Product Information for the User

Risperdal1mg/ml Oral Solution

risperidone

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist, evenif they are not listed in this product information.See section 4.

1.What is Risperdal and what is it used for

2.What you need to know before starting to take Risperdal

3.How to take Risperdal

4.Possible adverse effects

5.Storage of Risperdal

6.Contents of the package and additional information

Risperdal belongs to a group of medications known as “antipsychotics”.

Risperdal is used to treat the following:

• Schizophrenia, with which you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused
• Mania, with which you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. Alternative non-pharmacological treatments must have been tried previously
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with behavioral disorders.

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

Do not take Risperdal

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

If you are unsure, consult your doctor or pharmacist before starting to take Risperdal.

Warnings and precautions

Consult your doctor or pharmacist before taking Risperdal 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 medications for high blood pressure. Risperdal may lower your blood pressure. You may need to have your dose adjusted
• You know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the 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 have had low white blood cell counts in the past (which may or may not have been caused by other medications)
• You are diabetic
• You have epilepsy
• You are a male 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 tumor, which may be dependent on prolactin
• You or a family member has a history of blood clotting problems, as antipsychotics have been associated with blood clotting

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking Risperdal.

Because in very rare cases, a dangerously low count of a type of white blood cell necessary to fight infections in the blood has been observed in patients treated with Risperdal, your doctor may check your white blood cell count.

Risperdal may cause you to gain weight. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

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

Risperdal frequently increases levels of a hormone called prolactin. This can cause adverse effects such as menstrual disorders or fertility problems in women or breast enlargement in men (see Possible Adverse Effects). If these adverse effects appear, it is recommended to evaluate prolactin levels in the blood.

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

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. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behavior 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 in paying attention.

Before starting treatment, your weight or that of your child may be measured, and this should be regularly monitored 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 due to the medication or another reason.

Other medications and Risperdal

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

It is especially important to talk to your doctor or pharmacist if you are taking any of the following

• Medications that act on your brain, such as those used to calm down (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase their sedative effect
• Medications capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medications for mental health problems
• Medications that cause a slow heart rate
• Medications that cause low potassium levels in the blood (such as some diuretics)
• Medications for high blood pressure. Risperdal may lower blood pressure
• Medications for Parkinson's disease (such as levodopa)
• Medications that increase the activity of the central nervous system (psychoestimulants, 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). Risperdal, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may reduce the effect of risperidone

• Rifampicin (a medication for treating some infections)
• Carbamazepine, phenytoin (medications for epilepsy)
• Phenobarbital.

If you start or stop taking these medications, you may need a different dose of risperidone.

The following medications may increase the effect of risperidone

• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medications known as beta-blockers (used to treat high blood pressure)
• Fenothiazines (such as medications used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (gastric acid blockers)
• Itraconazole and ketoconazole (medications used to treat fungal infections)
• Some medications used to treat HIV/AIDS, such as ritonavir
• Verapamil, a medication used to treat high blood pressure and/or abnormal heart rhythm
• Sertraline and fluvoxamine, medications used to treat depression and other psychiatric disorders.

If you start or stop taking these medications, you may need a different dose of risperidone.

If you are unsure about whether the above information affects you, consult your doctor or pharmacist before taking Risperdal.

Use of Risperdal with food, drinks, and alcohol

You can take this medication with or without food. You should avoid consuming alcohol while taking Risperdal.

Pregnancy, breastfeeding, and fertility

1. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication. Your doctor will decide if you can take it
2. The following symptoms may occur in newborn babies, from mothers who have been treated with Risperdal in the last trimester of pregnancy (last three months of pregnancy): tremor, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor
3. Risperdal may increase levels of a hormone called "prolactin" that may affect fertility (see Possible Adverse Effects).

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with Risperdal. Do not drive or operate tools or machines without consulting your doctor first.

Risperdal oral solution contains benzoic acid (E210) and sodium

This medication contains 2 mg of benzoic acid in each 1 ml of oral solution. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The usual initial dose is 2 milligrams per day, which can be increased to 4 milligrams per day on the second day
• Your doctor may adjust your dose based on how you respond to treatment
• Most people feel better with daily doses of 4 to 6 milligrams
• 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 be 0.5 milligrams twice a day, usually
• Your doctor may later increase the dose gradually from 1 to 2 milligrams twice a day
• Your doctor will tell you what is best for you.

For the treatment of mania

Adults

• The initial dose will be 2 milligrams once a day, usually
• Your doctor may later adjust the dose gradually based on your response to treatment
• Most people feel better with doses of 1 to 6 milligrams once a day.

Older adults

• The initial dose will be 0.5 milligrams twice a day, usually
• Your doctor may later adjust the dose gradually from 1 milligram to 2 milligrams twice a day based on your response to treatment.

