Ibuprofen Kern Pharma 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibuprofen Kern Pharma 600 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ibuprofen Kern Pharma 600 mg is and what it is used for
2. What you need to know before taking Ibuprofen Kern Pharma 600 mg
3. How to take Ibuprofen Kern Pharma 600 mg
4. Possible side effects
5. How to store Ibuprofen Kern Pharma 600 mg
6. Contents of the pack and other information

1. What is Ibuprofeno Kern Pharma 600 mg and what is it 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, mild to moderate pain including migraine, arthritis (inflammation of the joints, usually affecting hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing damage to 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 taking Ibuprofen Kern Pharma 600 mg

Do not take Ibuprofen Kern Pharma 600 mg

• If you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine. Signs of allergy may include: itchy rash, swelling of the face, lips or tongue, runny nose, 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 perforation of the gastrointestinal tract.

• If you are vomiting blood.

• If you have black stools or bloody diarrhea.

• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants 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

Talk to your doctor, pharmacist, or nurse before starting to take this medicine.

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

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have an infection; see the section “Infections” below.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular check-ups. Your doctor will advise you on how often these checks should occur.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case 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 severe or 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 clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of 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 leads to bloody diarrhea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are taking diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve 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 infection) 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, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will perform closer monitoring if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.

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

Skin reactions

Take special care with Ibuprofen Kern Pharma:

Serious skin reactions have been reported with ibuprofen, including 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). Stop treatment with Ibuprofen Kern Pharma and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. 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 artery 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 ischemic 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, especially 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 and miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

In the third trimester, administration of coated ibuprofen is contraindicated.

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

Taking Ibuprofen Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription. Ibuprofen Kern Pharma may affect or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs such as acetylsalicylic acid.
• Antiplatelet agents (prevent blood clots or coagulation in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g., to treat or prevent coagulation problems, 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 (an 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 output).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin for 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, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

Other medicines may also affect or be affected by treatment with Ibuprofen Kern Pharma. Therefore, you should always consult your doctor or pharmacist before using Ibuprofen Kern Pharma with other medicines.

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)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase levels

Inform your doctor if you are scheduled for a clinical test and are taking or have recently taken ibuprofen.

Taking Ibuprofen Kern Pharma 600 mg with food and drinks

You may take it alone or with food. In general, it is recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section "Precautions during pregnancy and in women of childbearing age"). It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labor. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

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, vision 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 use it for a short period, no special precautions are necessary.

3. How to take Ibuprofeno Kern Pharma 600 mg tablets

Follow exactly the administration instructions for Ibuprofeno as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

This medicine is administered orally. Patients experiencing stomach discomfort should take the medicine with milk and/or during meals.

Adults:

For adults and adolescents aged 14 to 18 years, one tablet (600 mg) should be taken every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

In some conditions, higher doses may be required; however, 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.

Use in children and adolescents:

This medicine is not recommended for children and adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosage in these children.

Use in elderly people:

If you are over 60 years old, your doctor may prescribe a lower than usual dose. In such case, 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 suffer from kidney and/or liver disease, your doctor may prescribe a lower than usual dose. In such case, 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 Ibuprofeno Kern Pharma 600 mg than you should

If you have taken more Ibuprofeno Kern Pharma 600 mg than prescribed, or if a child has accidentally ingested the contents of the package, contact your doctor or pharmacist or the Toxicology Information Service immediately at telephone number: 91 562 04 20, or go to the nearest hospital to assess the risk and obtain advice on necessary measures, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Mild symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), indifference, drowsiness, headache, involuntary eye movements, tinnitus, confusion, and lack of muscle coordination.

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

At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, 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 emptying should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Ibuprofeno Kern Pharma 600 mg

Do not take a double dose to make up for missed 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 the usual time.

4. Possible adverse effects

Like all medicines, this medicine can 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 10 patients); common (between 1 and 10 out of 100 patients); uncommon (between 1 and 10 out of 1,000 patients); rare (between 1 and 10 out of 10,000 patients); very rare (in fewer than 1 out of 10,000 patients); frequency not known (cannot be estimated from the available data).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects are:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: inflammation of the esophagus, narrowing of the esophagus (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

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

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments using medicines of the ibuprofen type.

Dermatological:

Discontinue treatment with Ibuprofen Kern Pharma and seek immediate medical attention if you notice any of the following symptoms:

• Red, flat spots on the trunk, often in target or circular shapes, with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, or eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and swollen 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).

Medicines such as ibuprofen may, very rarely, be associated with 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).

Drug reaction with eosinophilia and systemic symptoms: 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).

Other adverse effects are:

Common: skin rash.

Uncommon: skin redness, itching or swelling of the skin, purpura (purple skin spots).

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light exposure, inflammation of blood vessels in the skin.

Serious skin infections and soft tissue complications may exceptionally occur during chickenpox.

Frequency not known: Generalized red, scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Kern Pharma if you experience these symptoms and seek immediate medical attention. See also section 2.

Immune system:

Uncommon: transient swelling in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi obstructing airflow to the lungs).

Rare: 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.

Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or sensation of unsteadiness.

Rare: paresthesia (numbness, tingling, "pins and needles," more commonly in hands, feet, arms, or legs).

Very rare: aseptic meningitis. In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: dizziness. Uncommon: tinnitus (ringing or buzzing in the ears).

Rare: hearing impairment.

Ocular:

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Hematological:

Rare: decreased platelets, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present 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 decrease in granulocytes), aplastic anemia (bone marrow failure to produce various types of 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.

Very rare: prolonged bleeding time.

Renal:

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.

Hepatic:

Medicines such as ibuprofen may, rarely, be associated with liver injury.

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

Frequency not known: liver failure (severe liver impairment).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have 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.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of adverse effects

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

5. Storage of Ibuprofen Kern Pharma 600 mg Tablets

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Kern Pharma 600 mg tablets

• The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components are: corn starch, pregelatinized corn starch, microcrystalline cellulose, colloidal anhydrous silica, and magnesium stearate in the tablet core; and hypromellose, microcrystalline cellulose, polyoxyl 40 stearate, titanium dioxide (E-171), polyethylene glycol, and propylene glycol in the coating.

Appearance of the product and contents of the container

Ibuprofen Kern Pharma 600 mg are white, elongated tablets. They are supplied in blisters, in packs containing 20 tablets, 40 tablets, and hospital pack of 500 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer responsible

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Farmalider, S.A.

C/ Aragoneses, 2, Alcobendas

28108 Madrid

Spain

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2, Alcobendas

28108 Madrid

Spain

or

SAG MANUFACTURING, S.L.

Carretera Nacional I, Km 36

San Agustín de Guadalix 28750

Madrid, Spain

Date of the most recent review of this leaflet: January 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/.