Risperidone Teva 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidone Teva 1 mg/ml oral solution EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

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

Risperidone is used to treat the following conditions:

• Schizophrenia, in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a condition called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer-type dementia who are harming themselves or others. Alternative (non-pharmacological) treatments should have been tried first.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged at least 5 years) and adolescents with conduct disorders.

Risperidone can help reduce the symptoms of your condition and help prevent them from returning.

2. What you need to know before taking Risperidone Teva

Do not take Risperidone Teva:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

If you are unsure whether this applies to you, consult your doctor or pharmacist before using Risperidone Teva.

Warnings and precautions

Talk to your doctor or pharmacist before starting Risperidone if:

• You have any heart problems. Examples include irregular heart rhythms, or if you are prone to low blood pressure or are taking medications for blood pressure. Risperidone may lower blood pressure. You may need a dose adjustment.
• You have any risk factors that may predispose you to a 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 have previously had low levels of white blood cells in your blood (whether or not caused by other medications).
• You are diabetic.
• You have epilepsy.
• You are male and have ever had prolonged or painful erections. If this occurs while taking Risperidone, contact your doctor immediately.
• You have difficulty regulating 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.
• If you or a family member 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 Risperidone Teva.

Rarely, patients treated with Risperidone have been observed to have a dangerously low number of a type of white blood cells necessary to fight infections. Your doctor may monitor your white blood cell count.

Risperidone may cause weight gain. Significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

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

Risperidone frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual cycle disturbances 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 eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You must not take risperidone if your dementia is caused by 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 sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or confusion in speech, even briefly, seek immediate medical attention. These may be signs of 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.

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

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

Other medicines and Risperidone Teva

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:

• Medicines that act on your brain, such as those used to calm you (benzodiazepines), or some pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines capable of altering 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 slow heart rate.
• Medicines that cause low potassium levels in the blood (e.g., some diuretics).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics, used for heart problems or to treat swelling in parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, 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 types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
• Medicines known as beta-blockers (used to treat high blood pressure).
• Phenothiazines (such as medicines 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 Risperidone Teva.

Taking Risperidone Teva with food, drinks, and alcohol

You may take this medicine with or without food. You should avoid consuming alcohol while taking Risperidone.

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 been treated with risperidone during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn baby develops any of these symptoms, contact your doctor.
• Risperidone may increase levels of a hormone called "prolactin" which may affect fertility (see Possible side effects).

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Risperidone Teva 1 mg/ml oral solution contains sorbitol (E 420)

This medicine contains 150 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Risperidone Teva 1 mg/ml oral solution contains benzoic acid (E 210)

This medicine contains 2 mg of benzoic acid in each ml of oral solution.

3. How to take Risperidone Teva

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

Recommended dosage is as follows:

For the treatment of schizophrenia

Adults

• The starting dose is 2 mg per day; it may be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose depending on your response to treatment.
• Most people respond well to daily doses of 4 to 6 mg.
• This total daily dose may be divided into one or two doses per day. Your doctor will tell you what is best for you.

Elderly patients

• The usual starting dose is 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.

Children and adolescents

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

For the treatment of mania

Adults

• The usual starting dose is 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people respond well to daily doses of 1 to 6 mg.

Elderly patients

• The usual starting dose is 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.

Children and adolescents

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

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

Adults (including elderly patients)

• The usual starting dose is 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml) twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people respond well to a dose 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.

For the treatment of conduct disorders in children and adolescents

The dose will depend on your child's weight:

If weight is less than 50 kg

• The usual starting dose is 0.25 mg (0.25 ml of risperidone oral solution 1 mg/ml) 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 (0.25 ml of risperidone oral solution 1 mg/ml) once daily.

If weight is 50 kg or more

• The usual starting dose is 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 starting 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.

Method of administration

Oral use.

How to take Risperidone Teva

Always take risperidone exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Your doctor will tell you how much medicine to take and for how long. This will depend on your illness and may vary from person to person. The amount of medicine you should take is explained above under the heading “How much to take”.

