RISPERIDONE STADA 3 mg FILM-COATED TABLETS

Contents of the package leaflet:

1. What is Risperidona Stada and what is it used for
2. What you need to know before taking Risperidona Stada
3. How to take Risperidona Stada
4. Possible side effects
5. Storage of Risperidona Stada

1. Contents of the pack and further information

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

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

Risperidona is used to treat the following:

• Schizophrenia, where you may see, hear, or feel things that are not there, believe things that are not true, or feel unusually suspicious or confused.
• Mania, where you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, who harm themselves or others. Other alternative treatments (non-pharmacological) should have been tried before.

• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children and adolescents with conduct disorders.

Risperidona may help to decrease the symptoms of your illness and prevent them from returning.

2. What you need to know before taking Risperidona Stada

Do not take Risperidona Stada:

• If you are allergic to risperidona or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, consult your doctor or pharmacist before taking risperidona.

Warnings and precautions

Consult your doctor or pharmacist before taking 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 use medicines for blood pressure. 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 stroke, such as high blood pressure, cardiovascular diseases, or problems with the 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 decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• If 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 male and have ever had a prolonged or painful erection.
• 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 the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• You or a family member have a history of blood clotting problems, as antipsychotics have been associated with the formation of blood clots.

If you are unsure about any of the above, consult your doctor or pharmacist before taking risperidona.

Because very rarely, patients treated with risperidona have had a dangerously low number of a type of white blood cell needed to fight infections in the blood, your doctor may check your white blood cell count.

Risperidona may cause you to gain weight. A significant weight gain can affect your health unfavorably. 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 high blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Risperidona often increases the levels of a hormone called prolactin. This can cause side effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible side effects). If these side effects occur, it is recommended to evaluate the levels of prolactin in the blood.

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

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of having a stroke. You should 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 confused speech, even if only for a short time, seek medical attention immediately. It 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 risperidona you experience fatigue, changing the administration times may improve your difficulties in paying attention.

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

A small, inconclusive study has reported an increase in height in children who took risperidona, but it is not known if this is an effect of the medicine or due to another reason.

Other medicines and Risperidona Stada

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

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

• Medicines that act on your brain, such as those used to calm you down (benzodiazepines) or some pain medicines (opioids), allergy medicines (some antihistamines), as risperidona may increase their sedative effect.
• Medicines that can change the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medicines for mental problems.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (such as 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 (psychostimulants, such as methylphenidate).
• Diuretics, which are used for heart problems or to treat swelling of 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 decrease 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 diseases).
• Antidepressants such as paroxetine, fluoxetine, 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).
• 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 any of the above, consult your doctor or pharmacist before taking risperidona.

Taking Risperidona Stada 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 taking 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 trimester of pregnancy (the last three months of pregnancy): shaking, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.
• Risperidona may increase the levels of a hormone called “prolactin” that can affect fertility (see Possible side effects).

Driving and using machines

Risperidona may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Risperidona Stada film-coated tablets contain lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Risperidona Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The usual initial dose is 2 milligrams per day, which can be increased to 4 milligrams 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 milligrams.
• This daily total dose can be divided into one or two doses per day. Your doctor will indicate what is best for you.

Elderly patients

• The initial dose will be 0.5 milligrams twice a day, usually.
• Later, your doctor may gradually increase your dose to 1 to 2 milligrams twice a day.
• Your doctor will indicate what is best for you.

For the treatment of mania

Adults

• The initial dose will be 2 milligrams once a day, usually.
• Later, your doctor may adjust your dose gradually depending on your response to treatment.
• Most people feel better with doses of 1 to 6 milligrams once a day.

Elderly patients

• The initial dose will be 0.5 milligrams twice a day, usually.
• Later, your doctor may adjust your dose gradually to 1 to 2 milligrams twice a day depending on your response to treatment.

