Ibuprofen Aurovitas Spain 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibuprofen Aurovitas Spain 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ibuprofeno Aurovitas Spain is and what it is used for

Ibuprofeno Aurovitas Spain belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which reduce pain, inflammation, and fever.

This medicine is used for the symptomatic treatment of mild to moderate pain, including migraine, menstrual pain, and/or fever. In addition, ibuprofen is used for the symptomatic treatment of pain and inflammation in rheumatic diseases (e.g. rheumatoid arthritis), degenerative joint diseases (e.g. osteoarthritis), and pain and inflammation following soft tissue injuries.

2. What you need to know before taking Ibuprofeno Aurovitas Spain

Do not take Ibuprofeno Aurovitas Spain:

• If you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• If you have had allergic reactions such as asthma, runny nose, itchy skin rash, or swelling of the lips, face, tongue, or throat after taking medications containing acetylsalicylic acid (such as aspirin) or other pain or anti-inflammatory medicines (NSAIDs).
• If you have experienced gastrointestinal bleeding or perforation related to the use of pain or anti-inflammatory medicines (NSAIDs).
• If you currently have a stomach or small intestine (duodenum) ulcer or bleeding, or if you have had two or more such episodes in the past.
• If you have severe liver, kidney, or heart problems.
• If you are in the third trimester of pregnancy.
• If you have significant dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you have any active bleeding (including in the brain).
• If you suffer from an unknown-origin disease leading to abnormal blood cell formation.

Do not administer this medicine to children weighing less than 20 kg or under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Ibuprofeno Aurovitas Spain if:

• You have systemic lupus erythematosus (SLE) or mixed connective tissue disease.
• You have inherited a disorder of hemoglobin, the red pigment in blood (porphyria).
• You have chronic inflammatory bowel diseases, such as ulcerative colitis (inflammation and ulcers in the colon), Crohn’s disease (affecting the digestive tract), or other stomach or intestinal disorders.
• You have disorders affecting blood cell formation.
• You have problems with normal blood clotting mechanisms.
• You have allergies, allergic rhinitis, asthma, chronic inflammation of the nasal mucosa, sinuses, adenoids, or chronic obstructive respiratory disease, as the risk of developing airway narrowing with breathing difficulty is higher.
• You have liver, kidney, or heart problems.
• You have recently undergone surgery.
• You are in the first six months of pregnancy.
• You are breastfeeding.
• You have an infection; see the section «Infections» below.
• Signs of an allergic reaction to this medicine have been reported, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain due to ibuprofen. Stop using this medicine immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
• Serious skin reactions have been reported with ibuprofen treatment, 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 ibuprofen treatment and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and 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.

Elderly patients

If you are elderly, you are more likely to experience adverse effects, especially gastrointestinal bleeding and perforation, which could be fatal.

Stomach and intestinal ulcers, perforation, and bleeding

If you have previously had a stomach or intestinal ulcer, especially if complicated by perforation or accompanied by bleeding, pay attention to any unusual abdominal symptoms and notify your doctor immediately, particularly if these symptoms occur at the beginning of treatment. This is because the risk of gastrointestinal bleeding or ulceration is higher in such cases, especially in elderly patients. If gastrointestinal bleeding or ulceration occurs, treatment must be discontinued.

Bleeding, ulceration, or perforation in the stomach or intestines may occur without warning signs, even in patients who have never previously experienced such problems. These events may also be fatal.

The risk of stomach or intestinal ulcers, perforation, or bleeding generally increases with higher doses of ibuprofen. The risk also increases if ibuprofen is taken simultaneously with other medicines (see below “Other medicines and Ibuprofeno Aurovitas Spain”).

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Skin reactions

Serious skin reactions have been reported with ibuprofen treatment. Stop taking ibuprofen and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

It is advisable to avoid using this medicine during chickenpox.

Effects on the heart and brain

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

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, 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 ischemic attack “TIA”).
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Effects on the kidneys

Ibuprofen may cause kidney function problems even in patients who have not previously had kidney issues. This may lead to leg swelling and could even result in heart failure or high blood pressure in susceptible individuals.

Ibuprofen may cause kidney damage, especially in patients who already have kidney, heart, or liver problems, or who are taking diuretics or ACE inhibitors, as well as in elderly patients. However, discontinuation of ibuprofen treatment usually leads to recovery.

