RISPERIDONE TEVA-RATIO 3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Risperidona Teva-ratio 3 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Risperidona Teva-ratio and what is it used for
2. What you need to know before you take Risperidona Teva-ratio
3. How to take Risperidona Teva-ratio
4. Possible side effects
   1. Storage of Risperidona Teva-ratio

1. Contents of the pack and further information

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

Risperidona Teva-ratio belongs to a group of medicines called “antipsychotics”.

Risperidona is used to treat the following:

• Schizophrenia, where you may see, hear, or feel things that are not there, believe things that are not true, or feel unusually suspicious or confused.
• Mania, where you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a condition called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, who may harm themselves or others. Other non-pharmacological treatments should have been tried before.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children and adolescents with conduct disorders.

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

Do not take Risperidona Teva-ratio:

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

If you are not sure, consult your doctor or pharmacist before taking Risperidona Teva-ratio.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risperidona if:

• You have any heart problems. Examples include irregular heartbeats, or if you are prone to having low blood pressure or if you are taking medicines for 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 stroke, such as high blood pressure, cardiovascular diseases, or problems with the blood vessels in the brain.
• 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 male and have ever had a prolonged or painful erection. If you experience this while taking Risperidona, contact your doctor immediately.
• 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 the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• If you or someone in your family has a history of blood clots, as medicines like this have been associated with the formation of blood clots.

Consult your doctor immediately if you:

• have rhythmic involuntary movements of the tongue, mouth, or face. It may be necessary to discontinue Risperidona.
• have a fever, severe muscle stiffness, sweating, or a low level of consciousness (a condition called “neuroleptic malignant syndrome”). You may need immediate medical treatment.

If you are unsure about any of the above, consult your doctor or pharmacist before taking Risperidona Teva-ratio.

Because very rarely, patients treated with Risperidona have had a dangerously low number of a type of white blood cell needed to fight infections in the blood, your doctor may check your white blood cell count.

Risperidona may cause you to gain weight. A significant increase in weight can affect your health unfavorably. 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 high blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of having a stroke. You should 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 your face, arms, or legs, especially on one side, or confused speech, even if only for a short time, seek medical treatment immediately. It may be a sign of a stroke.

Children and adolescents

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

If during treatment with Risperidona you experience fatigue, changing the administration times may improve your difficulties in paying attention.

Use of Risperidona Teva-ratio with other medicines

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

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

• 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 Risperidona may increase their sedative effect.
• Medicines that can change the electrical activity of your heart, such as those used for malaria, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants, or other medicines for mental problems.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (such as some diuretics).
• Medicines for high blood pressure. Risperidona may lower blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Diuretics, which are used for heart problems or to treat swelling of 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 decrease the effect of Risperidona:

• 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 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 (e.g., used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).

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

If you are unsure about any of the above, consult your doctor or pharmacist before taking Risperidona Teva-ratio.

Taking Risperidona Teva-ratio with food and drinks

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

Pregnancy, breast-feeding, and fertility

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Tremors, muscle stiffness, and feeding problems, all of which are reversible, have been seen in newborns whose mothers received Risperidona during the last trimester of pregnancy.
• Newborns of mothers who have used Risperidona Teva-ratio in the last trimester of pregnancy may present with the following symptoms: tremor, muscle stiffness and/or weakness, somnolence, agitation, breathing problems, and feeding problems. If your newborn presents any of these symptoms, contact your doctor.
• Risperidona may increase the levels of a hormone called “prolactin” that may affect fertility (see Possible side effects).

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dizziness, tiredness, 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-ratio 3 mg film-coated tablets contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Risperidona Teva-ratio 3 mg film-coated tablets contains sodium

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

3. How to take Risperidona Teva-ratio

How much to take

For the treatment of schizophrenia

Adults

• The 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 depending on how you respond 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.

Elderly patients

• The initial dose will normally be 0.5 mg, twice a day.
• Later, your doctor may gradually increase your dose to 1 mg - 2 mg, twice a day.
• Your doctor will tell you what is best for you.

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperidona for schizophrenia.

For the treatment of mania

Adults

• The initial dose will normally be 2 mg, once a day.
• Later, your doctor may gradually adjust your dose depending on your response to treatment.
• Most people feel better with daily doses of 1 to 6 mg.

