Leaflet: information for the user

Risperidona Teva1mg/ml oral solution EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Risperidona Teva

3.How to take Risperidona Teva

4.Possible side effects

5.Storage of Risperidona Teva

6.Contents of the pack and additional information

Risperidona Teva belongs to a group of medicines called “antipsychotics”.

Risperidona 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. They must have tried alternative non-pharmacological treatments 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 may help reduce the symptoms of your disease and prevent them from coming back.

Do not take Risperidona Teva:

• if you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6).

If you are unsure, consult your doctor or pharmacist before using Risperidona Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risperidona if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you are taking blood pressure medications. Risperidona 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 heart attack, 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 white blood cell counts in the past (which may or may not have been caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are a male and have ever had a prolonged or painful erection. If you experience this 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 an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• If you or a family member has a history of blood clotting problems, as antipsychotics have been associated with blood clotting.

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

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 Risperidona, your doctor may check your white blood cell count.

Risperidona may cause you to gain weight.A significant weight gain may 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, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Risperidona frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual irregularities or fertility problems in women or breast swelling in men (see "Possible adverse effects"). If these adverse effects appear, it is recommended to evaluate prolactin levels in the blood.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning eye surgery, make sure to inform your ophthalmologist that you are using this medicine.

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 risperidona if you have dementia caused by a stroke.

During treatment with Risperidona, you should see your doctor frequently.

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 confusedly, 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 behavioral disorders.

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

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

A small, inconclusive study has reported an increase in height in children who took Risperidona, but it is unknown whether this is due to the medication or another reason.

Other medicines and Risperidona Teva

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

It is especially important to 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 down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as Risperidona may increase their sedative effect.
• Medicines capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other mental health medications.
• Medicines that cause a slow heart rate.
• Medicines that cause low potassium levels in the blood (for example: some diuretics).
• Medicines for high blood pressure. Risperidona may lower blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychoestimulants, such as methylphenidate).
• 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, 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 Risperidona:

• Rifampicin (a medicine for treating some infections).
• Carbamazepine, phenytoin (medicines for epilepsy).
• Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of Risperidona.

The following medicines may increase the effect of Risperidona:

• 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).
• Fenothiazines (such as medicines used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (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 Risperidona.

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

Taking Risperidona Teva with food, drinks, and alcohol

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

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 using this medicine. Your doctor will decide if you can take it.
• The following symptoms may occur in newborn babies of mothers who have been treated with Risperidona in the last three months of pregnancy (last three months of pregnancy): tremor, muscle stiffness, weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your newborn baby develops any of these symptoms, contact your doctor.
• Risperidona may increase levels of a hormone called "prolactin" that may affect fertility (see "Possible adverse effects").

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Risperidona Teva 1 mg/ml oral solution contains sorbitol (E 420)

This medicine contains 150 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you (or they) have an intolerance to certain sugars, or if you (or they) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medicine.

Risperidona Teva 1 mg/ml oral solution contains benzoic acid (E 210)

This medicine contains 2 mg of benzoic acid in each ml of oral solution.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day, which can be increased to 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 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 usually be 0.5 mg, taken twice a day.
• Your doctor will gradually increase your dose to 1 mg - 2 mg, taken twice a day.
• Your doctor will indicate what is best for you.
  

Children and adolescents

• Children and adolescents under 18 years old should not receive risperidone treatment for schizophrenia.

For the treatment of mania

Adults

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

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor may adjust your dose gradually to 1 mg - 2 mg, taken twice a day based on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years old should not receive risperidone treatment for mania bipolar.

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

Adults (including older adults)

• The initial dose will usually be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml), taken twice a day.
• Your doctor may adjust your dose gradually based on your response to treatment.
• Most people find relief with doses of 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.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than50 kg

• The initial dose will usually be 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml), taken once a day.
• The dose can be increased, one day yes and one day no, by 0.25 mg per day
• The usual maintenance dose is 0.25 mg to 0.75 mg (0.25 ml of risperidone oral solution 1 mg/ml), taken once a day

If they weigh50 kg or more

• The initial dose will usually be 0.5 mg, taken once a day.
• The dose can be increased, one day yes and one day no, by 0.5 mg per day
• The usual maintenance dose is 0.5 mg to 1.5 mg, taken 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 risperidone treatment for behavioral disorders.

