Leaflet: information for the user

Risperidone Flas Teva-ratiopharm 0.5 mg buccodispersible tablets EFG

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others even if they have similar symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

6.Additional information

Risperidona Flas Teva-ratiopharm belongs to a group of medicines called “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 disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. 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.

Do not take Risperidona Flas Teva-ratiopharm if:

• You are allergic (hypersensitive) to the active ingredient or any of the components of Risperidona Flas Teva-ratiopharm (listed in section 6 below).

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

Be especially careful with Risperidona Flas Teva-ratiopharm

Consult your doctor or pharmacist before taking Risperidona if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to low blood pressure or if you are taking 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 heart attack, such as high blood pressure, cardiovascular disease, or problems with 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 medications).
• You are diabetic.
• You have epilepsy.
• You are a male and have had a prolonged or painful erection at any time. 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 clots, these medications may be associated with the formation of blood clots.

Consult your doctor immediately if you have:

• Uncontrollable, rhythmic movements of the tongue, mouth, or face. You may need to discontinue Risperidona.
• Fever, severe muscle stiffness, sweating, or low levels of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.

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

Because in very rare cases, patients treated with Risperidona have had 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.

Risperidona may cause you to gain weight. 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.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of having a heart attack. Do not take risperidona if you have dementia caused by a heart attack.

You should see your doctor frequently during treatment with Risperidona.

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 in paying attention.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription and herbal products.

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

• 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 (such as quinidine), 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 (e.g., some diuretics).
• Medications to treat 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, used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or hydrochlorothiazide). 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).
• Phenothiazines (e.g., 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.

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

Taking Risperidona Flas Teva-ratiopharm with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

Newborns of mothers who have used Risperidona Flas Teva-ratiopharm in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn experiences any of these symptoms, contact your doctor.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating 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 Flas Teva-ratiopharm contains aspartame (E 951)

This medication contains 0.40 mg of aspartame in each buccal tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Risperidona Flas Teva-ratiopharm contains saccharose

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

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 based on how you respond to treatment.
• Most people find relief 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 initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor will gradually increase your dose to 1 mg to 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 initial dose will usually be 2 mg, taken once a day.
• Your doctor may adjust your dose gradually based on your response to treatment.
• Most people find relief with daily doses of 1 to 6 mg.

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor may adjust your dose gradually to 1 mg to 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 initial dose will usually be 0.25 mg, taken twice a day.
• Your doctor may adjust your dose gradually based on your response to treatment.
• Most people find relief 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 initial dose will usually be 0.25 mg, taken once a day.
• The dose can be increased, one day yes and one day no, by 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg, taken once a day.

If they weigh 50 kg or more

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

How to take Risperidone Flas Teva-ratiopharm

Take Risperidone Flas Teva-ratiopharm exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

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 earlier in the "How much to take" section.

Remove one tablet from the blister pack when it is time to take the medication,

• 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 the tongue immediately
• The tablet will begin 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. Bring the packaging of the medicine with you. You can also call the Toxicological 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, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have irregular heartbeats or convulsions.

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 almost 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 the missed doses.

If you interrupt treatment with Risperidone Flas Teva-ratiopharm

You should not stop taking the treatment 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 product, ask your doctor or pharmacist

Like all medications, Risperidone may cause side effects, although not everyone will experience them.

Very common:affect more than 1 in 10 people

Common:affect between 1 and 10 in 100 people

Uncommon:affect between 1 and 10 in 1000 people

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

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

Unknown:the frequency cannot be estimated from available data

The following side effects may occur:

Very common (affect more than 1 in 10 people)

• Parkinsonism. This is a medical term that includes several symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: increased salivation or a very wet mouth, muscular rigidity, drooling, pain when bending the limbs, slower, reduced, or difficult body movements, facial expressionlessness, muscle tension, torticollis, muscular rigidity, short, rapid steps, dragging the feet, and absence of normal arm movements, persistent blinking as a response to forehead taps (an abnormal reflex).
• Headache, difficulty staying or remaining asleep.
• Feeling drowsy or less attentive.

