Leaflet: information for the user

Risperidone Krka 1 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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 Risperidone Krka is and what it is used for

2.What you need to know before you start taking Risperidone Krka

3.How to take Risperidone Krka

4.Possible side effects

5.Storage of Risperidone Krka

6.Contents of the pack and additional information

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

Risperidona Krka is used to treat:

• Schizophrenia, which may cause you to see, hear or feel things that are not present, believe things that are not true or feel excessively suspicious or confused.
• Mania, which may cause you to feel extremely excited, euphoric, agitated, enthusiastic or hyperactive. Mania occurs in a condition called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's disease, who harm themselves or others. Alternative non-pharmacological treatments must have been followed.
• 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 illness and prevent them from returning.

Do not take Risperidona Krka

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

If you are unsure whether this applies to you, consult your doctor or pharmacist before using this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take risperidone:

• If you have heart problems. Examples include irregular heart rhythm or a tendency to low blood pressure or if you are taking medicines for high blood pressure. Risperidone may lower blood pressure.

You may need your dose adjusted.

• If you know of factors that may increase the risk of a stroke, such as high blood pressure, cardiovascular disorders or problems with the blood vessels in the brain.
• If you have ever had involuntary movements of the tongue, mouth and face.
• If you have ever had symptoms that include fever, muscle stiffness, sweating or a decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease or dementia.
• If you have had low white blood cell counts (which may or may not have been caused by other medicines) in the past.
• 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 difficulty 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 tumour that may be dependent on prolactin.
• If you or a member of your family has a history of blood clots, as antipsychotics have been associated with the formation of blood clots.

If you are unsure whether 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 cell necessary to fight infections in the blood has been observed in patients treated with risperidone, your doctor may check your white blood cell count.

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

Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking risperidone, 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 controlled regularly.

Risperidone Krka frequently 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 that the levels of prolactin in the blood be evaluated.

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

Patients with advanced age and dementia

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

You should consult your doctor frequently during treatment with risperidone.

Go quickly to your doctor 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 for a short time. These may be symptoms of a stroke.

Children and adolescents

Before starting treatment for conduct disorders, other causes of aggressive behaviour should be ruled out.

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

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

A small, inconclusive study has reported an increase in the height of children who took risperidone, but it is unknown whether this is a side effect of the drug or due to another reason.

Other medicines and Risperidona Krka

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

It is especially important to inform your doctor or pharmacist if you are taking:

• Medicines that act on the brain to, for example, calm (benzodiazepines) or some pain medicines (opioids), allergy medicines (some antihistamines), because risperidone may increase the sedative effect of all these.
• Medicines that may alter the heart's electrical activity, such as malaria medicines, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental problems.
• Medicines that slow down the heart rate.
• Medicines that lower potassium levels in the blood (for example, some diuretics).
• Medicines to treat high blood pressure. Risperidone may lower blood pressure.
• Medicines to treat Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psycho-stimulants, such as methylphenidate).
• Diuretics used for heart problems or for swelling due to excessive accumulation of fluid (such as furosemide or chlorothiazide). Risperidone 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 risperidone:

• 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 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).
• Fenothiazines (such as medicines used to treat psychosis or as tranquilizers).
• Cimetidine, ranitidine (gastric acid blockers).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Ritonavir (a medicine used to treat HIV/AIDS).
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline andfluvoxamine, 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 whether 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 risperidone.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.Your doctor will decide if you can take this medicine.

The following symptoms may appear in newborns of mothers who have taken risperidone 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 shows any of these symptoms, it may be necessary to contact your doctor.

Risperidone may increase the levels of a hormone called“prolactin” which may affect fertility (see Possible side effects).

Driving and operating machinery

During treatment with Risperidona Krka, dizziness, fatigue and vision problems may occur. 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 him before taking this medicine.

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

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

• This total daily dose may be divided into one or two doses per day. Your doctor will inform you of what is best for you.

Older adults

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

For the treatment of mania

Adults

Older adults

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

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

Adults (including older adults)

• The initial dose is usually 0.25 mg twice a day.
• The dose may be gradually adjusted based 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 disease should not be prolonged for more than 6 weeks.

Use in children and adolescents

• Childrenand adolescentsunder 18 years old should not receive treatment with risperidone for schizophrenia or mania.

For the treatment of behavioral disorders

The dose depends on the child's weight:

For children weighing less than 50 kg

• The initial dose is usually 0.25 mg per day.
• The dose may be increased in alternate days by 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg per day.

For children weighing 50 kg or more

• The initial dose is usually 0.5 mg per day.
• The dose may be increased in alternate days by 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg per day.

Treatment in patients with behavioral disorders should not be prolonged for more than 6 weeks.

Children under 5 years old should not be treated with risperidone for behavioral disorders.

Patients with kidney or liver problems

Regardless of the disease being treated, all initial and subsequent doses should be reduced by half. Dose increases should be slower in these patients.Risperidone should be used with caution in this group of patients.

Administration form

For oral administration

Swallow the tablet with water.

If you take more Risperidone Krka than you should

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

If you forget to take Risperidone 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 usual dosing schedule. If you forget two or more doses, contact your doctor.

