IBUPROFEN NUTRA ESSENTIAL 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibuprofen Nutra Essential 200 mg Film-Coated Tablets

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, pharmacist, or nurse .

• 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

You should consult your doctor if the fever worsens or does not improve after 3 days or the pain after 5 days (3 days in adolescents).

Package Leaflet Contents

1. What is Ibuprofen Nutra Essential and what is it used for
2. What you need to know before taking Ibuprofen Nutra Essential
3. How to take Ibuprofen Nutra Essential
4. Possible side effects
5. Storage of Ibuprofen Nutra Essential
6. Package Contents and Additional Information

1. What is Ibuprofen Nutra Essential and what is it used for

This medication is indicated for adults and children from 7 years old (21 kg body weight) for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental, menstrual, muscular (cramps) or back (lumbago) pain, as well as in febrile conditions.

2. What you need to know before taking Ibuprofen Nutra Essential

Do not take Ibuprofen Nutra Essential:

• if you are allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• if you have a severe liver or kidney disease.
• if you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• if you vomit blood.
• if you have black stools or bloody diarrhea.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.

Warnings and Precautions

Tell 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 are receiving treatment with Ibuprofen, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• if you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• if you 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 using high doses and prolonged treatments, in patients with a history of peptic ulcer, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• if you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents 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 like Ibuprofen may worsen these conditions.
• if you are being treated with diuretics (medications to urinate), 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 that protect the brain and spinal cord, not caused by bacteria).
• if you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• if you experience headaches after prolonged treatment, do not take higher doses of the medication.
• allergic reactions may occur with this medication.
• your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• it is advisable not to take this medication if you have chickenpox.
• if you have an infection; see the "Infections" section below.

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.

Precautions in Elderly Patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular Precautions

Medications like Ibuprofen may be associated with a moderate 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 discuss your treatment with your doctor or pharmacist before taking Ibuprofen Nutra Essential 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 can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory Disorders

Ibuprofen should be used with caution when administered to patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

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, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Ibuprofen Nutra Essential may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen Nutra Essential may delay the 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.

Children and Adolescents

There is a risk of renal failure in dehydrated children and adolescents.

The use of this medication is not recommended in children under 7 years old (21 kg body weight), as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

Precautions during Pregnancy and in Women of Childbearing Age

Since the administration of medications like Ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Ibuprofen is contraindicated.

For women of childbearing age, it should be taken into account that medications like Ibuprofen have been associated with a decrease in fertility.

Interference with Analytical Tests

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

Other Medications and Ibuprofen Nutra Essential

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

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

Other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.

Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels) such as ticlopidine.

Anticoagulant medications (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 atenolol, and angiotensin-II receptor antagonists such as losartan)

Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.

Methotrexate (for the treatment of cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.

Mifepristone (abortion inducer).

Digoxin and cardiac glycosides (used in the treatment of heart disorders).

Hydantoins such as phenytoin (used in the treatment of epilepsy).

Sulfonamides such as sulfamethoxazole and clotrimoxazole (used in the treatment of certain bacterial infections).

Corticosteroids such as cortisone and prednisolone.

Pentoxifylline (for the treatment of intermittent claudication).

Probenecid (used in patients with gout or with penicillin in infections).

Quinolone antibiotics such as norfloxacin.

Sulfinpyrazone (for gout).

Sulfonylureas such as tolbutamide (for diabetes).

Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).

Zidovudine (medication against the AIDS virus).

Antihypertensives: to decrease high blood pressure.

Thrombolytics (medications that dissolve clots).

Aminoglycoside antibiotics such as neomycin.

Ginkgo biloba tree extracts.

CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Ibuprofen Nutra Essential with Food, Drinks, and Alcohol

You can 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.

Consumption of alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication.

Pregnancy

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age).

Breastfeeding

Minimal amounts of ibuprofen and its degradation products are excreted in breast milk. As no undesirable effects are known in the breastfed infant, it is not usually necessary to interrupt breastfeeding during short-term use at recommended doses.

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

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or use hazardous machinery. If you only take a single dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofen Nutra Essential contains lactose.

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Ibuprofeno Nutra Essential

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

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

It is essential to use the smallest dose that relieves-controls pain and should not take Ibuprofeno Nutra Essential for longer than necessary to control symptoms.

This medication is administered orally. Patients with stomach discomfort should take the medication during meals.

Use in children and adolescents:

The dose of ibuprofen to be administered depends on age and weight. The following table provides the recommended doses:

It is recommended not to exceed the maximum daily dose of 40 mg of ibuprofen per kilogram of body weight.

The interval between doses will depend on the evolution of symptoms, but it will never be less than 4 hours.

The use of this medication is not recommended in children under 21 kg of weight (approximately 7-8 years).

Adolescents from 12 years and adults:

The recommended daily dose is 1,200 mg of ibuprofen per day, divided into 3 or 4 doses (1 or 2 sachets 3 or 4 times a day), with a maximum recommended daily dose of 1,200 mg.

Elderly patients:

The dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

Patients with kidney, liver, or heart disease: reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe renal or hepatic insufficiency.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days (3 days in children and adolescents), you should consult a doctor.

