Risperidone Krka 0.5 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Risperidone Krka 0.5 mg film-coated tablets

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Risperidone Krka is and what it is used for
2. What you need to know before taking Risperidone Krka
3. How to take Risperidone Krka
4. Possible side effects
5. How to store Risperidone Krka
6. Contents of the pack and other information

1. What Risperidone Krka is and what it is used for

Risperidone belongs to a group of medicines called "antipsychotics".

Risperidone Krka is used to treat:

• Schizophrenia, in which you may see, hear or feel things that are not present, believe things that are not true, or feel excessively suspicious or confused.
• Mania, in which you may feel extremely excited, euphoric, restless, 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 dementia who harm themselves or others. Alternative (non-pharmacological) treatments should have been tried first.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged at least 5 years) and adolescents with conduct disorders.

Risperidone may help reduce the symptoms of your illness and help prevent them from returning.

2. What you need to know before taking Risperidona Krka

Do not take Risperidona Krka

• If you are allergic to risperidone or to 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

Talk to your doctor or pharmacist before starting risperidone:

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

You may need to have your dose adjusted.

• If you have risk factors that may increase the chance of having a stroke, such as high blood pressure, cardiovascular disorders, or problems with blood vessels in the brain.
• If you have ever experienced involuntary movements of the tongue, mouth, or face.
• If you have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease or dementia.
• If you have previously had low levels of white blood cells (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 difficulty controlling your body temperature or experience excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If you have abnormally high levels of the hormone prolactin in your blood or if you have a tumour that may be prolactin-dependent.
• If you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before using this medicine.

Very rarely, patients treated with risperidone have developed a dangerously low number of a type of white blood cell needed to fight infections. Your doctor may monitor your white blood cell count.

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

Cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking risperidone. Therefore, your doctor should check for signs of sugar in the blood. In patients with pre-existing diabetes mellitus, blood glucose should be monitored regularly.

Risperidona Krka frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see Possible side effects). If these adverse effects occur, measurement of prolactin levels in the blood is recommended.

During eye surgery for lens clouding (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 floppy during surgery, which could lead to eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist 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 your dementia is caused by a stroke.

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

Seek medical attention immediately if you or your caregiver notice a sudden change in mental status, sudden weakness or numbness in the face, arms, or legs—especially on one side—or difficulty speaking, even if only briefly. These may be symptoms of a stroke.

Children and adolescents

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

If fatigue occurs during treatment with risperidone, changing the dosing schedule may improve attention deficits.

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

A small, inconclusive study reported increased height in children taking risperidone, but it is unknown whether this is a drug effect or due to other reasons.

Other medicines and Risperidona Krka

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

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

• Medicines that act on the brain, such as sedatives (benzodiazepines), certain pain medicines (opioids), or antihistamines for allergies, because risperidone may increase the sedative effect of these medicines.
• Medicines that may alter the electrical activity of the heart, such as medicines for malaria, heart rhythm disorders, allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
• Medicines that reduce heart rate.
• Medicines that lower potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics used for heart problems or swelling due to excessive fluid accumulation (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 used to treat certain 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 (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 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 risperidone.

If you are unsure whether any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Taking Risperidona Krka with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

The following symptoms may occur in newborns whose mothers have taken risperidone during the third trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding difficulties. If your baby shows any of these symptoms, you may need to contact your doctor.

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

Driving and using machines

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

Risperidona Krka contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult him or her 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 Risperidone Krka

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in 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 may be increased to 4 mg per day on the second day of treatment.
• Your doctor may adjust the dose depending on how you respond to treatment.
• Most people feel better with daily doses of 4 to 6 mg.
• This total daily dose may be divided into one or two doses per day. Your doctor will inform you which is most suitable for you.

Elderly patients

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

For the treatment of mania

Adults

• The initial dose is usually 2 mg once daily.
• Your doctor may gradually adjust the dose depending on how you respond to treatment.
• Most people feel better with doses of 1 to 6 mg once daily.

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Your doctor may gradually adjust the dose to 1 mg or 2 mg twice daily depending on how you respond to treatment.

For the treatment of prolonged aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

• The initial dose is usually 0.25 mg twice daily.
• The dose may then be gradually adjusted depending on how you respond to treatment.
• Most people feel better with 0.5 mg twice daily. Some patients require a dose of 1 mg twice daily.
• Treatment in patients with Alzheimer-type dementia should not last longer than 6 weeks.

Use in children and adolescents

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

For the treatment of behavioural disorders

The dose depends on the child's weight:

For children weighing less than 50 kg

• The initial dose is usually 0.25 mg once daily.
• The dose may be increased every other day by increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once daily. ?