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

If you interrupt treatment with Risperidone Krka

You should not stop taking this medication unless your doctor tells you to. It is possible that symptoms will reappear. If your doctor decides to stop treatment, the dose should be gradually reduced over a few days.

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

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

Inform your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 100 people):

• You have dementia and experience sudden changes in your mental state or sudden weakness or numbness in your face, arms, or legs, especially on one side, or confused speech, even for a short period of time. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or movements in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary rhythmic movements of your tongue, mouth, or face. Risperidone withdrawal may be necessary.

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

• You have blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which can 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 have a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

• You experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.

The following side 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 is then restarted. Other signs of parkinsonism include walking slowly dragging your feet, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Feeling drowsy or less attentive.
• Headache.

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

• Pneumonia, chest infection (bronchitis), common cold symptoms, sinusitis.
• Urinary tract infection, ear infection, feeling like you have the flu.
• Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactinoccur rarely andmay include in men, breast swelling, difficulty getting or maintaining erections, decreased sex driveor other sexual dysfunctions. In womenmay include breast discomfort, milk secretion, 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 disease involves involuntary slow or continuous muscle contractions. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or jaw.

• Dizziness.
• Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or writhing movements, or spasms.
• Tremor (agitation).
• Blurred vision, eye infection, or "red eye."
• Fast heart rate, increased blood pressure, labored breathing.
• Throat pain, cough, nasal bleeding, nasal congestion.
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Rash, skin redness.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence.
• Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
• Falls.

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

• Respiratory tract infection, urinary tract infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or part of the body, viral infection, skin inflammation caused by mites.
• Decreased white blood cell count, decreased white blood cell count, decreased platelet count, anemia, decreased red blood cell count, increased eosinophil count (a type of white blood cell).
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar, excessive water intake.
• Weight loss, decreased appetite causing malnutrition and weight loss.
• Increased cholesterol in the blood.
• Euphoria (mania), confusion, decreased sex drive, nervousness, nightmares.
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.

• Seizures (epileptic crises), fainting.
• Anxiety that causes movement of parts of the body, abnormal balance, abnormal coordination, dizziness when standing up, altered attention, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, feeling of pins and needles, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tear production, eye redness.
• Sensation of spinning (vertigo), buzzing in the ears, ear pain.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, abnormal heart electrical activity, prolonged QT interval in the heart, slow heart rate, abnormal heart electrical conduction (electrocardiogram or ECG), feeling of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure, decreased blood pressure when standing up (as a result, some people taking Risperidone Krka may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly), flushing.

• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, lung crepitus, wheezing, voice disorder, breathing difficulty.
• Stomach or intestinal infection, fecal incontinence, hard stools, difficulty swallowing, excessive gas or flatulence.
• Hives (urticaria), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly skin or scalp with itching, skin 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.
• Urinating frequently, inability to urinate, painful urination.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstrual periods, loss of menstrual periods or other problems with the cycle (women).
• Male breast development, milk secretion, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
• Swelling of the face, mouth, eyes, or lips.
• Chills, increased body temperature.
• Change in gait.
• Feeling thirsty, feeling unwell, chest discomfort, feeling "off," 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.
• Incorrect secretion of a hormone that controls urine volume.
• Somnambulism.
• 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 achieve orgasm.
• Lack of movement or response while awake (catatonia).
• Problems with blood vessels in the brain.
• Diabetic coma due to uncontrolled diabetes.
• Head agitation.
• Glaucoma (increased intraocular pressure), eye movement problems, eye rotation, corneal ulcers.
• 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 medicine.
• Pelvicly low count of a type of white blood cell necessary to fight infections in the blood.

• Excessive water intake.
• Irregular heartbeat.
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Swelling of the tongue, cracked lips, skin rash related to the medication.
• Dandruff.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, breast enlargement, breast secretion.
• Increased insulin (a hormone that controls blood sugar levels) in the blood.
• Skin hardening.
• Decreased body temperature, coldness in arms and legs.
• Medication withdrawal syndrome.
• Yellow 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 difficulty.
• Lack ofmovement of the intestinalmusclesthatcauses obstruction.

Frequency unknown: the frequency cannot be estimated from available data

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

The following side 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: Rapid heartbeat when standing up.

Other side effects in children and adolescents

In general, it is expected that side effects in children will be similar to those that appeared in adults.

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter 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 packaging: This medication does not require special storage conditions

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of your pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Risperidone Krka Composition

The active ingredient is risperidone.

Each film-coated tablet contains1 mg of risperidone.

The other components are:

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

Tablet coating:hypromellose, titanium dioxide(E171), talc, propylene glycol.

See section 2 “Risperidone Krka contains lactose and sodium”.

Product Appearance and Packaging Contents

Film-coated tabletwhite, oval, biconvex, scored on one side.

The tablet can be divided into equal doses.

Packaging Sizes

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

Plastic container: 500 film-coated tablets in a plastic container.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

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

For more information about this medication, please contact 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 authorized in the European Economic Area member states with the following names:

DenmarkRisperidon Krka

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

PortugalRisperidone Krka

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

SlovakiaTorendo 0.5 mg/1 mg/2 mg/3 mg/4 mg/6 mg

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

Last review date of this leaflet: March 2023

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/