Package Leaflet: Information for the User

Ibuprofen ABDrug 600 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

1. What Ibuprofen ABDrug is and what it is used for

2. Before taking Ibuprofen ABDrug

3. How to take Ibuprofen ABDrug

4. Possible side effects

5. Storage of Ibuprofen ABDrug

6. Further information

Ibuprofeno belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain in processes such as dental pain, postoperative pain, headache including migraine, symptomatic relief of pain, fever, and inflammation that accompanies processes such as pharyngitis, tonsillitis, and otitis, among others, the treatment of rheumatoid arthritis (inflammation of the joints, including those of the hands and feet, resulting in swelling and pain), psoriatic arthritis (skin disease), gout (deposits of uric acid in the joints that cause pain), osteoarthritis (chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation or other types of inflammatory injuries of traumatic or sports origin, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno ABDrug:

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of this medication. Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you are taking Ibuprofeno ABDrug treatment, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.

This risk is higher when taking high doses and prolonged treatment, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider associating a stomach protector medication.

• If you take anticoagulant medications, such as warfarin, ticlopidine, or aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as Ibuprofeno ABDrug may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus, as it may cause meningitis.
• It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.
• If you have an infection (see the "Infections" section below).

Severe skin reactions:

Severe skin reactions have been reported with Ibuprofeno ABDrug treatment. Stop taking Ibuprofeno ABDrug and see your doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Ibuprofeno ABDrug treatment. Discontinue treatment with Ibuprofeno ABDrug and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

CARDIOVASCULAR PRECAUTIONS:

Nonsteroidal anti-inflammatory drugs (NSAIDs) like Ibuprofeno ABDrug may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking Ibuprofeno ABDrug if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

This type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Signs of allergic reaction to Ibuprofeno ABDrug, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno ABDrug immediately and contact your doctor or emergency medical services if you notice any of these signs.

Infections:

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

Pregnancy and lactation:

Due to the association of Ibuprofeno ABDrug with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, the administration of this medication is contraindicated.

For women of childbearing age, it is essential to consider that Ibuprofeno ABDrug has been associated with a decrease in fertility.

Use of Ibuprofeno ABDrug with other medications:

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Ibuprofeno ABDrug may affect or be affected by other medications. For example:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin.
• Antiplatelet agents (prevent blood clots) like ticlopidine.
• Anticoagulant medications (e.g., warfarin, ticlopidine).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Diuretics (medications to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide (used to treat diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.

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

Ibuprofeno ABDrug may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Urea nitrogen concentration, serum creatinine, and potassium concentration (may increase).
• Liver function tests: increased transaminase values.

Inform your doctor if you are to undergo a clinical analysis and are taking or have recently taken Ibuprofeno ABDrug.

Taking Ibuprofeno ABDrug with food and beverages:

You can take it alone or with food. Generally, it is recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

Do not take Ibuprofeno ABDrug during pregnancy, especially during the third trimester. Although only small amounts of the medication pass into breast milk, it is recommended not to take Ibuprofeno ABDrug for prolonged periods during lactation.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and operating machinery:

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of Ibuprofeno ABDrug or for a short period, no special precautions are necessary.

Important information about some components of Ibuprofeno ABDrug:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for Ibuprofeno ABDrug as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will inform you of the duration of treatment with this medication. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use Ibuprofeno ABDrug for a longer period than indicated by your doctor.

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

Adults

In adults and young people aged 12 to 18 years, one tablet (600 mg) will be taken every 6 to 8 hours, depending on the severity of the condition and the response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in young people aged 12 to 18 years.

Children

Do not administer Ibuprofeno ABDrug to children under 12 years without consulting a doctor.

Seniors

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If this is the case, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with kidney and/or liver diseases

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If this is the case, take the exact dose prescribed by your doctor.

If you estimate that the action of Ibuprofeno ABDrug is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno ABDrug than you should

If you have taken more Ibuprofeno ABDrug than you should, or if a child has ingested the medication accidentally, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, to inform yourself of the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional. If a severe overdose has occurred, the doctor will take the necessary measures.

The symptoms of an overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus),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, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine,low potassium levels in the blood, a feeling of coldness in the body, and respiratory problems.In addition, the prothrombin time/INR may be prolonged due to interaction with circulating clotting factors. Acute renal failure and liver damage may occur. It is possible to exacerbate asthma in asthmatics. Additionally, hypotension and decreased respiration may occur.

