Risperidone Tarbis 1 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Risperidone Tarbis 1 mg/ml oral solution 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, consult 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 you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Risperidona Tarbis is and what it is used for

Risperidona Tarbis belongs to a group of medicines known as "antipsychotics".

Risperidona Tarbis is used to treat the following conditions:

• 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 an illness 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 (aged at least 5 years) and adolescents with conduct disorders.

Risperidona Tarbis can help reduce the symptoms of your condition and help prevent them from returning.

2. What you need to know before taking Risperidone Tarbis

Do not take Risperidone Tarbis if:

• You are allergic to risperidone or to any of the other components of this medicine (listed in section 6).

If you are unsure, consult your doctor or pharmacist before starting to take Risperidone Tarbis.

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidone Tarbis 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 Tarbis may reduce blood pressure. You may need your dose adjusted.
• You have any risk factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems 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 male and have ever had a prolonged or painful erection. If this occurs while taking Risperidone Tarbis, contact your doctor immediately.
• You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
• 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 taking Risperidone Tarbis.

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

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

Because diabetes mellitus has been observed or pre-existing diabetes mellitus has worsened in patients taking Risperidone Tarbis, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored.

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 experience confusion in speech, even briefly, 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.

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

Taking Risperidone Tarbis 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 speak with 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 some pain medicines (opioids), or allergy medicines (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, 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 (such as some diuretics).
• Medicines for high blood pressure. Risperidone Tarbis may decrease blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone Tarbis, taken alone or 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 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 (such as medicines 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 taking Risperidone Tarbis.

Taking Risperidone Tarbis with food, drinks, and alcohol

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

Risperidone Tarbis 1 mg/ml oral solution must not be mixed with tea.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you may take it.
• The following symptoms may occur in newborns whose mothers have used Risperidone Tarbis during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
• Risperidone Tarbis may increase levels of a hormone called “prolactin,” which may affect fertility (see Possible side effects).

Driving and using machines

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

Risperidone Tarbis contains sodium

Patients on low-sodium diets should be aware that this medicine contains 11.14 mg (0.484 mmol) of sodium per ml.

3. How to take Risperidone Tarbis

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

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The initial dose is 2 ml (2 mg) per day; it may be increased to 4 ml (4 mg) per day on the second day.
• Your doctor may adjust your dose depending on how you respond to treatment.
• Most people feel better with daily doses of 4 to 6 ml (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 usually 0.5 ml (0.5 mg) twice daily.
• Later, your doctor may gradually increase your dose to 1 to 2 ml (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 usually 2 ml (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 ml (1 to 6 mg).

Elderly patients

• The initial dose is usually 0.5 ml (0.5 mg) twice daily.
• Later, your doctor may gradually adjust your dose to 1 to 2 ml (1 to 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 usually 0.25 ml (0.25 mg) twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people feel better with doses of 0.5 ml (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 Tarbis for schizophrenia or mania.

For the treatment of behavioural disorders in children and adolescents

The dose will depend on your child's weight:

If weight is less than 50 kg:

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

If weight is 50 kg or more:

• The initial dose is usually 0.5 ml (0.5 mg) once daily.
• The dose may be increased every other day in increments of 0.5 ml (0.5 mg) per day.
• The usual maintenance dose is 0.5 to 1.5 ml (0.5 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 Tarbis for behavioural disorders.

Patients with kidney or liver 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.

How to take Risperidone Tarbis

Always take Risperidone Tarbis 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 explained above under the heading “How to take”.

The solution comes with a syringe (pipette). Use only the syringe (pipette) supplied with this medicine to measure the prescribed dose. Measure the exact dose of medicine you need. Pay attention when measuring a small dose; for example, for 0.25 mg, you must measure 0.25 ml (a quarter of a millilitre); for 0.5 mg, you must measure 0.5 ml (half a millilitre).

Follow these steps:

1. Remove the child-resistant cap. Push down the plastic cap while turning it counterclockwise (Figure 1).
2. Insert the pipette into the bottle.
3. Holding the lower ring, pull the upper ring up to the mark corresponding to the number of millilitres to be administered (Figure 2).
4. Holding the lower ring, remove the entire pipette from the bottle (Figure 3).
5. Empty the pipette into a non-alcoholic drink (not tea). Slide the upper ring down.
6. Close the bottle.
7. Rinse the pipette with water and allow it to air dry.

If you take more Risperidone Tarbis than you should

• Seek medical help immediately. Take the medicine package 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 low blood pressure, or have irregular heartbeats or seizures.

If you forget to take Risperidone Tarbis

• 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 a forgotten dose.

