Label: information for the useruser

Risperidone Tarbis 1 mg/ml oral solution EFG

Read this label carefully before starting to take this medicationmedication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other peoplepeopleeven if they have the samesymptomsas you, as it may harm them.
• If you experienceadverse effects, consult yourdoctor or pharmacist, even if they are not listed in this label.Seesection4.

Risperidona Tarbis belongs to a group of medications known as “antipsychotics”.

Risperidona Tarbis is used to treat the following:

• Schizophrenia, with which you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused.
• Mania, with which you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. Alternative non-pharmacological treatments must have been tried previously.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years old), and adolescents with behavioral disorders.

Risperidona Tarbis may help reduce the symptoms of your illness and prevent them from returning.

Do not take Risperidona Tarbis if:

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

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

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidona Tarbis if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to low blood pressure or if you are taking blood pressure medications. Risperidona Tarbis may lower your blood pressure. You may need to have your dose adjusted.
• You know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• You have ever had involuntary movements of the tongue, mouth, and face.
• You have ever had symptoms that include fever, muscle stiffness, sweating, or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• You have had low levels of white blood cells in the past (which may or may not have been caused by other medications).
• You are diabetic.
• You have epilepsy.
• You are male and have ever had an erection that is prolonged or painful. If you experience this while taking Risperidona 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 an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• You or a family member has a history of blood clots, as antipsychotics have been associated with the formation of blood clots.

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking Risperidona Tarbis.

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

Risperidona Tarbis may cause you to gain weight. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

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

Patients with advanced age and dementia

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

You should see your doctor frequently during treatment with risperidone.

If you or your caregiver notice a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or if you speak in a confused manner, even for a short time, seek medical treatment immediately. This may be a sign of a stroke.

Children and adolescents

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

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

Before starting treatment, your weight or that of your child may be measured, and this should be done regularly during treatment.

Taking Risperidona Tarbis with other medications

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

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

• Medications that act on your brain, such as those used to calm down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase their sedative effect.
• Medications capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medications for mental health problems.
• Medications that cause a slow heart rate.
• Medications that cause low potassium levels in the blood (such as some diuretics).
• Medications for high blood pressure. Risperidona Tarbis may lower blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Diuretics, which are used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidona Tarbis, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may reduce the effect of risperidone:

• Rifampicin (a medication for treating some infections).
• Carbamazepine, phenytoin (medications for epilepsy).
• Phenobarbital.

If you start or stop taking these medications, you may need a different dose of risperidone.

The following medications may increase the effect of risperidone:

• Quinidine (used for certain types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
• Medications known as beta blockers (used to treat high blood pressure).
• Fenothiazines (such as medications used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (blockers of stomach acid).

If you start or stop taking these medications, you may need a different dose of risperidona.

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking Risperidona Tarbis.

Taking Risperidona Tarbis with food, drinks, and alcohol

You can take this medication with or without food. You should avoid consuming alcohol while taking Risperidona Tarbis.

Risperidona Tarbis 1 mg/ml oral solution should not be mixed with tea.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will decide if you can take it.
• The following symptoms may occur in newborn babies of mothers who used Risperidona Tarbis in the last three months of pregnancy: tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.
• Risperidona Tarbis may increase levels of a hormone called "prolactin" that may affect fertility (see Possible side effects).

Driving and using machines

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

Risperidona Tarbis contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. 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, which can be increased to 4 ml (4 mg) per day on the second day.
• Your doctor may adjust your dose based on your response to treatment.
• Most people find relief 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 indicate what is best for you.

Older adults

• The initial dose will be 0.5 ml (0.5 mg) twice a day, usually.
• Your doctor will gradually increase the dose from 1 to 2 ml (1 to 2 mg) twice a day.
• Your doctor will indicate what is best for you.

For the treatment of mania

Adults

• The initial dose will be 2 ml (2 mg) once a day, usually.
• Your doctor may adjust the dose gradually based on your response to treatment.
• Most people find relief with daily doses of 1 to 6 ml (1 to 6 mg).