Risperidone Teva oral solution

The solution comes with a syringe (pipette). Use only the syringe (pipette) supplied with this medicine to measure the prescribed dose. Measure the exact dose of medicine you need. Pay attention when measuring a small dose; for example, 0.25 mg requires measuring 0.25 ml (a quarter of a millilitre); for 0.5 mg, 0.5 ml (half a millilitre) must be measured.

Follow these steps:

1. Remove the child-resistant cap. Push down the plastic cap while turning it counterclockwise (Figure 1).
2. Insert the syringe into the bottle.
3. Holding the lower ring, pull the upper ring to the mark corresponding to the number of millilitres or mg to be administered (Figure 2).
4. Holding the lower ring, remove the entire syringe from the bottle (Figure 3).
5. Empty the syringe into a non-alcoholic drink (not tea). Slide the upper ring downward to dispense.
6. Close the bottle.
7. Wash the syringe with water and allow it to air dry.

If you take more Risperidone Teva than you should

• Seek medical help immediately. Take the medicine package with you. You may also call the Toxicology Information Service at phone number 91 562 04 20.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidone Teva

• If you forget 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 the same time) to make up for a missed dose.

If you stop taking Risperidone Teva

Do not stop treatment unless instructed by your doctor. Symptoms may return. If your doctor decides to discontinue 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 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking, even for a short period of time. These may be signs of a stroke.
• You develop tardive dyskinesia (involuntary spasms or twitching movements of the face, tongue, or other parts of the body). Immediately inform your doctor if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

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

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of 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 immediate medical advice.
• You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• You are male and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

The following side effects may also occur:

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

• Parkinsonism: This condition may include slow or impaired movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a "freezing" of movement that later restarts. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness.
• Difficulty falling or staying asleep.
• Feeling drowsy or less alert.
• Headache.

Common adverse effects (may affect up to 1 in 10 people):