If you stop taking Risperidone Tarbis

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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Immediately inform your doctor if:

• 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 have dementia and experience a sudden change in mental status or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking even for a short period. These may be signs of a stroke.
• 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 involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

The following side effects may occur:

Very common (affects 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 subsequently restarts. Other signs of parkinsonism include shuffling slow gait, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness.
• Feeling drowsy or less alert.
• Headache.

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

• Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu.
• Risperidone Tarbis may increase levels of a hormone called "prolactin" detectable in blood tests (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.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: A condition involving slow or sustained involuntary muscle contractions. Although any part of the body may be affected (and may lead to 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, or twisting movements or spasms.
• Tremor (agitation).
• 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.
• 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 (affects between 1 and 10 in 1,000 people):

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection or infection in a single body area, 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) in the blood.
• 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.
• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.
• Tardive dyskinesia (uncontrollable spasms or jerking movements of the face, tongue, or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of Risperidone Tarbis may be necessary.
• Sudden interruption of blood flow to the brain (stroke or "mini" stroke).
• 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, prickling, 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 in the heart, slow heartbeat, abnormal electrical conduction of the heart (electrocardiogram or 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 Tarbis may feel weak, dizzy, or lose consciousness 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 incontinence, very hard stools, difficulty swallowing, excess gas or flatulence.
• Hives (or "urticaria"), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy scalp or skin, skin disorder, skin lesion.
• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, inability to urinate, painful urination.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstruation, missed menstrual periods, or other menstrual cycle problems (women).
• Breast development in men, milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
• Swelling of the face, mouth, eyes, or lips.
• Chills, increased body temperature.
• Change in walking pattern.
• Thirst sensation, malaise, chest discomfort, feeling "unwell", discomfort.
• Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood.
• Pain due to the procedure.

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

• Infection.
• Inappropriate secretion of a hormone controlling urine volume.
• Sugar in urine, decreased blood sugar, increased blood triglycerides (a type of fat).
• Absence of emotions, inability to reach orgasm.
• Neuroleptic Malignant Syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle rigidity).
• Problems with blood vessels in the brain.
• Coma due to uncontrolled diabetes.
• Head agitation.
• Glaucoma (increased pressure in the eyeball), eye movement problems, eye rolling, crusts at the eyelid margin.
• Dangerously low number of a type of white blood cell needed to fight infections in the blood.
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, shortness of breath, itching, skin rash, and sometimes low blood pressure.
• Dangerously excessive water intake.
• Irregular heartbeat.
• Blood clots in the legs, blood clots in the lungs.
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis (inflammation of the pancreas), intestinal obstruction.
• Swelling of the tongue, cracked lips, drug-related skin rash.
• Dandruff.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, increased mammary glands, breast enlargement, milk secretion from the breasts.
• Increased insulin (a hormone controlling blood sugar levels) in blood.
• Priapism (a prolonged erection that may require surgical treatment).
• Skin hardening.
• Decreased body temperature, coldness in arms and legs.
• Drug withdrawal syndrome.
• Yellowing of the skin and eyes (jaundice).

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

• Life-threatening complications from uncontrolled diabetes.
• Severe allergic reaction with swelling, which may affect the throat and cause breathing difficulty.

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 TARBIS: Rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those observed in adults. The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, symptoms of common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (lack of bladder control).

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 Risperidona Tarbis

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

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

Do not store above 30°C. Do not freeze. Store in the original packaging to protect from light and moisture.

Once the bottle has been opened, any unused portion of Risperidona Tarbis oral solution must be discarded after 3 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Risperidone Tarbis

• The active substance is risperidone: Each ml of Risperidone Tarbis oral solution contains 1 mg of risperidone.
• The other components (excipients) are: sodium chloride, domiphen bromide, anhydrous citric acid, disodium phosphate dodecahydrate, lemon flavour (containing maltodextrin derived from corn starch), and purified water.

Appearance of Risperidone Tarbis and contents of the container

Risperidone Tarbis is presented as a clear, slightly yellowish oral solution.

Each container contains 30 ml or 100 ml of oral solution.

Each Risperidone Tarbis package includes a dosing syringe. The smallest amount this syringe can measure is 0.25 ml and the maximum is 3 ml.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

Laboratorios Tedec Meiji Farma, S.A.

Ctra. M-300, km 30.500

28802 Alcalá de Henares (Spain)

or

FARMALABOR, PRODUCTOS FARMACEUTICOS S.A.

Zona Industrial de Condeixa-a-Nova

Condeixa-a-Nova- P-3150-194 (Portugal)

Date of latest revision of this package leaflet: December 2024

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/