Older adults

• The initial dose will be 0.5 ml (0.5 mg) twice a day, usually.
• Your doctor may adjust the dose gradually from 1 to 2 ml (1 to 2 mg) twice a day based on your response to treatment.

For the long-term treatment of aggression in people with Alzheimer's disease

Adults (including older adults)

• The initial dose will be 0.25 ml (0.25 mg) twice a day, usually.
• Your doctor may change the dose gradually based on your response to treatment.
• Most people find relief with doses of 0.5 ml (0.5 mg) twice a day. Some patients may need 1 mg twice a day.
• The duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years old should not receive Risperidona Tarbis treatment for schizophrenia or mania.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than 50 kg:

• The initial dose will be 0.25 ml (0.25 mg) once a day, usually.
• The dose can be increased one day yes and one day no by 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 a day.

If they weigh 50 kg or more:

• The initial dose will be 0.5 ml (0.5 mg) once a day, usually.
• The dose can be increased one day yes and one day no by 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 a day.

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

Children under 5 years old should not receive Risperidona Tarbis treatment for behavioral disorders.

Patients with kidney or liver problems

Unless the disease being treated is considered, all initial doses 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 Risperidona Tarbis

Take Risperidona Tarbis exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Your doctor will indicate how much medication you should take and for how long. This will depend on your illness and may vary from person to person. The amount of medication you should take is explained earlier in the "How much to take" heading.

The solution comes with a syringe (pipette). You should use it to measure the exact amount of medication you need.

Follow these steps:

1. Remove the child-resistant cap. Push the plastic cap down, turning it at the same time against the direction of the clock (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 milliliters you should administer (Figure 2).
4. Holding the lower ring, remove the pipette from the bottle (Figure 3).
5. Empty the pipette into a non-alcoholic beverage that is not tea. Slide the upper ring down.
6. Close the bottle.
7. Wash the pipette with water.

If you take more Risperidona Tarbis than you should

• Go to your doctor immediately. Bring the medication packaging with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken..
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, difficulty standing and walking, a sensation of dizziness due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidona Tarbis

• If you forget to take a dose, take it as soon as you remember. But if it's almost time for your next dose, skip the missed one and continue as usual. If you forget two or more doses, contact your doctor..
• Do not take a double dose (two doses at once) to compensate for the missed dose.

If you interrupt treatment with Risperidona Tarbis

Do not stop taking the medication unless your doctor tells you to. Symptoms may reappear. If your doctor decides to stop treatment, the dose may be gradually reduced over a few days.

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

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

Inform your doctor immediately if:

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the 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 your mental state or sudden weakness or numbness in 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 experience fever, muscle stiffness, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• You experience involuntary rhythmic movements of the tongue, mouth, and face. You may need to discontinue risperidona.

The following side effects may occur:

Very common (affects more than 1 in 10 people):

• Difficulty staying or falling asleep.
• Parkinsonism: This condition can include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly with a dragging gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Feeling drowsy or less attentive.
• Headache.

