IBUPROFEN/PSEUDOEPHEDRINE NUTRA ESSENTIAL 20 mg/mL + 3 mg/mL ORAL SUSPENSION

Introduction

Leaflet:information for the user

Ibuprofen/Pseudoephedrine Nutra Essential 20 mg/ml + 3 mg/ml oral suspension

Ibuprofen/pseudoephedrine hydrochloride

Read the entire 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 leaflet or as 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 side effects, consult your doctor or pharmacist, including if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days in adolescents and 5 days in adults.

Contents of the leaflet

1. What is Ibuprofen/Pseudoephedrine Nutra Essential and what is it used for
2. What you need to know before taking Ibuprofen/Pseudoephedrine Nutra Essential
3. How to take Ibuprofen/Pseudoephedrine Nutra Essential
4. Possible side effects

5 Conservation of Ibuprofen/Pseudoephedrine Nutra Essential

1. Package contents and additional information

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

Ibuprofen/Pseudoephedrine Nutra Essential contains two active ingredients: ibuprofen and pseudoephedrine.

Ibuprofen belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and high fever. Pseudoephedrine belongs to a group of medications called vasoconstrictors, which act on the blood vessels in the nose to relieve nasal congestion.

Ibuprofen/Pseudoephedrine Nutra Essential is indicated for the symptomatic relief of nasal congestion that occurs with headache, fever, and/or pain in the common cold and flu in adults and adolescents over 12 years of age.

Use this medication only if you have nasal congestion with pain or fever. If you only have one of these symptoms, you should consult your doctor or pharmacist about using ibuprofen or pseudoephedrine alone.

You should consult a doctor if it worsens or does not improve after 3 days in adolescents, and 5 days in adults.

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

Do not take Ibuprofeno/Pseudoefedrina Nutra Essential:

• if you are allergic to ibuprofen, pseudoephedrine, or any of the other components of this medication (included in section 6).
• if you are under 12 years old.
• if you are pregnant or breastfeeding.
• if you have previously suffered an allergic reaction or asthma, skin rashes, itching, runny nose, or swelling of the face or hives when you have taken this medication, ibuprofen, acetylsalicylic acid, or similar medications.
• if you have a stomach ulcer or a history of stomach ulcers.
• if you have previously suffered gastrointestinal bleeding related to the use of NSAIDs.
• if you have severe liver or kidney disease.
• if you have heart or circulation problems (heart disease, hypertension, angina, tachycardia), hyperthyroidism, diabetes, pheochromocytoma (a tumor in the adrenal gland).
• if you have a history of heart attack (myocardial infarction).
• if you have uncontrolled high blood pressure.
• if you have had a stroke or have been told you are at risk of having a stroke.
• if you have a history of seizures (epileptic attacks).
• if you have disorders of unknown origin in the formation of blood elements.
• if you have high eye pressure (angle-closure glaucoma).
• if you have difficulty urinating due to prostate problems.
• if you have Systemic Lupus Erythematosus (SLE), a disease that affects the immune system and causes joint pain, skin changes, and other problems.
• if you are taking:
• • acetylsalicylic acid (more than 75 mg/day), other non-steroidal anti-inflammatory drugs (NSAIDs), or other analgesics.
  • other nasal decongestants (vasoconstrictor medications) administered orally or nasally (e.g., phenylpropanolamine, phenylephrine, ephedrine, xylometazoline, or oxymetazoline) or methylphenidate.
  • non-selective monoamine oxidase inhibitor medications (known as MAOIs, used to treat Parkinson's disease or depression) or if you have taken them in the last 14 days.

Children and adolescents under 12 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen/Pseudoephedrine Nutra Essential:

• if you have asthma; taking this medication may trigger an asthma attack.
• if your doctor has informed you that you have a blood coagulation disorder.
• if you are taking anticoagulant medications such as warfarin or low-dose acetylsalicylic acid.
• if you are taking medications that may increase the risk of stomach ulcers or bleeding, such as steroids, selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine or paroxetine, or NSAIDs, including aspirin.
• if you have psychosis or diabetes.
• if you have a history of gastrointestinal disorders (such as ulcerative colitis, hiatal hernia, gastrointestinal bleeding, Crohn's disease).
• if you have liver or kidney problems.
• if you are taking medications for migraines.
• 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").
• if you have high blood pressure, diabetes, or high cholesterol, have a family history of heart disease or stroke, or are a smoker.
• if you have hyperthyroidism (overactive thyroid gland).
• if you have an infection; see the "Infections" section below.

Pain relievers/anti-inflammatory medications like ibuprofen may be associated with a small increased risk of having a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

If you develop a generalized febrile erythema associated with pustules, stop taking Ibuprofen/Pseudoephedrine Nutra Essential and contact your doctor or seek immediate medical attention. See section 4.

With Ibuprofen/Pseudoephedrine Nutra Essential, blood flow to the optic nerve may be reduced. If you experience sudden loss of vision, stop taking Ibuprofen/Pseudoephedrine Nutra Essential and contact your doctor or seek immediate medical attention. See section 4.