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

If you need to use this medication for more than 3 days in children and adolescents (from 7 years to less than 18 years), or if symptoms worsen, you should consult a doctor.

In adults, you should consult a doctor if you need to use this medication for more than 3 days in case of fever or 5 days in case of pain or if symptoms worsen.

If you take more Ibuprofeno Nutra Essential than you should

If you have taken more Ibuprofeno than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the prospectus of the medication to the healthcare professional. If a severe poisoning has occurred, the doctor will take the necessary measures.

If you have taken more Ibuprofeno Nutra Essential than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

Also, in rare cases, cases of metabolic acidosis, hypothermia, altered renal function, gastrointestinal bleeding, coma, apnea, and depression of the central nervous system and respiratory system have been reported. In cases of significant overdose, renal failure and liver damage can occur.

If you forgot to take Ibuprofeno Nutra Essential

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

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

If you interrupt treatment with Ibuprofeno Nutra Essential

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

4. Possible adverse effects

Like all medications, ibuprofen can cause adverse effects, although not everyone will experience them.

Adverse effects of medications like ibuprofen are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 people); frequent (may affect up to 1 in 10 people); infrequent (may affect up to 1 in 100 people); rare (may affect up to 1 in 1000 people); very rare (may affect up to 1 in 10,000 people); unknown frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal

The most frequent adverse effects that occur with medications like ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly people. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stools, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other adverse effects are: Infrequent: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of diverticular disease, hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Infections and infestations

Very rare: Exacerbation of inflammation-related infections (e.g., the development of necrotizing fasciitis), coinciding with the use of non-steroidal anti-inflammatory drugs.

Note: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to go to the doctor immediately, in case antibiotic therapy needs to be initiated.

Gastrointestinal disorders

The most frequent adverse effects that occur with medications like ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Gastrointestinal disorders such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that can cause anemia in exceptional cases have also been observed. Infrequent: gastrointestinal ulcers, potentially with bleeding and perforation, stomatitis, worsening of colitis and Crohn's disease, gastritis.

Other adverse effects are:

Infrequent: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of diverticular disease, hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: esophagitis, pancreatitis, intestinal stenosis.

Cardiac and vascular disorders

Medications like ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medications of the Ibuprofen type.

Disorders of the skin and subcutaneous tissue

Medications like ibuprofen can be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis).

Other adverse effects are:

Frequent: skin rash.

Infrequent: skin redness, itching or skin swelling, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), skin reactions influenced by light, inflammation of the skin blood vessels. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

A severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Unknown frequency: generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Disorders of the immune system

Infrequent: hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly along with a drop in blood pressure). Very rare: severe hypersensitivity reactions (these can be characterized by swelling of the face, tongue, and larynx with bronchospasm, dyspnea, tachycardia, and hypotension that can include potentially fatal shock).

Note: In the event of these symptoms, which can occur with the first use, immediate medical attention is required.

Disorders of the nervous system

Frequent: fatigue or drowsiness, headache, and dizziness or feeling of instability.

Infrequent: headache, dizziness.

Rare: paresthesia (sensation of numbness, tingling, burning, etc., more frequent in hands, feet, arms, or legs).

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

Psychiatric disorders

Infrequent: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability.

Very rare: depression, psychotic reaction.

Disorders of the ear and labyrinth

Frequent: vertigo.

Infrequent: ringing or buzzing in the ears.

Rare: hearing difficulty.

Eye disorders

Infrequent: vision changes.

Rare: abnormal or blurred vision.

Disorders of the blood and lymphatic system

Rare: decreased platelets, decreased white blood cells (which can manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which can manifest as difficulty breathing and paleness of the skin), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (significant decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, nasal and skin bleeding.

Very rare: prolonged bleeding time.

Renal and urinary disorders

Very rare: edema (signs that may indicate kidney disease, which can sometimes include kidney failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration.

Hepatobiliary disorders

Medications like ibuprofen may be associated, in rare cases, with liver damage.

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

Very rare: liver dysfunction, liver damage (particularly with long-term treatment), liver failure, acute hepatitis.

Unknown frequency: liver failure (severe liver deterioration).

General

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment and go to the doctor immediately:

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest, or difficulty breathing.
• Blood vomiting or coffee grounds-like vomiting.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines included in www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Nutra Essential

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

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

6. Content of the package and additional information

Composition of Ibuprofeno Nutra Essential

• The active ingredient is ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen.
• The other components (excipients) are:

Core: Hypromellose, sodium croscarmellose, lactose, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate, purified water.

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

Appearance of the product and package content

Ibuprofeno Nutra Essential are oval, biconvex, white film-coated tablets, scored on one face and smooth on the other face, presented in packages of 20 tablets packaged in aluminum-PVC/PVDC blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Nutra Essential OTC, S.L.

La Granja, 1. 28108

Alcobendas (Madrid)

Spain

Manufacturer:

Toll Manufacturing Services, S.L.

Aragoneses, 2 28108

Alcobendas (Madrid)

Spain

or

Farmalider, S.A.

Aragoneses 15

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this prospectus: August 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency.