Ibuprofen Aurovitas Spain 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofeno Aurovitas Spain 600 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could 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

1. What Ibuprofeno Aurovitas Spain is and what it is used for
2. What you need to know before taking Ibuprofeno Aurovitas Spain
3. How to take Ibuprofeno Aurovitas Spain
4. Possible side effects
5. How to store Ibuprofeno 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 and inflammation.

This medicine 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 previously experienced allergic reactions such as asthma, nasal discharge, itchy skin rash, or swelling of the lips, face, tongue, or throat after taking medications containing acetylsalicylic acid (such as aspirin) or other pain and anti-inflammatory medicines (NSAIDs).
• If you have had gastrointestinal bleeding or perforation related to the use of pain or anti-inflammatory medicines (NSAIDs).
• If you currently have or have previously had a stomach or small intestine (duodenum) ulcer or bleeding, or if you have had two or more such episodes in the past.
• If you suffer from 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 an undetermined origin disease leading to abnormal blood cell formation.

Do not administer this medicine to children and adolescents under 15 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno 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 blood (porphyria).
• If you have chronic inflammatory bowel diseases, such as ulcerative colitis (inflammation of the colon with ulcers), Crohn’s disease (inflammation affecting the digestive tract), or other stomach or intestinal disorders.
• If you have disorders in blood cell formation.
• If you have problems with normal blood clotting mechanisms.
• If you have allergies, allergic rhinitis, asthma, chronic inflammation of the nasal mucosa, sinuses, adenoids, or chronic obstructive respiratory tract disease, as the risk of developing airway narrowing with breathing difficulty 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 section “Infections” below.
• Signs of allergic reaction to this medicine, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain due to ibuprofen, have been reported. Immediately stop using this medicine and contact your doctor or emergency medical services if you notice any of these signs.
• Serious skin reactions, such as 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), have been reported in association with ibuprofen treatment. 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 the infection, increasing 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 infection symptoms persist or worsen, consult a doctor without delay.

Elderly patients

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

Ulcers, perforation, and bleeding in the stomach and intestine

If you have previously had a stomach or intestinal ulcer, especially if complicated by perforation or accompanied by bleeding, you should pay attention to any unusual abdominal symptoms and report them immediately to your doctor, 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 any warning signs, even in patients who have never previously experienced such problems. These events may 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 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 consult your doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a very serious 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 myocardial infarction 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 the 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)

Some cases of meningitis (manifesting as neck stiffness, headache, nausea, vomiting, fever, or confusion) have been observed 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, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. At the first signs of hypersensitivity reaction after taking ibuprofen, stop treatment immediately and inform your doctor without delay.

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

With prolonged use and high doses of analgesics, headache may occur, which should not be treated with higher doses of this medicine.

Regular use of analgesics 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 intend to become pregnant or if you have difficulty conceiving.

Adolescents

This medicine is contraindicated in children and adolescents under 15 years of age (see section 3).

It may cause kidney problems in dehydrated 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.

The adverse effects of ibuprofen may be increased when certain medicines are taken at the same time. Conversely, ibuprofen may increase or decrease the effect of other medicines or increase their side effects when taken together.

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 anticoagulant effect may be enhanced.
• Antiplatelet agents (prevent blood clotting) such as clopidogrel and ticlopidine.
• Methotrexate (used to treat cancer or autoimmune diseases).
• Digoxin (for treatment of 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 reduce blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin II receptor antagonists such as losartan).
• Cholestyramine (used in the treatment of high cholesterol).
• 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 treatment of 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 in the treatment of circulatory disease of the arteries in the legs or arms.
• Baclofen (a muscle relaxant), due to its high toxicity.
• Medicinal preparations of Gingko biloba (possible increased bleeding risk when taken with ibuprofen).
• Voriconazole and fluconazole (CYP2C9 inhibitors) (used to treat fungal infections), as the effect of ibuprofen may be increased. A reduction in ibuprofen dose should be considered, especially when high doses of ibuprofen are used 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 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 fetus. It may affect your tendency and your baby’s tendency to bleed and may delay or prolong labor more than expected. 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, 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, 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 may make it more difficult to become pregnant. Inform your doctor if you plan to become pregnant or have difficulty conceiving.

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

Driving and using machines

Generally, ibuprofen has no adverse effects on the ability to drive or operate machinery. However, at high doses, side effects such as fatigue, drowsiness, dizziness (reported as common), and visual disturbances (reported as uncommon) may occur, which could affect 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 use of 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 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 on the duration of treatment.

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

This medicine is contraindicated in children and adolescents under 15 years of age (see section 2).

Rheumatic diseases

Adults:

The recommended dose is 1,200 mg – 1,800 mg daily in divided doses. Your doctor may prescribe lower doses. Depending on the nature and severity of your clinical condition, your doctor may increase your medication up to a maximum of 2,400 mg per day, 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 per day (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, tablets may be divided into equal doses.

Elderly patients:

If you are an elderly patient, you may be 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, telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4), diarrhea, 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 exacerbation is possible 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 missed 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 experiences 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 or Crohn's disease have been reported. Gastritis (inflammation of the stomach lining) 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), elevated 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 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 available data.

The following adverse effects are important and will require immediate action if experienced. You must stop treatment with ibuprofen and see 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) causing 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, and mouth, throat, nose, genital, and eye ulcers. 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). There may also be a severe infection with destruction of the skin (necrosis), subcutaneous tissue, and muscle (necrotizing fasciitis).

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:

• Burning sensation, abdominal pain, indigestion.

Uncommon:

• Vision disturbances.
• Hypersensitivity reactions such as skin rash, itching, asthma attacks (sometimes with decreased 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 renal 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 and increased blood uric acid levels.
• Kidney tissue damage.

Very rare:

• Uncomfortable sensation of heartbeat, heart failure, or heart attack.
• Disorders in blood cell formation (anemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). Early symptoms or signs may include fever, sore throat, mouth surface ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• Ringing or buzzing in the ears.
• 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 membrane covering the brain without bacterial infection (aseptic meningitis).

Frequency not known:

• Tingling in the hands and feet.
• Anxiety.
• Hearing loss.
• Feeling of general malaise.
• Inflammation of the optic nerve which may lead to 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.
• Generalized red, scaly rash with bumps under the skin and blisters mainly located 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 severe deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for 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 should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This 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 600 mg of ibuprofen.
• The other components are:

Tablet core: maize starch, pregelatinized maize starch, colloidal anhydrous silica, sodium croscarmellose, talc, stearic acid.

Tablet coating: 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 off-white in colour, oval-shaped, with a score line on one side and smooth on the other. The tablet can 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.

Only some 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 (EEA) member states under the following names:

Germany: Ibuprofen PUREN 600 mg Filmtabletten

Belgium: Ibuprofen AB 600 mg filmomhulde tabletten

Spain: Ibuprofeno Aurovitas Spain 600 mg comprimidos recubiertos con película EFG

Netherlands: Ibuprofen Aurobindo 600 mg filmomhulde tabletten

Portugal: Ibuprofeno Generis Phar

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

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