Risperidone Flas Krka 1 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidona Flas Krka 1 mg orodispersible tablets EFG

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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Risperidone Flas Krka is used to treat the following conditions:

• 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 excessively 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 should have already been tried.
• 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 can help reduce the symptoms of your condition and help prevent them from returning.

2. What you need to know before taking Risperidona Flas Krka

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 above applies to you, consult your doctor or pharmacist before using Risperidona Flas Krka.

Warnings and precautions

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

• You have any heart problems. Examples include irregular heartbeat, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidona Flas Krka may lower blood pressure. You may need your dose adjusted.
• You have any risk factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
• You have ever experienced involuntary movements of the tongue, mouth, or face.
• You have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• You know you have had low levels of white blood cells in the past (whether or not caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are male and have ever had a prolonged or painful erection. You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
• 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 applies to you, consult your doctor or pharmacist before using Risperidona Flas Krka.

Because a dangerous drop in the number of certain types of white blood cells needed to fight infections has been observed rarely in patients taking risperidone, your doctor may monitor your white blood cell levels.

Risperidona Flas Krka may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed 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 levels 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 enlargement in men (see Possible side effects). If these adverse effects occur, evaluation of blood prolactin levels is recommended.

During cataract surgery (clouding of the lens), the pupil (the black circle in the center of your eye) may not dilate sufficiently. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could lead to eye damage. If you are scheduled for 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.

While being treated with risperidone, you should see your doctor regularly.

If you or your caregiver notice a sudden change in your mental state, or sudden weakness or numbness in your face, arms, or legs—especially on one side—or if you experience confusion, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for behavioral disorders.

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

Body weight should be measured before starting treatment and monitored regularly during treatment.

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

Other medicines and Risperidona Flas 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 talk to your doctor or pharmacist if you are taking any of the following:

• Medicines that act on the brain, such as those used to calm you (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders, allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidona Flas Krka 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 to treat swelling in 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 decrease 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 heart conditions)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (e.g., used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines used to treat fungal infections)
• Some medicines used to treat HIV/AIDS, such as ritonavir
• Verapamil, a medicine used to treat high blood pressure and/or 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 applies to you, consult your doctor or pharmacist before using Risperidona Flas Krka.

Taking Risperidona Flas Krka with food, drinks, and alcohol

You may 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take it.
• The following symptoms may occur in newborn babies of mothers who have used Risperidona Flas Krka during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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 side effects).

Driving and using machines

Risperidona Flas Krka may cause dizziness, tiredness, and vision problems during treatment. Do not drive or operate tools or machinery without first consulting your doctor.

Risperidona Flas Krka contains aspartame (E951)

This medicine contains 0.80 mg of aspartame in each 1 mg orodispersible tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Risperidone Flas Krka

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Please note that not all strengths of these medicines may be marketed, or not all recommended doses may be available with these medicines. Other pharmaceutical forms/strengths 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; this may be increased to 4 mg per day on the second day
• Your doctor may adjust your dose depending on how you respond to treatment
• Most people do best 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.

Elderly patients

• The initial dose is usually 0.5 mg twice daily
• Your doctor may gradually increase your dose later to 1 mg – 2 mg twice daily
• Your doctor will tell you what is best for you.

For the treatment of mania

Adults

• The initial dose is usually 2 mg once daily
• Your doctor may gradually adjust your dose depending on your response to treatment
• Most people do best with daily doses of 1 to 6 mg.

Elderly patients

• The initial dose is usually 0.5 mg twice daily
• Your doctor may gradually adjust your dose later to 1 mg – 2 mg twice daily, depending on your response to treatment.

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

Adults (including elderly patients)

• The initial dose is usually 0.25 mg twice daily
• Your doctor may gradually change your dose depending on your response to treatment
• Most people do best with doses of 0.5 mg twice daily. Some patients may require 1 mg twice daily
• The duration of treatment in patients with Alzheimer-type dementia should not exceed 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 conduct disorders

The dose will depend on your child’s weight:

If weight is less than 50 kg

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

If weight is 50 kg or more

• The initial dose is usually 0.5 mg once daily
• The dose may be increased every other day in 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 conduct disorders should not exceed 6 weeks.

