Risperidone Flas Teva-Ratiopharm 0.5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidona Flas Teva-ratiopharm 0.5 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Risperidona Flas Teva-ratiopharm is and what it is used for
2. Before taking Risperidona Flas Teva-ratiopharm
3. How to take Risperidona Flas Teva-ratiopharm
4. Possible side effects
5. How to store Risperidona Flas Teva-ratiopharm
6. Further information

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

Risperidona Flas Teva-ratiopharm belongs to a group of medicines known as “antipsychotics”.

Risperidone is used to treat the following:

• Schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, a condition in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a disorder called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who are a danger to themselves or others. Alternative non-pharmacological treatments should have been attempted previously.

Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) 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 to any of the components of Risperidone Flas Teva-ratiopharm (listed in section 6 below).

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

Take special care with Risperidone Flas Teva-ratiopharm

Consult your doctor or pharmacist before taking Risperidone if:

• You have any heart problems. Examples include irregular heart rhythms, or if you are prone to low blood pressure, or if you are taking medications for blood pressure. Risperidone may reduce blood pressure. You may need a dose adjustment.
• You are aware of any factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• You have Parkinson's disease or dementia.
• You have previously had low levels of white blood cells (which may or may not have been caused by other medications).
• You are diabetic.
• You have epilepsy.
• You are male and have ever experienced prolonged or painful erection. If this occurs while taking Risperidone, contact your doctor immediately.
• You have difficulty regulating your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.

If you or a family member has a history of blood clots, these medications may be associated with clot formation.

Contact your doctor immediately if you experience:

• Involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of Risperidone may be necessary.
• Fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.

If you have any doubts about whether the above applies to you, consult your doctor or pharmacist before using Risperidone Flas Teva-ratiopharm.

Very rarely, patients treated with Risperidone have developed a dangerously low number of a type of white blood cell needed to fight infections. Your doctor may monitor your white blood cell count.

Risperidone may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking Risperidone, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if your dementia is 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 sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or confusion in speech, even if brief, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

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

If you experience fatigue during treatment with risperidone, changing the time of administration may improve difficulties with attention.

Use of other medicines

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

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

• Medicines that act on the brain, such as those used to calm you (benzodiazepines), or certain pain medications (opioids), or allergy medications (some antihistamines), as risperidone may increase their sedative effect.
• Medicines capable of altering the electrical activity of your heart, such as those used for malaria, heart rhythm disorders (e.g., quinidine), allergies (antihistamines), certain antidepressants, or other medicines for mental disorders.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Medicines for Parkinson's disease (e.g., levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics used for heart problems or to treat swelling in certain body parts due to fluid retention (e.g., furosemide or hydrochlorothiazide). Risperidone, alone or in combination with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

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

If you start or stop taking these medicines, you may require a different dose of risperidone.

The following medicines may increase the effect of risperidone:

• 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 require a different dose of risperidone.

If you have any doubts about whether the above applies to you, consult your doctor or pharmacist before using Risperidone Flas Teva-ratiopharm.

Taking Risperidone Flas Teva-ratiopharm with food and drink

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

Pregnancy, breast-feeding, and fertility

• Consult your doctor before using Risperidone if you are pregnant, trying to become pregnant, or breast-feeding. Your doctor will decide whether you may take it.

Newborns of mothers who have used Risperidone Flas Teva-ratiopharm during the last trimester of pregnancy may experience symptoms such as tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

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

Consult your doctor or pharmacist before using 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 machinery without first consulting your doctor.

Risperidone Flas Teva-ratiopharm contains aspartame (E 951)

This medicine contains 0.40 mg of aspartame per 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 properly eliminate it.

Risperidone Flas Teva-ratiopharm contains sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult him 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; this may be increased to 4 mg per day on the second day
• Your doctor may adjust your dose depending on your response to treatment
• Most people feel better with daily doses of 4 to 6 mg
• This total daily dose may be divided into one or two doses per day. Your doctor will tell you what is best for you

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Later, your doctor may gradually increase your dose to 1 mg – 2 mg twice daily.
• Your doctor will tell you what is best for you.

Children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperidone for schizophrenia.

For the treatment of mania

Adults

• The initial dose is usually 2 mg once daily.
• 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 is usually 0.5 mg twice daily.
• Your doctor may gradually adjust your dose to 1 mg – 2 mg twice daily, depending on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperidone for bipolar mania.

For the long-term treatment of aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

• The initial dose is usually 0.25 mg twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people feel better with a dose of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer-type dementia should not exceed 6 weeks.

For the treatment of behavioural disorders in children and adolescents

The dose will depend on your child's weight:

If your child weighs less than 50 kg

• The initial dose is usually 0.25 mg once daily.
• The dose may be increased every other day in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once daily.

If your child weighs 50 kg or more

• The initial dose is usually 0.5 mg once daily.
• The dose may be increased every other day in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once daily.

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

Children under 5 years of age should not be treated with Risperidone for behavioural disorders.

Patients with liver or kidney problems

Regardless of the condition 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 patient group.

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 unsure.