If you forget to take Ibuprofeno ABDrug

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

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

As with all medications, Ibuprofeno ABDrug may have adverse effects, although not everyone will experience them.

Adverse effects of medications such as Ibuprofeno ABDrug are more common in people over 65 years old.

The incidence of adverse effects is lower in short-term treatments and when the daily dose is below the maximum recommended dose.

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other adverse effects are:

Infrequent(at least 1 in every 1,000 patients): inflammation of the oral mucosa with the formation of ulcers.

Rare(at least 1 in every 10,000 patients): inflammation of the esophagus, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Medications such as Ibuprofeno ABDrug 600 mg tablets may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke. Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medications of the type Ibuprofeno ABDrug.

Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Cutaneous:

Medications such as Ibuprofeno ABDrug may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Other adverse effects are:

Frequent(at least 1 in every 100 patients): skin rash.

Infrequent(at least 1 in every 1,000 patients): redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin).

Very rare(less than 1 in every 10,000 patients): hair loss, erythema multiforme (skin lesion), skin reactions caused by light, inflammation of the skin blood vessels.Unknown frequency: The skin becomes sensitive to light. Generalized red scaly rash, with blisters under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Ibuprofeno ABDrug if you experience these symptoms and seek medical attention immediately. See section 2.

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell)

Immunological:

Infrequent(at least 1 in every 1,000 patients): transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm.

Rare(at least 1 in every 10,000 patients): severe allergic reactions (anaphylactic shock).

Very rare(less than 1 in every 10,000 patients): joint pain and fever (lupus erythematosus).

Central nervous system:

Frequent(at least 1 in every 100 patients): fatigue or drowsiness, headache, dizziness, or feeling unsteady.

Rare(at least 1 in every 10,000 patients): tingling sensation.

Very rare(less than 1 in every 10,000 patients): aseptic meningitis. 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 was a risk factor.

Psychiatric:

Infrequent(at least 1 in every 1,000 patients): insomnia, anxiety, restlessness.

Rare(at least 1 in every 10,000 patients): paresthesia, disorientation or confusion, agitation, irritability, depression, psychotic reaction.

Auditory:

Frequent(at least 1 in every 100 patients): vertigo.

Infrequent(at least 1 in every 1,000 patients): ringing or buzzing in the ears.

Rare(at least 1 in every 10,000 patients): hearing difficulty.

Ocular:

Infrequent(at least 1 in every 1,000 patients): visual disturbances.

Rare(at least 1 in every 10,000 patients): abnormal or blurred vision.

Haematological:

Very rare(less than 1 in every 10,000 patients): prolonged bleeding time, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin).

Renal:

Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (kidney disorder characterized by protein in the urine and swelling of the body), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Hepatic:

Medications such as Ibuprofeno ABDrug may be associated, in rare cases, with liver damage.

Other rare adverse effects(at least 1 in every 10,000 patients) are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Unknown frequency: liver failure (severe deterioration of the liver).

General:

Exacerbation of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with Ibuprofeno ABDrug, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, severe abdominal pain, intense and persistent headache, nausea, vomiting, facial swelling, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the adverse effects listed below appear, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee ground-like vomit. Blood in stools or diarrhea with blood.
• Severe stomach pain.
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions can be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized rash, red and scaly, with blisters under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Reporting of adverse effects

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

Keep out of reach and sight of children.

Store at a temperature below 30° C.

Do not use Ibuprofeno ABDrug after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ibuprofeno ABDrug

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components are:Core: Sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, cornstarch, anhydrous colloidal silica, magnesium stearate, purified water.Coating: Hypromellose, titanium dioxide (E-171), talc, purified water, and propylene glycol.

Appearance of the product and contents of the package

Oval, biconvex, white-coated tablets.

They are presented in packages with

40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

MABO-FARMA, S.A.

Vía de los Poblados, 3, Building 6

28033 Madrid,

Spain.

Responsible for manufacturing:

Farmalider, S.A.

Aragoneses Street, nº 2.

28108-Alcobendas (Madrid)

Spain

or

FROSST IBERICA, S.A.

Via Complutense, 140

28805 Alcalá de Henares (Madrid), Spain

or

PHARMALOOP, S.L.

Bolivia Street, 15 – Industrial Park Azque

28806 Alcalá de Henares (Madrid), Spain

or

TOLL MANUFACTURING SERVICES S.L.

Aragoneses Street, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this prospectus: November 2024.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)AEMPS websitehttp://www.aemps.gob.es/