Ibuprofen Kern Pharma 20 mg/ml oral suspension EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibuprofen Kern Pharma 20 mg/ml oral suspension 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 you should not give it to other people, even if they have the same symptoms, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

What Ibuprofen Kern Pharma is and what it is used for
What you need to know before taking Ibuprofen Kern Pharma
How to take Ibuprofen Kern Pharma
Possible adverse effects
How to store Ibuprofen Kern Pharma
Contents of the pack and other information

1. What Ibuprofeno Kern Pharma is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever and mild to moderate pain.

2. What you need to know before taking Ibuprofen Kern Pharma

Do not take Ibuprofen Kern Pharma

If you are allergic (hypersensitive) to ibuprofen, to other medicines in the NSAID group (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other components of this medicine. Signs of allergy may include itchy skin rash, swelling of the face, lips or tongue, nasal discharge, breathing difficulties or asthma.
If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
If you are vomiting blood.
If you have black stools or diarrhoea with blood.
If you have severe liver or kidney disease.
If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used concomitantly, your doctor will perform blood coagulation tests.
If you have severe heart failure.
If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

Allergic reactions to ibuprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Ibuprofen Kern Pharma immediately and contact your doctor or emergency medical services immediately if you experience any of these symptoms.

Inform your doctor:

If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms.
This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
If you have oedema (fluid retention).
If you have asthma or any other respiratory disorder.
If you have or have had heart problems or high blood pressure.
If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.
If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure as a consequence of dehydration.
If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you have Crohn’s disease or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis may occur.
If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you have an infection; see the section “Infections” below.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
Allergic reactions to this medicine may occur.
Your doctor will monitor you more closely if you are receiving ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.
It is important to use the lowest effective dose to relieve or control pain and not to take this medicine longer than necessary to control your symptoms.

Skin reactions

Take special care with Ibuprofen Kern Pharma:

Severe skin reactions have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Discontinue treatment with Ibuprofen Kern Pharma and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions:

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Kern Pharma if:

You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Pregnancy and fertility:

Ibuprofen is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary, as use of medicines like ibuprofen has been associated with an increased risk of congenital malformations (birth defects) or miscarriage. If use is considered essential, the dose and duration should be limited to the minimum possible.

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Interference with laboratory tests:

Taking ibuprofen may affect the following laboratory tests:

Bleeding time (may be prolonged for up to 1 day after stopping treatment)
Blood glucose concentration (may decrease)
Creatinine clearance (may decrease)
Haematocrit or haemoglobin (may decrease)
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
Liver function tests: increased transaminase levels.

Inform your doctor if you are scheduled for clinical laboratory testing and are currently taking or have recently taken ibuprofen.

Taking Ibuprofen Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Ibuprofen Kern Pharma may interact with or be affected by other medicines. For example:

Anticoagulants (e.g. medicines to treat or prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels), such as ticlopidine.
Corticosteroids such as cortisone and prednisolone.
Selective serotonin reuptake inhibitors (used in depression).
Other NSAIDs such as aspirin.
Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
Mifepristone (an abortion-inducing agent).
Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
Hydantoins such as phenytoin (used in the treatment of epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Diuretics (medicines used to increase urine output).
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in patients with gout or in combination with penicillin for infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes).
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Medicines that lower high blood pressure (such as ACE inhibitors like captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists like losartan).
Thrombolytics (medicines that dissolve blood clots).
Zidovudine (an anti-HIV medicine).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts (from Ginkgo biloba tree).

Other medicines may also interact with or be affected by treatment with Ibuprofen Kern Pharma. Therefore, always consult your doctor or pharmacist before using Ibuprofen Kern Pharma with other medicines.

Taking Ibuprofen Kern Pharma with food and drink

It is recommended to take Ibuprofen Kern Pharma with food or immediately after a meal to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester, as it may be harmful to the fetus (see section on precautions during pregnancy and in women of childbearing age). It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended. It is not necessary to interrupt breastfeeding during short-term treatment with the recommended dose for pain and fever.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and using machines

If a single dose of ibuprofen is administered or treatment is short-term, no special precautions are necessary.

For long-term treatment, caution is advised due to the possibility of adverse effects related to the central nervous system, such as dizziness, vertigo, visual disturbances, or other effects. If you experience these symptoms, you must not drive or operate machinery.

Important information about some of the components of Ibuprofen Kern Pharma

This medicine may cause headache, stomach discomfort, and diarrhoea because it contains glycerol.

This medicine contains maltitol syrup. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Patients on low-sodium diets should be aware that this medicine contains 1.84 mg (0.08 mmol) of sodium per ml of oral suspension.

3. How to take Ibuprofen Kern Pharma

Follow exactly the administration instructions provided by your doctor. If in doubt, consult your doctor or pharmacist.

Remember to take your medicine.

Your doctor will indicate how long you should continue treatment with Ibuprofen Kern Pharma. Do not stop treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not use Ibuprofen longer than indicated by your doctor.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

This medicine is an oral suspension.

For accurate dosing, the packaging contains a 5 ml graduated oral syringe. The syringe should be cleaned and dried after each use.

Patients experiencing stomach discomfort should take the medicine during meals.

Children:

The dose of ibuprofen to be administered depends on the child's age and weight. As a general rule, the recommended daily dose is 20 to 30 mg per kg of body weight, divided into three or four individual doses. It is recommended not to exceed the maximum daily dose of 40 mg per kg of body weight of ibuprofen.

This medicine is not recommended for children under 3 months of age.

The interval between doses will depend on the progression of symptoms, but must never be less than 4 hours.

