Leaflet: information for the user

Risperidone Flas Krka 0.5 mg buccal tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• • If you have any doubts, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only and should not be given 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 Flas Krka is and what it is used for

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

3. How to take Risperidone Flas Krka

4. Possible side effects

5. Storage of Risperidone Flas Krka

6. Contents of the pack and additional information

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

Risperidona Flas Krka is used to treat the following:

• Schizophrenia, in which you may see, hear or feel things that are not present, believe things that are not true or feel particularly suspicious or confused.
• Mania, in which you may feel very 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 dementia, who injure 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 Flas 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 the information applies to you, consult your doctor or pharmacist before using Risperidona Flas Krka.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risperidona Flas Krka if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you are taking medicines for high blood pressure. Risperidona Flas Krka may lower your blood pressure. You may need your dose adjusted.
• You know of any factor that may make you prone to having a heart attack, such as high blood pressure, cardiovascular diseases or problems with the blood vessels in your 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 decrease in level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• You know that 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 a man and have ever had a prolonged or painful erection. You have difficulty controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of prolactin in your blood or if you have a tumour that may be dependent on prolactin.
• You or a family member has a history of blood clot formation, as antipsychotics have been associated with blood clot formation.

If you are unsure whether the information above applies to you, consult your doctor or pharmacist before using Risperidona Flas Krka.

Because, in rare cases, a dangerous drop 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 check your white blood cell counts in the blood.

Risperidona Flas Krka may cause you to gain weight. A significant weight gain may affect your health unfavourably. Your doctor will regularly monitor your weight.

Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen in patients taking Risperidona Flas Krka, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored.

Risperidona Flas 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 swelling in men (see Possible adverse effects). If these adverse effects occur, it is recommended that prolactin levels in the blood be evaluated.

During eye surgery for cataract, the pupil (the black circle in the centre of your eye) may not enlarge enough. In addition, the iris (the coloured part of your eye) may become flexible during the procedure and may cause eye damage. If you are planning eye surgery, make sure to tell your ophthalmologist that you are taking this medicine.

Patients with advanced age and dementia

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

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

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 speak confusedly, even for a short time, seek medical treatment immediately. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behaviour should be ruled out before starting treatment for conduct disorders.

If during treatment with risperidone you experience fatigue, changing the administration times may improve your difficulties with attention.

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 Flas Krka

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

It is especially important to talk to 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 capable of modifying 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 heart rate.
• Medicines that cause low potassium levels in the blood (e.g. some diuretics).
• Medicines for high blood pressure. Risperidona 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 (psycho-stimulants, such as methylphenidate)
• Diuretics, which are used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidona Flas Krka, taken 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 treating 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 (e.g. used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (gastric 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 the information above applies to you, consult your doctor or pharmacist before using Risperidona Flas Krka.

Taking Risperidona Flas Krka with food, drinks and alcohol

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

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

Driving and operating machinery

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

Risperidona Flas Krka contains aspartame (E951)

This medicine contains 0.40 mg of aspartame in each 0.5 mg buccal dispersible tablets. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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.

Please note that not all doses of these medications are commercially available or that not all recommended doses can be administered with these medications. 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 based on your response to treatment.
• Most people find relief 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.

Older adults

• The initial dose will usually be 0.5 mg, twice a day.
• Your doctor will 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 usually be 2 mg, once a day.
• Your doctor may adjust your dose gradually based on your response to treatment.
• Most people find relief with daily doses of 1 to 6 mg.

Older adults

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

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

Adults (including older adults)

• The initial dose will be 0.25 mg, twice a day, usually.
• Your doctor may change your dose gradually based on your response to treatment.
• Most people find relief 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 dementia should not exceed 6 weeks.

Use in children and adolescents

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

For the treatment of behavioral disorders

The dose will depend on your child's weight:

If they weigh less than 50 kg

• The initial dose will usually 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 usual maintenance dose is 0.25 mg to 0.75 mg, once a day.

If they weigh 50 kg or more

• The initial dose will usually 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 usual maintenance dose is 0.5 mg to 1.5 mg, once a day.

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

Children under 5 years old should not receive risperidone treatment for behavioral disorders.

Patients with liver or kidney problems

Unless the disease being treated is taken into account, all initial doses 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.

Administration form

Oral administration.

