Leaflet: information for the user

Ibuprofen Almus 600 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine.

-Keep this leaflet as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you think you have suffered a side effect you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

2.What you need to know before taking Ibuprofen Almus

3.How to take Ibuprofen Almus

4.Possible side effects

5.Storage of Ibuprofen Almus

6.Contents of the pack and other information

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

This medicine is indicated for the treatment of:

- fever,

- the treatment of moderate pain, including migraine, the treatment of rheumatoid arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno Almus

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno Almus:

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

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

• If you are taking anticoagulants (medicines used to "thin" the blood) such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that alter blood clotting.You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as Ibuprofeno Almus may worsen these conditions.
• If you are taking diuretics (medicines used 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), for your doctor to evaluate the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" section below.

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

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

Be especially careful with Ibuprofeno Almus

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Severe skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Almus treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

NSAIDs, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno Almus if:

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

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

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, or other respiratory allergies, as it may cause bronchospasm, urticaria, or angioedema in these patients.

Precautions during pregnancy and in fertile women

Due to the association of NSAID administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer Ibuprofeno Almus during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible. It is believed that the risk increases with the dose and duration of treatment.

In the third trimester, the administration of Ibuprofeno Almus is contraindicated.

For fertile women, it should be noted that NSAIDs, such as Ibuprofeno Almus, have been associated with a decrease in the ability to conceive.

Infections

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

Other medications and Ibuprofeno Almus

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

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

• Other NSAIDs, such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots) such as ticlopidine.
• Anticoagulants (medicines used to "thin" the blood) such as aspirin, warfarin, ticlopidine.
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas such as tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Trombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

The use of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Clearance of creatinine (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase).
• With liver function tests: increase in transaminase values.

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

Taking Ibuprofeno Almus with food and drinks

It is recommended to take the medication with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

The use of this medication is not recommended in women trying to become pregnant. It should not be takenduring pregnancy, especially in the last 3 months(see section on precautions during pregnancy and in fertile women),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 predisposition and that of your baby to bleeding and delay or prolong delivery more than expected.

Do not take ibuprofen during the first 6 months of pregnancy unless it is absolutely necessary and your doctor tells you to. If you need treatment during this period or while trying to become pregnant, you should take the lowest dose for the shortest time possible. If you take it for more than a few daysafter week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus, which may result in low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Although only small amounts of the medicationpass into breast milk, it is recommended not to takeibuprofen for prolonged periods during breastfeeding.

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

Driving and operating machinery

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

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Ibuprofeno Almus contains lactose and sodium

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

This medication contains less than 1 mmolof sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The effective dose should be used for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents over 14 years:

The recommended dose for adults and adolescents over 14 years is one tablet (600 mg) every 6 to 8 hours, depending on the severity 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 aged 14 to 18 years.

Use in children and adolescents under 14 years:

This medication is not recommended for use in children or adolescents under 14 years, as the dose of ibuprofen contained is not suitable for the recommended dosage in these patients.

Older patients:

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

Patients with kidney and/or liver disease:

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

Administration form

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. Patients with sensitive stomachs are recommended to take ibuprofen with food.

Take ibuprofen with sufficient water. The tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

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

If you take more doses of Ibuprofeno Almus than you should

If you have taken more Ibuprofeno Almus than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately, call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen and may include: nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination weakness. At high doses, symptoms of 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. In rare cases, cases of metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system and respiratory system depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe overdose has occurred, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered.

If you forget to take Ibuprofeno Almus

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

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

Like all medications,Ibuprofeno Almusmay cause side effects, although not everyone will experience them.

The side effects of medications such asIbuprofeno Almusare more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose:

• Frequent side effects(may affect up to 1 in 10 people): gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.
• Less frequent side effects(may affect up to 1 in 100 people): gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple spots on the skin), skin reactions due to light exposure, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more common in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety, auditory disorders, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing), tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (kidney disorder characterized by proteinuria and body swelling), and acute renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.
• Rare side effects(may affect up to 1 in 1,000 people): disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, may appear facial swelling, tongue, and larynx, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects are thrombocytopenia, leukopenia (decrease in white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (decrease in red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and hemolytic anemia (premature destruction of red blood cells). The first symptoms are fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, unexplained bleeding, and hematomas.
• Very rare side effects(may affect up to 1 in 10,000 people): pancreatitis, prolonged bleeding time, systemic lupus erythematosus (joint pain and fever), severe skin reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions with necrosis and epidermal detachment), toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or these worsen during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Unknown frequency(cannot be estimated from available data): exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood).

A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red scaly rash, with bumps under the skin and localized blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Ibuprofeno Almus if you experience these symptoms and seek medical attention immediately (see section 2).

Interrupt the treatment with ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Flat, non-elevated red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and symptoms similar to the flu (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with protuberances under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).
• Allergic reactions such as skin rashes, facial swelling, wheezing in the chest, or difficulty breathing.
• Vomiting blood or coffee grounds-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Intense or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the extremities or fluid accumulation in the arms or legs.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medication out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Ibuprofeno Almus

The active ingredient is ibuprofen.

The other components are: lactose monohydrate, cornstarch, hypromellose 6 CPS, anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, and opadry 04G 280001 white and purified water.

Appearance of the product and contents of the packaging

Ibuprofeno Almus are white, oval-shaped, coated tablets marked with a “237” on one face and smooth on the other face.

They are presented in packaging with 40 and 500 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans, Barcelona,

Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible for manufacturing:

Generis Farmacêutica, S.A

Rua João de Deus, No. 19

Venda Nova, Amadora

2700-487 Portugal

Date of the last review of this leaflet:November2024

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/