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

Adults (including elderly patients)

• The initial dose will be 0.25 milligrams twice a day, usually.
• Later, your doctor may adjust your dose gradually depending on your response to treatment.
• Most people feel better with doses of 0.5 milligrams twice a day. Some patients may need 1 milligram twice a day.
• The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with risperidona for schizophrenia or mania.

For the treatment of conduct disorders

The dose will depend on your child's weight:

If they weigh less than 50 kilograms

• The initial dose will be 0.25 milligrams once a day, usually.
• The dose can be increased every other day by 0.25 milligrams per day.
• The usual maintenance dose is 0.25 milligrams to 0.75 milligrams once a day.

If they weigh 50 kilograms or more

• The initial dose will be 0.5 milligrams once a day, usually.
• The dose can be increased every other day by 0.5 milligrams per day.
• The usual maintenance dose is 0.5 milligrams to 1.5 milligrams once a day.

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

Children under 5 years of age should not receive treatment with risperidona for conduct disorders.

Patient with kidney or liver problems

Regardless of the disease being treated, all initial and subsequent doses of risperidona should be reduced by half. Dose increases should be made more slowly in these patients.

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

Method of administration

Oral use

Risperidona Stada film-coated tablets

• You should take the medicine with a glass of water.
• The 0.5 mg, 1 mg, and 3 mg tablets can be divided into equal doses.

If you take more Risperidona Stada than you should

In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing and walking, dizziness due to low blood pressure, or have abnormal heartbeats or convulsions.

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take Risperidona Stada

• If you forget to take a dose, take it as soon as you remember. But if it is close to the time of the next dose, skip the missed dose 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 dose.

If you stop taking Risperidona Stada

Do not stop taking this medicine unless your doctor tells you to. The symptoms may return. If your doctor decides to stop this treatment, your dose may be gradually decreased over a few days.

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Report immediately to your doctor if you experience any of the following rare 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, or have difficulty speaking even for a short period. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or jerky movements that cannot be controlled in the face, tongue, or other parts of the body). Report to your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, and face. Withdrawal of risperidone may be necessary.

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

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate 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 experience fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder 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.

The following side effects may also occur:

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

• Difficulty staying or falling asleep.
• Parkinsonism: This disease may include slow or altered movement, feeling of stiffness or tension in the muscles (making jerky movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness.
• 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 like you have the flu.
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin occur rarely and may include in men, breast swelling, difficulty having or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle or fertility problems.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: This is a disease that involves involuntary slow or continuous contraction of the muscles. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness.
• Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremor (shakiness).
• Blurred vision, eye infection, or "red eye).
• Fast heartbeat, increased blood pressure, shortness of breath.
• 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 (loss of 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 infection of the nails, skin infection, localized infection in a single area of the skin or body part, viral infection, skin inflammation caused by mites.
• Decrease in a type of white blood cell that helps fight infections, decrease in the number of white blood cells, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in the number of eosinophils (a type of white blood cell) in the blood.
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar level, excessive water intake.
• Weight loss, loss of appetite that causes malnutrition and weight loss.
• Increased cholesterol in the blood.
• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.
• Unresponsiveness, loss of consciousness, decreased level of consciousness.
• Seizures (epileptic fits), fainting.
• A restlessness that causes movement of body parts, balance disorder, abnormal coordination, dizziness when standing up, attention problems, speech problems, loss or alteration of taste, decreased sensitivity of the skin to pain or touch, sensation of tingling, pinching, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes.
• Sensation that everything is spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, anomaly in the electrical activity of the heart, prolongation of the QT interval in the heart, slow heartbeat, anomaly in the electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure, decreased blood pressure when standing up (as a result, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when getting up or sitting down suddenly), flushing.
• Aspiration pneumonia, pulmonary congestion, respiratory tract congestion, crackling sounds in the lungs, wheezing, 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 skin or scalp, skin disorder, skin injury.
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with 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, loss of menstrual periods, or other problems with the cycle (in women).
• Development of breasts 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 gait.
• Sensation of thirst, sensation of discomfort, chest discomfort, feeling "unwell", discomfort.
• Increased liver transaminases 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 (may affect up to 1 in 1,000 people):

