Leaflet: information for the user

Risperidone Flas Krka 2 mg buccal tablets EFG

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, consult 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 Flas Krka is and what it is used for

2. What you need to know before you start taking 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, which may cause you to see, hear or feel things that are not present, believe things that are not true or feel particularly suspicious or confused.
• Mania, which may cause you to 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 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 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 an erection that lasted too long or was painful. 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 hormone 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. Significant weight gain can 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 often increases levels of a hormone called prolactin. This can 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 cataracts, 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 eye surgeon 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 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 speak confusedly, even for a short time, seek medical treatment immediately. It 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 taken recently 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 heartbeat
• Medicines that cause low potassium levels in the blood (e.g. some diuretics)
• Medicines for high blood pressure. Risperidona Flas Krka may lower 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 1.60 mg of aspartame in each 2 mg buccal dispersible tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder 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 how you respond to treatment.
• Most people find they do 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 tell you what is best for you.

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor will later increase your dose gradually to 1 mg to 2 mg, taken twice a day.
• Your doctor will tell you what is best for you.

For the treatment of mania

Adults

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

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor may later adjust your dose gradually to 1 mg to 2 mg, taken 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, taken twice a day, usually.
• Your doctor may later change your dose gradually based on your response to treatment.
• Most people find they do better with doses of 0.5 mg, taken twice a day. Some patients may need 1 mg, taken 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 treatment with risperidone 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, taken once a day.
• The dose may be increased, one day yes and one day no, by 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg, taken once a day.

If they weigh 50 kg or more

• The initial dose will usually be 0.5 mg, taken once a day.
• The dose may be increased, one day yes and one day no, by 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg, taken 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 treatment with risperidone 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. They should not be pressed 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 then 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 of 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
• In case of overdose, you may feel drowsy or tired, have 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 is almost 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 the missed doses.

If you interrupt treatment with Risperidone Flas Krka

You should 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 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 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 are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• 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 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" in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin occur rarely and may include in men, breast swelling, difficulty getting or maintaining erections, decreased sexual desire or other sexual dysfunction. In women, they may 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 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 infection of the nails, 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 sexual desire, 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.
• Frequent urination, 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 secretion.
• 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 enzymes 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 pressure in the eyeball), 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.
• Very 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 of movement of the intestinal muscles that causes obstruction.

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

• Severe or life-threatening skin rash with blisters and skin peeling 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: Fast heart rate 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 experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use or: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 conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

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

Risperidone Flas Krka Composition

• The active ingredient is risperidone. Each tablet contains 2 mg of risperidone.
• The other components are mannitol (E421), basic butyl methacrylate copolymer, povidone K-25, microcrystalline cellulose, partially substituted hydroxypropyl cellulose, aspartame (E951), crospovidone, iron oxide red (E172), peppermint flavor, magnesium stearate.

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

Appearance of the product and packaging contents

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

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

Only some packaging 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 2 mg Schmelztabletten

DenmarkRisperidonKrka

SpainRisperidone Flas Krka 2 mg Buccal Dispersible Tablets EFG

EstoniaTorendo Q-Tab 2 mg

FinlandRisperidon Krka 2 mg Orodispersible Tablets

HungaryTorendo Q-Tab 2 mg

LithuaniaTorendo Q-Tab 2 mg, orodispersible tablets

LatviaTorendo Q-Tab 2 mg mute dispergejamas tabletes

NorwayRisperidon Krka 2 mg Orodispersible Tablets

PolandTorendo Q-Tab 2 mg

PortugalRisperidon Krka

United KingdomRisperidone 2 mg Orodispersible Tablets

Czech RepublicRorendo Oro Tab 2 mg, orodispersible tablets

Slovak RepublicTorendo Q-Tab 2 mg

SwedenRisperidon Krka 2 mg ODT tablet

Last review date of this leaflet: March 2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/