• Fatigue, tiredness, restlessness, irritability, anxiety, dizziness, feeling of exhaustion, sleep disturbances, depression.
• Vomiting, diarrhea, constipation, nausea, abdominal pain or discomfort, sore throat, dry mouth, toothache, indigestion.
• Dyskinesia: This condition involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Dystonia: A condition involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• Tremor (agitation).
• Weight gain, increased appetite, decreased appetite.
• Sinusitis, lung infection (pneumonia), symptoms of a common cold, feeling as if you have the flu, chest infection (bronchitis), nasal congestion, nosebleeds, cough, ear infection.
• Urinary tract infection, urinary incontinence (loss of control).
• Muscle spasms, bone or muscle pain, joint pain, back pain, swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
• Rash, skin redness.
• Rapid heartbeat, increased blood pressure, shortness of breath.
• Increased blood levels of the hormone prolactin (which may or may not cause symptoms). Symptoms of elevated prolactin are rare and may include, in men, breast enlargement, difficulty achieving or maintaining erections, or other sexual dysfunction. In women, symptoms may include breast discomfort, milk secretion from the breasts, absence of menstrual periods, or other menstrual cycle problems or fertility issues.
• Blurred vision, eye infection, or "red eye."
• Falls.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Fecal incontinence, sensation of thirst, very hard stools, excess gas or flatulence.
• Respiratory tract infection, bladder infection, eye redness, viral infection, tonsillitis, skin infection, eye infection, stomach or intestinal infection, fungal nail infection.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical conduction in the heart, low blood pressure upon standing. As a result, some people taking risperidone may feel weakness, dizziness, or fainting when standing up or sitting down suddenly, flushing, low blood pressure, dizziness when changing position, QT interval prolongation on the electrocardiogram (ECG), abnormal heart electrical activity (ECG), irregular heartbeat, sensation of fluttering or pounding in the chest (palpitations), slow heartbeat.
• Pain when urinating, frequent urination, inability to urinate.
• Confusion, attention disturbance, decreased level of consciousness, nervousness, euphoria (mania), nightmares.
• Seizures (epileptic fits).
• Diabetes or worsening of diabetes, increased blood glucose, excessive water intake.
• Increased blood cholesterol.
• Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood.
• Decreased number of white blood cells, decreased hemoglobin or red blood cell count (anemia), increased eosinophils (a type of white blood cell), increased creatine phosphokinase (CPK) in blood (an enzyme sometimes released during muscle breakdown), decreased platelet count (blood cells that help stop bleeding).
• Muscle weakness, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort.
• Skin injury, skin disorder, dry skin, severe itching, acne, hair loss, skin inflammation due to mites, skin discoloration, skin thickening, scaly and itchy skin or scalp, localized infection in a single area of skin or body part, reduced skin sensitivity to pain or touch.
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, milk secretion from the breasts, breast enlargement in males, breast pain, breast discomfort, decreased sexual desire, absence of menstrual periods or other cycle problems (in women), vaginal discharge.
• Fainting, change in walking pattern, weight loss, loss of appetite with malnutrition and weight loss, feeling unwell, discomfort, feeling "under the weather," balance disorder, sensation of spinning (vertigo), allergic reaction, eczema, hives (or "urticaria"), speech problems, loss or changes in taste, chills, increased body temperature, coordination problems.
• Restlessness causing body movements, tingling, prickling, or numbness of the skin.
• Light sensitivity of the eyes, dry eyes, increased tearing.
• Difficulty breathing, wheezing, lung congestion, crackling lung sounds, respiratory tract congestion, voice disorders, difficulty swallowing, pneumonia caused by aspiration of food.
• Absence of response to stimuli, loss of consciousness, swelling of the face, mouth, lips, and eyes, ringing in the ears.
• Pain due to the procedure.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Inability to achieve orgasm, delayed menstruation, increased breast glands, breast enlargement, milk secretion from the breasts.
• Dandruff.
• Sleepwalking.
• Sleep-related eating disorder.
• Lack of movement or response while awake (catatonia).
• Head agitation.
• Irregular heartbeat.
• Glaucoma (increased pressure in the eye), eye rolling, crusting at the edge of the eyelid, eye movement problems.
• Absence of emotions.
• Decreased body temperature, coldness in arms and legs.
• Rapid and shallow breathing, breathing problems during sleep (sleep apnea), intestinal obstruction.
• Problems in the blood vessels of the brain.
• Inadequate secretion of a hormone controlling urine volume.
• Sugar in urine, low blood sugar, increased blood triglycerides (a type of fat), increased insulin (a hormone controlling blood sugar levels) in blood.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), movement disorder.
• Coma due to uncontrolled diabetes.
• Yellowing of the skin and eyes (jaundice).
• Pancreatitis (inflammation of the pancreas).
• Infection.
• 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. If you need cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.
• Tongue swelling, cracked lips, drug-related skin rash.
• Dangerously low count of a type of white blood cells needed to fight infections.
• Dangerously excessive water intake.
• Drug withdrawal syndrome.

Very rare adverse effects (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 and cause breathing difficulties.
• Ileus (lack of intestinal muscle movement causing obstruction).

Frequency not known: cannot be estimated from available data

• Severe or life-threatening 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 adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with risperidone: rapid heartbeat upon standing.

Long-acting injectable risperidone

The following adverse effects have been reported with the use of long-acting injectable risperidone. If you experience any of these effects, speak with your doctor, even if you are not receiving long-acting risperidone injections:

• Intestinal infection.
• Skin abscess, tingling, prickling, or numbness of the skin, skin inflammation.
• Decreased number of white blood cells (cells that help protect you from bacterial infections).
• Depression.
• Seizures.
• Eye twitching.
• Sensation of spinning or oscillation.
• Slow heartbeat, increased blood pressure.
• Toothache, tongue spasm.
• Buttock pain.
• Weight loss.

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 the 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Teva

No special storage conditions are required.

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

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

Once the bottle has been opened, any unused portion must be discarded after three months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Risperidone Teva

The active substance is risperidone.

Each ml of Risperidone Teva oral solution contains 1 mg of risperidone.

The other components are:

Benzoic acid (E 210), 70% sorbitol solution (E 420), purified water.

Appearance of the product and contents of the container

The oral solution is clear and colourless.

It is available in 30 ml and 100 ml bottles, both supplied with a syringe.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Czech Industries s.r.o.

Ostravská 29, 747 70,

Opava-Komárov

Czech Republic

Date of the most recent review of this leaflet: November 2024

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69514/P_69514.html