• Infection.
• Inappropriate secretion of a hormone that controls urine volume.
• Sleepwalking.
• Sleep-related eating disorder.
• Sugar in the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat).
• Lack of emotions, inability to reach orgasm.
• Lack of movement or response while awake (catatonia).
• Problems in the blood vessels of the brain.
• Coma due to uncontrolled diabetes.
• Head shaking.
• Glaucoma (increased eye pressure), problems with eye movement, eye rotation, crusts on the eyelid margin.
• 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.
• Dangerously low number of a type of white blood cell necessary to fight infections in the blood.
• Dangerously excessive water intake.
• Irregular heartbeat.
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Tongue swelling, cracked lips, skin rash related to the medication.
• Dandruff.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, breast enlargement, breast swelling, milk secretion from the breasts.
• Increased insulin (a hormone that controls blood sugar levels) in the blood.
• Skin hardening.
• Decreased body temperature, coldness in arms and legs.
• Drug withdrawal syndrome.
• Yellowing of the skin and eyes (jaundice).

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

• Complications of uncontrolled diabetes, life-threatening.
• Severe allergic reaction with swelling, which can affect the throat, causing breathing difficulties.
• Lack of movement of the intestinal muscles, causing obstruction.

Frequency not known: cannot be estimated from the available data

• Severe rash with blisters and peeling of the skin, which can start around the mouth, nose, eyes, genitals, and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following adverse effect has appeared with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to appear with risperidone: fast heartbeat when standing up.

Other adverse effects in children and adolescents

In general, it is expected that the adverse effects in children will be similar to those that appeared 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, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (loss of control).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Risperidona Stada

Keep this medication out of 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.

This medication does not require special storage conditions.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Risperidona Stada

The active ingredient is risperidone.

Each film-coated tablet of Risperidona Stada 0.5 mg contains 0.5 mg of risperidone.

Each film-coated tablet of Risperidona Stada 1 mg contains 1 mg of risperidone.

Each film-coated tablet of Risperidona Stada 3 mg contains 3 mg of risperidone.

Each film-coated tablet of Risperidona Stada 6 mg contains 6 mg of risperidone.

The other components are:

Tablet core:lactose, cornstarch, pregelatinized starch (derived from corn), sodium lauryl sulfate, microcrystalline cellulose, sodium croscarmellose, hydrated silica, and magnesium stearate.

Coating:

Risperidona 0.5 mg: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 400.

Risperidona 1 mg: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and macrogol 400.

Risperidona 3 mg: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), and macrogol 400.

Risperidona 6 mg: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), and macrogol 400.

Appearance of the product and package contents

The film-coated tablets of Risperidona Stada 0.5 mg are packaged in Al/Al or PVC/Al blisters.

The film-coated tablets of Risperidona Stada 1, 3, and 6 mg are packaged in Al-Al, PVDC-Al, or PVC-Al blisters.

The 0.5 mg risperidone film-coated tablets are oblong, biconvex, brown, with the inscription "0.5" on one side and a score line on the other. The tablet can be divided into two equal halves.

The 1 mg risperidone film-coated tablets are oblong, biconvex, orange, with the inscription "1" on one side and a score line on the other. The tablet can be divided into two equal halves.

The 3 mg risperidone film-coated tablets are oblong, biconvex, yellow, with the inscription "3" on one side and a score line on the other. The tablet can be divided into two equal halves.

The 6 mg risperidone film-coated tablets are oblong, biconvex, salmon-colored, with the inscription "6" on one side.

Package sizes:

The film-coated tablets of Risperidona Stada 0.5 mg are available in the following package sizes: 28 or 56 tablets.

The film-coated tablets of Risperidona Stada 1 mg and 3 mg are available in the following package sizes: 20 or 60 tablets.

The film-coated tablets of Risperidona Stada 6 mg are available in the following package sizes: 30 or 60 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the last revision of this leaflet:July 2023

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