IBUPROFEN ALTER GENERICOS 400 mg FILM-COATED TABLETS

Introduction

PROSPECTUS: INFORMATION FOR THE USER

Ibuprofen Alter Generics 400 mg film-coated tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.
• Consult your doctor if you do not improve or if you worsen after 3 days of treatment in adolescents and adults.

Contents of the prospectus

1. What is Ibuprofen Alter Generics and what is it used for
2. What you need to know before starting to take Ibuprofen Alter Generics
3. How to take Ibuprofen Alter Generics
4. Possible adverse effects
5. Storage of Ibuprofen Alter Generics
6. Package contents and additional information

1. What is Ibuprofen Alter Generics and what is it used for

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

This medication is indicated for the treatment of fever, treatment of pain of mild or moderate intensity including migraine, treatment of arthritis (inflammation of the joints, including usually those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before starting to take Ibuprofen Alter Generics

Do not take Ibuprofen Alter Generics

• If you are allergic to the active ingredient, to other medications of the non-steroidal anti-inflammatory drug group (NSAIDs), to aspirin, or to any of the other components of this medication (included in section 6). The reactions that indicate allergy may be: skin rash with itching, swelling of the face, lips, or tongue, 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 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 (medications 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

Inform 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, 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 medication 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 experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure due to dehydration.
• 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 prior 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-protecting medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type.

• 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 (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as medications like ibuprofen 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 (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" section below.
• With ibuprofen, signs of allergic reaction to this medication have been reported, 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 immediately if you notice any of these signs.
• Severe skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay adequate treatment of the infection, which may 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.

It is essential to use the smallest dose that relieves/controls the pain and not to take this medication for longer than necessary to control your symptoms.

Skin reactions

Severe skin reactions have been reported in association with ibuprofen treatment. Stop taking ibuprofen 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.

Children and adolescents

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

Cardiovascular precautions

Medications like ibuprofen may be associated with a moderate increase in the risk of suffering cardiac or cerebral attacks. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration.

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

Similarly, this type of medication 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

Since the administration of medications like ibuprofen 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 ibuprofen is contraindicated.

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

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

Use of Ibuprofen Alter Generics with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The following medications may interfere and should not be taken with ibuprofen without first consulting your doctor:

• Other non-steroidal anti-inflammatory drugs, such as aspirin.
• Anticoagulant medications (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications for high blood pressure (e.g., ACE inhibitors, beta-blockers, angiotensin II antagonists).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.

• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• Digoxin and other 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 (for 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 cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Antihypertensives: to decrease high blood pressure.
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.

Taking Ibuprofen Alter Generics with food and beverages

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 discomfort.

Pregnancy and breastfeeding

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

Do not take ibuprofen during pregnancy, especially during the third trimester.

Do not take Ibuprofen Alter if you are in the last 3 months of pregnancy, as it may 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 delay or prolong delivery more than expected. You should not take Ibuprofen Alter during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Alter may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

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, you should not drive or operate hazardous machinery.

If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofen Alter Generics 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 Alter Genéricos

Follow the administration instructions for ibuprofeno exactly as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of treatment with ibuprofeno. Do not suspend treatment beforehand, as this will not produce the expected results. Similarly, do not use ibuprofeno for longer than indicated by your doctor.

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

This medication is administered orally.

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

The lowest effective dose should be used for the shortest time necessary to alleviate 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 from 12 years old, take one 400 mg ibuprofeno tablet every 6 to 8 hours, depending on the intensity of the condition and 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 adolescents from 12 to 18 years old.

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

Children:

The use of this medication is not recommended in children under 40 kg in weight or under 12 years old, as the ibuprofeno dose it contains is not suitable for the recommended dosage in this age group.

Elderly patients:

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.

Patients 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 this medication 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 ibuprofeno than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital immediately to find out about the risk and ask for advice on the measures to be taken.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain bloody sputum), gastrointestinal bleeding (see 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, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Additionally, hypotension and decreased breathing may occur.

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

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if significant amounts have been ingested and within 60 minutes after ingestion.

Consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

It is recommended to take the medication 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 forgotten doses.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for 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, this medication can cause adverse effects, although not everyone will experience them.

Adverse effects of medications like ibuprofeno 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.

Frequencies are established according to the following classification: very frequent (in more than 1 in 10 patients); frequent (between 1 and 10 in 100 patients); uncommon (between 1 and 10 in 1,000 patients); rare (between 1 and 10 in 10,000 patients); very rare (in less than 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects that occur with medications like ibuprofeno 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 stool, vomiting blood, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other adverse effects are: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal stricture, exacerbation of diverticular disease, hemorrhagic colitis. Very rare: pancreatitis.

Cardiovascular:

Medications like ibuprofeno may be associated with a moderate increase in the risk of suffering a heart attack or stroke.

Edema, hypertension, and heart failure have also been observed in association with treatments with ibuprofeno-type medications.

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

Dermatological:

Medications like ibuprofeno 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: skin rash. Uncommon: skin redness, itching or skin swelling, purpura. Very rare: hair loss, erythema multiforme, photosensitivity reactions, skin vasculitis. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox. Unknown frequency: generalized red scaly rash, with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment, the skin becomes sensitive to light. Stop taking ibuprofeno if you experience these symptoms and seek medical attention immediately. See also section 2.

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in viscera, nasal mucosa inflammation, bronchospasm. Rare: severe allergic reactions. In case of generalized severe hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare: joint pain and fever.

Central nervous system:

Frequent: fatigue or drowsiness, headache, and dizziness or feeling of instability. Rare: paresthesia. Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofeno, the patient had some form of autoimmune disease, which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

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

Auditory:

Frequent: vertigo. Uncommon: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Uncommon: vision changes. Rare: abnormal or blurred vision.

Hematological:

Rare: decreased platelet count, decreased white blood cell count, decreased red blood cell count, decreased granulocyte count, pancytopenia, agranulocytosis, aplastic anemia, or hemolytic anemia. The first symptoms are: fever, sore throat, superficial mouth ulcers, pseudo-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, nephrotic syndrome, and renal failure cannot be excluded.

Hepatic:

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

Other rare adverse effects are: hepatitis, abnormal liver function, and jaundice. Unknown frequency: liver failure.

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofeno, 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, breathing difficulties, asthma, palpitations, hypotension, or shock.

Unknown frequency: a severe skin reaction known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils. If you experience any of the following adverse effects, stop treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
• Vomiting blood or coffee grounds-like material.
• Blood in stool 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, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms.
• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

If you think any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Alter Genéricos

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication 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 disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Packaging contents and additional information

Composition of Ibuprofeno Alter Genéricos

The active ingredient is ibuprofeno. Each tablet contains 400 mg of ibuprofeno. The other ingredients are:

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

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

Appearance of the product and packaging contents

Ibuprofeno Alter Genéricos is presented in the form of film-coated tablets.

Each package contains 30 oval, biconvex, scored tablets, white in color, packaged 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 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