weakness, dizziness or loss of consciousness when getting up or sitting down suddenly, flushing, decreased blood pressure, feeling of dizziness when changing position, prolonged QT interval in the heart, abnormal heart activity (electrocardiogram or ECG), abnormal heart rhythm, feeling of fluttering or pounding in the chest (palpitations), slow heart rate.
• Difficulty urinating, frequent urination, inability to urinate.
• Confusion, altered attention, decreased level of consciousness, nervousness, euphoria (mania), nightmares.
• Seizures (epileptic crises).
• Diabetes or worsening of diabetes, increased blood glucose, excessive water intake.

• Increased cholesterol in the blood.
• Increased liver transaminases in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood.
• Decreased white blood cell count, decreased hemoglobin or red blood cell count (anemia), increased eosinophil count (special white blood cells), increased creatine phosphokinase (CPK) in the blood, an enzyme that is sometimes released with muscle breakdown, decreased platelet count (blood cells that help stop bleeding).
• Muscle weakness, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort.
• Skin lesions, skin disorder, dry skin, intense itching, acne, hair loss, skin inflammation caused by mites, skin discoloration, skin thickening, scaly or crusty skin on the skin or scalp, localized infection in a single area of the skin or part of the body, reduced skin sensitivity to pain or touch.
• Menstrual absence, sexual dysfunction, erectile dysfunction, ejaculation disorder, milk secretion from the breasts, breast enlargement in men, breast pain, breast discomfort, decreased sexual desire, menstrual absence or other cycle problems (women), vaginal discharge.
• Fainting, change in gait, weight loss, loss of appetite with malnutrition and weight loss, feeling unwell, feeling "off", balance disorder, feeling like everything is spinning (vertigo), allergic reaction, eczema, hives (urticaria), speech problems, loss or alteration of taste, chills, increased body temperature, coordination disorder.
• Anxiety that causes movement of parts of the body, feeling of tingling, pins and needles or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tear production.
• Difficulty breathing, wheezing, lung congestion, lung crepitus, respiratory tract congestion, voice disorders, difficulty swallowing, pneumonia caused by aspiration of food.
• Loss of response to stimuli, loss of consciousness, facial swelling, buzzing in the ears.
• Pain due to the procedure

Rare side effects (which may affect up to 1 in 1,000 people):

• Inability to achieve orgasm, delayed menstruation, breast enlargement, breast secretion.
• Dandruff.
• Somnambulism
• Sleep-related eating disorder
• Catatonia (lack of movement or response while awake)
• Head agitation
• Irregular heartbeat.
• Glaucoma (increased pressure in the eyeball), eye rolling, formation of crusts on the eyelid edge, eye movement problems.
• Loss of emotions.
• Decreased body temperature, coldness in arms and legs.
• Shallow and rapid breathing, respiratory problems during sleep (sleep apnea).
• Intestinal obstruction.
• Problems with blood vessels in the brain.
• Inadequate secretion of a hormone that controls urine volume.
• Sugar in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat), increased insulin (a hormone that controls blood sugar levels) in the blood.
• Muscle fiber rupture and muscle pain (rhabdomyolysis), movement disorder.
• Diabetic coma due to uncontrolled diabetes.
• Yellow skin and eyes (jaundice).
• Pancreatitis inflammation.
• Infection.
• 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.
• Swelling of the tongue, cracked lips, skin rash related to the medication
• Pelvicly low count of a type of white blood cells necessary to fight blood infections
• Excessive water intake.
• Medication withdrawal syndrome.

Very rare side effects (which 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.
• Intestinal ileus (lack of movement of the intestinal muscles causing obstruction).

Frequency unknown: cannot be estimated from available data

• Severe rash or blistering of the skin that may 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 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 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 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.

Do not store above 25 °C

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, after CAD. The expiration date is the last day of the month indicated.

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

Composition of Risperidona Teva

The active ingredient is risperidone.

Risperidona Teva 1 mg: each tablet contains 1mg of risperidone.

The other components are:

Tablet core:

Lactose monohydrate, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose, pregelatinized cornstarch, sodium starch glycolate, and magnesium stearate.

Tablet coating:

Hydroxypropyl methylcellulose 5cP, titanium dioxide, macrogol 6000, and macrogol 400

Appearance of the product and contents of the packaging

Coated tabletswith a filmcoating of white color, round shape, slightly arched, engraved RIS 1, and scored on one face andscored on the other face.

The tablet can be divided into equal doses.

They are marketed in packs of 20 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.C/ Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas. Madrid

Spain

Responsible for manufacturing

Teva Pharmaceutical Works Co.

Pallagi út 13

Debrecen

Hungary

Last review date of this leaflet:November 2024

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