However, as a general guideline, the following dosing schedule is recommended:

*Age*	*Body weight*	*Dosage*
Children 3 to 6 months	Approx. 5 to 7.6 kg	2.5 ml three times a day (equivalent to 150 mg of ibuprofen/day)
Children 6 to 12 months	Approx. 7.7 to 9 kg	2.5 ml three to four times a day (equivalent to 150 mg–200 mg of ibuprofen/day)
Children 1 to 3 years	Approx. 10 to 15 kg	5.0 ml three to four times a day (equivalent to 300 mg–400 mg of ibuprofen/day)
Children 4 to 6 years	Approx. 16 to 20 kg	7.5 ml three to four times a day (equivalent to 450 mg–600 mg of ibuprofen/day)
Children 7 to 9 years	Approx. 21 to 29 kg	10.0 ml three to four times a day (equivalent to 600 mg–800 mg of ibuprofen/day)
Children 10 to 12 years	Approx. 30 to 40 kg	15.0 ml three to four times a day (equivalent to 900 mg–1200 mg of ibuprofen/day)

Adults and adolescents:

The recommended dose is 20 ml 3 to 4 times a day (equivalent to 1200–1600 mg of ibuprofen/day), for as long as symptoms persist.

Due to the amount of ibuprofen contained in this medicine, other more suitable formulations are recommended for ibuprofen treatment in adults and adolescents (over 12 years of age).

Patients with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe you a lower than usual dose. If so, take exactly the dose prescribed by your doctor.

Elderly patients:

If you are over 60 years of age, your doctor may prescribe you a lower than usual dose. If so, you may only increase the dose once your doctor has confirmed that you tolerate the medicine well.

It is important to use the lowest dose that relieves/controls your pain, and you should not take this medicine longer than necessary to control your symptoms.

Consult your doctor if symptoms persist or worsen during treatment.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Kern Pharma than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the contents of the container, contact your doctor or pharmacist immediately, the Toxicology Information Service, telephone: 91 562 04 20, or go to the nearest hospital to find out about the risk and obtain advice on the measures to be taken, indicating the medicine and the amount ingested. It is advisable to bring the medicine container and package leaflet to the healthcare professional.

Symptoms of an overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), indifference, drowsiness, headache, involuntary eye movements, tinnitus, confusion, and lack of muscle coordination. More severe symptoms may occur, such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingestion of large amounts).

At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

If severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of large amounts, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Ibuprofeno Kern Pharma

Do not take a double dose to make up for a missed dose.

If you forget to take your dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.

4. Possible adverse effects

Like all medicines, Ibuprofeno Kern Pharma may produce adverse effects, although not everyone experiences them.

If you consider that any of the adverse effects you experience is severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

Frequencies are defined according to the following classification: very common (in more than 1 in 10 patients); common (in 1 to 10 out of 100 patients); uncommon (in 1 to 10 out of 1,000 patients); rare (in 1 to 10 out of 10,000 patients); very rare (in fewer than 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, vomiting blood, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) have also been observed. Gastritis has been observed less frequently.

Other adverse effects: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophagitis, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis presenting with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using medicines of the ibuprofen type.

Skin-related:

Stop treatment with Ibuprofeno Kern Pharma and seek immediate medical attention if you notice any of the following symptoms:

Flat red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital or eye lesions. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
Generalized red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Medicines such as ibuprofen may, very rarely, be associated with serious blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis).

Drug reaction with eosinophilia and systemic symptoms: A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Other adverse effects are: Common: skin rash. Uncommon: skin redness, itching, or skin swelling, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), photosensitivity reactions, inflammation of blood vessels in the skin. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

Frequency not known: Generalized red, scaly rash with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue Ibuprofeno Kern Pharma immediately if you experience these symptoms and seek immediate medical attention. See also section 2.

Immune system-related:

Uncommon: transient swelling in areas of skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of nasal mucosa, bronchospasm (spasm of the bronchi preventing air passage to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur. Very rare: joint pain and fever (lupus erythematosus).

Central nervous system-related:

Common: fatigue or drowsiness, headache, dizziness, or unsteadiness. Rare: paresthesia (numbness, tingling, "pins and needles," more commonly in hands, feet, arms, or legs). Very rare: aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: dizziness. Uncommon: tinnitus (ringing or buzzing in the ears). Rare: hearing difficulty.

Ocular:

Uncommon: visual disturbances. Rare: abnormal or blurred vision.

Blood-related:

Rare: decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (bone marrow failure to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal:

Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Hepatic:

Medicines such as ibuprofen may, on rare occasions, be associated with liver damage. Other rare adverse effects include: hepatitis (liver inflammation), abnormal liver function tests, and jaundice (yellowing of the skin and eyes). Frequency not known: liver failure (severe liver impairment).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with Ibuprofeno, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

Allergic reactions such as skin rash, facial swelling, wheezing, or breathing difficulty.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
Blisters or extensive skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (see above in this section).
Swelling of limbs or fluid accumulation in arms or legs.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Ibuprofen Kern Pharma

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Kern Pharma

The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
The other components (excipients) are: glycerol (E-422), maltitol syrup (E-965), microcrystalline cellulose (E-460i), xanthan gum (E-415), anhydrous citric acid (E-330), sodium citrate (E-331), sodium benzoate (E-211), polysorbate 80 (E-433), sodium saccharin (E-954), orange flavour, and purified water.

Appearance of Ibuprofeno Kern Pharma and contents of the pack

White oral suspension with an orange odour and taste.

It is supplied in a plastic bottle containing 200 ml of oral suspension. It includes a 5 ml dosing syringe graduated in millilitres.

It is also available in 400 mg and 600 mg tablets, and in 200 mg and 600 mg effervescent granule sachets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/