Leaflet: information for the user

Ibuprofen Onedose 400 mg film-coated tablets

Ibuprofen

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4
• You should consult a doctorif your condition worsens or does not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

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

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

3. How to take Ibuprofen Onedose

4. Possible side effects

5. Storage of Ibuprofen Onedose

6. Contents of the pack and additional information

Ibuprofen, the active ingredient of this medication, works by reducing pain and fever.

This medication is indicated for adults and adolescents weighing at least 40 kg (12 years or older) for the symptomatic relief of occasional mild to moderate pain, such as headaches, toothaches, menstrual cramps, muscle aches (muscle spasms) or back pain (lumbago), as well as in febrile states.

Do not take Ibuprofeno Onedose:

• If you have a severe liver or kidney disease.
• If you have had a stomach ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions.

Consult your doctor, pharmacist, or nurse before starting to take this medication.

• If you have an infection; see the "Infections" heading below.If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• Inform your doctor if you are receiving ibuprofen treatment as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you present symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case could cause kidney failure as a consequence of dehydration.

-If you have had or develop a stomach ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

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

• If your doctor has prescribed anantiplatelet medication(to prevent blood clots) containing acetylsalicylic acid, and you are also taking ibuprofen, you must separate the intake of both medications. To do this, you can follow either of the following guidelines:
• • Take the dose of acetylsalicylic acid and waitat least half an hourbefore administering the dose of ibuprofen.
  • Take the dose of ibuprofenat least 8 hours beforeadministering the acetylsalicylic acid.

-If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet medications of the type of acetylsalicilic acid, also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.

-If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.

-If you are being treated with diuretics (medications to urinate) because 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).

-If you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine, bloody urine, or liver disease), so that your doctor can assess the advisability 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 you may experience allergic reactions with this medication.

-Your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery.

-It is recommended not to take this medication if you have chickenpox.

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

Skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking ibuprofen and see your doctor immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

CARDIOVASCULAR PRECAUTIONS

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

You should inform your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (problems with circulation 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.

Furthermore, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Infections

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

Precautions during pregnancy and in women of childbearing age

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where 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 noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Ibuprofeno Onedose with other medications

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

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

• Oral anticoagulants (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medications with atenolol, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (inducer of abortions).
• Digoxin and other cardiac glycosides (used in the treatment of heart problems).
• 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 production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to reduce blood cholesterol levels).
• Sulfinpyrazone (used for gout).
• Oral hypoglycemic agents (sulfonamides) such as tolbutamide (used for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV/AIDS).
• Antihypertensives: to lower high blood pressure.
• Fibrinolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.

If your doctor has prescribed anantiplatelet medication(to prevent blood clots) containing acetylsalicylic acid, and you are also taking ibuprofen, you must separate the intake of both medications (see sectionWarnings and precautions).

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

Taking Ibuprofeno Onedose with food, drinks, and alcohol

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

Do not administer ibuprofen with alcohol to avoid damaging the stomach.

The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor... per day) may cause stomach bleeding.

Use in children

Do not administer Ibuprofeno Onedose to children under 12 years old without consulting a doctor.

Use in people over 65 years old

Older people are more prone to the effects of ibuprofen, so sometimes the dose may need to be reduced. Consult your doctor.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Do not take ibuprofen during pregnancy, especially during the third trimester (see sectionPrecautions during pregnancy and in women of childbearing age).

Women who are breastfeeding should consult their doctor or pharmacist before taking this medication. 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.

IMPORTANT FOR WOMEN:

If you are pregnant or think you may be, consult your doctor before taking this medication. The consumption of medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

Although you should not expect any effects in this sense, sif you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, you do not need to take any special precautions.

Ibuprofeno Onedose 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

• Adults and adolescents from 12 years(with a weight of more than 40 kg)?will take one tablet (400 mg of ibuprofen) every 6 or 8 hours. No more than 3 tablets of 400 mg (1200 mg) should be taken within 24 hours.
• Use in children: do not administer to children, or to adolescents with a weight of less than 40 kg.
• Geriatric population:The dosage should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patients with renal, hepatic, or cardiac insufficiency:Your doctor will indicate the dose you should take, as you may need to reduce the usual dose.