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

Adults (including older adults)

• The initial dose will be 0.25 milligrams (0.25 ml of Risperdal oral solution 1 mg/ml) twice a day, usually
• Your doctor may later adjust the dose gradually based on your response to treatment
• Most people feel better with doses of 0.5 milligrams twice a day. Some patients may need 1 milligram twice a day
• The duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years old should not receive treatment with Risperdal 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 kilograms

• The initial dose will be 0.25 milligrams (0.25 ml of Risperdal oral solution 1 mg/ml) once a day, usually
• The dose can be increased one day yes and one day no in increments of 0.25 milligrams per day
• The usual maintenance dose is 0.25 milligrams to 0.75 milligrams (0.25 ml to 0.75 ml of Risperdal oral solution 1 mg/ml) once a day.

If they weigh 50 kilograms or more

• The initial dose will be 0.5 milligrams once a day, usually
• The dose can be increased one day yes and one day no in increments of 0.5 milligrams per day
• The usual maintenance dose is 0.5 milligrams to 1.5 milligrams 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 Risperdal for behavioral disorders.

Patients with kidney or liver 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 ROUTE

Risperdal oral solution

The solution comes with a syringe (pipette). You should use it to measure the exact amount of medication you need.

Follow these steps:

1Remove the child-resistant cap. Push the plastic cap down, turning it at the same time against the direction of the clock (Figure 1)

2.Insert the pipette into the bottle (Figure 2)

3.Holding the lower ring, pull the upper ring down to the mark corresponding to the number of milliliters or milligrams you should administer (Figure 3)

4.Holding the lower ring, remove the pipette from the bottle (Figure 4)

5.Empty the pipette into a non-alcoholic drink that is not tea. Slide the upper ring down

6.Close the bottle

7.Wash the pipette with water.

If you take more Risperdal than you should

• In case of overdose, you may feel drowsy or tired, have abnormal body movements, have trouble standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.
• Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Risperdal

• 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 dose.

If you interrupt treatment with Risperdal

You should not stop taking this medication unless your doctor tells you to. Symptoms may reappear.If your doctor decides to stop this 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 (which may affect up to 1 in 100 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in your face, arms, or legs, especially on one side, or it's hard for you to speak even for a short period of time. These may be signs of a stroke
• You experience tardive dyskinesia (involuntary spasms or movements that cannot be controlled in your face, tongue, or other parts of your body). Inform your doctor immediately if you experience involuntary, rhythmic movements of your tongue, mouth, and face. You may need to stop taking Risperdal

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

• You experience blood clots in your veins, especially in your legs (symptoms include swelling, pain, and redness of the leg), which may travel through the blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately
• You experience fever, muscle rigidity, sweating, or a decrease in your level of 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 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

You may also experience the following side effects:

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

• Difficulty staying or falling asleep
• Parkinsonism: This condition may include slow or altered movement, a feeling of stiffness or tension in your muscles (making sudden movements), and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly with your feet dragging, resting tremor, increased saliva and/or drooling, and loss of facial expression
• Feeling drowsy or less attentive
• Headache

Common side effects (which 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" that is detected 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 libido, or other sexual dysfunction. In women, they may include breast discomfort, nipple discharge, loss of menstrual periods, or other menstrual cycle problems, or fertility problems
• Weight gain, increased appetite, decreased appetite
• Sleep disorders, irritability, depression, anxiety, restlessness
• Dystonia: This is a condition that involves involuntary, slow, or continuous muscle contractions. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw
• Dizziness
• Dyskinesia: This condition involves involuntary, muscular 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
• Sore throat, 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 side effects (which may affect up to 1 in 100 people):

• You experience respiratory tract infections, urinary tract infections, eye infections, tonsillitis, fungal nail infections, skin infections, localized skin infections, viral infections, or scabies
• You experience a decrease in a type of white blood cell that helps fight infections, a decrease in white blood cells, a decrease in platelets (blood cells that help stop bleeding), anemia, a decrease in red blood cells, or an increase in eosinophils (a type of white blood cell) in your blood
• You experience an allergic reaction
• You experience diabetes or worsening of diabetes, high blood sugar, excessive water intake
• You experience weight loss, loss of appetite that causes malnutrition and weight loss
• You experience high cholesterol in your blood
• You experience euphoria (mania), confusion, decreased libido, nervousness, nightmares
• You experience a lack of response to stimuli, loss of consciousness, decreased level of consciousness
• You experience seizures (epileptic crises), fainting
• You experience an abnormal restlessness that causes movement of parts of your body, balance disorder, abnormal coordination, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, feeling of pins and needles, or numbness of the skin
• You experience increased sensitivity of your eyes to light, dry eyes, increased tearing, or eye redness
• You experience a sensation of spinning (vertigo), ringing in your ears, ear pain
• You experience abnormal heart rhythm, interruption of conduction between the upper and lower parts of your heart, abnormal heart activity, prolonged QT interval in your heart, slow heart rate, abnormal conduction of electricity in your heart (electrocardiogram or ECG), feeling of fluttering or pounding in your chest (palpitations)
• You experience decreased blood pressure, decreased blood pressure when standing up, which may cause some people taking Risperdal to feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly, flushing
• You experience pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crackling sounds in your lungs, wheezing, voice disorder, difficulty breathing
• You experience stomach or intestinal infection, fecal incontinence, hard stools, difficulty swallowing, excessive gas or flatulence
• You experience hives (urticaria), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly skin or scalp with itching, skin disorder, skin injury
• You experience increased CPK (creatine phosphokinase) in your blood, an enzyme that is sometimes released with muscle breakdown
• You experience abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• You experience frequent urination, inability to urinate, painful urination
• You experience erectile dysfunction, ejaculation disorder
• You experience loss of menstrual periods, loss of menstrual periods or other menstrual cycle problems (women)
• You experience breast development in men, nipple discharge, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• You experience facial swelling, mouth, eye, or lip swelling
• You experience chills, increased body temperature
• You experience a change in your gait
• You experience a sensation of thirst, feeling unwell, chest discomfort, feeling "off," feeling unwell
• You experience increased liver enzymes in your blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in your blood, increased liver enzymes in your blood
• You experience pain due to the procedure