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

Patients with liver or kidney problems

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

Risperidone should be used with caution in this patient group.

Method of administration

For oral use.

Risperidone Flas Krka orodispersible tablets are fragile. They must not be pushed through the blister foil as this will damage the tablet. Remove a tablet from the package as follows:

1. Hold the blister strip 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 it has been removed from the package.

Within seconds it will begin to disintegrate in the mouth and can then be swallowed with or without water. The mouth must be empty before placing the tablet on the tongue.

Alternatively, the tablet may be placed in a glass or cup filled with water and the solution drunk immediately.

If you take more Risperidone Flas Krka than you should

• Seek medical advice immediately. Take the medicine pack with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to a drop in blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidone Flas Krka

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for forgotten doses.

If you stop taking Risperidone Flas Krka

Do not stop taking this medicine unless instructed by your doctor. Symptoms may return. If your doctor decides to stop treatment, your dose may 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 experiences 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. Withdrawal 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"). You may require immediate medical treatment.
• You are male and experience a prolonged or painful erection. This is known as priapism. You may require 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 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 feeling of muscle stiffness or tightness (causing jerky movements), and sometimes a sensation of "freezing" of movement that then restarts. Other signs of parkinsonism include slow 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" in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin occur rarely and may include, in men, breast swelling, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems or fertility issues.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, 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 result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• Dizziness.
• Dyskinesia: A condition involving involuntary muscle movements, which 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, stomach discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Rash, skin redness.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence (loss of 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, viral infection, skin inflammation caused by mites.
• Decrease in a type of white blood cell that helps fight infections, decrease in the number of white blood cells, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in 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 blood cholesterol.
• Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.
• Lack of response to stimuli, loss of consciousness, decreased level of consciousness.
• Seizures (epileptic fits), fainting.
• A restlessness causing movement of body parts, 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, eye redness.
• 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 in 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 Risperidona Krka may feel weak, dizzy, or lose consciousness when standing or sitting up suddenly), flushing.
• Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract 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, painful urination.
• Erectile dysfunction, ejaculation disorder.
• Loss of menstruation, loss 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.
• Thirst sensation, 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.
• Procedure-related pain.

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, low blood sugar, increased blood triglycerides (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 on the eyelid margin.
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken Risperidona Krka. If you need 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 cell 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.
• Medication 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 rash with 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 adverse effects have been reported with use of another medicine called paliperidone, which is very similar to risperidone; therefore, they are also expected to occur with Risperidona 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 a 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 may 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 Flas Krka

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

This medicine does not require any 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 properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Risperidone Flas Krka

• The active substance is risperidone. Each orodispersible tablet contains 1 mg of risperidone.
• The other components are mannitol (E421), butyl methacrylate copolymer basic, povidone K-25, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, aspartame (E951), crospovidone, red iron oxide (E172), green mint flavor, mint flavor, calcium silicate, magnesium stearate.

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

What the medicine looks like and contents of the pack

Orodispersible tablets: pink speckled, round, slightly convex tablets.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

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

For further information about this medicinal product, contact the Local Representative of the Marketing Authorisation Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is registered in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Germany Risperidon TAD 1 mg Schmelztabletten
Denmark Risperidon Krka
Spain Risperidona Flas Krka 1 mg Comprimidos bucodispersables EFG
Estonia Torendo Q-Tab 1 mg
Finland Risperidon Krka 1 mg Orodispersible Tablets
Hungary Torendo Q-Tab 1 mg
Lithuania Torendo Q-Tab 1 mg, orodispersible tablets
Latvia Torendo Q-Tab 1 mg mute dispergejamas tabletes
Norway Risperidon Krka 1 mg Orodispersible Tablets
Poland Torendo Q-Tab 1 mg
Portugal Risperidon Krka
United Kingdom Risperidone 1 mg Orodispersible Tablets
Czech Republic Rorendo Oro Tab 1 mg/, orodispersible tablets
Slovakia Torendo Q-Tab 1 mg
Sweden Risperidon Krka 1 mg ODT tablet

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

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