IBUPROFEN ABDRUG 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen ABDrug 600 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Ibuprofen ABDrug and what is it used for
2. Before taking Ibuprofen ABDrug
3. How to take Ibuprofen ABDrug
4. Possible side effects
5. Storing Ibuprofeno ABDrug
6. Additional information

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

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

This medicine is indicated for the treatment of fever, pain of mild or moderate intensity in processes such as dental pain, post-surgical pain, headache including migraine, symptomatic relief of pain, fever, and inflammation that accompanies processes such as pharyngitis, tonsillitis, and otitis, among others, treatment of rheumatoid arthritis (inflammation of the joints, including usually those of the hands and feet, leading to swelling and pain), psoriatic arthritis (skin disease), gout (uric acid deposits 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).

2. Before taking Ibuprofen ABDrug

Do not take Ibuprofen ABDrug:

• If you are allergic (hypersensitive) to ibuprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of this medicine. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer 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 disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Tell your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with Ibuprofen ABDrug, as it may mask fever, which is an important sign of infection, making diagnosis 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 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications like Ibuprofeno ABDrug may worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus, as it may cause aseptic meningitis.
• It is essential to use the smallest dose that relieves/control the pain and not take this medication for longer than necessary to control your symptoms.
• if you have an infection (see the "Infections" section below)

Skin reactions

Severe skin reactions have been reported with Ibuprofen ABDrug treatment. Stop taking Ibuprofeno ABDrug and consult 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 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 medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like Ibuprofeno ABDrug may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno ABDrug if:

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

Additionally, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Ibuprofen has been associated with signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you observe any of these signs.

Infections

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

Precautions during pregnancy and in women of childbearing age

Because the administration of medications like Ibuprofeno ABDrug has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

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

For women of childbearing age, it should be taken into account that medications like Ibuprofeno ABDrug have been associated with a decrease in fertility.

Using Ibuprofeno ABDrug with other medications

Tell your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

• Other non-steroidal anti-inflammatory drugs like aspirin.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine.
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.

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

Taking ibuprofen may affect 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).
• Blood urea nitrogen and serum creatinine and potassium levels (may increase).
• Liver function tests: increased transaminase values.

Tell your doctor if you are going to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Taking Ibuprofeno ABDrug with food and drinks:

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

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

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

Driving and using machines:

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Important information about some of the 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.

3. How to take Ibuprofeno ABDrug

Follow the administration instructions of Ibuprofeno ABDrug indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor will indicate the duration of treatment with this medication. Do not stop treatment before, as the expected results will not be obtained. Similarly, do not use Ibuprofeno ABDrug for longer than indicated by your doctor.

The effective lowest dose should be used during the shortest necessary time 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). This medication is administered orally.

Adults

In adults and young people from 12 to 18 years, take one tablet (600 mg) every 6 to 8 hours, depending on the intensity of the condition and response to treatment.

In some processes, 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 from 12 to 18 years.

Children

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

Elderly

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

Patient with kidney and/or liver disease

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

If you think the effect of Ibuprofeno ABDrug is too strong or too weak, tell 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 accidentally ingested the medication, 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 take the package and the package leaflet of the medication to the healthcare professional. If a severe overdose has occurred, the doctor will take the necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), 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, blood in the urine, low potassium levels in the blood, feeling of cold in the body, and respiratory problems have been reported. Additionally, the prothrombin time/INR may be prolonged due to interaction with circulating coagulation factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma in asthmatics is also possible. Furthermore, hypotension and decreased respiration may occur.

If you forget to take Ibuprofeno ABDrug

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is near, skip the forgotten dose and take the next dose at the usual time.

4. Possible Adverse Effects

Like all medications, Ibuprofeno ABDrug may have adverse effects, although not all people suffer from them.

The adverse effects of medications like Ibuprofeno ABDrug are more common in people over 65 years old.

The incidence of adverse effects is lower in short treatments and if 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, heartburn, abdominal pain, blood in stools, oral thrush, worsening of ulcerative colitis, and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects are:

Uncommon(at least 1 in 1,000 patients): inflammation of the oral mucosa with ulcer formation.

Rare(at least 1 in 10,000 patients): esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticulitis, hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

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

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

Dermatological:

Medications like 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:

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

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

Very rare(less than 1 in 10,000 patients): hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the skin blood vessels. Frequency not known: The skin becomes sensitive to light. Generalized red scaly rash, with bumps under the skin and blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno ABDrug if you experience these symptoms and seek medical attention immediately. See also 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).

Immune system:

Uncommon(at least 1 in 1,000 patients): transient edema in skin, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm.

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

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

Central nervous system:

Common(at least 1 in 100 patients): fatigue or drowsiness, headache, and dizziness or feeling of instability.

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

Very rare(less than 1 in 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:

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

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

Auditory:

Common(at least 1 in 100 patients): vertigo.

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

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

Ocular:

Uncommon(at least 1 in 1,000 patients): vision changes.

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

Blood:

Very rare(less than 1 in 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 skin pallor).

Renal:

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

Hepatic:

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

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

Frequency not known: liver failure (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

To date, 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, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following adverse effects appear, discontinue treatment and seek medical attention immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like material. Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling. Severe or persistent headache. Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, oral, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and lymph node enlargement (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Adverse Effect Reporting

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ibuprofeno ABDrug

Keep out of the reach and sight of children.

Store at a temperature below 30°C.

Do not use Ibuprofeno ABDrug after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Additional Information

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 Packaging Content

Oval, biconvex, and white film-coated tablets.

Available in packaging with

40 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

MABO-FARMA, S.A.

Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer:

Farmalider, S.A.

C/Aragoneses, nº 2.

28108-Alcobendas (Madrid)

Spain

or

FROSST IBERICA, S.A.

Via Complutense, 140

28805 Alcalá de Henares (Madrid), Spain

or

PHARMALOOP, S.L.

c/ Bolivia, 15 – Polígono Industrial Azque

28806 Alcalá de Henares (Madrid), Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Leaflet: November 2024.

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