Elderly patients

• The initial dose will normally be 0.5 mg, twice a day.
• Later, your doctor may gradually adjust your dose to 1 mg - 2 mg, twice a day, depending on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperidona for bipolar mania.

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

Adults (including elderly patients)

• The initial dose will normally be 0.25 mg, twice a day.
• Later, your doctor may gradually adjust your dose depending on your response to treatment.
• Most people feel better 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 dementia should not exceed 6 weeks.

For the treatment of conduct disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than 50 kg

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

If they weigh 50 kg or more

• The initial dose will normally be 0.5 mg, once a day.
• The dose can be increased, one day yes and one day no, in increments of 0.5 mg per day.
• The normal maintenance dose is 0.5 mg to 1.5 mg, once a day.

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

Children under 5 years of age should not receive treatment with Risperidona for conduct disorders.

Patients with liver or kidney problems

Regardless of the disease being treated, all initial and subsequent doses of Risperidona should be reduced by half. Dose increases should be made more slowly in these patients.

Risperidona should be used with caution in this group of patients.

How to take Risperidona Teva-ratio

Always take Risperidona Teva-ratio exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how much medicine to take and for how long. This will depend on your illness and may vary from person to person. The amount of medicine you should take is explained above in the section “How much to take”.

Risperidona Teva-ratio film-coated tablets

• Swallow the medicine with a drink of water.

If you take more Risperidona Teva-ratio than you should

• Go to your doctor immediately. Take the medicine pack with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing and walking, dizziness due to low blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidona Teva-ratio

• If you forget to take a dose, take it as soon as you remember. But if it is near the time for the next dose, skip the missed dose and continue as normal. If you forget two or more doses, contact your doctor.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Risperidona Teva-ratio

Do not stop taking the treatment unless your doctor tells you to. The symptoms may come back. If your doctor decides to stop the treatment, your dose may be gradually decreased over a few days.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very frequent: affects more than 1 in 10 people

Frequent: affects between 1 and 10 in 100 people

Infrequent: affects between 1 and 10 in 1000 people

Rare: affects between 1 and 10 in 10,000 people

Very rare: affects less than 1 in 10,000 people

Unknown: frequency cannot be estimated from available data

The following side effects may appear:

Very frequent (affects more than 1 in 10 people)

• Parkinsonism. It is a medical term that includes several symptoms. Each individual symptom may occur with less frequency than 1 in 10 people. Parkinsonism includes: increased saliva secretion or very moist mouth, musculoskeletal stiffness, drooling, pain when bending limbs, slower, reduced, or difficult body movements, lack of facial expression, muscle tension, torticollis, muscle stiffness, short and rapid steps when walking, dragging feet, and absence of normal arm movements, persistent blinking as a response to forehead tapping (an abnormal reflex).
• Headache, difficulty staying or falling asleep.
• Feeling drowsy or less attentive.

Frequent (affects between 1 and 10 in 100 people):

• Fatigue, tiredness, inability to stay still, irritability, anxiety, dizziness, attention problems, feeling of exhaustion, sleep disturbance, depression.
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth, toothache, indigestion.
• Dyskinesia: this disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Weight gain, increased appetite, increased body temperature, decreased appetite.
• Difficulty breathing, sinusitis, lung infection (pneumonia), flu, upper respiratory tract infection, eye redness, nasal congestion, nosebleed, cough, ear infection, fever.
• Urinary tract infection, urinary incontinence (loss of control).
• Muscle spasms, bone or muscle pain, involuntary movements of the face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs, pain.
• Rash, skin redness.
• Rapid heartbeat, increased blood pressure, chest pain.
• Increased concentration of prolactin hormone in the blood (which may or may not cause symptoms). When symptoms of increased prolactin appear, they may include in men, breast swelling, difficulty having or maintaining erections or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle.
• Blurred vision, eye infection, or "red eye."
• Falls.

