RISPERIDONA 0.5 mg Orally Disintegrating Tablets

Contents of the leaflet

1. Introduction
2. What is Risperidone Flas Teva-ratiopharm and what is it used for
3. Before taking Risperidone Flas Teva-ratiopharm
4. How to take Risperidone Flas Teva-ratiopharm
5. Possible Adverse Effects
6. Storage of Risperidone Flas Teva-ratiopharm
7. Additional Information

Introduction

Package Leaflet: Information for the User

Risperidone Flas Teva-ratiopharm 0.5 mg Orodispersible Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Risperidone Flas Teva-ratiopharm and what is it used for
2. Before taking Risperidone Flas Teva-ratiopharm
3. How to take Risperidone Flas Teva-ratiopharm
4. Possible side effects
   1. Storage of Risperidone Flas Teva-ratiopharm

1. Additional information

1. What is Risperidone Flas Teva-ratiopharm and what is it used for

Risperidone Flas Teva-ratiopharm belongs to a group of medicines called "antipsychotics".

Risperidone 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 disease called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, who 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. Before taking Risperidone Flas Teva-ratiopharm

Do not take Risperidone Flas Teva-ratiopharm if:

• You are allergic (hypersensitive) to the active substance or any of the other ingredients of Risperidone Flas Teva-ratiopharm (listed in section 6 below).

If you are not sure, consult your doctor or pharmacist before taking Risperidone Flas Teva-ratiopharm.

Be especially careful with Risperidone Flas Teva-ratiopharm

Consult your doctor or pharmacist before taking Risperidone if:

• You have any heart problems. Examples include irregular heartbeats, or if you are prone to low blood pressure or if you are taking medicines for blood pressure. Risperidone 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 Risperidone, 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, these medicines may be associated with the formation of clots.

Consult your doctor immediately if you:

• Experience rhythmic, involuntary movements of the tongue, mouth, or face. It may be necessary to discontinue Risperidone.
• 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 Risperidone Flas Teva-ratiopharm.

Because it has been very rarely observed in patients treated with Risperidone that there is a dangerously low number of a type of white blood cell necessary to fight infections in the blood, your doctor may check your white blood cell count.

Risperidone may cause you to gain weight. A significant weight gain 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 Risperidone, 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 Risperidone if you have dementia caused by a stroke.

During treatment with Risperidone, 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 if it is on one side, or if you have slurred speech, even if it is only for a short time, seek medical attention 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 you experience fatigue while taking Risperidone, changing the administration times may improve your difficulties in paying attention.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription and herbal products.

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 Risperidone 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. Risperidone 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 hydrochlorothiazide). Risperidone, 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 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 heart diseases).
• 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 Risperidone.

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

Taking Risperidone Flas Teva-ratiopharm with food and drinks

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

Pregnancy, breastfeeding, and fertility

• Consult your doctor before taking Risperidone if you are pregnant, trying to become pregnant, or are breastfeeding. Your doctor will decide if you can take it.

Newborns of mothers who have used Risperidone Flas Teva-ratiopharm 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 with any of these symptoms, contact your doctor.

• Risperidone may increase the levels of a hormone called "prolactin" that can affect fertility (see Possible side effects).

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Risperidone Flas Teva-ratiopharm contains aspartame (E 951)

This medicine contains 0.40 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Risperidone Flas Teva-ratiopharm contains sucrose

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

3. How to take Risperidone Flas Teva-ratiopharm

How much to take

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day, which may 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 daily total 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 Risperidone for schizophrenia.

For the treatment of mania

Adults

• The initial dose will normally be 2 mg, once a day.
• Later, your doctor may adjust your dose gradually 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 adjust your dose gradually 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 Risperidone 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 adjust your dose gradually 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 may 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, once a day.

If they weigh 50 kg or more

• The initial dose will normally be 0.5 mg, once a day.
• The dose may 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, 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 Risperidone for conduct disorders.

Patients with liver or kidney problems

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

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

How to take Risperidone Flas Teva-ratiopharm

Always take Risperidone Flas Teva-ratiopharm 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 disease and vary from person to person. The amount of medicine you should take is explained above in the "How much to take" section.