Patients with liver or kidney problems

Unless the disease being treated is taken into account, 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.

Administration form

Oral.

How to take Risperidone Teva

Take risperidone 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.

Risperidone Teva oral solution

The solution comes with a syringe (pipette). Use only the syringe provided with this medication to measure the dose prescribed by your doctor. Measure the exact dose of medication you need. Be careful when measuring a small dose, for example, to measure 0.25 mg, you need to measure 0.25 ml (a quarter of a milliliter); to measure 0.5 mg, you need to measure 0.5 ml (half a milliliter).

Follow these steps:

1. Remove the child-resistant cap. Push the plastic cap down and turn it counterclockwise (Figure 1).
2. Insert the syringe into the bottle.
3. Hold the lower ring and pull the upper ring up to the mark corresponding to the number of milliliters or mg you should administer (Figure 2).
4. Hold the lower ring and remove the syringe from the bottle (Figure 3).
5. Empty the syringe into a non-alcoholic drink that is not tea. Slide the upper ring down.
6. Close the bottle.
7. Wash the syringe with water and let it air dry.

If you take more Risperidone Teva 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
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidone Teva

• 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 make up for the missed doses.

If you interrupt treatment with Risperidone Teva

You should not stop taking the treatment unless your doctor tells you to. Symptoms may reappear.If your doctor decides to stop treatment, your 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 medications, this medication can produce side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following rare side effects (which 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 in your face, arms, or legs, especially on one side, or it is difficult for you to speak even for a short period of time. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or movements that cannot be controlled in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary rhythmic movements of your tongue, mouth, and face. You may need to discontinue risperidone.

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

• You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You experience fever, muscle rigidity, sweating, or a decrease in your level of 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 a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or a drop in blood pressure.

Other possible side effects may also occur:

Very common side effects (which may affect more than 1 in 10 people):

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

Common side effects (which may affect up to 1 in 10 people):

• Fatigue, tiredness, restlessness, irritability, anxiety, dizziness, a feeling of exhaustion, sleep disorders, depression.
• Vomiting, diarrhea, constipation, nausea, 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.
• 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 muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Tremor (agitation).
• Weight gain, increased appetite, decreased appetite.
• Sinusitis, lung infection (pneumonia), common cold symptoms, feeling like you have the flu, chest infection (bronchitis), nasal congestion, nosebleeds, cough, ear infection.
• Urinary tract infection, urinary incontinence.
• Muscle spasms, bone or muscle pain, joint pain, back pain, swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
• Rash, skin redness.
• Fast heart rate, increased blood pressure, labored breathing.
• Increased concentration of prolactin hormone in the blood (which may or may not cause symptoms). Symptoms of increased prolactin occur rarely and 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, missed periods, or other problems with the cycle or fertility.
• Blurred vision, eye infection, or "red eye."
• Falls.

Rare side effects (which may affect up to 1 in 100 people):

• Urinary incontinence, feeling thirsty, hard stools, excessive gas or flatulence.
• Lung infection, urinary tract infection, eye redness, viral infection, tonsillitis, skin infection, eye infection, stomach or intestinal infection, fungal infection of the nails.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, abnormal heart conduction, drop in blood pressure when standing, as a result, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when standing or sitting suddenly, flushing, decreased blood pressure, feeling dizzy when changing position, prolonged QT interval in the heart, abnormal heart electrical activity (electrocardiogram or ECG), abnormal heart rhythm, feeling of fluttering or pounding in the chest (palpitations), slow heart rate.
• Difficulty urinating, frequent urination, inability to urinate.
• Confusion, altered attention, decreased level of consciousness, nervousness, euphoria (mania), nightmares.
• Seizures (epileptic crises).
• Diabetes or worsening of diabetes, increased blood glucose, excessive water intake.
• Increased cholesterol in the blood.
• Increased liver enzymes in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood.
• Decreased white blood cell count, decreased hemoglobin or red blood cell count (anemia), increased eosinophil count (special white blood cells), increased creatine phosphokinase (CPK) in the blood, an enzyme that is sometimes released with muscle breakdown, decreased platelet count (blood cells that help stop bleeding).
• Weakness, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort.
• Skin lesions, skin disorder, dry skin, intense itching, acne, hair loss, skin inflammation due to mites, skin discoloration, skin thickening, scaly skin or scalp with itching, localized skin or body infection, reduced skin sensitivity to pain or touch.
• Missing periods, sexual dysfunction, erectile dysfunction, ejaculation disorder, milk secretion from the breasts, breast enlargement in men, breast discomfort, decreased libido, missed periods or other problems with the cycle (women), vaginal discharge.
• Fainting, change in gait, weight loss, loss of appetite with malnutrition and weight loss, feeling unwell, feeling "off," balance disorder, feeling like everything is spinning (vertigo), allergic reaction, eczema, hives (urticaria) speech problems, loss or alteration of taste, chills, increased body temperature, coordination disorder.
• Restlessness causing movement of parts of the body, feeling of tingling, pinching, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tear production.
• Difficulty breathing, wheezing, lung congestion, lung crepitus, respiratory tract congestion, voice disorders, difficulty swallowing, pneumonia caused by aspiration of food.
• Loss of response to stimuli, loss of consciousness, facial, mouth, lip, and eye swelling, ringing in the ears.
• Pain due to the procedure.

