IBUPROFENO PHARMEX 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofeno Pharmex 600 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to use the medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Ibuprofeno Pharmex 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 taking Ibuprofeno Pharmex

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

Do not take Ibuprofeno Pharmex

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you are allergic to other medications of the non-steroidal anti-inflammatory drug group (NSAIDs), aspirin, or any of the other components of the medication. Allergic reactions may include: 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

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 immediately and contact your doctor or medical emergency services immediately if you observe any of these signs.

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart disorder or 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, e.g., 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 abdominal pain or persistent 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 like 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 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 undergoing treatment 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, which are the membranes 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.

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 Ibuprofeno Pharmex treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

Cardiovascular Precautions

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

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno 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, a family history of heart disease or stroke, or if you are a smoker.

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.

Other Medications and Ibuprofeno Pharmex

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) like ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart disorders).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas like tolbutamide (for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba tree.

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

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.

Taking Ibuprofeno Pharmex with Food and Drinks

You can take it alone or with food. In general, it is recommended to take it during/after meals or with milk to reduce the possibility of stomach discomfort.

Pregnancy, Fertility, 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.

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.

Consult your doctor or pharmacist before using any medication.

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

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 use hazardous machinery.

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

Ibuprofeno Pharmex contains Lactose

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.

Infections

Ibuprofeno Pharmex may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno Pharmex may delay appropriate 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.

3. How to take Ibuprofeno Pharmex

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

Remember to take your medication.

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

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

This medication is administered orally. You should swallow the tablet whole with the help of a little water. Patients with stomach discomfort should take the medication with milk and/or during meals.

Adults and adolescents:

In adults and adolescents from 14 to 18 years, the recommended dose is one tablet (600 mg of ibuprofen) 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.

Children and adolescents:

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 dosage in these patients.

Elderly population:

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 that your doctor has prescribed.

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

If you take more Ibuprofeno Pharmex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

It is recommended to take the package and the prospectus of the medication to the healthcare professional.

Mild symptoms of an overdose are: abdominal pain, nausea, vomiting, indifference, sleep, headache, rapid involuntary eye movements, ringing in the ears, and lack of muscle coordination.

It is rare for more serious symptoms to appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, altered kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingesting large amounts).

If you have taken more Ibuprofeno Pharmex than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital 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), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

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

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

If you forgot to take Ibuprofeno Pharmex

Do not take a double dose to make up for missed 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 missed 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 ibuprofen 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); infrequent (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 most frequent gastrointestinal adverse effects are peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Gastritis (inflammation of the stomach mucosa) has been observed less frequently.

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

The following adverse effects have been observed:

Frequent adverse effects (may affect between 1 and 10 in 100 patients):

• Skin rash.
• Fatigue or drowsiness, headache, dizziness or feeling of instability.
• Dizziness.

Infrequent adverse effects (may affect between 1 and 10 in 1,000 patients):

• Inflammation of the oral mucosa with ulcer formation.
• Redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin).
• Transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi that prevents air from passing to the lungs).
• Insomnia, anxiety, restlessness.
• Ringing or buzzing in the ears.
• Visual disturbances.

Rare adverse effects (may affect between 1 and 10 in 10,000 patients):

• Inflammation of the esophagus.
• Narrowing of the esophagus (esophageal stenosis).
• Worsening of diverticular disease.
• Non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea).
• Severe allergic reactions (anaphylactic shock).
• In case of severe generalized hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.
• Paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs).
• Disorientation or confusion, nervousness, irritability, depression, psychotic reaction.
• Hearing difficulties.
• Abnormal or blurred vision.
• 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 pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (significant decrease in granulocytes), aplastic anemia (bone marrow failure to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.
• Medications like ibuprofen may be associated with liver damage in rare cases.

Other rare adverse effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Very rare adverse effects (may affect less than 1 in 10,000 patients):

• Pancreatitis.
• Very severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple-colored lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the skin blood vessels.
• Joint pain and fever (lupus erythematosus).
• Aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.
• Worsening of inflammation during infectious processes.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.
• Medications like ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack (myocardial infarction) or stroke.
• Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with ibuprofen-like medications.
• Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and renal failure (sudden loss of kidney function) cannot be ruled out.
• Liver failure (severe liver damage).
• To date, no severe allergic reactions have been reported with ibuprofen, 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 (lower than usual blood pressure), or shock.
• The skin becomes sensitive to light.

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

• Allergic reactions such as skin rashes, facial swelling, wheezing in the chest, or breathing difficulties.
• Bloody vomiting or coffee-ground-like vomiting.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Significant skin blistering or 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, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• A generalized, red, and 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).

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Pharmex

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 package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Pharmex

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components (excipients) are: Core: Sodium croscarmellose, lactose, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate.

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

Appearance of Ibuprofeno Pharmex and package contents

The tablets are coated, white, and oval in shape.

Each package contains 40 tablets.

Marketing authorization holder and manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Date of the last revision of this prospectus: September 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/"