IBUPROFEN AUROVITAS SPAIN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen Aurovitas Spain 400 mg film-coated tablets 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 further 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Ibuprofen Aurovitas Spain belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), 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. Additionally, 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 after soft tissue injuries.

2. What you need to know before you take Ibuprofen Aurovitas Spain

Do not take Ibuprofen Aurovitas Spain:

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you have had allergic reactions such as asthma, nasal discharge, itchy rash, or inflammation of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other pain or inflammation medicines (NSAIDs).
• If you have had intestinal bleeding or perforation associated with the use of pain or inflammation medicines (NSAIDs).
• If you have a stomach or duodenal ulcer (ulcerative disease of the stomach or duodenum) or if you have had two or more episodes of this condition 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 have any disease of unknown origin that results in the abnormal formation of blood cells.

Do not give this medicine to children with a weight below 20 kg or under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen Aurovitas Spain:

• If you have systemic lupus erythematosus (SLE) or mixed connective tissue disease.
• If you have inherited a disorder of hemoglobin, the red pigment in the blood (porphyria).
• If you have chronic inflammatory bowel diseases, such as ulcerative colitis, Crohn's disease, or other stomach or intestinal diseases.
• If you have alterations in blood cell formation.
• If you have problems with the normal blood clotting mechanism.
• If you have allergies, allergic rhinitis, asthma, chronic nasal mucosa inflammation, sinusitis, adenoids, or chronic obstructive respiratory disease, as the risk of developing respiratory tract narrowing with difficulty breathing is higher.
• If you have liver, kidney, or heart problems.
• If you have recently undergone surgery.
• If you are in the first six months of pregnancy.
• If you are breastfeeding.
• If you have an infection; see the heading "Infections" below.
• Signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain due to ibuprofen, have been reported. Stop using this medicine immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
• Severe skin reactions, 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), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

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

Elderly patients

If you are an elderly patient, you will be more prone to experiencing side effects, especially bleeding and perforation of the digestive tract, which can be fatal.

Ulcers, perforation, and bleeding in the stomach and intestine

If you have previously had a stomach or intestinal ulcer, especially if it was complicated by a perforation or accompanied by bleeding, you should pay attention to any unusual symptoms in the abdomen and notify your doctor immediately, particularly if these symptoms occur at the beginning of treatment. This is because the risk of bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, treatment should be discontinued.

Bleeding, ulceration, or perforation in the stomach or intestines can occur without any warning signs, even in patients who have never had such problems before. It can also be fatal.

The risk of ulcers, perforation, or bleeding in the stomach or intestines generally increases with higher doses of ibuprofen. The risk also increases if ibuprofen is taken at the same time as other medicines (see "Other medicines and Ibuprofen Aurovitas Spain" below).

Side effects can be minimized by using the lowest effective dose for the shortest possible time necessary to control the symptoms.

Skin reactions

Severe skin reactions have been reported in association with ibuprofen treatment. Stop taking ibuprofen and consult a doctor immediately if you experience any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a severe skin reaction. See section 4.

It is advised to avoid using this medicine during chickenpox.

Effects on the heart and brain

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

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 if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

Effects on the kidneys

Ibuprofen may cause kidney problems, even in patients who have not had kidney problems before. This can lead to swelling of the legs and may even result in heart failure or high blood pressure in susceptible individuals.

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

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

Some cases of meningitis (manifested as stiffness of the neck, headache, nausea, vomiting, fever, or disorientation) have been detected during ibuprofen treatment. Although it is possibly more likely to occur in patients with autoimmune system disorders such as systemic lupus erythematosus or mixed connective tissue disease, it has been reported in patients without a pre-existing disease.

Other precautions

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

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

The prolonged use of any type of pain reliever for headaches may worsen them. If you experience or suspect this situation, stop taking ibuprofen and consult your doctor. The diagnosis of headache due to medication overuse should be suspected in patients who have frequent or daily headaches despite (or due to) the habitual use of headache medicines.

The habitual use of pain relievers can cause permanent kidney damage and increase the risk of kidney failure.

