Ibuprofen ABDRUG 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen ABDrug 600 mg film-coated tablets EFG

Read the entire 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 and should not be given to others, even if they have the same symptoms as you, because it could be harmful to them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Ibuprofen ABDrug is and what it is used for
2. Before you take Ibuprofen ABDrug
3. How to take Ibuprofen ABDrug
4. Possible side effects
5. How to store Ibuprofen ABDrug
6. Further information

1. What Ibuprofeno ABDrug is and what it is 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 and the relief of mild to moderate pain associated with conditions such as dental pain, post-surgical pain, headache including migraine, and symptomatic relief of pain, fever, and inflammation accompanying conditions such as pharyngitis, tonsillitis, and otitis, among others. It is also indicated for the treatment of rheumatoid arthritis (joint inflammation, usually affecting the hands and feet, leading to swelling and pain), psoriatic arthritis (a skin disease), gout (deposits of uric acid in the joints causing pain), osteoarthritis (a chronic disorder causing cartilage damage), ankylosing spondylitis (inflammation affecting the spinal joints), non-rheumatic inflammation, or other types of traumatic or sports-related inflammatory injuries, and primary dysmenorrhea (painful menstruation).

2. Before taking Ibuprofeno ABDrug

Do not take Ibuprofeno ABDrug:

• If you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of this medicine. Signs of allergy may include skin rash with itching, 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 perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding disorders or blood coagulation disorders, or if you are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines simultaneously, 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:

Inform your doctor:

• If you have oedema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are being treated with Ibuprofeno ABDrug, 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 to 2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
• 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 or prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protecting medicine.

• If you are taking medicines that affect blood coagulation, 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 inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines like Ibuprofeno ABDrug may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus, as aseptic meningitis may occur.
• It is important that you use the lowest dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms.
• If you have an infection (see the section "Infections" below).

Skin reactions

Serious skin reactions have been reported with Ibuprofeno ABDrug treatment. Stop taking Ibuprofeno ABDrug and contact your doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as Ibuprofeno 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 Ibuprofeno ABDrug if:

• You have heart problems, including heart failure, angina (chest pain), have had a 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 "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 are a smoker.

These types of medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Signs of allergic reaction to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking ibuprofen immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Infections

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

Precautions during pregnancy and in women of childbearing age

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

Administration of this medicine is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that medicines like Ibuprofeno ABDrug have been associated with a reduced ability to conceive.

Use of Ibuprofeno ABDrug with other medicines

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

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

• Other non-steroidal anti-inflammatory drugs such as aspirin.
• Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g. to treat coagulation disorders/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion-inducing agent).
• 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 elimination).
• Pentoxifylline (for treating 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).
• 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-containing medicines, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

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

Taking ibuprofen may alter 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 values.

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

Taking Ibuprofeno ABDrug with food and drinks:

You may take it alone or with food. It is generally recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester. Although only small amounts of the medicine 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 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, no special precautions are usually necessary.

Important information about some of the components of Ibuprofeno ABDrug:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ibuprofen ABDrug

Follow exactly the administration instructions for Ibuprofen ABDrug given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate how long you should take this medicine. Do not stop treatment earlier, as the expected results would not be achieved. Likewise, do not use Ibuprofen ABDrug for longer than indicated by your doctor.

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

Adults

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

Higher doses may be required in some conditions, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents aged 12 to 18 years.

Children

Do not administer Ibuprofen ABDrug to children under 12 years of age without consulting a doctor.

Elderly

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

Patients with kidney and/or liver disease

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

If you think that the effect of Ibuprofen ABDrug is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofen ABDrug than you should

If you have taken more Ibuprofen ABDrug 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 number: 91 562 04 20, indicating the medicine and amount ingested, to assess the risk and obtain advice on necessary measures. It is recommended to bring the medicine packaging and leaflet to the healthcare professional. If a severe poisoning has occurred, the doctor will take the necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4), diarrhea, headache, tinnitus, confusion, and involuntary eye movements.

Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and respiratory problems have been reported. Additionally, prothrombin time/INR may be prolonged due to interaction with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. In addition, hypotension and respiratory depression may occur.

If you forget to take Ibuprofen ABDrug

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

If you forget to take your scheduled 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 regular time.

4. Possible adverse effects

Like all medicines, Ibuprofeno ABDrug may have adverse effects, although not everyone will experience them.

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

The incidence of adverse effects is lower with short-term treatment 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, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects include:

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

Rare (at least 1 in 10,000 patients): inflammation of the esophagus, narrowing of the esophagus (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

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

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Dermatological:

Medicines such as Ibuprofeno ABDrug may very rarely be associated with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Other adverse effects include:

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

Uncommon (at least 1 in 1,000 patients): skin redness, itching or swelling of the skin, 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 exposure, inflammation of blood vessels in the skin. Frequency not known: Skin becomes sensitive to light. Generalized red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno ABDrug if you experience these symptoms and seek immediate medical attention. See also section 2.

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Immune system:

Uncommon (at least 1 in 1,000 patients): transient swelling in areas of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, 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:

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

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

Very rare (less than 1 in 10,000 patients): aseptic meningitis. In most reported cases of aseptic meningitis 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:

Frequent (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 disturbances.

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

Blood-related:

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

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:

Medicines such as Ibuprofeno ABDrug may rarely be associated with liver injury.

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

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

General:

Worsening of inflammation during infectious processes.

To date, severe allergic reactions have not been reported with Ibuprofeno ABDrug, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue and throat, breathing difficulties, asthma, palpitations, hypotension, or shock.

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

• Allergic reactions such as skin rashes, swelling of the face, wheezing or breathing difficulties.
• Vomiting blood or material resembling coffee grounds. Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters 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.
• Non-elevated red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen ABDrug

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Ibuprofen ABDrug after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Ibuprofen ABDrug

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

Appearance of the medicinal product and contents of the pack

Oval, biconvex, white coated tablets.

They are presented in packs containing

40 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

MABO-FARMA, S.A.

Calle 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 most recent review 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/