Ibuprofen Aurovitas Pharma 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Aurovitas Pharma 400 mg film-coated tablets EFG

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

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if fever worsens or does not improve after 3 days, or if pain persists beyond 5 days (3 days in adolescents).

Contents of the leaflet

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

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

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

This medicine is used in adults and adolescents over 12 years of age (weighing over 40 kg) for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, menstrual pain, muscle pain (muscle strains), or back pain (lumbago), as well as for fever.

2. What you need to know before taking Ibuprofen Aurovitas Pharma

Do not take Ibuprofen Aurovitas Pharma:

• If you are allergic (hypersensitive) to ibuprofen or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.

• If you have severe liver or kidney disease.

• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a gastrointestinal tract perforation.

• If you are vomiting blood.

• If you have black stools or bloody diarrhoea.

• If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used together, your doctor will perform blood clotting tests.

• If you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

• If you have severe heart failure.

• If you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor:

• If you have oedema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on the frequency of these checks.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.

• If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually leads to bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), as your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve various vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial infection) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection: see the “Infections” section below.
• Hypersensitivity reactions to ibuprofen, such as breathing problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop taking ibuprofen immediately 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 with ibuprofen treatment. Discontinue ibuprofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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

Skin reactions

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

Cardiovascular precautions

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

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

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

Children and adolescents

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

Pregnancy and women of childbearing potential

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

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing potential, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor without delay.

Other medicines and Ibuprofen Aurovitas Pharma

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

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

• Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding.
• Antiplatelet agents (prevent blood clot or thrombus formation in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g., for treating or preventing blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
• Mifepristone (used to induce abortion).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output), as this may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as this may cause hypoglycaemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking ibuprofen may affect the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Haematocrit or haemoglobin (may decrease).
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase).
• Liver function tests: increased transaminase levels.

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

Taking Ibuprofen Aurovitas Pharma with food, drinks and alcohol:

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

Pregnancy, breastfeeding and fertility:

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing potential), 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 and your baby’s tendency to bleed and may delay or prolong labour beyond the expected duration.

Do not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest necessary duration. 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.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Driving and using machines:

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

Ibuprofen may slow your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving or operating machinery. This is especially important when combined with alcohol.

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

3. How to take Ibuprofeno Aurovitas Pharma

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

This medicine is taken orally.

For occasional use only and for limited periods.

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

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

The tablets must be swallowed whole with a glass of water, without chewing, breaking, crushing, or sucking, to avoid mouth irritation and throat irritation.

The recommended dose is:

Adults and adolescents over 12 years of age (over 40 kg body weight): one tablet (400 mg) every 6–8 hours.

Do not take more than 3 tablets (1,200 mg of ibuprofen) within 24 hours.

Elderly patients: dosage should be determined by the physician, as a reduction from the usual dose may be necessary.

Patients with kidney, liver, or heart disease: reduce the dose and consult your doctor.

If symptoms worsen, if fever persists for more than 3 days, or pain for more than 5 days (3 days in adolescents), consult a doctor.

This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This medicine is not recommended for use in children (under 12 years of age) or adolescents weighing less than 40 kg.

If you take more Ibuprofeno Aurovitas Pharma than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the name of the medicine and the amount taken, or go to the nearest hospital to obtain information about the risks and advice on the measures to be taken.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see section 4), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, seizures may develop. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties may be reported. In addition, prothrombin time/INR may be prolonged, likely due to interference with 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.

Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also occurred.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

If you forget to take Ibuprofeno Aurovitas Pharma

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

If you forget to take your dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.

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

4. Possible adverse effects

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

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

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

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

• Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur). Aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) has also been reported. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), neutropenia (reduced neutrophils), agranulocytosis (severe reduction in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), and hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising.

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

Exacerbation of infection-related inflammation has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical advice promptly.

• Frequency not known (cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhea).

A serious skin reaction known as DRESS syndrome (an acronym from English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell). Generalized red, scaly rash with lumps under the skin and blisters primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). 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.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor:

• Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant peeling of the skin.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in arms or legs.
• Flat, non-elevated red circular spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Aurovitas Pharma

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

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Aurovitas Pharma:

• The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components are:
  • Tablet core: maize starch, pregelatinized maize starch, anhydrous colloidal silica, sodium croscarmellose, talc and stearic acid.
  • Coating: talc, Macrogol 3350, poly (vinyl alcohol) and titanium dioxide (E171).

Appearance of Ibuprofeno Aurovitas Pharma and contents of the pack

White or almost white, round, film-coated tablets, with a score line on one side. The tablet can be divided into equal doses.

Supplied in packs of 20 tablets, packed in aluminum-PVC blisters.

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

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

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