Infrequent (affects between 1 and 10 in 1000 people):

• Fecal incontinence, thirst, very hard stools, excess gas or flatulence.
• Lung infection caused by food passing into the airways, bladder infection, eye redness, viral infection, tonsil infection, infection under the skin, eye infection, stomach or intestine infection, fungal infection of the nails.
• Anomaly in the electrical conduction of the heart, drop in blood pressure when standing up, decreased blood pressure, feeling of dizziness when changing position, prolonged QT interval in the heart, anomaly of heart electrical activity (electrocardiogram or ECG), abnormal heart rhythm, feeling heartbeats, rapid or slow heartbeat.
• Urinary incontinence, pain when urinating, frequent urination, inability to urinate.
• Confusion, attention disorder, low level of consciousness, nervousness, elevated mood (mania), lack of energy and interest, 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 number of white blood cells, decreased hemoglobin or number of red blood cells (anemia), increased number of eosinophils (special white blood cells), increased creatine phosphokinase in the blood (an enzyme that is sometimes released with muscle degradation), decreased number of platelets (blood cells that help stop bleeding).
• Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest muscle and bone pain, chest discomfort.
• Skin injury, skin disorder, dry skin, intense itching, acne, hair loss, skin inflammation caused by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, fatty skin inflammation.
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, increased breast size in males, breast pain, breast discomfort, decreased sexual desire, irregular menstruation, vaginal discharge.
• Fainting, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling of "indisposition," discomfort, balance disorder, feeling of vertigo, allergy, edema, speech disorder, chills, increased body temperature, coordination anomaly.
• A restlessness that causes movement of body parts, sensation of tingling, pinching, or numbness of the skin.
• Painful sensitivity to light, increased blood flow to the eye, eye swelling, dry eyes, increased tearing.
• Respiratory tract disorder, pulmonary congestion, lung crepitus, respiratory tract congestion, speech problems, difficulty swallowing, cough with sputum, wheezing or whistling sound when breathing, pseudoinfluenza syndrome, pneumonia.
• Absence of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with difficulty breathing, sudden weakness or numbness of face, arms, or legs, especially on one side, or cases of confused speech lasting less than 24 hours (called mini-stroke or stroke), involuntary movements of face, arms, or legs, ringing in the ears, facial edema.

Rare (affects between 1 and 10 in 10,000 people):

• Inability to reach orgasm, delayed menstruation, increased mammary glands, increased breast size, breast secretion.
• Dandruff.
• Drug allergy, coldness in arms and legs, hardening, swelling of the mouth, face, lips, or tongue, fever, shortness of breath, itching, skin rash, and sometimes decreased blood pressure.
• Irregular heartbeat.
• Glaucoma, decreased visual acuity, crust formation on the eyelid edge, eye movement.
• Absence of emotions.
• Alteration of consciousness with increased body temperature and muscle spasms, drug withdrawal syndrome, decreased body temperature.
• Rapid and shallow breathing, respiratory problems during sleep, chronic middle ear otitis.
• Intestinal obstruction.
• Decreased blood flow to the brain.
• Decreased number of white blood cells, 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.
• Yellowing of the skin and eyes (jaundice).
• Pancreatitis.
• Infection.
• Intraoperative floppy iris syndrome (IFIS).

• Severe allergic reaction leading to difficulty breathing and shock.

• Absence of granulocytes (a type of white blood cell that helps fight infections).
• Prolonged and painful erection.
• Dangerously excessive water intake.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg) these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• Drug withdrawal syndrome.

Very rare (affects less than 1 in 10,000 people):

• Complications of uncontrolled diabetes, with risk to life.
• Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing.
• Intestinal ileus (lack of movement of intestinal muscles causing obstruction).

The following adverse effects have appeared with the use of another medicine called paliperidone, which is very similar to risperidone, so it is also expected to appear with Risperidone: Rapid heartbeat when standing up.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Risperidona Teva-ratio

It does not require special storage conditions.

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

Do not use this medicine 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 thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Risperidona Teva-ratio

The active ingredient is risperidone.

Each film-coated tablet of Risperidona Teva-ratio contains 3 mg of risperidone.

The other components are:

Core of the tablet:

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

Coating:

Hypromellose 6cP, titanium dioxide (E-171), macrogol 6000, macrogol 400, and yellow quinoline lake (E104)

Appearance of the Product and Package Contents

The 3 mg risperidone film-coated tablets are yellow, round, slightly curved, engraved RIS 3, and scored on one side and scored on the other side.

The tablet can be divided into equal doses.

They are marketed in packages of 20 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TEVA PHARMA SLU

C/ Anabel Segura, 11

Edifio Albatros B, 1ª planta

28108 Alcobendas. Madrid

Manufacturer

Teva Pharmaceutical Works Co.

Pallagi út 13

Debrecen (Hungary)

Date of the Last Revision of this Prospectus: September 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69508/P_69508.html