Rare side effects (which may affect up to 1 in 1,000 people):

• Inability to achieve orgasm, delayed menstruation, breast enlargement, milk secretion from the breasts.
• Dandruff.
• Somnambulism.
• Sleep-related eating disorder.
• Catatonia (lack of movement or response while awake).
• Head agitation.
• Irregular heartbeat.
• Glaucoma (increased pressure in the eyeball), eye rolling, formation of crusts on the edge of the eyelid, eye movement disorders.
• Loss of emotions.
• Decreased body temperature, coldness in arms and legs.
• Shallow and rapid breathing, respiratory problems during sleep (sleep apnea) Intestinal obstruction.
• Problems with blood vessels in the brain.
• Inadequate secretion of a hormone that controls urine volume.
• Sugar in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat), increased insulin (a hormone that controls blood sugar levels) in the blood.
• Muscle fiber rupture and muscle pain (rhabdomyolysis), movement disorder.
• Diabetic coma due to uncontrolled diabetes.
• Yellow skin and eyes (jaundice).
• Pancreatitis (inflammation of the pancreas).
• Infection.
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication.
• Swollen tongue, cracked lips, skin rash related to the medicationLow number of a type of white blood cell necessary to fight bacterial infectionsExcessive water intake.
• Medication withdrawal syndrome.

Very rare side effects (which may affect up to 1 in 10,000 people):

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

Unknown frequency: cannot be estimated from available data

• Severe rash or skin blistering that may begin around the mouth, nose, eyes, genitals, and spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following side effect has occurred with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to occur with Risperidone: Fast heart rate when standing.

Risperidone long-acting injectable

The following side effects have been reported with the use of Risperidone long-acting injectable. If you experience any of the following side effects, talk to your doctor, even if you are not receiving injections of long-acting Risperidone:

• Intestinal infection
• Subcutaneous abscess, paresthesia, numbness, or tingling of the skin, skin inflammation
• Decreased white blood cell count, cells that help protect you from bacterial infections
• Depression
• Seizures
• Eye twitching
• Sensation of spinning or oscillation
• Slow heart rate, increased blood pressure
• Toothache, tongue spasm
• Gluteal pain
• Weight loss

Other side effects in children and adolescents

In general, it is expected that side effects in children will be similar to those that occurred 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, tremors, 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 leaflet. 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.

No special storage conditions are required.

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, after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, unused portions should be discarded after three months.

Medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

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Composition of Risperidona Teva

The active ingredient is risperidone.

Each ml of Risperidona Teva oral solution contains 1 mg of risperidone

The other components are:

Benzoic acid (E 210), 70% sorbitol solution (E 420), purified water.

Appearance of the product and contents of the packaging

The oral solution is transparent and colorless.

It is presented in 30 and 100 ml bottles, both with a syringe.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Albatros B Building, 1st floor.

28108 Alcobendas. Madrid

Spain

Responsible for manufacturing

Teva Czech Industries s.r.o

Ostravská 29, 747 70,

Opava-Komárov

Czech Republic

Last review date of this leaflet:November2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69514/P_69514.html