RISPERIDONE KRKA 0.5 mg FILM-COATED TABLETS

2. What you need to know before you take Risperidona Krka

Do not take Risperidona Krka

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

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before using this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take risperidona:

• If you have heart problems. Examples include irregular heartbeat or tendency to low blood pressure or if you are using medicines for blood pressure. Risperidona may decrease blood pressure.

You may need to have your dose adjusted.

• If you know of factors that may favor the occurrence of a stroke, such as high blood pressure, cardiovascular disorders or problems with the blood vessels in the brain.
• If you have ever presented involuntary movements of the tongue, mouth, and face.
• If you have ever presented symptoms that include fever, muscle stiffness, sweating, or a decrease in the level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease or dementia.
• If you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• If you are diabetic.
• If you have epilepsy.
• If you are a man and have ever had a prolonged or painful erection. If you have problems controlling your body temperature or have excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If you have an abnormally high level of the hormone prolactin in the blood or if you have a tumor that may be dependent on prolactin.
• If you or someone in your family has a history of blood clots, as antipsychotics have been associated with the formation of blood clots.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before using this medicine.

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

Risperidona may cause weight gain. Significant weight gain can negatively affect your health. Your doctor should weigh you regularly.

Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking risperidona, so your doctor should determine if there are signs of sugar in the blood. In patients with pre-existing diabetes mellitus, blood glucose should be regularly monitored.

Risperidona Krka 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 appear, it is recommended to evaluate the levels of prolactin in the blood.

During eye surgery for cataracts, the pupil (the black circle in the middle 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 damage to the eye. If you are considering 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 a higher risk of stroke. You should not take risperidona if you have dementia caused by a stroke.

During treatment with risperidona, you should consult your doctor frequently.

Go to the doctor immediately if you or your caregiver notice a sudden change in your mental state, sudden weakness or numbness of the face, arms, or legs, especially on one side, or difficulty speaking, even if it is for a short period. These may be symptoms of a stroke.

Children and adolescents

Before starting treatment in the case of conduct disorders, other causes of aggressive behavior should have been ruled out.

If during treatment with risperidona, fatigue occurs, a change in the administration regimen may improve attention deficits.

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

A small and 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 drug or due to another reason.

Other medicines and Risperidona Krka

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

It is especially important that you tell your doctor or pharmacist if you are taking:

• Medicines that work in the brain to, for example, calm (benzodiazepines) or some pain medicines (opioids), allergy medicines (some antihistamines), because risperidona may increase the sedative effect of all these.
• Medicines that may alter the electrical activity of the heart, such as medicines for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medicines for mental problems.
• Medicines that decrease heart rate.
• Medicines that decrease potassium levels in the blood (such as some diuretics).
• Medicines to treat high blood pressure. Risperidona may decrease blood pressure.
• Medicines to treat Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Diuretics used for heart problems or for swelling due to excessive fluid accumulation (such as furosemide or chlorthiazide). Risperidona 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 the treatment of 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 tranquilizers).
• 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 irregular heartbeat.
• 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 not sure if any of the above applies to you, consult your doctor or pharmacist before using this medicine.

Taking Risperidona Krka with food, drinks, and alcohol

You can take this medicine with or without food, but you should avoid drinking alcohol while taking risperidona.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take this medicine.

The following symptoms may appear in newborns of mothers who have been taking risperidona in the last trimester (the last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If your baby presents any of these symptoms, it is possible that you may need to 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

During treatment with Risperidona Krka, you may experience dizziness, fatigue, and vision problems. Do not drive or operate tools or machinery without consulting your doctor first.

Risperidona Krka contains lactose and sodium

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

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

3. How to take Risperidona Krka

Follow exactly the administration instructions of this medicine given 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 usual initial dose is 2 mg per day, which can be increased to 4 mg per day on the second day of treatment.
• The dose can be adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with daily doses of 4 to 6 mg.
• This daily total dose can be divided into one or two doses per day. Your doctor will inform you what is most convenient for you.

Elderly patients

• • The usual initial dose is 0.5 mg twice a day.
  • Your doctor may gradually increase your dose to 1 mg to 2 mg twice a day.
• Your doctor will inform you what is most convenient for you.

For the treatment of mania

Adults

• The usual initial dose is 2 mg once a day.
• The dose can be gradually adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with doses of 1 to 6 mg once a day.

Elderly patients

• The usual initial dose is 0.5 mg twice a day.
• The dose can be adjusted gradually by your doctor to 1 mg or 2 mg twice a day depending on how you respond to treatment.