Aseptic meningitis (inflammation of the brain membrane without bacterial infection)

A few cases of meningitis (manifesting as neck stiffness, headache, nausea, vomiting, fever, or confusion) have been reported during ibuprofen treatment. Although it may be more likely in patients with autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue disease, it has also been reported in patients without pre-existing chronic illness.

Other precautions

Very rare cases of severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking ibuprofen, stop treatment and inform your doctor immediately.

Ibuprofen may temporarily inhibit platelet function in the blood (platelet aggregation). Therefore, patients with blood clotting disorders should be closely monitored.

Prolonged use of any type of painkiller for headaches may worsen them. If you experience or suspect this condition, stop taking ibuprofen and consult your doctor. Medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medications.

Regular use of painkillers may cause permanent kidney damage and risk of kidney failure.

Ibuprofen may mask symptoms or signs of infection (fever, pain, swelling) and prolong bleeding time.

Ibuprofen may reduce your chances of becoming pregnant. Inform your doctor if you plan to become pregnant or if you have difficulty conceiving.

Children and adolescents

This medicine is contraindicated in children weighing less than 20 kg or under 6 years of age (see section 3).

It may cause kidney problems in dehydrated children and adolescents.

Other medicines and Ibuprofeno Aurovitas Spain

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

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

• Other NSAIDs, including COX-2 inhibitors, as the risk of gastrointestinal ulcers and bleeding may increase.
• Anticoagulants (prevent blood clotting), such as warfarin or heparin, as the anticoagulant effect may be enhanced.
• Platelet aggregation inhibitors (prevent blood clotting) such as clopidogrel and ticlopidine.
• Methotrexate (used to treat cancer or autoimmune diseases).
• Digoxin (for treating various heart conditions), as the effect of digoxin may be enhanced.
• Phenytoin (used to prevent epileptic seizures), as the effect of phenytoin may be enhanced.
• Lithium (used to treat depression and mania), as the effect of lithium may be enhanced.
• Diuretics (medicines used to increase urine elimination), as their effect may be reduced.
• Potassium-sparing diuretics, as hyperkalemia may occur.
• Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin II receptor antagonists such as losartan).
• Cholestyramine (used to treat high cholesterol levels).
• Aminoglycosides (medicines against certain types of bacteria), as NSAIDs may reduce aminoglycoside elimination.
• SSRIs (medicines for depression) such as paroxetine, sertraline, citalopram, as these may increase the risk of gastrointestinal bleeding.
• Cyclosporine, tacrolimus (for immunosuppression after organ transplant), as kidney damage may occur.
• Zidovudine or ritonavir (used to treat HIV patients).
• Mifepristone, as NSAIDs may reduce the effect of mifepristone.
• Probenecid or sulfinpyrazone (for treating gout), as they may delay ibuprofen elimination.
• Quinolone antibiotics, as the risk of seizures may increase.
• Sulfonylureas (for treating type 2 diabetes), as blood sugar levels may be affected.
• Glucocorticoids (used to treat inflammation), as they may increase the risk of gastrointestinal ulcers or bleeding.
• Bisphosphonates (used for osteoporosis, Paget’s disease, and to reduce high blood calcium levels).
• Pentoxifylline (oxpentifylline), used to treat circulatory disease in leg or arm arteries.
• Baclofen (a muscle relaxant), due to its high toxicity.
• Medicinal preparations of Ginkgo biloba (may increase bleeding risk when taken with ibuprofen).
• Voriconazole and fluconazole (CYP2C9 inhibitors) (used to treat fungal infections), as the effect of ibuprofen may increase. A reduction in ibuprofen dose should be considered, especially when high doses of ibuprofen are used together with voriconazole or fluconazole.

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 Ibuprofeno Aurovitas Spain with alcohol

Avoid alcohol, as it may increase adverse reactions of ibuprofen, especially those affecting the stomach, intestine, or central nervous system.

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.

Do not take ibuprofen during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney, lung, and heart problems in your unborn baby. It may affect your tendency and your baby’s tendency to bleed and may delay or prolong labor. Do 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, the lowest possible dose should be taken 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, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby’s heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Ibuprofen passes into breast milk in very small amounts, and generally, breastfeeding does not need to be stopped during short-term treatment. However, if a longer treatment is prescribed, early weaning should be considered.