Take one tablet out of the blister pack when it is time to take your medicine,

• Open a blister pack to expose the tablet.
• Do not press the tablet through the foil, as it may break.
• Remove the tablet from the blister pack with dry hands.
• Place the tablet on your tongue immediately.
• The tablet will start to dissolve in seconds.
• You can swallow it with or without water.

If you take more Risperidone Flas Teva-ratiopharm than you should

• Go to your doctor immediately. Take the medicine package 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 seizures.

If you forget to take Risperidone Flas Teva-ratiopharm

If you forget to take a dose, take it as soon as you remember. But if it is close to the time for your next dose, skip the missed dose 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 missed doses.

If you stop taking Risperidone Flas Teva-ratiopharm

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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

Very common: affects more than 1 in 10 people

Common: affects between 1 and 10 in 100 people

Uncommon: affects between 1 and 10 in 1,000 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 common (affects more than 1 in 10 people)

• Parkinsonism. This 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 in response to forehead tapping (an abnormal reflex).
• Headache, difficulty staying or falling asleep.
• Feeling drowsy or less attentive

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

• Fatigue, tiredness, inability to remain 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.

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

• Fecal incontinence, thirst, very hard stools, excess gas or flatulence
• Aspiration pneumonia, bladder infection, eye redness, viral infection, tonsillitis, skin infection, eye infection, stomach or intestine infection, fungal infection of the nails
• Abnormality in the electrical conduction of the heart, decrease in blood pressure when standing up, decrease in blood pressure, feeling of dizziness when changing position, prolongation of the QT interval in the heart, abnormality of heart electrical activity (electrocardiogram or ECG), irregular heartbeat, 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 glucose in the blood, 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
• Decrease in the number of white blood cells, decrease in hemoglobin or red blood cell count (anemia), increase in the number of eosinophils (special white blood cells), increase in creatine phosphokinase in the blood (an enzyme that is sometimes released with muscle degradation), decrease in platelet count (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, skin dryness, 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
• Amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in males, breast pain, breast discomfort, decreased sexual desire, irregular menstruation, vaginal discharge
• Fainting, gait disorder, inactivity, decreased 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 hypersensitivity 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, pseudocroup, pneumonia
• Lack 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, breast enlargement, breast growth, 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
• Dangerously excessive water intake
• Irregular heartbeat
• Glaucoma, decreased visual acuity, crust formation on the eyelid margin, eye movement
• Lack of emotions
• Altered 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

• 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.

• Decrease in the number of white blood cells, inadequate secretion of a hormone that controls urine volume
• Sugar in the urine, decreased sugar in the blood, 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
• Drug withdrawal syndrome

Very rare (affects less than 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 (ileus)

The following adverse effects have appeared with the use of another medication 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 medication.

5. Storage of Risperidone Flas Teva-ratiopharm

Store in the original packaging.

Keep out of the reach and sight of children.

Do not use after the expiration date shown 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 medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional Information

Composition of Risperidone Flas Teva-ratiopharm

The active ingredient is risperidone.

Each 0.5 mg Risperidone Flas Teva-ratiopharm orodispersible tablet contains 0.5 mg of risperidone.

The other components are: Mannitol (E421), butyl methacrylate, povidone, microcrystalline cellulose, hydroxypropyl cellulose, aspartame (E951), crospovidone, red iron oxide (E172), peppermint flavor (contains sucrose), green peppermint flavor, calcium silicate, and magnesium stearate.

Appearance of Risperidone Flas Teva-ratiopharm and packaging contents

The 0.5 mg risperidone orodispersible tablets are slightly biconvex, round, and mottled pink in color.

They are marketed in packs of 28 or 56 tablets.

Marketing authorization holder and manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren. (Germany)

Or

KRKA, d.d., Novo mesto

Smarjeska cesta, 6

8501 Novo mesto

Slovenia

This prospectus was revised in June 2024

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

You can access detailed and updated information about this medication 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/68773/P_68773.html