Risperidone Teva-Ratio 3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidone 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Risperidone Teva-ratio is and what it is used for
2. What you need to know before taking Risperidone Teva-ratio
3. How to take Risperidone Teva-ratio
4. Possible side effects
5. How to store Risperidone Teva-ratio
6. Contents of the pack and other information

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

Risperidona Teva-ratio belongs to a group of medicines called "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 people with Alzheimer's type dementia who are harming themselves or others. Alternative non-pharmacological treatments should have been tried first.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged at least 5 years) and adolescents with conduct disorders.

2. What you need to know before taking 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 unsure, consult your doctor or pharmacist before using Risperidona Teva-ratio.

Warnings and precautions

Talk to your doctor or pharmacist before starting Risperidona 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 medicines for blood pressure. Risperidone may lower blood pressure. You may need your dose adjusted.
• You have any risk factors that may make you more likely to have a stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems 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 medicines).
• You are diabetic.
• You have epilepsy.
• You are male and have ever experienced prolonged or painful erection. If this occurs 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 abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
• You or a family member have a history of blood clots, as medicines like this have been associated with blood clot formation.

Contact your doctor immediately if you experience:

• involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of Risperidona may be necessary.
• fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using Risperidona Teva-ratio.

Because a dangerously low number of a type of white blood cells necessary to fight infections has been observed very rarely in patients treated with Risperidone, 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.

Because diabetes mellitus has been reported or pre-existing diabetes worsened 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 Risperidona, you should see your doctor regularly.

If you or your caregiver notice a sudden change in your mental state, or sudden weakness or numbness of the face, arms, or legs—especially on one side—or slurred 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.

Taking Risperidona Teva-ratio with other medicines

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

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

• Medicines that act on your brain, such as those used to calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can alter 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 heart rate.
• 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 (such as levodopa).
• Medicines that increase the activity of the central nervous system (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 chlorothiazide). Risperidone, 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 used to treat certain 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 conditions).
• 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 whether any of the above applies to you, consult your doctor or pharmacist before using Risperidona Teva-ratio.

Taking Risperidona Teva-ratio with food and drink

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

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
• Tremors, muscle stiffness, and feeding difficulties—reversible in all cases—have been observed in newborns whose mothers received Risperidone during the last trimester of pregnancy.
• Newborns of mothers who used Risperidona Teva-ratio during the last trimester of pregnancy may experience the following symptoms: 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 reported during treatment with Risperidona. Do not drive or operate tools or machinery without first consulting your doctor.

Risperidona Teva-ratio 3 mg film-coated tablets contain lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free."

3. How to take Risperidone Teva-ratio

How much to take

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg once daily, which may be increased to 4 mg once daily on the second day.
• Your doctor may adjust your dose depending on your response to treatment.
• Most people respond well to 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 usual initial dose is 0.5 mg twice daily.
• Your doctor may gradually increase your dose later 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 usual initial dose is 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people respond well to daily doses of 1 to 6 mg.

Elderly patients

• The usual initial dose is 0.5 mg twice daily.
• Your doctor may gradually increase 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's type dementia

Adults (including elderly patients)

• The usual initial dose is 0.25 mg twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people respond well to a dose of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer's type 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 weighing less than 50 kg

• The usual initial dose is 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 weighing 50 kg or more

• The usual initial dose is 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 conduct disorders should not exceed 6 weeks.

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

Patients with liver or kidney problems

Regardless of the condition being treated, all initial and subsequent doses of risperidone should be halved. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this patient group.

How to take Risperidone Teva-ratio

Always take Risperidone Teva-ratio 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 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”.

Risperidone Teva-ratio film-coated tablets

• Swallow the tablet with a glass of water.

If you take more Risperidone Teva-ratio than you should

• Seek medical help immediately. Take the medicine packaging with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or have irregular heartbeat or seizures.

If you forget to take Risperidone Teva-ratio

• If you miss 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 to make up for a missed dose.

If you stop taking Risperidone Teva-ratio

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to discontinue 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, this medicine can cause adverse effects, although not everyone experiences them.

Very common: affects more than 1 in 10 people
Common: affects between 1 and 10 in every 100 people
Uncommon: affects between 1 and 10 in every 1,000 people
Rare: affects between 1 and 10 in every 10,000 people
Very rare: affects fewer than 1 in every 10,000 people
Not known: frequency cannot be estimated from 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 and rapid steps when walking with shuffling of the feet, 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 every 100 people):

• Fatigue, tiredness, inability to stay still, irritability, anxiety, dizziness, attention problems, feeling of exhaustion, sleep disturbances, 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, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems.
• Blurred vision, eye infection, or "red eye".
• Falls.

Uncommon (affects between 1 and 10 in every 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, tonsillitis, 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, rapid or slow heartbeat.
• Urinary incontinence, painful urination, frequent urination, inability to urinate.
• Confusion, attention disorder, reduced level of consciousness, restlessness, elevated mood state (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 special 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, walking disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling of "being unwell", malaise, balance disorder, sensation of spinning (vertigo), allergy, edema, speech disorder, chills, increased body temperature, coordination abnormality.
• Restlessness causing body part movements, 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, speech problems, difficulty swallowing, cough with sputum, hoarse or wheezing breathing sounds, flu-like 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 every 10,000 people):

• Inability to achieve orgasm, delayed menstruation, increased mammary glands, breast enlargement, milk secretion from breasts.

• Dandruff.

• Drug allergy, coldness in arms and legs, hardening, swelling of mouth, face, lips or tongue, fever, labored breathing, itching, skin rash, and sometimes low blood pressure.

• Irregular heartbeat.

• Glaucoma, decreased visual acuity, crust formation at eyelid margins, eye movement.

• 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.

• Reduced blood flow to the brain.

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

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

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

• Coma due to uncontrolled diabetes.

• Yellowing of the skin and eyes (jaundice).

• Pancreatitis.

• 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.

• Dangerously excessive water intake.

• Blood clots in 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 breathing difficulty. If you experience any of these symptoms, contact your doctor immediately.

• Drug withdrawal syndrome.

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

• Complications of uncontrolled diabetes, life-threatening.
• Severe allergic reaction with swelling, which may affect the throat causing breathing difficulty.
• Ileus (lack of movement of intestinal muscles causing obstruction).

The following adverse effects have been reported with 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for 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 Teva-ratio

No special storage conditions are required.

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

Do not use this medicine 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 a SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Risperidone Teva-ratio

The active substance is risperidone.

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

The other components are:

Tablet core:

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

Coating:

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

Appearance of the product and contents of the container

The 3 mg risperidone film-coated tablets are yellow, round, slightly biconvex, with the imprint RIS 3 and a score line on one side, and a score line on the other side.

The tablet can be divided into equal doses.

Available in packs of 20 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TEVA PHARMA SLU
C/ Anabel Segura, 11
Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid

Manufacturer

Teva Pharmaceutical Works Co.
Pallagi út 13
Debrecen (Hungary)

Date of the most recent review of this package leaflet: September 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://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 packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69508/P_69508.html