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

• Pneumonia, chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infection, feeling like you have the flu.
• Risperidona Tarbis may increase levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). When symptoms of increased prolactin appear, they may include in men, breast swelling, difficulty getting 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 problems with the menstrual cycle.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: This is a condition that involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness.
• Discinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremor (agitation).
• Blurred vision, eye infection, or "red eye."
• Fast heart rate, increased blood pressure, labored breathing.
• Sore throat, cough, nasal bleeding, 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.
• 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, urinary tract infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or part of the body, viral infection, cutaneous inflammation caused by mites.
• Decreased white blood cell count, decreased white blood cell count, decreased platelet count, anemia, decreased red blood cell count, increased eosinophil count in the blood.
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar, excessive water intake.
• Weight loss, loss of appetite leading to malnutrition and weight loss.
• High cholesterol in the blood.
• Euphoria (mania), confusion, decreased libido, nervousness, nightmares.
• Tardive dyskinesia (involuntary spasms or movements that cannot be controlled in 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. You may need to discontinue Risperidona Tarbis.
• Sudden loss of blood flow to the brain (stroke or "mini" stroke).
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
• Seizures (epileptic crises), fainting.
• Restlessness that causes movement of parts of the body, abnormal balance, abnormal coordination, dizziness when standing up, altered attention, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, feeling of pins and needles, numbness, or tingling of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tear production, eye redness.
• Sensation of spinning (vertigo), buzzing in the ears, ear pain.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, abnormal heart activity, prolonged QT interval in the heart, slow heart rate, abnormal heart conduction (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure, decreased blood pressure when standing up (as a result, some people taking Risperidona Tarbis may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly), flushing.
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, lung crepitus, wheezing, voice disorder, difficulty breathing.
• Stomach or intestinal infection, fecal incontinence, hard stools, difficulty swallowing, excessive gas or flatulence.
• Hives (urticaria), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly skin or scalp with itching, skin or scalp disorder.
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle degradation.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, inability to urinate, painful urination.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstrual periods, loss of menstrual periods or other problems with the menstrual cycle (women).
• Male breast development, 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 gait.
• Feeling thirsty, feeling unwell, chest discomfort, feeling "off," feeling unwell.
• Increased liver enzymes in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood.
• Pain due to the procedure.

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

• Infection.
• Incorrect secretion of a hormone that controls urine volume.
• Sugar in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat).
• Lack of emotions, inability to achieve orgasm.
• Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness).
• Problems with blood vessels in the brain.
• Diabetes-induced coma.
• Head agitation.
• Glaucoma (increased pressure in the eyeball), eye movement problems, eye rotation, crusts on the eyelid border.
• Pelvicly low count of a type of white blood cell necessary to fight infections in the blood.
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, labored breathing, itching, rash, and sometimes decreased blood pressure.
• Excessive water intake.
• Irregular heartbeat.
• Blood clots in the legs, blood clots in the lungs.
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Swelling of the tongue, cracked lips, skin rash related to the medication.
• Dandruff.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, breast enlargement, breast secretion.
• Increased insulin (a hormone that controls blood sugar levels) in the blood.
• Priapism (prolonged erection that may require surgical treatment).
• Skin hardening.
• Decreased body temperature, coldness in arms and legs.
• Medication withdrawal syndrome.
• Yellow skin and eyes (jaundice).

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

• Complications of uncontrolled diabetes, life-threatening.
• Severe allergic reaction with swelling that can affect the throat, causing difficulty breathing.

The following side effects have appeared with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to appear with RISPERIDONA TARBIS: Fast heart rate when standing up.

Other side effects in children and adolescents

In general, it is expected that side effects in children will be similar to those that appeared in adults. The following side effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy, or less attentive, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhea, and urinary incontinence.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C). Do not freeze. Store in the original packaging to protect it from light and moisture.

Once the bottle is opened, any unused Risperidona Tarbis oral solution should be discarded after 3 months.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risperidona Tarbis

• The active ingredient is risperidone: Each ml of oral solution of Risperidona Tarbis contains 1 mg of risperidone.Risperidone.
• The other components (excipients) are: sodium chloride, domifen bromide, anhydrous citric acid, disodium dodecahydrate phosphate, lemon aroma (with maltodextrin derived from cornstarch)and purified water.

Appearance of Risperidona Tarbis and content of the container

Risperidona Tarbis is presented in the form of a transparent and slightly yellowish oral solution.

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

Each container of Risperidona Tarbis contains a dosing syringe. The smallest amount that this syringe can dose is 0.25 ml and the maximum is 3 ml.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona(Spain)

Responsible for manufacturing:

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 the last review of this prospectus:November2013

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/