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

Ibuprofen may decrease your ability to become pregnant. You should inform your doctor if you intend to become pregnant or if you have problems becoming pregnant.

Children and adolescents

This medicine is contraindicated in children with a weight below 20 kg or under 6 years of age (see section 3).

It may cause kidney problems in children and adolescents who are dehydrated.

Other medicines and Ibuprofen Aurovitas Spain

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

Ibuprofen may affect 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 effect of anticoagulants may be enhanced.
• Platelet aggregation inhibitors (prevent blood clotting) such as clopidogrel and ticlopidine.
• Methotrexate (used to treat cancer or autoimmune diseases).
• Digoxin (for the treatment of various heart diseases), as the effect of digoxin may be enhanced.
• Phenytoin (used to prevent the onset of 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 decreased.
• 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).
• Colestyramine (used to treat high cholesterol levels).
• Aminoglycosides (medicines against certain bacteria), as NSAIDs may decrease the elimination of aminoglycosides.
• SSRIs (medicines for depression) such as paroxetine, sertraline, citalopram, as they may increase the risk of gastrointestinal bleeding.
• Cyclosporine, tacrolimus (for immunosuppression after organ transplantation), as kidney damage may occur.
• Zidovudine or ritonavir (used to treat HIV-infected patients).
• Mifepristone, as NSAIDs may reduce the effect of mifepristone.
• Probenecid or sulfinpyrazone (for the treatment of gout), as they may delay the elimination of ibuprofen.
• Quinolone antibiotics, as the risk of seizures may increase.
• Sulfonylureas (for the treatment of type 2 diabetes), as blood sugar levels may be affected.
• Corticosteroids (used to treat inflammation), as the risk of gastrointestinal ulcers or bleeding may increase.
• Bisphosphonates (used for osteoporosis, Paget's disease, and to reduce high blood calcium levels).
• Oxpentifylline (pentoxifylline), used to treat circulatory disease of the arteries of the legs or arms.
• Baclofen (a muscle relaxant), due to its high toxicity.
• Gingko biloba medicinal preparations (there is a possibility that you may bleed more easily if taken with ibuprofen).
• Voriconazole and fluconazole (CYP2C9 inhibitors) (used to treat fungal infections), as the effect of ibuprofen may be increased. A dose reduction of ibuprofen should be considered, especially when high doses of ibuprofen are used together with voriconazole or fluconazole.

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

Taking Ibuprofen Aurovitas Spain with alcohol

Avoid taking alcohol, as it may increase the 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney, lung, or heart problems in your fetus. It may affect your and your baby's ability to bleed and prolong or delay delivery more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week 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 the fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductal constriction) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Ibuprofen appears in breast milk in very small amounts, and it is generally not necessary to stop breastfeeding during short-term treatments. 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 machines. However, given that high doses may cause side effects such as fatigue, drowsiness, dizziness (reported as common), and visual disturbances (reported as uncommon), the ability to drive or operate machinery may be affected in individual cases. This effect is enhanced by simultaneous alcohol consumption.

Ibuprofen Aurovitas Spain contains sodium:This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Ibuprofeno Aurovitas Spain

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

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

The lowest effective dose should be used for the shortest time necessary 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 the duration of treatment.

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

This medication is contraindicated in children with a weight below 20 kg or under 6 years of age (see section 2).

The dose of ibuprofen depends on the patient's age and 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):

From ½ (half a tablet) to 1 tablet administered as a single dose or 3-4 times a day at 6-hour intervals, as needed. The maximum daily dose should not exceed 3 tablets (1200 mg).

Pediatric population

Children with a body weight≥20 kg (6-11 years):

Other formulations are more suitable for this age group. Your doctor will inform you accordingly.

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

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

Migraine

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

1 tablet administered as a single dose, if necessary, 1 tablet at 6-hour intervals.

The maximum daily dose should not exceed 3 tablets (1200 mg).

Menstrual pain

Adults and adolescents with a bodyweight>40 kg (over 12 years):

½ (half a tablet) - 1 tablet, 1 to 3 times a day, at 6-hour intervals, as needed.