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

The administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

If the pain persists for more than 5 days or the fever for more than 3 days, consult your doctor.

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

Administration form

This medication is administered orally.

Swallow the tablets, whole or broken, without chewing with a sufficient amount of liquid, preferably water.

Take the medication with meals, with some food, or with milk, especially if digestive discomfort is noted.

If you take more Ibuprofeno Onedose than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement.At high 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.

It is rare for more severe symptoms such as intestinal hemorrhage, hypotension, hypothermia, metabolic acidosis, seizures, renal function impairment, coma, dyspnea/acute respiratory distress syndrome in adults, and transient respiratory arrest in children (after ingesting large amounts) to appear.

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

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

If you forgot to take Ibuprofeno Onedose

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

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Ibuprofeno Onedose may cause side effects, although not everyone will experience them. Side effects of medicines like Ibuprofeno Onedose are more common in people over 65 years old.

The incidence of side effects is lower in short treatments and when the daily dose is below the maximum recommended dose.

Common (can affect up to 1 in 10 patients): fatigue, headache, stomach and intestinal disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (skin rashes, itching) and ear buzzing.

Uncommon (can affect up to 1 in 100 patients): allergic reactions, asthma, rhinitis and urticaria, bleeding and gastric ulcers, sleep disturbances and mild anxiety, blurred vision, decreased visual acuity or changes in color perception and hearing disturbances.

Rare (can affect up to 1 in 1,000 patients): edema (swelling due to fluid retention), blood disorders (leucopenia), stomach and intestinal perforation, liver disorders (including jaundice), kidney disorders consisting of: acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination through urine) and occasionally nephrotic syndrome; depression, visual disorders (obscurement of vision), neck stiffness and bronchospasm (sudden sensation of choking), dyspnea (difficulty breathing) and angioedema (inflammation of the deep layers of the skin, which can cause swelling of the face, lips, tongue or throat, and may cause difficulty swallowing or breathing).

Very rare (in up to 1 in 10,000 patients), the following may occur: aseptic meningitis (inflammation of the meninges not caused by bacteria), blood disorders (aplastic anemia and hemolytic anemia) and coagulation disorders, hypertension and heart failure, severe skin disorders (erythema cutaneum), eyes and mucous membranes such as Stevens-Johnson syndrome (severe erythema multiforme) and toxic epidermal necrolysis (skin and mucous membrane lesions that cause skin detachment) and erythema multiforme.

Unknown frequency: a severe skin reaction known as DRESS syndrome (by its English acronym) may occur. Symptoms of DRESS syndrome include: skin rash, lymph node inflammation and elevated eosinophils (a type of white blood cell). The skin becomes sensitive to light.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

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

Medications should not be disposed of through drains or in the trash.Depositthe packaging and medications that you no longer needat the SIGRE collection pointof your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protecttheenvironment.

Composition of Ibuprofeno Onedose

The active ingredient is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.

The other components are:

Core:

Sodium croscarmellose, hypromellose, lactose, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, purified water.

Coating:

Hypromellose, titanium dioxide (E-171), talc, purified water, and propylene glycol.

Appearance of the product and content of the packaging

Oval, biconvex, white film-coated tablets.

They are presented in packaging of 1, 40, and 500 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

LABORATORIOS BLUEPHARMA, S.L.

Pl. Gal·la Placídia 8, 08006 Barcelona

SPAIN

Responsible for manufacturing:

FARMALIDER, S.A.

C/Aragoneses 2

28108 Alcobendas

Madrid, SPAIN

TOLL MANUFACTURING SERVICES, S.L.

C/Aragoneses 2

28018 Alcobendas

Madrid Spain

This leaflet has been reviewed in January 2021

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