IBUPROFEN ALMUS 600 mg FILM-COATED TABLETS

2. What you need to know before you take Ibuprofeno Almus

Do not take Ibuprofeno Almus

• If you are allergic (hypersensitive) to ibuprofen, other NSAIDs, aspirin, or any of the other ingredients of Ibuprofeno Almus. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

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

• If you have edema (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 receiving treatment with Ibuprofeno Almus, as it may mask fever, which is 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 checks. Your doctor will indicate the frequency of these checks.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcers, 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 type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• 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 of the type of Ibuprofeno Almus may worsen these conditions.
• If you are being treated with diuretics (medicines used to increase urine elimination), as your doctor must 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 suffer from 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 later.

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

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 Ibuprofeno Almus immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Be 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.

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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Almus and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

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

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

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

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

Respiratory disorders

Ibuprofeno should be used with caution when administered to patients who have or have had bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofeno has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Precautions during pregnancy and in women of childbearing age

Because the administration of medications of the type of Ibuprofeno Almus 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. 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 women of childbearing age, it should be taken into account that medications of the type of Ibuprofeno Almus have been associated with a decrease in fertility.

Infections

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

Other medications and Ibuprofeno Almus

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

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

• Other NSAIDs, such as aspirin, as the risk of stomach ulcers and bleeding may increase.
• Antiplatelet agents (which prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestyramine (a medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• 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 cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine elimination), as they may increase the risk of kidney toxicity.
• 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), as they may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Ginkgo biloba tree extracts.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking ibuprofen may alter the following laboratory tests:

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

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

Taking Ibuprofeno 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 drink 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 who are trying to become pregnant. It should not be taken during pregnancy, especially in the last 3 months (see section precautions during pregnancy and in women of childbearing age), 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 ability to bleed and delay or prolong delivery more than expected.

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

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

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

Driving and using machines

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

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

This applies to a greater extent to the combination with alcohol.

Ibuprofeno Almus contains lactose and sodium

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

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

3. How to Take Ibuprofeno Almus

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

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

The effective lowest dose should be used during 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 in adults and adolescents from 14 years is one tablet (600 mg) every 6 to 8 hours, depending on the intensity of the condition and response to treatment.

In some processes, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in young people from 14 to 18 years.

Use in children and adolescents under 14 years:

The use of this medication is not recommended in children or adolescents under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended posology in these patients.

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

Method of administration

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food.

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

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

If you take more 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

It is recommended to take the packaging and the prospectus of the medication 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 bloody sputum), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in urine, low potassium levels in blood, chills, and breathing problems have been reported. In rare cases, there have been cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. There have also been cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate).

If a severe poisoning 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 forgot to take Ibuprofeno Almus

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

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

4. Possible Adverse Effects

Like all medications, Ibuprofeno Almus can cause adverse effects, although not all people suffer from them.

The adverse effects of medications like Ibuprofeno Almus 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:

• Frequent Adverse Effects(may affect up to 1 in 10 people): gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.
• Uncommon Adverse Effects(may affect up to 1 in 100 people): gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function anomalies, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing), interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by proteins in the urine and body swelling), and renal failure (sudden loss of kidney function). Acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea have also been reported.
• Rare Adverse Effects(may affect up to 1 in 1,000 people): disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or sounds in the ear), hearing impairment, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx, dyspnea, tachycardia, hypotension, anaphylaxis, or severe shock may appear). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from 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 adverse effects are decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and skin pallor), neutropenia (decreased neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow failure to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, bleeding, and bruises of unknown cause.
• Very Rare Adverse Effects(may affect up to 1 in 10,000 people): pancreatitis, prolonged bleeding time, lupus erythematosus (joint pain and fever), severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and epidermal shedding), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe liver damage), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation-related infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening occur during the use of ibuprofen, it is recommended to consult 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 usually produces bloody diarrhea).

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 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 Almus if you present these symptoms and seek immediate medical attention (see also section 2).

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

• Reddish, non-elevated spots, target-like or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and hypertrophic 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).
• Allergic reactions such as skin rashes, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• 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.
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting Adverse Effects

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

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

5. Conservation of Ibuprofeno Almus

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

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 Package Contents

Ibuprofeno Almus are white, oval, film-coated tablets, marked with a "237" on one side and smooth on the other side.

They are available in packages of 40 and 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans, Barcelona,

Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Generis Farmacêutica, S.A

Rua João de Deus, No. 19

Venda Nova, Amadora

2700-487 Portugal

Date of the Last Revision of this Prospectus:November 2024

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