Rare side effects (which 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 your 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 your brain
• Diabetes coma due to uncontrolled diabetes
• Head agitation
• Glaucoma (increased pressure in the eyeball), eye movement problems, eye rotation, corneal ulcers on the edge of the eyelid
• Eye problems during cataract surgery
• Low white blood cell count necessary to fight infections in your blood
• Excessive water intake
• Irregular heartbeat
• Respiratory problems during sleep (sleep apnea), rapid, shallow breathing
• Pancreatitis, intestinal obstruction
• Tongue swelling, 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 your blood
• Skin hardening
• Decreased body temperature, coldness in your arms and legs
• Medication withdrawal syndrome
• Yellow skin and eyes (jaundice)

Very rare side effects (which may affect up to 1 in 10,000 people):

• Complications of uncontrolled diabetes that can be life-threatening
• Severe allergic reaction with swelling that can affect your throat, causing difficulty breathing
• Intestinal obstruction due to muscle paralysis

Unknown frequency: cannot be estimated from available data

• Severe rash or skin blistering that can begin around your mouth, nose, eyes, genitals, and spread to other parts of your body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following side effect has appeared with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to appear with Risperdal: Fast 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, 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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

Do not store above30°C.

Do not refrigerate or freeze.

Once the bottle is opened, any unused Risperdal oral solution should be discarded after 3 months.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at theSIGREdrop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risperdal

The active ingredient is risperidone

1 ml of Risperdal oral solution contains 1 milligram of risperidone.

The other components (excipients) are:

Tartaric acid (E334), Benzoic acid (E210), Sodium hydroxide, Distilled water

Appearance of Risperdal and packaging contents

Risperdal oral solution is presented in an amber bottle with a child-resistant cap containing 30 ml, 60 ml, 100 ml, or 120 ml of a transparent and colorless liquid. A dosing pipette is also supplied.

The pipette supplied with the 30 ml, 60 ml, and 100 ml bottles is graduated in milligrams and milliliters with a minimum volume of 0.25 ml and a maximum volume of 3 ml. The graduation marks in increments of 0.25 ml (equivalent to 0.25 mg of oral solution) to 3 ml (equivalent to 3 mg of oral solution) are printed on this pipette.

The pipette supplied with the 120 ml bottle is graduated in milligrams and milliliters with a minimum volume of 0.25 ml and a maximum volume of 4 ml. The graduation marks of 0.25 ml (equivalent to 0.25 mg of oral solution) that increase to 4 ml (equivalent to 4 mg of oral solution) are printed on this pipette.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042 Madrid, Spain

+34 917228100

+34 917228101

Responsible for batch release

JANSSEN PHARMACEUTICA NV

Turnhoutseweg, 30 (Beerse) – B-2340 – Belgium.

Lusomedicamenta Sociedade Técnica Farmacêutica S.A.

Estrada Consiglieri Pedroso 66, 69-B

Queluz de Baixo

2730-055 Barcarena

Portugal

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Austria:Risperdal

Bélgica: RISPERDAL

Chipre:RISPERDAL

República Checa:RISPERDAL

Dinamarca: RISPERDAL

Estonia:RISPOLEPT

Finlandia:RISPERDAL

Francia:RISPERDAL

Alemania:RISPERDAL1mg; 2mg; 3mg; 4mg/ Risperdal 0,5mg; 6mg / Risperdal Lösung 1 mg/ml

Grecia:RISPERDAL

Hungría:RISPERDAL

Islandia:RISPERDAL

Irlanda:RISPERDAL

Italia:RISPERDAL

Lituania:RISPOLEPT

Letonia:RISPOLEPT

Luxemburgo:RISPERDAL

Malta:RISPERDAL

Países Bajos:RISPERDAL

Noruega:RISPERDAL

Polonia:RISPOLEPT

Portugal:RISPERDAL

Rumanía:RISPOLEPT

Eslovenia:RISPERDAL

España:RISPERDAL

Suecia:RISPERDAL

Reino Unido(Irlanda del Norte):RISPERDAL

Last revision date of this leaflet:April 2025.

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