Ibuprofen Normon 40 mg/ml oral suspension EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofen Normon 40 mg/ml oral suspension EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days in case of fever, or after 5 days (3 days in children aged 6 months and older) in case of pain. In children aged 3 to 5 months, you should consult a doctor if symptoms worsen or persist after 24 hours.

Leaflet Contents

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

1. What Ibuprofeno Normon is and what it is used for

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

This medicine is used in children from 3 months of age, adolescents and adults for the symptomatic relief of mild to moderate occasional pain, as well as for feverish conditions.

2. What you need to know before taking Ibuprofeno Normon

Do not take Ibuprofeno Normon

• If you are allergic (hypersensitive) to ibuprofen or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used together, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor:

• If you have oedema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you are receiving treatment with this medicine, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (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 done.
• 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, or even without prior warning symptoms.
• This risk is higher when high doses or long-term treatment are used, 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 are taking medicines that affect blood clotting, 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 such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like Ibuprofeno Normon may worsen these conditions.
• If you are taking diuretics (medicines to increase urine output), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) 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 suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Signs of allergic reaction to this medicine, such as breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno Normon immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
• Allergic reactions may occur with this medicine.
• Your doctor will carry out stricter monitoring if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection: see the “Infections” section below.

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

Serious skin adverse reactions (SSARs)

Serious skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), associated with ibuprofen treatment. Discontinue treatment with Ibuprofeno Normon 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 Ibuprofeno Normon if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in the 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).

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Pregnancy and women of childbearing age

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, their use is not recommended during the first and second trimesters of pregnancy, unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of this medicine 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 the 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 the symptoms persist or worsen, consult your doctor without delay.

Other medicines and Ibuprofeno Normon

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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

• Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
• Antiplatelet agents (which prevent blood clots or thrombi in blood vessels), such as ticlopidine.
• Anticoagulant medicines, e.g., for treating or preventing blood clotting (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• 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 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).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as hypoglycaemia may occur.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medicine against the HIV virus).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking ibuprofen may alter 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 levels (may increase).
• Liver function tests: increased transaminase values.

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

Taking Ibuprofeno Normon with food, drinks and alcohol

It is recommended to take this medicine with milk or food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not drink alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding and fertility

The use of this medicine is not recommended in women trying to become pregnant.

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. Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age), as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond expectations.

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 fetus 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 is needed for longer than a few days, 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.

Driving and use of machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are not usually necessary.

Ibuprofen may slow your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving and operating machinery.

This is especially important when combined with alcohol.

Ibuprofeno Normon contains sucrose, sodium benzoate (E-211) and sunset yellow FCF (E-110)

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 0.44 g of sucrose per millilitre.

It may cause tooth decay.

This medicine contains 2.5 mg of sodium benzoate per dose unit.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine may cause allergic reactions as it contains the colouring agent sunset yellow FCF (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains less than 1 mmol of sodium (23 mg) per millilitre; hence, it is essentially "sodium-free".

3. How to take Ibuprofen Normon

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

For occasional use only and for limited periods.

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

Administration of the medicine should be based on the occurrence of pain or fever. As these symptoms subside, the medication should be discontinued.

Adults and adolescents over 12 years (≥40 kg):

The recommended dose is 5–10 ml (200–400 mg of ibuprofen) at intervals of no less than 4 hours, if necessary and while symptoms persist, without exceeding 1200 mg of ibuprofen in a 24-hour period.

The maximum single dose should not exceed 400 mg of ibuprofen. Taking more than 400 mg in a single dose does not provide better analgesic effect.

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

In adults and adolescents, consult a doctor if it is necessary to use this medicine for more than 3 days for fever or 4 days for pain, or if symptoms worsen.

Children from 3 months to 12 years:

The recommended dose of ibuprofen depends on the child's age and weight. Generally, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight, depending on the severity of symptoms, divided into three doses.

The use of this medicine in children under 2 years of age must always be under medical prescription.

As a general guide, the doses in the following table may be followed:

The suspension can also be dosed according to a schedule of 4 doses per day. In this case, the maximum daily doses (see last column of the table above) must not be exceeded within 24 hours. The dose to be administered every 6 hours will be recalculated/reduced proportionally.

Use of this medicine is not recommended in children under 3 months of age or weighing less than 5 kg.

??Elderly patients over 65 years: dosage must be established by the physician, as dose reduction from the usual dose may be necessary.

??Patients with kidney, liver, or heart disease: dosage must be reduced and medical advice sought. Ibuprofen must not be used in patients with severe heart, renal, or hepatic failure.

Adults and adolescents should consult a doctor if symptoms worsen or do not improve after 3 days in case of fever, or after 5 days in case of pain.

Children aged 6 months to 12 years should consult a doctor if symptoms worsen or do not improve after 3 days.

Children aged 3 to 5 months should consult a doctor if symptoms worsen or persist after 24 hours.

Method of administration:

Ibuprofeno Normon is an oral suspension. It may be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the pierced cap's opening.
3. Invert the bottle and withdraw the required dose.
4. Administer the contents of the syringe directly into the mouth or onto a spoon.
5. The syringe should be washed after each use and may be sterilized by boiling in water or by immersion in the sterilizing solution used for baby bottles.

A burning sensation in the mouth or throat may occur with oral ibuprofen suspension; ensure that the bottle has been shaken well before administering the medicine.

Patients experiencing stomach discomfort should take the medicine with milk and/or during meals.

If you take more Ibuprofeno Normon than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 5620420, stating the name of the medicine and the amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken.

Normally, overdose symptoms occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination.

Nervousness, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. Low blood pressure and reduced breathing rate may also occur.

Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, transient cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been observed.

If you forget to take Ibuprofeno Normon

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

If you forget to take your scheduled 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.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

The frequencies shown below refer to short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

• Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or unsteadiness, fatigue.

• Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple skin spots), photosensitivity reactions, hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), and renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

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

Disorientation or confusion, depression, vertigo, tinnitus (ringing or noises in the ear), hearing impairment, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial, tongue, and laryngeal swelling, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema, or severe shock), 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 with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, bleeding, and unexplained bruising.

• Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Rarely, severe skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver damage), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Frequency not known (cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhea).

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

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

Widespread, red, scaly rash with bumps under the skin and blisters primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), and skin photosensitivity. Stop taking Ibuprofeno Normon if you experience these symptoms and seek immediate medical attention. See also section 2.

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

• Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
• 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.
• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. 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 enlarged lymph nodes (DRESS syndrome).
• Widespread, 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).

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 Ibuprofen Normon

Keep this medicine 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at the pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Normon 40 mg/ml oral suspension EFG:

• The active substance is ibuprofen.
• The other components are: xanthan gum, hypromellose, sodium benzoate (E-211), citric acid, sucrose, glycerol (E-422), sunset yellow FCF colour (E-110), peach flavouring, and purified water.

Ibuprofen Normon 40 mg/ml oral suspension comes in a 150 ml bottle contained in a cardboard box. Each ml contains 40 mg of ibuprofen.

Appearance of the product and contents of the pack

Ibuprofen Normon is a viscous orange-coloured suspension with a peach odour.

It is supplied in 150 ml containers. The pack includes an oral dosing syringe and a syringe stopper for the dosing syringe.

Other available presentations

Ibuprofen Normon 20 mg/ml oral suspension EFG

Ibuprofen Normon 400 mg coated tablets EFG

Ibuprofen Normon 600 mg coated tablets EFG

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos – Madrid (SPAIN)

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://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 in the package leaflet and packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/75244/P_75244.html