Package Leaflet: Information for the User

Ibuprofen Aurovitas Spain 400 mg Film-Coated Tablets

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ibuprofeno Aurovitas Spain belongs to a group of medicines called NSAIDs (nonsteroidal 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. 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 injuries to soft tissues.

Do not take Ibuprofeno Aurovitas Spain:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have had allergic reactions such as asthma, nasal secretion, skin rash with itching or inflammation of the lips, face, tongue, or throat after taking medications containing acetylsalicylic acid (such as aspirin) or other pain or anti-inflammatory medications (NSAIDs).
• If you have had intestinal hemorrhage or perforation associated with the use of pain or anti-inflammatory medications (NSAIDs).
• If you have a stomach or duodenal ulcer or have had two or more of these 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 inadequate fluid intake).
• If you have any active bleeding (including in the brain).
• If you have any unknown disease that results in the abnormal formation of blood cells.

Do not administer this medication to children weighing less than 20 kg or under 6 years old.

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 hemoglobin disorder, the pigment responsible for red blood cells (porphyria).
• If you have chronic inflammatory bowel diseases, such as ulcerative colitis, Crohn's disease, or other stomach or intestinal diseases.
• If you have blood cell formation disorders.
• If you have problems with the normal mechanism of blood coagulation.
• If you have allergies, allergic rhinitis, asthma, chronic mucosal inflammation, nasal polyps, adenoids, or chronic obstructive pulmonary disease, as the risk of developing airway narrowing with difficulty breathing is higher.
• If you have severe 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 "Infections" heading below.
• Signs of an allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain due to ibuprofen. Stop using this medication immediately and contact your doctor or emergency medical services immediately if you observe 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), generalized acute pustular exanthema (PEGA), associated 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

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

Older patients

If you are an older patient, you will be more prone to experiencing 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 it has been complicated by perforation or accompanied by bleeding, you should 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 this case, especially in older patients. If bleeding or ulceration of the gastrointestinal 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 these 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 medications (see below "Other medications and Ibuprofeno Aurovitas Spain").

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

Severe skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking ibuprofen and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

It is recommended to avoid using this medication during varicella.

Effects on the heart and brain

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of myocardial infarction 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, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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 have 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 previous kidney problems. This can cause swelling of the legs and may even lead to heart failure or high blood pressure in susceptible individuals.

Ibuprofen may cause renal damage, especially in patients who have had previous kidney, cardiac, or hepatic problems, or who are taking diuretics or ACE inhibitors, as well as in older patients. However, discontinuing ibuprofen treatment generally leads to recovery.

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

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

Other precautions

Very rarely, acute hypersensitivity reactions (e.g., anaphylactic shock) have been reported. If you experience the first signs of a hypersensitivity reaction after taking ibuprofen, discontinue treatment and inform your doctor immediately.

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

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

The habitual use of analgesics can cause permanent damage to the kidneys and an increased risk of renal insufficiency.

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

Ibuprofen may decrease your chances of becoming pregnant. You should inform your doctor if you plan to become pregnant or have difficulty becoming pregnant.

Children and adolescents

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

Ibuprofen may cause kidney problems in dehydrated children and adolescents.

Other medications and Ibuprofeno Aurovitas Spain

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

Ibuprofen may affect or be affected by other medications. 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 potentiated.
• Inhibitors of platelet aggregation (prevent blood clotting), such as clopidogrel and ticlopidine.
• Metotrexate (used to treat cancer or autoimmune diseases).
• Digoxin (used to treat various heart diseases), as the effect of digoxin may be potentiated.
• Fenitoína (used to prevent the onset of seizures), as the effect of fenitoína may be potentiated.
• Litio (used to treat depression and mania), as the effect of litio may be potentiated.
• Diuretics (used to increase urine production), as their effect may be reduced.
• Diuretics that conserve potassium, as hyperkalemia may occur.
• Medications that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin II receptor antagonists such as losartan).
• Colestiramina (used to treat high cholesterol levels).
• Aminoglucósides (used to treat certain types of bacterial infections), as NSAIDs may reduce the elimination of aminoglucósides.
• SSRIs (used to treat depression), such as paroxetine, sertraline, citalopram, as they may increase the risk of gastrointestinal bleeding.
• Ciclosporina, tacrolimus (used for immunosuppression after organ transplantation), as renal damage may occur.
• Zidovudina or ritonavir (used to treat HIV patients).
• Mifepristona, as NSAIDs may reduce the effect of mifepristona.
• Probenecid or sulfinpirazona (used to treat gout), as ibuprofen elimination may be delayed.
• Quinolone antibiotics, as the risk of seizures may increase.
• Sulfonilureas (used to treat type 2 diabetes), as blood sugar levels may be affected.
• Glucocorticoids (used to treat inflammation), as the risk of gastrointestinal ulcers or bleeding may increase.
• Bisphosphonates (used to treat osteoporosis, Paget's disease, or to reduce high calcium levels in the blood).
• Oxpentifilina (pentoxifilina), used to treat circulatory disorders of the arteries in the legs or arms.
• Baclofeno (a muscle relaxant), due to its high toxicity.
• Ginkgo biloba preparations (there is a possibility of increased bleeding if taken with ibuprofen).
• Voriconazol and fluconazol (CYP2C9 inhibitors) (used to treat fungal infections), as the effect of ibuprofen may increase. Consider reducing the ibuprofen dose, especially when high doses of ibuprofen are used together with voriconazol or fluconazol.

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

Taking Ibuprofeno Aurovitas Spain with alcohol

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

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

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

The adverse effects can be minimized by using the most effective dose for the shortest time necessary to control the symptoms.