Risperidone Flas Krka buccodispersible tablets are fragile. Do not press them through the foil in the blister pack as this will damage the tablet. Remove a tablet from the pack as follows:

1. Hold the blister pack by the edges and separate one blister from the rest of the strip along the perforations.

2. Lift the corner of the foil and remove it completely.

3. Empty the tablet into your hand.

4. Place the tablet on your tongue as soon as you remove it from the pack.

In a few seconds, it will start to dissolve in your mouth and you can swallow it 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. Bring the packaging of the medication with you. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.

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's almost time for your next dose, skip the missed one and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for the missed doses.

If you interrupt treatment with Risperidone Flas Krka

Do not stop taking the medication unless your doctor tells you to. Symptoms may reappear. If your doctor decides to stop treatment, your dose may be gradually reduced over a few days.

If you have any other questions about using 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 1,000 people):

• You have thrombophlebitis (blood clots in the veins, especially in the legs, which can cause swelling, pain, and redness of the leg) that can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.

• You have a fever, muscle rigidity, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• You 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.

The following side effects may occur:

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

• Difficulty staying or falling asleep.
• Parkinsonism: This disease may include: slow or altered movement, feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly dragging the 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" 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 libidoor other sexual dysfunctions. In womenmay include breast discomfort, nipple discharge, amenorrhea, or other menstrual cycle problems or fertility problems.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, restlessness.
• Dystonia: A disease that involves involuntary slow or continuous muscle contraction. 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, loss of appetite causing malnutrition and weight loss.
• High cholesterol in blood.
• Euphoria (mania), confusion, decreased libido, 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 tingling, pinpricks, or numbness of the skin.
• Increased sensitivity of the eyes to light, dry eyes, increased tearing, 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 activity, prolonged QT interval in the heart, slow heart rate, abnormal heart 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 Risperidona 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 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.
• Amenorrhea, menstrual cycle problems, or other menstrual cycle problems (women).
• Male breast development, nipple discharge, 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", feeling unwell.
• 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.
• Incorrect secretion of a hormone that controls urine volume.
• Somnambulism.
• Sleep-related eating disorder.
• High blood sugar, decreased blood sugar, increased triglycerides in 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 pressure in the eyeball), eye movement problems, eye rotation, corneal ulcers.
• Eye problems during cataract surgery. During cataract surgery, there may be a condition called intraoperative floppy iris syndrome (IFIS) if you are taking or have taken Risperidona 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, chapped lips, skin rash related to the medication.
• Dandruff.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).
• Delayed menstrual periods, breast enlargement, nipple discharge.
• Increased insulin (a hormone that controls blood sugar levels) in 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 of movement of the intestinal musclesthatcauses obstruction.

Frequency unknown: the frequency cannot be estimated from available data

• Severe or life-threatening skin rash with blisters and skin peeling that can 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 Risperidona 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 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 Useor:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Risperidone Flas Krka Composition

• The active ingredient is risperidone. Each buccal dispersible tablet contains 0.5 mg of risperidone.
• The other components are mannitol (E421), butylated basic methacrylate copolymer, povidone K-25, microcrystalline cellulose, hydroxypropyl cellulose, aspartame (E951), crospovidone, iron oxide red (E172), peppermint flavor, silica calcium, magnesium stearate.

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

Appearance of the product and contents of the package

The buccal dispersible tablets are pink speckled, round, slightly convex tablets.

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

Only some package sizes may be commercially available.

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

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 registered in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

GermanyRisperidon TAD 0.5 mg Schmelztabletten

DenmarkRisperidon Krka

SpainRisperidone Flas Krka 0.5 mg Buccal Dispersible Tablets EFG

EstoniaTorendo Q-Tab 0.5 mg

FinlandRisperidon Krka 0.5 mg Orodispersible Tablets

HungaryTorendo Q-Tab 0.5 mg

LithuaniaTorendo Q-Tab 0.5 mg, orodispersible tablets

NorwayRisperidon Krka 0.5 mg Orodispersible Tablets

PolandTorendo Q-Tab 0.5 mg

PortugalRisperidon Krka

United KingdomRisperidone 0.5 mg Orodispersible Tablets

Czech RepublicRorendo Oro Tab 0.5 mg, orodispersible tablets

Slovak RepublicTorendo Q-Tab 0.5 mg

SwedenRisperidon Krka 0.5 mg ODT tablet

Last review date of this leaflet: March 2023

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