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

• Fatigue, tiredness, inability to remain calm, 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
• Respiratory difficulty, sinusitis, pulmonary infection (pneumonia), flu, upper respiratory tract infection, eye redness, nasal congestion, nasal bleeding, cough, ear infection, fever
• Urinary tract infection, urinary incontinence (loss of control)
• Muscle spasms, bone or muscle pain, involuntary facial or arm and leg movements, joint pain, back pain, arm and leg swelling, pain
• Rash, skin redness
• Fast heart rate, increased blood pressure, chest pain
• Increased prolactin concentration in the blood (which may or may not cause symptoms). When symptoms of increased prolactin appear, they may include in men, breast enlargement, difficulty getting or maintaining erections, or other sexual dysfunction. In women, they may include breast discomfort, milk secretion, menstrual irregularity, or other menstrual cycle problems.
• Blurred vision, eye infection, or "red eye"
• Falls

Uncommon (affect between 1 and 10 in 1000 people):

• fecal incontinence, thirst, hard stools, excessive gas or flatulence
• Pulmonary infection caused by food passing through the respiratory tract, urinary tract infection, eye redness, viral infection, tonsillitis, skin infection, eye infection, stomach or intestinal infection, fungal nail infection
• Abnormal heart conduction, decreased blood pressure when standing, 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 heartbeats, fast or slow heart rate
• Urinary incontinence, painful urination, frequent urination, inability to urinate
• Confusion, attention disorder, low level of consciousness, nervousness, manic state, 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 white blood cell count, decreased hemoglobin or red blood cell count (anemia), increased eosinophil count (special white blood cells), increased creatine phosphokinase in the blood (an enzyme that sometimes is released with muscle degradation), decreased 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 lesions, skin disorder, dry skin, intense itching, acne, hair loss, skin inflammation by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, oily skin inflammation
• Menstrual absence, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in men, breast pain, breast discomfort, decreased sexual desire, irregular menstruation, vaginal secretion
• Loss of consciousness, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling unwell, discomfort, balance disorder, sensation of spinning (vertigo), allergy, edema, speech disorder, chills, increased body temperature, coordination disorder
• Restlessness causing movement of body parts, sensation of tingling, pinching, or numbness of the skin
• Increased sensitivity to light, increased blood flow to the eye, eye swelling, dry eyes, increased tear production
• Respiratory tract disorder, pulmonary congestion, lung crepitus, respiratory tract congestion, speech problems, difficulty swallowing, cough with sputum, hoarse or hissing breathing sound, pseudogripal disease, pneumonia
• Loss of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with respiratory difficulty, 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 cerebral attack), involuntary facial, arm, or leg movements, tinnitus, facial edema.

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

• Inability to achieve orgasm, delayed menstruation, breast enlargement, breast secretion
• Dandruff
• Medication allergy, coldness in arms and legs, hardening, swelling of the mouth, face, lips, or tongue, fever, labored breathing, itching, skin rash, and sometimes decreased blood pressure
• Excessive water intake
• Irregular heart rate
• Glaucoma, decreased visual acuity, corneal scarring, eye movement
• Lack of emotions
• Altered consciousness with increased body temperature and muscle spasms, medication withdrawal syndrome, decreased body temperature
• Shallow and rapid breathing, respiratory problems during sleep, chronic middle ear infection
• 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 immediate medical attention.

• Decreased white blood cell count, 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
• Flaccid iris syndrome (intraoperative)

• Severe allergic reaction leading to respiratory difficulty and shock

• Granulocyte absence (a type of white blood cell that helps fight infections)
• Prolonged and painful erection
• Medication withdrawal syndrome

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

• Life-threatening complications of uncontrolled diabetes
• Severe allergic reaction with swelling, which can affect the throat and cause respiratory difficulty
• Intestinal ileus (lack of movement of the intestinal muscles that causes obstruction)

The following side 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: Fast heart rate when standing up

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 prospectus. 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.

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 disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Risperidona Flas Teva-ratiopharm

The active ingredient is risperidone.

Each buccal dispersible tablet of Risperidona Flas Teva-ratiopharm 0.5 mg contains 0.5 mg of risperidone.

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

Appearance of Risperidona Flas Teva-ratiopharm and packaging contents

The 0.5 mg risperidone buccal dispersible tablets are slightly biconvex, round, and speckled pink.

They are sold in packs of 28 or 56 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren. (Germany)

Or

KRKA, d.d., Novo mesto

Smarjeska cesta, 6

8501 Novo mesto

Slovenia

This leaflet was revised in June 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)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 smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68773/P_68773.html