For children weighing 50 kg or more

• The initial dose is usually 0.5 mg once daily.
• The dose may be increased every other day by increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once daily.

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

Children under 5 years of age should not be treated with risperidone for behavioural disorders.

Patients with kidney or liver problems

Regardless of the condition 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 patient group.

Method of administration

Oral use

Swallow the tablet with water.

If you take more Risperidone Krka than you should

• In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 maintaining your balance or walking, feel dizzy due to low blood pressure, or experience an abnormal heart rate 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 regular dosing schedule. If you miss 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 Risperidone Krka

You should not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop treatment, the dose should be gradually reduced over several days.

If you have any further 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 everyone will experience them.

Immediately inform your doctor if you experience any of the following uncommon adverse 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 the face, arms, or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or spasmodic movements of the face, tongue, or other body parts). Immediately inform your doctor if you notice involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

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

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You develop fever, muscle rigidity, sweating, or decreased level of consciousness (a condition known as “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be required.
• You are male and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

The following adverse effects may occur:

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

• Difficulty falling or staying asleep.
• Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of “freezing” of movement that then restarts. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• 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 as if you have the flu.
• Increased levels of a hormone called “prolactin” detected in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin occur rarely and may include, in men, breast swelling, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, symptoms may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems or fertility issues.
• Weight gain, increased appetite, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, restlessness.
• Dystonia: A condition involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• Dizziness.
• Dyskinesia: A condition involving involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremor (shakiness).
• Blurred vision, eye infection, or “red eye.”
• Rapid 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, redness of the skin.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence (loss of bladder 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 nail infection, 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 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 leading to malnutrition and decreased body weight.

• Increased cholesterol in blood.

• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.

• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.

• Seizures (epileptic fits), fainting.

• Restlessness causing body movements, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin.

• Light sensitivity of the eyes, dry eyes, increased tearing, redness of the eyes.

• Sensation of spinning (vertigo), ringing in the ears, ear pain.

• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation on the heart, slow heartbeat, abnormal electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).

• Decreased blood pressure, decreased blood pressure upon standing (as a result, some people taking Risperidone Krka may feel weakness, dizziness, or loss of consciousness when standing up or sitting up suddenly), flushing.

• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory congestion, crackling lung sounds, 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 scalp or skin, skin disorder, skin lesion.

• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown.

• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.

• Frequent urination, inability to urinate, pain during urination.

• Erectile dysfunction, ejaculation disorder.

• Loss of menstruation, absence of menstrual periods, or other menstrual cycle problems (in women).

• Breast development 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 walking pattern.

• Feeling thirsty, feeling unwell, chest discomfort, feeling “under the weather,” malaise.

• Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in 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 urine, decreased blood sugar, increased triglycerides in blood (a type of fat).

• Absence of emotions, inability to achieve orgasm.

• Lack of movement or response while awake (catatonia).

• Problems with blood vessels in the brain.

• Coma due to uncontrolled diabetes.

• Head agitation.

• Glaucoma (increased pressure in the eyeball), eye movement problems, eye rolling, crusts at the eyelid margin.

• Eye problems during cataract surgery. During cataract surgery, a disturbance 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.

• Dangerously low number of a type of white blood cells needed to fight infections in the blood.

• Dangerously excessive water intake.

• Irregular heartbeat.

• Breathing problems during sleep (sleep apnea), rapid, shallow breathing.

• Pancreatitis, intestinal obstruction.

• Swelling of the tongue, cracked lips, drug-related skin rash.

• Dandruff.

• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

• Delayed menstrual periods, increased mammary glands, breast enlargement, milk secretion from the breasts.

• Increased insulin (a hormone that controls blood sugar levels) in 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):

• Life-threatening complications of uncontrolled diabetes.
• Severe allergic reaction with swelling, which may affect the throat causing breathing difficulty.
• Lack of movement in intestinal muscles leading to obstruction.

Frequency not known: frequency cannot be estimated from available data

• Severe or life-threatening blistering and peeling rash starting around the mouth, nose, eyes, genitals, and spreading to other body areas (Stevens-Johnson Syndrome or toxic epidermal necrolysis).

The following adverse effects have been reported with the use of another medicine called paliperidone, which is very similar to risperidone, and therefore may also be expected with Risperidone Krka: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those seen 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, symptoms of common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (lack of bladder control).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Risperidone Krka

The active substance 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, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate.

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 contents of the pack

Film-coated, red-brown, oval, biconvex tablet, scored on one side.

The tablet can be divided into equal doses.

Pack sizes

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For further information about this medicinal product, 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 medicinal product is authorized in the Member States of the European Economic Area under 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 Comprimidos recubiertos con película

Date of the most recent revision of this leaflet: March 2023

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