Your doctor will tell you how much medicine to take and for how long. This depends on your condition and may vary from person to person. The amount of medicine you should take is described above under the heading "How much to take".

Remove one tablet from the blister when it is time to take your medication:

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

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

• Seek medical advice immediately. Take the medicine packaging with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, difficulty standing or walking, dizziness due to a drop in 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. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.

• Do not take a double dose (two doses at the same time) to make up for forgotten doses.

If you stop taking Risperidone Flas Teva-ratiopharm

You should not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop treatment, your dose may be gradually reduced over several days.

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

4. Possible adverse effects

Like all medicines, Risperidone may cause adverse effects, although not everybody gets 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

Not known: frequency cannot be estimated from the available data

The following side effects may occur:

Very common (affects 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 very wet mouth, musculoskeletal rigidity, drooling, pain when bending limbs, slowed, reduced, or difficult body movements, lack of facial expression, muscle tightness, torticollis, muscle stiffness, short, shuffling steps when walking, shuffling gait, absence of normal arm movements, persistent blinking in response to tapping the forehead (an abnormal reflex).
• Headache, difficulty falling or staying asleep.
• Feeling drowsy or less alert

Common (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 condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Weight gain, increased appetite, increased body temperature, decreased appetite
• Breathing difficulty, sinusitis, lung infection (pneumonia), flu, upper respiratory tract infection, eye redness, nasal congestion, nosebleeds, cough, ear infection, fever
• Urinary tract infection, urinary incontinence (loss of bladder 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 elevated prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erections, or other sexual dysfunction. In women: breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual problems.
• 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
• Lung infection caused by food entering the airways, bladder infection, eye redness, viral infection, tonsil infection, skin infection, eye infection, stomach or intestinal infection, fungal nail infection
• Abnormality in the heart's electrical conduction, drop in blood pressure upon standing, decreased blood pressure, dizziness when changing position, QT interval prolongation in the heart, abnormal electrical activity of the heart (electrocardiogram or ECG), abnormal heart rhythm, awareness of heartbeat, fast or slow heartbeat
• Urinary incontinence, pain when urinating, frequent urination, inability to urinate
• Confusion, attention disorder, decreased level of consciousness, restlessness, elevated mood (mania), lack of energy and interest, nightmares
• Seizures (epileptic fits)
• Diabetes or worsening of diabetes, increased blood glucose, excessive water intake
• Increased cholesterol in blood
• Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood
• Decreased number of white blood cells, decreased hemoglobin or number of red blood cells (anemia), increased number of eosinophils (a type of white blood cell), increased blood creatine phosphokinase (an enzyme sometimes released during muscle breakdown), 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, severe itching, acne, hair loss, skin inflammation due to mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, greasy skin inflammation
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, milk secretion from breasts, breast enlargement in males, breast pain, breast discomfort, decreased sexual desire, irregular menstruation, vaginal discharge
• Fainting, gait disturbance, inactivity, reduced appetite with malnutrition and weight loss, feeling unwell, malaise, balance disorder, sensation of spinning (vertigo), allergy, edema, speech disorder, chills, increased body temperature, coordination abnormality
• Restlessness causing body parts to move, tingling sensation, prickling 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, crackling lung sounds, respiratory tract congestion, difficulty speaking, difficulty swallowing, cough with sputum, hoarse or wheezing breathing sound, pseudoinfluenza illness, pneumonia
• Absence of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with breathing difficulty, sudden weakness or numbness of face, arms or legs, especially on one side, or episodes 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 gland enlargement, breast enlargement, milk secretion from breasts

• 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 low blood pressure

• Dangerously excessive water intake

• Irregular heartbeat

• Glaucoma, decreased visual acuity, crusting at the edge of the eyelid, eye movement disorder

• Absence of emotions

• Altered consciousness with increased body temperature and muscle spasms, drug withdrawal syndrome, decreased body temperature

• Rapid and shallow breathing, breathing 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 travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

• Decreased number of white blood cells, inappropriate secretion of a hormone controlling urine volume

• Sugar in urine, decreased blood sugar, increased triglycerides in blood (a type of fat), increased insulin (a hormone controlling blood sugar levels) in blood

• Muscle fiber breakdown and muscle pain (rhabdomyolysis), movement disorder

• Diabetic coma due to uncontrolled diabetes

• Yellowing of the skin and eyes (jaundice)

• Pancreatitis (inflammation of the pancreas)

• Infection

• Floppy iris syndrome (intraoperative)

• Severe allergic reaction leading to breathing difficulty 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 may affect the throat and cause breathing difficulty
• Ileus (lack of movement in the intestinal muscles causing obstruction)

The following adverse effects have been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, they are also expected to occur with Risperidone: Rapid heartbeat upon standing

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Flas Teva-ratiopharm

Keep in the original packaging.

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of Risperidona Flas Teva-ratiopharm

The active substance is risperidone.

Each orodispersible 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 flavour (contains sucrose), green peppermint flavour, calcium silicate and magnesium stearate.

Appearance of Risperidona Flas Teva-ratiopharm and contents of the pack

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

They are marketed in packs of 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

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 leaflet was last reviewed in June 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68773/P_68773.html