Ibuprofen Pharmex 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Pharmex 600 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if these adverse reactions are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ibuprofeno Pharmex is and what it is used for

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

This medicine is indicated for the treatment of fever, and for the relief of mild to moderate pain including migraine. It is also indicated for the treatment of arthritis (joint inflammation, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing damage to the cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before starting to take Ibuprofen Pharmex

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

Do not take Ibuprofen Pharmex

• If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of the medicine. Signs indicating an allergic reaction may include itchy skin rash, swelling of the face, lips, or tongue, nasal discharge, breathing difficulties, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a gastrointestinal perforation.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used simultaneously, 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

Allergic reactions to ibuprofen have been reported, including respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Immediately stop using Ibuprofen and contact your doctor or emergency medical services immediately if you notice any of these signs.

Inform your doctor:

• If you have oedema (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 being treated with ibuprofen, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
• If you experience symptoms of dehydration, e.g., severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to kidney failure due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
• If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial cause) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
• If you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will conduct closer monitoring if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the section "Infections" below.

Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofen Pharmex and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as 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 duration of treatment.

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

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Also, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Precautions during pregnancy and in women of childbearing age

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital abnormalities/miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of ibuprofen is contraindicated during the third trimester.

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

Other medicines and Ibuprofen Pharmex

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin.
• Antiplatelet agents (prevent blood clots or thrombi in blood vessels), such as ticlopidine.
• Anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion-inducing agent).
• 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 (medicines used to increase urine elimination).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in gout patients or together 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 (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Haematocrit or haemoglobin (may decrease).
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase).
• Liver function tests: increased transaminase values.

Inform your doctor if you are undergoing clinical testing and are taking or have recently taken ibuprofen.

Taking Ibuprofen Pharmex with food and drinks:

You may 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 medicine.

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital abnormalities/miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of ibuprofen is contraindicated during the third trimester.

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

Consult your doctor or pharmacist before using any medicine.

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

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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

Driving and using machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

If you take only a single dose of ibuprofen, or take it for a short period, no special precautions are necessary.

Ibuprofen Pharmex contains lactose

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

Infections

Ibuprofen Pharmex may mask signs of infection such as fever and pain. Therefore, Ibuprofen Pharmex may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin bacterial infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

3. How to take Ibuprofen Pharmex

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with ibuprofen. Do not stop the treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not use ibuprofen for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest duration 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 medicine is administered orally. The tablet should be swallowed whole with a little water. Patients experiencing stomach discomfort should take the medicine with milk and/or during meals.

Adults and adolescents:

In adults and adolescents aged 14 to 18 years, the recommended dose is one tablet (600 mg of ibuprofen) every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

Higher doses may be required in some conditions, 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 12 to 18 years.

Children and adolescents:

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

Elderly population:

If you are over 60 years of age, your doctor may prescribe a lower than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Patients with kidney and/or liver disease:

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

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

If you take more Ibuprofen Pharmex than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken.

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

Mild symptoms of an overdose include: abdominal pain, nausea, vomiting, indifference, drowsiness, headache, rapid involuntary eye movements, tinnitus, and lack of muscle coordination.

More severe symptoms such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient cessation of breathing in children (after ingestion of large quantities) are rare.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At higher doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

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

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

If you forget to take Ibuprofen Pharmex

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

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

4. Possible adverse effects

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

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

The most frequent gastrointestinal adverse effects are peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Inflammation of the stomach lining (gastritis) has been observed less frequently.

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

The following adverse effects have been observed:

Common adverse effects (may affect between 1 and 10 out of every 100 patients):

• Skin rash.
• Fatigue or drowsiness, headache, dizziness, or feeling unsteady.
• Vertigo.

Uncommon adverse effects (may affect between 1 and 10 out of every 1,000 patients):

• Inflammation of the oral mucosa with ulcer formation.
• Skin redness, itching, or swelling of the skin, purpura (purple spots on the skin).
• Transient swelling in areas of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi that restricts airflow to the lungs).
• Insomnia, anxiety, restlessness.
• Ringing or buzzing in the ears.
• Vision disturbances.

Rare adverse effects (may affect between 1 and 10 out of every 10,000 patients):

• Inflammation of the esophagus.
• Narrowing of the esophagus (esophageal stricture).
• Exacerbation of intestinal diverticular disease.
• Unspecified hemorrhagic colitis (gastroenteritis with bloody diarrhea).
• Severe allergic reactions (anaphylactic shock).
• In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.
• Paresthesia (numbness, tingling, pins and needles, etc., more frequent in hands, feet, arms, or legs).
• Disorientation or confusion, nervousness, irritability, depression, psychotic reaction.
• Hearing difficulty.
• 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 shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (failure of the bone marrow to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.
• Medicines such as ibuprofen may rarely be associated with liver injury.

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

Very rare adverse effects (may affect fewer than 1 out of every 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 purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), hair loss, erythema multiforme (skin lesion), photosensitivity reactions (skin reactions due to light exposure), inflammation of blood vessels in the skin.
• Joint pain and fever (lupus erythematosus).
• Aseptic meningitis. In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.
• Worsening of inflammation during infectious processes.

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

• Rarely, severe skin infections and complications in soft tissues may occur during chickenpox.
• Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack (myocardial infarction) or stroke.
• Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with ibuprofen-type medicines.
• Based on 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 excluded.
• Liver failure (severe deterioration of liver function).
• To date, severe allergic reactions have not been reported with ibuprofen, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.
• Skin becomes sensitive to light.

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

• Allergic reactions such as skin rashes, swelling of the face, wheezing, or difficulty breathing.

• Vomiting blood or material resembling coffee grounds.

• Blood in stools or diarrhea with blood.

• Severe stomach pain.

• Blisters or extensive peeling of the skin.

• Severe or persistent headache.

• Yellowing of the skin (jaundice).

• Signs of severe hypersensitivity (allergy) (see above in this section).

• Swelling of the limbs or fluid accumulation in the arms or legs.

• Flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofeno Pharmex

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Pharmex

• The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components (excipients) are: Core: Croscarmellose sodium, lactose, microcrystalline cellulose, pregelatinized maize starch, anhydrous colloidal silica, magnesium stearate.

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

Appearance of Ibuprofeno Pharmex and contents of the pack

The tablets are film-coated, white and oval-shaped.

Each pack 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 most recent revision of this leaflet: September 2024

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"