For the treatment of prolonged aggression in patients with Alzheimer's dementia

Adults (including elderly patients)

• The usual initial dose is 0.25 mg twice a day.
• The dose can be adjusted gradually depending on how you respond to treatment.
• Most people feel better with 0.5 mg twice a day. Some patients require a dose of 1 mg twice a day.
• Treatment in patients with Alzheimer's dementia should not be prolonged for more than 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 depends on the child's weight:

For children weighing less than 50 kg

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

For children weighing 50 kg or more

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

The duration of treatment in patients with conduct disorders should not be prolonged for more than 6 weeks.

Children under 5 years of age should not be treated with risperidona for conduct disorders.

Patients with kidney or liver problems

Regardless of the disease for which you are being treated, all initial and subsequent doses should be reduced by half. The increase in dose should be slower in these patients. Risperidona should be used with caution in this group of patients.

Method of administration

Oral use

Swallow the tablet with water.

If you take more Risperidona Krka than you should

• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing or walking, feel dizzy due to low blood pressure, or experience an irregular heartbeat or seizures.

If you forget to take Risperidona Krka

• 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 forget two or more doses, contact your doctor.

• Do not take a double dose (two doses at the same time) to make up for missed doses.

If you stop taking Risperidona Krka

Do not stop taking this medicine unless your doctor has told you to do so. It is possible that the symptoms will return. If your doctor decides to stop the treatment, the dose should 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 medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor ifyou experience any of the following rare adverse effects (may affect up to 1 in 100 people):

• Suffers from dementia and experiences sudden changes in mental state or sudden weakness or numbness in the face, arms, or legs, especially on one side, or confused speech, even for a short period. These may be signs of a stroke.
• Experiences tardive dyskinesia (spasms or involuntary spasmodic movements that cannot be controlled in the face, tongue, or other parts of the body). Report immediately to your doctor if you experience involuntary rhythmic movements of the tongue, mouth, or face. Withdrawal of risperidone may be necessary.

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

• Presents 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.

• Presents 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.
• Is a man and presents a prolonged or painful erection. It is known as priapism. You may need immediate medical treatment.
• Presents 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 adverse effects may appear:

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 sudden movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors at rest, increased saliva and/or drooling, and loss of facial expressiveness.
• Feeling drowsy or less attentive.
• 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 having the flu.
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). The 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: It is a disease that involves slow or continuous involuntary 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.
• Discinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremors (shakiness).
• Blurred vision, eye infection, or "red eye".
• Fast 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 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 cells that help 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).
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar levels, 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.
• Absence of response to stimuli, loss of consciousness, decreased level of consciousness.

• Seizures (epileptic crises), 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 skin sensitivity to pain or touch, tingling, pinching, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tearing, eye redness.
• Feeling 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), feeling of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure, decreased blood pressure when standing up (as a consequence, some people taking Risperidone Krka 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 difficulties.
• Stomach or intestine 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 degradation.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, inability to urinate, pain when urinating.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstruation, loss of menstrual periods, or other problems with the cycle (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, an increase in body temperature.
• Change in gait.
• Feeling of thirst, feeling 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).
• Absence 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 Krka. 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 cells 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.
• Rupture of muscle fibers 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.
• Hardening of the skin.
• 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 difficulty breathing.
• Lack of movement of the intestinal muscles that causes obstruction.

Frequency not known: the frequency cannot be estimated from the available data

• Severe rash with blisters and peeling of the skin that 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 effects have appeared with the use of another medicine called paliperidone, which is very similar to risperidone, so it is also expected to appear with Risperidone Krka: 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 attentive, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors (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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Risperidone Krka

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

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

PVC/PE/PVDC-Alu blister: Store below 30°C.

HDPE container: This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

6. Package contents and additional information

Composition of Risperidone Krka

The active ingredient is risperidone.

Each film-coated tablet contains 0.5 mg of risperidone.

The other components are:

Core: lactose monohydrate, powdered cellulose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), talc, propylene glycol, and red iron oxide (E172).

See section 2 "Risperidone Krka contains lactose and sodium".

Appearance of the product and package contents

Red-brown film-coated tablet, oval, biconvex, scored on one side.

The tablet can be divided into equal doses.

Package sizes

Blister packs: 20, 28, 30, 56, 60, or 100 film-coated tablets in a box.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the Local Representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Denmark Risperidon Krka

Finland Risperidon Krka 0.5 mg/1 mg/2 mg/3 mg/4 mg/6 mg Film-coated Tablets

Portugal Risperidona Krka

Sweden Risperidon Krka 0.5 mg/1 mg/2 mg/3 mg/4 mg/6 mg Film-coated Tablet

Slovakia Torendo 0.5 mg/1 mg/2 mg/3 mg/4 mg/6 mg

Spain Risperidona Krka 0.5 mg/1 mg/2 mg/3 mg/4 mg/6 mg Film-coated Tablets

Date of the last revision of this prospectus: March 2023

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