IBUPROFEN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen Onedose 400 mg Film-Coated Tablets

Ibuprofen

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

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

Contents of the Package Leaflet

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

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

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

This medication is indicated for adults and adolescents from 40 kg in weight (from 12 years or older) for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps), or back pain (lumbago), as well as in febrile conditions.

2. What you need to know before taking Ibuprofen Onedose

Do not take Ibuprofeno Onedose:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have ever had reactions such as skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma after taking acetylsalicylic acid or other NSAIDs.

• 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.

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

• If you have an infection; see the "Infections" section later. If you have edema (fluid retention).
• If you have a history of heart disorders or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• Inform your doctor if you are receiving treatment with ibuprofen, as it may mask fever, which is an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the 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 in this case could 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 intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

• If your doctor has prescribed an antiplatelet medication(to prevent blood clot formation) that contains acetylsalicylic acid, and you are also taking ibuprofen, you should separate the administration of both medications. To do this, you can follow either of the following guidelines:
• • Take the acetylsalicylic acid dose and wait at least half an hourbefore administering the ibuprofen dose.
  • Take the ibuprofen dose at least 8 hours beforeadministering the acetylsalicylic acid.

• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. 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 of the ibuprofen type may worsen these conditions.
• If you are being treated 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, you should 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.

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

Skin Reactions

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

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased 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 discuss your treatment with 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 arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

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

Infections

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

Precautions during Pregnancy and in Women of Childbearing Age

Since the administration of medications of the ibuprofen type 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 of the ibuprofen type have been associated with a decrease in fertility.

Interference with Analytical Tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, 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:

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for treating cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins like phenytoin (used in the treatment of epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Pentoxifylline (for treating intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group like norfloxacin.
• Ion exchange resins like cholestyramine (used to decrease blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Oral hypoglycemics (sulfonylureas) like tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medication).
• Antihypertensives: to decrease high blood pressure.
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: from the Ginkgo biloba tree.

If your doctor has prescribed an antiplatelet medication(to prevent blood clot formation) that contains acetylsalicylic acid, and you are also taking ibuprofen, you should separate the administration of both medications (see the "Warnings and Precautions" section).

Other medications may also affect or be affected by treatment with ibuprofen. 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.

You should not administer ibuprofen with alcohol to avoid damaging the stomach.

The use of ibuprofen in patients who habitually 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 Adults over 65 Years

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

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medication.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see the "Precautions during Pregnancy and in Women of Childbearing Age" section).

Breastfeeding women 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 pregnant, 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 Using Machines

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

Ibuprofeno Onedose contains Lactose

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

3. How to Take Ibuprofeno Onedose

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

The recommended dose is:

• Adults and adolescents from 12 years old (with a weight over 40 kg) - take one tablet (400 mg of ibuprofen) every 6 or 8 hours. Do not take more than 3 tablets of 400 mg (1200 mg) in 24 hours.
• Use in children: do not administer to children or adolescents with a weight under 40 kg.
• Elderly 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 a reduction in the usual dose.

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

Administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be suspended.

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

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

Method of Administration

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 you experience digestive discomfort.

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the package leaflet of the medication to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as 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.

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

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. Stomach emptying will be considered if large amounts have been ingested and within 60 minutes after ingestion.

If you forget to take Ibuprofeno Onedose

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

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

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

4. Possible Adverse Effects

Like all medicines, Ibuprofeno Onedose can have adverse effects, although not all people suffer from them. The adverse effects of medicines like Ibuprofeno Onedose are more common in people over 65 years of age.

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

Frequent (May affect up to 1 in 10 patients): fatigue, headache, stomach and intestine disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (rash, itching) and ringing in the ears.

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

Rare (may affect up to 1 in 1000 patients): edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestine perforation, liver disorders (including jaundice), kidney disorders consisting of: acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination in urine) and occasionally nephrotic syndrome; depression, vision disorders (vision loss), neck stiffness and bronchospasms (sudden feeling of suffocation), dyspnea (difficulty breathing) and angioedema (inflammation of the deep layers of the skin, which occurs with swelling of the face, lips, tongue or throat, which can cause difficulty swallowing or breathing).

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

Frequency not known: a severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation and elevated eosinophils (a type of white blood cell). The skin becomes sensitive to light.

Reporting of Adverse Effects

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

5. Conservation of Ibuprofeno Onedose

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

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 corn starch, anhydrous colloidal silica, magnesium stearate, purified water.

Coating:

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

Appearance of the Product and Packaging Content

White, oval, biconvex film-coated tablets.

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

Marketing Authorization Holder and Manufacturer

Holder:

LABORATORIOS BLUEPHARMA, S.L.

Pl. Gal·la Placídia 8, 08006 Barcelona

SPAIN

Manufacturer:

FARMALIDER, S.A.

C/Aragoneses 2

28108 Alcobendas

Madrid, SPAIN

TOLL MANUFACTURING SERVICES, S.L.

C/Aragoneses 2

28018 Alcobendas

Madrid, SPAIN

This prospectus was revised in January 2021

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