RISPERIDONE FLAS KRKA 2 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before you take Risperidone Flas Krka

Do not take Risperidone Flas Krka

• If you are allergic to risperidone 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 taking Risperidone Flas Krka.

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidone Flas Krka if:

• You have any heart problems. Examples include irregular heartbeats, or if you are prone to having low blood pressure or if you take medicines for blood pressure. Risperidone Flas Krka can 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.
• You know 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 depend on prolactin.
• You or someone in your family has a history of blood clot formation, as antipsychotics have been associated with the formation of blood clots.

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking Risperidone Flas Krka.

Because, in rare cases, a dangerous decrease in the number of certain types of white blood cells necessary to fight infections in the blood has been observed in patients taking risperidone, your doctor may need to check your white blood cell counts.

Risperidone Flas Krka may cause you to gain weight. A significant increase in weight 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 Risperidone Flas Krka, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored.

Risperidone Flas 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 occur, it is recommended to evaluate prolactin levels in the blood.

During eye surgery for cataracts, the pupil (the black circle in the center of your eye) may not increase in size sufficiently. Additionally, the iris (the colored part of the eye) may become flexible during the procedure and may lead to eye damage. If you are scheduled for eye surgery, make sure to tell your eye doctor that you are taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by a stroke.

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

If you or your caregiver notice a sudden change in your mental state or 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 risperidone you experience fatigue, changing the administration hours may improve your attention difficulties.

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

A small, inconclusive study reported an increase in height in children taking risperidone, but it is not known if this is a drug effect or due to another reason.

Other medicines and Risperidone Flas Krka

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

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

• 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 risperidone 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 (e.g., some diuretics)
• Medicines for high blood pressure. Risperidone Flas Krka may lower your 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). Risperidone Flas Krka, 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 risperidone

• Rifampicin (a medicine used to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital

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

The following medicines may increase the effect of risperidone

• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (e.g., 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 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 risperidone.

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking Risperidone Flas Krka.

Taking Risperidone Flas Krka with food, drinks, and alcohol

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

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 it.
• The following symptoms may occur in newborn babies of mothers who have used Risperidone Flas Krka in the last trimester (last three months of pregnancy): shaking, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you may need to contact your doctor.
• Risperidone Flas Krka may increase your levels of a hormone called "prolactin" that can affect fertility (see Possible side effects).

Driving and using machines

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

Risperidone Flas Krka contains aspartame (E951)

This medicine contains 1.60 mg of aspartame in each 2 mg oral disintegrating tablet. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Risperidone Flas Krka

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

Please note that not all doses of these medicines are marketed or not all recommended doses can be administered with these medicines. Other pharmaceutical forms/doses may be available for prescription.

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 depending on how you respond to treatment
• Most people feel better 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.

Elderly patients

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

For the treatment of mania

Adults

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

Elderly patients

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

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

Adults (including elderly patients)

• The initial dose will normally be 0.25 mg, twice a day
• Later, your doctor may adjust your dose gradually depending on your response to treatment
• Most people feel better 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.

Use in children and adolescents

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

For the treatment of conduct disorders

The dose depends on your child's weight:

If they weigh less than 50 kg

• The initial dose will normally be 0.25 mg, once a day.
• The dose can be increased, one day yes and one day no, in increments of 0.25 mg per day
• The normal maintenance dose is 0.25 mg to 0.75 mg, once a day.

If they weigh 50 kg or more

• The initial dose will normally be 0.5 mg, once a day
• The dose can be increased, one day yes and one day no, in increments of 0.5 mg per day
• The normal maintenance dose is 0.5 mg to 1.5 mg, 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 risperidone for conduct disorders.

Patients with liver or kidney problems

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

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

Method of administration

For oral use.

Risperidone Flas Krka oral disintegrating tablets are fragile. They should not be pressed through the blister packaging as this will damage the tablet. Remove a tablet from the packaging as follows:

1. Hold the blister packaging by the edges and separate one blister from the rest of the strip along the perforations.
2. Lift the corner of the foil and completely remove it.
3. Empty the tablet into your hand.
4. Place the tablet on your tongue as soon as it is removed from the packaging.

It will start to dissolve in your mouth within seconds and can be swallowed with or without water. Your mouth should be empty before placing the tablet on your tongue.

You can also place the tablet in a glass or cup filled with water and drink it immediately.

If you take more Risperidone Flas Krka than you should

• Go to your doctor immediately. Take the medicine packaging with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.
• 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 seizures.

If you forget to take Risperidone Flas Krka

• If you forget to take a dose, take it as soon as you remember. But if it is close to the time for your 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 missed doses.

If you stop taking Risperidone Flas Krka

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

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

4. Possible Adverse Effects

Like all medications, this medication 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 (involuntary spasms or 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 very 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"). May require immediate medical treatment.
• Is a man and presents a prolonged or painful erection. It is known as priapism. May require 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 muscle tension (making sudden 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 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" 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: 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.
• 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).
• 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.
• Lack 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, prolonged 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 difficulty.
• 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, increased 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).
• 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 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 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 breakdown 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 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 skin peeling 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 medication 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, 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 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 medication.

5. Conservation of Risperidone Flas Krka

Keep this medication out of 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.

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 at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Risperidone Flas Krka

• The active ingredient is risperidone. Each tablet contains 2 mg of risperidone.
• The other components are mannitol (E421), methacrylic acid copolymer, povidone K-25, microcrystalline cellulose, hypromellose, aspartame (E951), crospovidone, red iron oxide (E172), green mint flavor, mint flavor, calcium silicate, magnesium stearate.

See section 2 "Risperidone Flas Krka contains aspartame (E951)".

Appearance of the product and package contents

The orodispersible tablets: are pink mottled, round, slightly convex tablets.

Package sizes: 20, 28, 30, 50, 56, 60, 98, or 100 tablets in blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

KRKA, d.d., Novo mesto

Smarjeska cesta 6

8501 Slovenia

Manufacturer

KRKA, d.d., Novo mesto

Smarjeska cesta 6

8501 Slovenia

You can request more information about this medication 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 medication is registered in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany Risperidon TAD 2 mg Schmelztabletten

Denmark Risperidon Krka

Spain Risperidona Flas Krka 2 mg Orodispersible Tablets EFG

Estonia Torendo Q-Tab 2 mg

Finland Risperidon Krka 2 mg Orodispersible Tablets

Hungary Torendo Q-Tab 2 mg

Lithuania Torendo Q-Tab 2 mg, orodispersible tablets

Latvia Torendo Q-Tab 2 mg mute dispergejamas tabletes

Norway Risperidon Krka 2 mg Orodispersible Tablets

Poland Torendo Q-Tab 2 mg

Portugal Risperidon Krka

United Kingdom Risperidone 2 mg Orodispersible Tablets

Czech Republic Rorendo Oro Tab 2 mg, orodispersible tablets

Slovakia Torendo Q-Tab 2 mg

Sweden Risperidon Krka 2 mg ODT tablet

Date of the last revision of this prospectus: March 2023

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