Ibuprofen Alter Genericos 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibuprofeno Alter Genéricos 400 mg film-coated tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.
• Consult your doctor if you do not improve or if your condition worsens after 3 days of treatment in adolescents and adults.

Leaflet contents

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

1. What Ibuprofeno Alter Genéricos 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, mild to moderate pain (including migraine), arthritis (inflammation of the joints, usually affecting the hands and feet, resulting in swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibuprofeno Alter Genéricos

Do not take Ibuprofeno Alter Genéricos

• If you are allergic to the active substance, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). 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 perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used at the same time, 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 oedema (fluid retention).

• If you have or have had heart problems or high blood pressure.

• If you suffer from asthma or any other respiratory disorder.

• If you are being treated with ibuprofen, 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 carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.

• If you experience symptoms of dehydration, such as severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to kidney failure due to dehydration.

• 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 long-term treatment are used, 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 inform your doctor about using other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

• 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 urine production), because your doctor needs to monitor your kidney function.

• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect 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 section "Infections" below.

• Allergic reactions to ibuprofen, such as breathing difficulties, facial and neck swelling (angioedema), or 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 in association with ibuprofen treatment. Stop taking ibuprofeno and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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 a doctor without delay.

It is important to use the lowest effective dose to relieve or 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 ibuprofen and contact 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.

Children and adolescents

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

Cardiovascular precautions

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke. This risk is more likely when high doses or long-term treatment are used. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), discuss this treatment with your doctor or pharmacist.

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

Precautions during pregnancy and in women of childbearing age

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital malformations and 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 of pregnancy.

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

Interference with laboratory tests

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 scheduled for clinical laboratory testing and are taking or have recently taken ibuprofen.

Use of Ibuprofeno Alter Genéricos with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may interact and therefore should not be taken together with ibuprofen without first consulting your doctor:

• Other non-steroidal anti-inflammatory drugs such as aspirin.

• Anticoagulant medicines (e.g., acetylsalicylic acid / acetyl salicylic acid, warfarin, ticlopidine).

• Medicines for high blood pressure (ACE inhibitors such as captopril, beta-blockers, angiotensin II antagonists).

• 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 (an abortion-inducing agent).

• Digoxin and other cardiac glycosides (used to treat heart disorders).

• Hydantoins such as phenytoin (used to treat 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).

• Pentoxifylline (used to treat intermittent claudication).

• Probenecid (used in gout patients or with penicillin for 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).

• Antihypertensives: to reduce high blood pressure.

• Thrombolytics (medicines that dissolve blood clots).

• Aminoglycoside antibiotics such as neomycin.

• Herbal extracts: Ginkgo biloba.

Taking Ibuprofeno Alter Genéricos with food and drinks

You may take it with or without food. It is generally recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

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

Ibuprofen should not be taken during pregnancy, especially during the third trimester.

Do not take Ibuprofeno Alter if you are in the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour. You should not take Ibuprofeno Alter during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno Alter 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). If treatment for longer than a few days is needed, 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.

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

Driving and using machines

If you experience dizziness, vertigo, visual 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 necessary.

Ibuprofeno Alter Genéricos contains lactose

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

3. How to take Ibuprofeno Alter Genéricos

Follow exactly the dosing instructions for ibuprofen given by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate how long you should take ibuprofen. Do not stop treatment earlier, as this would prevent achieving the expected results. Likewise, do not use ibuprofen for longer than indicated by your doctor.

It is important to use the lowest dose that relieves/controls pain, and you should not take ibuprofen for longer than necessary to control your symptoms.

This medicine is taken orally.

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

The lowest effective dose should be used for the shortest duration necessary 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).

Adults:

In adults and adolescents aged 12 years and older, one 400 mg ibuprofen tablet 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; however, 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.

Consult your doctor if, in adolescents, treatment lasts longer than 3 days or if symptoms worsen.

Children:

This medicine is not recommended for children weighing less than 40 kg or under 12 years of age, as the ibuprofen dose contained is not suitable for the recommended dosing in this age group.

Elderly patients:

If you are over 60 years old, your doctor may prescribe a lower than usual dose. In such cases, 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 have kidney and/or liver disease, your doctor may prescribe a lower than usual dose. In such cases, take exactly the dose prescribed by your doctor.

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

If you take more Ibuprofeno Alter Genéricos than you should:

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

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, patients may develop seizures. At high doses, 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 occur. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in asthmatic patients. Hypotension and respiratory depression may also occur.

If severe poisoning has occurred, the doctor will take the necessary measures.

In cases of ingestion of large amounts, activated charcoal should be administered. Gastric emptying may be considered if large amounts have been ingested and within 60 minutes of ingestion.

Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Ibuprofeno Alter Genéricos

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 your usual time.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen 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 recommended maximum dose.

Frequencies are defined according to the following classification: very common (in more than 1 in 10 patients); common (in 1 to 10 in 100 patients); uncommon (in 1 to 10 in 1,000 patients); rare (in 1 to 10 in 10,000 patients); very rare (in less than 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines such as ibuprofen 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, vomiting of blood, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects include: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophagitis, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using ibuprofen-like medicines.

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

Dermatological:

Medicines such as ibuprofen may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purple-colored lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis). Other adverse effects include: Common: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesions), photosensitivity reactions, inflammation of blood vessels in the skin. Severe skin infections and soft tissue complications during chickenpox may exceptionally occur. Frequency not known: widespread 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); skin becomes sensitive to light. Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2.

Immune system:

Uncommon: transient swelling in areas of skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of nasal mucosa, bronchospasm (spasm of the bronchi obstructing airflow to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or feeling unsteady. Rare: paresthesia (numbness, tingling, "pins and needles," more frequent in hands, feet, arms, or legs). Very rare: 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 represented a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: dizziness. Uncommon: tinnitus (ringing or buzzing in the ears). Rare: hearing impairment.

Ocular:

Uncommon: visual disturbances. Rare: abnormal or blurred vision.

Hematological:

Rare: decreased platelets, 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), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (bone marrow failure to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

Medicines such as ibuprofen may, rarely, be associated with liver injury.

Other rare adverse effects 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, no severe allergic reactions have been reported with ibuprofen, 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 (lower than usual blood pressure), or shock.

Frequency not known: 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).

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

• Allergic reactions such as skin rashes, swelling of the face, 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 (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in arms or legs.
• Flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. 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).
• Widespread 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).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Ibuprofeno Alter Genéricos

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Ibuprofeno Alter Genéricos

The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen. The other components are:

Core: Sodium croscarmellose, hypromellose, lactose, microcrystalline cellulose, corn starch, colloidal anhydrous silica, magnesium stearate.

Coating: Titanium dioxide (E-171), purified talc, hypromellose, and propylene glycol.

Appearance of the medicinal product and contents of the container

Ibuprofeno Alter Genéricos is presented as film-coated tablets.

Each package contains 30 white, oval, biconvex, scored tablets on both sides, packed in blisters.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer:

FARMALIDER, S.A.,

C/Aragoneses, 2 28108

Alcobendas (Madrid)

Spain

OR

PHARMALOOP, S.L.

C/ Bolivia, 15 - Polig Industrial Azque

Alcalá de Henares, 28806 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es