Risperidone Ratio 6 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Risperidone ratio 6 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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 you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What risperidone ratio is and what it is used for

Risperidone ratio belongs to a group of medicines called "antipsychotics".

Risperidone ratio 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-type dementia who harm themselves or others. Alternative non-pharmacological treatments should have been tried 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.

Risperidone ratio can help reduce the symptoms of your condition and help prevent them from returning.

2. What you need to know before starting Risperidone ratiopharm

Do not take Risperidone ratiopharm:

• If you are allergic to risperidone 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 Risperidone ratiopharm.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Risperidone ratiopharm if:

• You have any heart problems. Examples include irregular heartbeat, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone may reduce blood pressure. You may need your dose adjusted.
• You are aware of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• You have ever experienced involuntary movements of the tongue, mouth, or face.
• You have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• You have previously had low levels of white blood cells in your blood (which may or may not have been caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are a man and have ever had a prolonged or painful erection.
• 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 tumour that may be prolactin-dependent.
• If you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using Risperidone ratiopharm.

Very rarely, patients treated with Risperidone have been observed to have a dangerously low number of a type of white blood cell needed to fight infections. Your doctor may check 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 diabetes mellitus has been observed or pre-existing diabetes mellitus has 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.

Risperidone frequently increases levels of a hormone called "prolactin". This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see section 4. "Possible side effects"). If these adverse effects occur, evaluation of prolactin levels in the blood is recommended.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the coloured part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You must 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 if you speak unclearly, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

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

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

Before starting treatment, your weight or your child's weight may be measured and should be monitored regularly during treatment.

A small and inconclusive study has reported increased height in children taking risperidone, but it is unknown whether this is an effect of the active substance or due to another reason.

Taking Risperidone ratiopharm with other medicines

Tell 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:

• Medicines that act on your brain, such as those used to calm you (benzodiazepines), or some 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 (like quinidine), allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (e.g., 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, used for heart problems or to treat swelling in certain body parts 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 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 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., medicines used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Some medicines used to treat HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

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 Risperidone ratiopharm.

Taking Risperidone ratiopharm with alcohol

You should avoid consuming alcohol while taking Risperidone ratiopharm.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take it.
• Newborns of mothers who have used Risperidone during the third trimester (the last three months 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 section 4. "Possible side effects").

Driving and using machines

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

Risperidone ratiopharm contains lactose and sodium

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

This medicine contains less than 23 mg (1 mmol) of sodium per film-coated tablet; this is essentially "sodium-free".

3. How to take Risperidone ratio

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

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 how you respond to treatment.
• Most people improve with daily doses of 4 to 6 mg.
• This total daily dose can be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

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

For the treatment of mania

Adults

• The initial dose is normally 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people improve with daily doses of 1 to 6 mg once daily.

Elderly patients

• The initial dose is normally 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.

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

Adults (including elderly patients)

• The initial dose is normally 0.25 mg (0.25 ml of an oral solution of 1 mg/ml), twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most patients improve 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.

Use in children and adolescents

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

For the treatment of conduct disorders

The dose will depend on your child's weight:

If weight is less than 50 kg

• The initial dose is normally 0.25 mg (0.25 ml of an oral solution of 1 mg/ml), 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 (0.25 ml to 0.75 ml of an oral solution of 1 mg/ml), once daily.

If weight is 50 kg or more

• The initial dose is normally 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 reduced by half. Dose increases should be made more slowly in these patients.

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

Method of administration

For oral use.

Swallow the medicine with a glass of water.

You may take this medicine with or without food.

Tablets may be divided into equal doses.

If you take more Risperidone ratio than you should

Seek medical help immediately. Take the medicine pack 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, have difficulty standing or walking, feel dizzy due to a drop in blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidone ratio

If you forget to take a dose, take it as soon as you remember. However, if it is nearly 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 a missed dose.

If you stop taking Risperidone ratio

Do 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately if you experience any of the following uncommon adverse effects (may affect up to 1 in 100 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side of the body, or have difficulty speaking even for a short time. These may be signs of a stroke.
• You develop tardive dyskinesia (involuntary spasms or twitching movements of the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

Tell your doctor immediately if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 patients):

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be required.
• You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

The following secondary adverse effects may also occur:

Very common (may affect more than 1 in 10 people)

• Difficulty falling or staying asleep
• Parkinsonism: this condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Feeling drowsy or less alert
• Headache

Common (may affect up to 1 in 10 people)

• Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu
• Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin occur rarely and may include, in men, breast swelling, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, symptoms may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle or fertility problems.
• Weight gain, increased appetite, decreased appetite
• Sleep disorders, irritability, depression, anxiety, restlessness
• Dystonia: a condition involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• Dizziness
• Dyskinesia: a condition involving involuntary muscle movements, which may include repetitive, jerking, twisting, or spasmodic movements
• Tremor (shakiness)
• Blurred vision, eye infection, or "red eye"
• Rapid heartbeat, increased blood pressure
• Shortness of breath, sore throat, cough, nosebleeds, nasal congestion
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Skin rash, skin redness
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence (loss of bladder control)
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Falls

Uncommon (may affect up to 1 in 100 people)

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or body, viral infection, skin inflammation caused by mites
• Decreased levels of a type of white blood cell that helps fight infections, decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), anemia, decreased red blood cells, increased number of eosinophils (a type of white blood cell)
• Allergic reaction
• Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake
• Weight loss, loss of appetite leading to malnutrition and reduced body weight
• Increased blood cholesterol levels
• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness
• Seizures (epileptic fits), fainting
• Restlessness causing body movements, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, pricking, or numbness of the skin
• Light sensitivity of the eyes, dry eyes, increased tearing, eye redness
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation on the electrocardiogram (ECG), slow heartbeat, abnormal electrical conduction of the heart (ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure, decreased blood pressure upon standing (as a result, some people taking Risperidone may feel weakness, dizziness, or fainting when standing up or sitting up suddenly), flushing
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crackling lung sounds, voice disorder, breathing difficulty
• Stomach or intestinal infection, fecal incontin游戏副本

5. Storage of Risperidone ratio

Keep 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 is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and other information

Composition of Risperidone ratio

The active substance is risperidone.

Each Risperidone ratio 6 mg film-coated tablet contains 6 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 (type A) from potato, magnesium stearate.

Coating: titanium dioxide (E-171), hypromellose, macrogol 6000, macrogol 400, iron oxide red (E 172), iron oxide yellow (E 172).

Appearance of the product and contents of the pack

Risperidone 6 mg film-coated tablets are light brown, round, slightly biconvex tablets, approximately 10.5 mm in diameter and 4.5 mm thick, engraved with "RIS 6" and a score line on one side, and another score line on the opposite side.

The tablet can be divided into equal doses.

Risperidona ratio 6 mg is available in blisters. Pack sizes are 10, 20, 30, and 60 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Manufacturer

Teva Pharmaceuticals Works Private Ltd. Co.

Pallagi út 13

4042 Debrecen

Hungary

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: July 2023

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