The maximum daily dose should not exceed 3 tablets (1200 mg).

Rheumatic diseases

Adults:

The recommended dose is 3-4½ (four and a half tablets) (1200 mg – 1800 mg) per day 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 (2400 mg) per day, taken in 3 or 4 divided doses.

Adolescents from 15 to 17 years:

The recommended dose is 20 mg/kg up to a maximum of 40 mg/kg of body weight (maximum 2400 mg daily) in 3 or 4 divided doses. Your doctor will advise you accordingly.

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

Elderly patients:

If you are an elderly patient, you will be more prone to adverse effects, especially bleeding, ulceration, and perforation of the digestive tract, which can be fatal. Your doctor will advise you accordingly.

Reduced renal or hepatic function:

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

If you take more Ibuprofeno Aurovitas Spain than you should

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

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain bloody stools), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, metabolic acidosis, chills, and breathing difficulties have been reported. Additionally, the 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. Exacerbation of asthma is possible in asthmatic patients. Additionally, there may be low blood pressure and reduced breathing.

If you forget to take Ibuprofeno Aurovitas Spain

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

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

The most frequently observed adverse effects are of a gastrointestinal nature. Ulcers, perforation, or gastrointestinal bleeding may occur, especially in elderly patients, and in some cases can be fatal. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease have been reported. Gastritis has been observed less frequently.

Medications like ibuprofen may be associated with a small increased risk of suffering a 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 indicated according to their frequency of occurrence. The following classification is used:

Very common: may affect more than 1 in 10 patients.

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

Rare: may affect up to 1 in 1,000 patients.

Very rare: may affect up to 1 in 10,000 patients.

Frequency not known: cannot be estimated from the available data.

The following adverse effects are important and will require immediate action if you experience them. You should discontinue treatment with ibuprofen and consult your doctor immediately if you experience the following symptoms:

Common:

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

Very rare:

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

If you experience the following adverse effects, you should discontinue treatment with this medication and contact your doctor as soon as possible:

Very common:

• Burning sensation, abdominal pain, indigestion.

Uncommon:

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

Rare:

• Vision loss.

Very rare:

• Sudden swelling of the lungs that causes difficulty breathing, high blood pressure, fluid retention, and weight gain.

Other possible adverse effects with ibuprofen are:

Very common:

• Gastrointestinal disorders, 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 diverticula of the large intestine (perforation or fistula).
• Microscopic bleeding from the intestine that can cause anemia.
• Mouth ulcers and inflammation (ulcerative stomatitis).
• Headache, drowsiness, dizziness, dizziness, fatigue, agitation, insomnia, and irritability.

Uncommon:

• Inflammation of the stomach lining.
• Kidney problems, including edema, kidney inflammation, and renal failure.
• Nasal secretion.
• Breathing difficulties (bronchospasm).

Rare:

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

Very rare:

• Unpleasant sensation of heartbeat, heart failure, or heart attack.
• Disorders of blood cell formation (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). The first symptoms or signs may include fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• Noise or ringing in the ears.
• Inflammation of the esophagus or pancreas.
• Narrowing of the intestine.
• Acute liver inflammation, yellowing of the skin or whites of the eyes, liver dysfunction, damage, or failure.
• Liver damage, especially during prolonged treatment or liver failure.
• Hair loss.
• Inflammation of the brain membrane without bacterial infection (aseptic meningitis).

Frequency not known:

• Tingling of hands and feet.
• Anxiety.
• Hearing loss.
• General feeling of discomfort.
• Inflammation of the optic nerve that can cause vision problems.
• A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Stop taking this medication if you experience these symptoms and seek medical attention immediately.
• Generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See also section 2.
• Chest pain, which can 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 experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local 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 possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medication.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Aurovitas Spain

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Aurovitas Spain

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

Core of the tablet:cornstarch, pregelatinized cornstarch, 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 package contents

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

This medication is available in boxes containing blisters.

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

Not all package 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

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medication is authorized in the Member States of the European Economic Area 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 last revision of this leaflet:April 2025

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