Use the most effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if the 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 of time.

This medication is contraindicated in children with a weight less than 20 kg or under 6 years old (see section 2).

The dose of ibuprofen depends on the age and weight of the patient. The maximum 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):

½ (half tablet) to 1 tablet administered as a single dose or 3-4 times a day in intervals of 6 hours, as needed. The maximum daily dose should not exceed 3 tablets (1,200 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 in intervals of 6 hours, as needed. The maximum number of tablets should not exceed 1½ (one and a half) per day.

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

Migraine

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

One tablet administered as a single dose, as needed, one tablet in intervals of 6 hours.

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

Menstrual pain

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

½ (half tablet) - 1 tablet, 1-3 times a day, in intervals of 6 hours, as needed.

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

Rheumatic diseases

Adults:

The recommended dose is 3-4½ (four tablets and a half) (1,200 mg – 1,800 mg) per day in divided doses. Your doctor may prescribe lower doses.

In accordance with the severity of your clinical condition, your doctor may increase your medication to a maximum of 6 tablets(2,400 mg) per day, taken in 3 or 4 divided doses.

Adolescents 15 to 17 years:

The recommended dose is 20 mg/kg up to a maximum of 40 mg/kg of body weight (maximum 2,400 mg per day) 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 delicate stomach should take ibuprofen preferably during meals. To facilitate swallowing or adjust the dose, tablets can be divided into equal doses.

Older patients:

If you are an older patient, you will be more prone to experiencing adverse effects, especially bleeding, ulceration, and perforation of the digestive tract, which could 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The symptoms may include nausea, stomach pain, vomiting (which may contain blood), or less frequently, diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion, involuntary eye movement, and exacerbation of asthma in asthmatic patients. At high doses, symptoms of drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), dizziness, weakness, and dizziness, blood in the urine, low blood pressure, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, chills, and breathing difficulties.

If you forgot to takeIbuprofeno Aurovitas Spain

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Regarding the following side effects, it should be noted that they depend to a great extent on the dose and vary from patient to patient.

The side effects observed most frequently are of a gastrointestinal nature. They may appear, particularly in elderly patients, peptic ulcers, gastrointestinal perforation or hemorrhage, in some cases 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. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

Medicines such as ibuprofen may be associated with a small increase in the 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.

The side effects are indicated according to the frequency of appearance. The following classification is used:

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

Frequent: may affect up to 1 in 10 patients.

Infrequent: 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.

Unknown frequency: cannot be estimated from available data.

The following side 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:

Frequent:

• Black stools or vomiting blood (peptic ulcer with hemorrhage).

Very rare:

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

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

Very frequent:

• Heat, abdominal pain, indigestion.

Infrequent:

• Visual disturbances.
• Hypersensitivity reactions such as urticaria, itching, purpura, exanthema, asthma attacks (sometimes with a drop in blood pressure).
• Increased sensitivity to sunlight.

Rare:

• Loss of vision.

Very rare:

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

Other possible side effects with ibuprofen are:

Very frequent:

• Alterations in the digestive tract, such as diarrhea, discomfort, vomiting, gas, constipation.

Frequent:

• Peptic ulcer with or without perforation.
• Inflammation of the intestine, worsening of colitis, digestive tract (Crohn's disease), and complications of intestinal diverticula (perforation or fistula).
• Microscopic hemorrhage from the intestine that may cause anemia.
• Mouth ulcers and inflammation (ulcerative stomatitis).
• Headache, drowsiness, dizziness, vertigo, fatigue, agitation, insomnia, and irritability.

Infrequent:

• Inflammation of the stomach lining.
• Renal problems, including edema, kidney inflammation, and renal insufficiency.
• Nasal secretion.
• Difficulty breathing (bronchospasm).

Rare:

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

Very rare:

• Unpleasant sensation of the heartbeat, heart failure, or heart attack.
• Blood disorders (anemia, leukopenia, thrombocytopenia, pancitopenia, agranulocytosis, neutropenia). The first symptoms or signs may include fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding).
• Ringling or buzzing in the ears.
• Inflammation of the esophagus or pancreas.
• Intestinal narrowing.
• Acute inflammation of the liver, yellowing of the skin or eyes, liver dysfunction, damage, or insufficiency.
• Liver damage, especially during prolonged treatment or liver insufficiency.
• Hair loss.
• Asymptomatic inflammation of the brain membrane without bacterial infection (aseptic meningitis).

Unknown frequency:

• Tingling in the hands and feet.
• Anxiety.
• Loss of hearing.
• Generalized feeling of discomfort.
• Inflammation of the optic nerve that may cause vision problems.
• A severe skin rash known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin rash, fever, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Stop taking this medicine if you experience these symptoms and seek medical attention immediately.
• A generalized red scaly rash with blisters, especially on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (generalized acute pustular exanthema). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See section 2.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

Reporting side effects

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

Keep this medication out of the 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 disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno Aurovitas Spain

• The active ingredient is ibuprofen. Each 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: talco (E553b), polyvinyl alcohol, macrogol 3350 (E1521), titanium dioxide (E171).

Appearance of Ibuprofeno Aurovitas Spain and content of the container

Coated tablets, white to off-white in color, round, with a notch on one face and smooth on the other. The tablet can be divided into equal doses.

This medicine is available in boxes containing blisters.

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

Only some container sizes may be commercially marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Ibuprofen PUREN 400 mg Filmtabletten

Spain: Ibuprofeno Aurovitas Spain 400 mg coated tablets EFG

Portugal: Ibuprofeno Generis Phar

Last review date of this leaflet: March 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es )