Driving and using machines

Generally, ibuprofen does not have adverse effects on the ability to drive or use machinery. However, at high doses, side effects such as fatigue, drowsiness, dizziness (reported as common), and visual disturbances (reported as uncommon) may occur, potentially affecting the ability to drive or operate machinery in individual cases. This effect is enhanced by simultaneous alcohol consumption.

Ibuprofeno Aurovitas Spain contains sodium: This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Ibuprofen Aurovitas Spain

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

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The lowest effective dose should be used for the shortest time needed to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The prescribing doctor will decide on the duration of treatment.

The use of ibuprofen for rheumatic diseases may be necessary over a prolonged period of time.

This medicine is contraindicated in children weighing less than 20 kg or under 6 years of age (see section 2).

The dose of ibuprofen depends on the patient's age and body weight. The maximum single daily dose for adults should not exceed 800 mg of ibuprofen (2 tablets). The recommended dose is:

Mild to moderate pain and fever

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

From ½ tablet to 1 tablet as a single dose or 3–4 times daily at 6-hour intervals, when necessary. The maximum daily dose should not exceed 3 tablets (1,200 mg).

Paediatric population

Children with body weight ≥20 kg (6–11 years of age):

Other formulations are more suitable for this age group. Your doctor will advise you appropriately.

Children with body weight 20–29 kg (6–9 years of age): ½ tablet 1–3 times daily at 6-hour intervals, when necessary. The maximum number of tablets should not exceed 1½ (one and a half tablets) per day.

Children with body weight 30–39 kg (10–11 years of age): ½ tablet 1–4 times daily at 6-hour intervals, when necessary. The maximum number of tablets should not exceed 2 tablets per day.

Migraine

Adults and adolescents with body weight ≥40 kg (over 12 years of age):

One tablet as a single dose, if necessary, one tablet every 6 hours.

The maximum daily dose should not exceed 3 tablets (1,200 mg).

Menstrual pain

Adults and adolescents with body weight >40 kg (over 12 years of age):

½ tablet to 1 tablet, 1 to 3 times daily at 6-hour intervals, when necessary.

The maximum daily dose should not exceed 3 tablets (1,200 mg).

Rheumatic diseases

Adults:

The recommended dose is 3–4½ tablets (1,200 mg – 1,800 mg) daily in divided doses. Your doctor may prescribe lower doses.

Depending on the severity of your clinical condition, your doctor may increase your medication up to a maximum of 6 tablets (2,400 mg) daily, taken in 3 or 4 divided doses.

Adolescents aged 15 to 17 years:

The recommended dose is 20 mg/kg up to a maximum of 40 mg/kg body weight (maximum 2,400 mg daily) in 3 or 4 divided doses. Your doctor will advise you appropriately.

The tablet should be swallowed with a glass of water, preferably after meals. Patients with a sensitive stomach should preferably take ibuprofen during meals. To facilitate swallowing or adjust the dose, the tablets may be divided into equal doses.

Elderly patients:

If you are an elderly patient, you are more likely to experience adverse effects, especially gastrointestinal bleeding, ulceration, and perforation, which could be fatal. Your doctor will advise you appropriately.

Reduced renal or hepatic function:

If you have reduced renal or hepatic function, your doctor will advise you appropriately.

If you take more Ibuprofen Aurovitas Spain than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained material), gastrointestinal bleeding (see also section 4), diarrhoea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, 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, metabolic acidosis, chills, and breathing difficulties have been reported. In addition, prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. In addition, low blood pressure and reduced breathing may occur.

If you forget to take Ibuprofen Aurovitas Spain

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

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 will experience them.

With regard to the following adverse effects, it should be noted that they largely depend on the dose and may vary from patient to patient.

The most frequently observed adverse effects are of a gastrointestinal nature. Peptic ulcers, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, may occur, particularly in elderly patients. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, melena, hematemesis, ulcerative stomatitis, and exacerbation of colitis and Crohn's disease have been reported. Inflammation of the stomach lining (gastritis) has been observed less frequently.

Medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Fluid retention (edema), high blood pressure, and heart failure have been reported in association with NSAIDs.

Adverse effects are listed according to frequency of occurrence. The following classification is used:

Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.
Frequency not known: cannot be estimated from the available data.

The following adverse effects are serious and require immediate action if experienced. You must stop treatment with ibuprofen and contact your doctor immediately if you experience any of the following symptoms:

Common:

• Black, tarry stools or vomiting blood (gastrointestinal ulcer with bleeding).

Very rare:

• Swelling of the face, tongue, or throat (larynx) that may cause difficulty breathing (angioedema), rapid heartbeat, severe drop in blood pressure, or shock that may be life-threatening.
• Sudden allergic reaction with difficulty breathing, wheezing, and drop in blood pressure.
• Severe skin rash with blisters, especially on the legs, arms, hands, and feet, which may also affect the face and lips, mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome). This may become even more serious; blisters enlarge, spread, and parts of the skin may peel off (Lyell syndrome/toxic epidermal necrolysis). A severe infection with destruction of the skin (necrosis), subcutaneous tissue, and muscle (necrotizing fasciitis) may also occur.

If you experience any of the following adverse effects, you must stop treatment with this medicine and contact your doctor as soon as possible:

Very common:

• Heartburn, abdominal pain, indigestion.

Uncommon:

• Vision disturbances.
• Hypersensitivity reactions such as hives, itching, purpura, exanthema, asthma attacks (sometimes with low blood pressure).
• Photosensitivity (increased sensitivity to sunlight).

Rare:

• Loss of vision.

Very rare:

• Sudden fluid accumulation in the lungs causing difficulty breathing, increased blood pressure, fluid retention, and weight gain.

Other possible adverse effects with ibuprofen include:

Very common:

• Gastrointestinal disturbances such as diarrhea, discomfort, vomiting, gas, constipation.

Common:

• Gastrointestinal ulcer with or without perforation.
• Inflammation of the intestine, worsening of colon inflammation (colitis), gastrointestinal tract (Crohn's disease), and complications of colonic diverticula (perforation or fistula).
• Microscopic gastrointestinal bleeding that may lead to anemia.
• Mouth ulcers and inflammation (ulcerative stomatitis).
• Headache, drowsiness, dizziness, vertigo, fatigue, restlessness, insomnia, and irritability.

Uncommon:

• Inflammation of the stomach lining.
• Kidney problems including development of edema, kidney inflammation, and kidney failure.
• Nasal discharge.
• Breathing difficulty (bronchospasm).

Rare:

• Depression, confusion, hallucinations.
• Erythematous lupus syndrome.
• Increased blood urea nitrogen, serum transaminases, and alkaline phosphatase; decreased hemoglobin and hematocrit values; inhibition of platelet aggregation and prolonged bleeding time; decreased blood calcium levels; increased blood uric acid levels.
• Kidney tissue damage.

Very rare:

• Palpitations, heart failure, or heart attack.
• Disorders in blood cell formation (anemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). Initial symptoms or signs may include fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• Ringing or buzzing in the ears (tinnitus).
• Inflammation of the esophagus or pancreas.
• Intestinal narrowing.
• Acute liver inflammation, yellowing of the skin or whites of the eyes (jaundice), liver dysfunction, liver damage, or liver failure.
• Liver damage, especially during prolonged treatment, or liver failure.
• Hair loss.
• Inflammation of the brain's lining without bacterial infection (aseptic meningitis).

Frequency not known:

• Tingling sensations in the hands and feet.
• Anxiety.
• Hearing loss.
• Generalized malaise.
• Optic nerve inflammation that may cause vision problems.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and elevated eosinophils (a type of white blood cell). Stop taking this medicine if you experience these symptoms and seek immediate medical attention.
• Widespread 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). Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Ibuprofen may cause a reduction in the number of white blood cells and may decrease your resistance to infections. If you develop an infection with symptoms such as fever and a significant deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary problems, you should consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Aurovitas Spain

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

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.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Ibuprofeno Aurovitas Spain

• The active substance is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
• The other components are:

Core of the tablet: maize starch, pregelatinized maize starch, anhydrous colloidal silica, sodium croscarmellose, talc, stearic acid.

Coating of the tablet: talc (E553b), polyvinyl alcohol, macrogol 3350 (E1521), titanium dioxide (E171).

Appearance of Ibuprofeno Aurovitas Spain and contents of the pack

Film-coated tablets, white to almost white, round, with a score line on one side and smooth on the other. The tablet may be divided into equal doses.

This medicine is available in boxes containing blisters.

Pack sizes: 10, 20, 24, 30, 40, 50, 56, 60, 84 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Ibuprofen PUREN 400 mg Filmtabletten

Spain: Ibuprofeno Aurovitas Spain 400 mg film-coated tablets EFG

Portugal: Ibuprofeno Generis Phar

Date of the most recent revision of this leaflet: April 2025

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