Skin reactions

Severe skin reactions have been reported with Ibuprofen/Pseudoephedrine Nutra Essential treatment. Stop taking Ibuprofen/Pseudoephedrine Nutra Essential and see a 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 severe skin reaction. See section 4.

Sudden abdominal pain or rectal bleeding may occur with the use of Ibuprofen/Pseudoephedrine Nutra Essential due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Ibuprofen/Pseudoephedrine Nutra Essential and contact your doctor or seek immediate medical attention. See section 4.

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

Interference with laboratory tests

If you are going to have any diagnostic tests (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.

Pseudoephedrine may interfere with some blood tests used for diagnosis. You should inform your doctor that you are taking this medication if you need to have a blood test.

Children

Ibuprofen/Pseudoephedrine Nutra Essential is contraindicated in children and adolescents under 12 years of age.

Taking Ibuprofen/Pseudoephedrine Nutra Essential withother medications

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

Do not take Ibuprofen/Pseudoephedrine Nutra Essential if you are taking:

• acetylsalicylic acid.
• other non-steroidal anti-inflammatory drugs (NSAIDs).
• other analgesics or medications that reduce fever.
• if you have been treated with non-selective monoamine oxidase inhibitors in the last 2 weeks (used to treat Parkinson's disease or depression).
• other vasoconstrictor agents used as nasal decongestants (e.g., phenylpropanolamine, phenylephrine, and ephedrine, administered orally and nasally).

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

• anticoagulant medications (e.g., to treat circulation problems/avoid coagulation, e.g., acetylsalicylic acid, warfarin, and 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).
• medications that may increase the risk of stomach ulcers or bleeding, such as steroids, selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine), or NSAIDs, including aspirin and selective cyclooxygenase-2 (COX-2) inhibitors.
• medications for arrhythmias, angina, heart failure, or fluid retention (cardiac glycosides) since Ibuprofen/Pseudoephedrine Nutra Essential may reduce their effects or increase the risk of arrhythmias, hypertension, or worsen renal function.
• cyclosporine (an immunosuppressant) since it may increase the risk of worsening renal function.
• medications for treating depression (lithium, tricyclic antidepressants) that may increase the risk of adverse reactions.
• concomitant use of phenytoin may increase plasma levels of this active ingredient. If used correctly, no monitoring of phenytoin plasma levels is required, as a general rule (max. during 5 days).
• other decongestants or medications to reduce appetite since they may increase the risk of adverse effects.
• probenecid or sulfinpyrazone may delay the excretion of ibuprofen.
• sulfonylureas (antidiabetics): although interactions with ibuprofen have not been described, it is recommended as a precaution when taken concomitantly to monitor blood glucose levels.
• medications to increase urination (diuretics).
• corticosteroids.
• high-dose methotrexate (20 mg per week), as it may increase the effect of methotrexate.
• quinolone antibiotics due to the increased risk of seizures.
• cyclosporine, tacrolimus, and trimethoprim.
• medications for migraines (including medications derived from ergot alkaloids)
• zidovudine (a medication for the treatment of HIV/AIDS).
• injectable heparin or preparations containing Ginkgo biloba, as it increases the risk of bleeding.
• mifepristone, NSAIDs may reduce the effect of mifepristone up to 8-12 days after taking it.
• antacids due to a possible increase in ibuprofen absorption.
• aminoglycoside antibiotics, as NSAIDs may increase the toxicity of these antibiotics.

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

Due to the administration of pseudoephedrine, acute hypertension may appear in the perioperative period. Therefore, discontinue treatment with Ibuprofen/Pseudoephedrine Nutra Essential several days before surgery and inform your anesthesiologist.

Taking Ibuprofen/Pseudoephedrine Nutra Essential withfood, beverages, and alcohol

Avoid consuming alcohol during treatment.

Pregnancy andbreastfeeding

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

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, Ibuprofen/Pseudoephedrine Nutra Essential may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Ibuprofen/Pseudoephedrine Nutra Essential is contraindicated during pregnancy and breastfeeding. The active ingredients, ibuprofen and pseudoephedrine, may cause serious problems in unborn children and have been detected in breastfed infants of mothers who have taken them.

Ibuprofen/Pseudoephedrine Nutra Essential contains ibuprofen, which belongs to a group of medications (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of treatment.

Athletes

Pseudoephedrine may produce positive results in doping tests.

Driving and using machines

Ibuprofen/Pseudoephedrine Nutra Essential has not shown effects on the ability to drive or use machines. However, dizziness and hallucinations may occur in exceptional cases.

Ibuprofen/Pseudoephedrine Nutra Essential contains

This medication may cause headaches, stomach upset, and diarrhea because it contains glycerol.

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

Patients on low-sodium diets should note that this medication contains 26.8 mg (1.17 mmol) of sodium per 10 ml.

3. How to take Ibuprofen/Pseudoephedrine Nutra Essential

Follow exactly the administration instructions of this medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is only for short-term use. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Do not take for more than 5 days in adults or 3 days in adolescents over 12 years unless your doctor indicates so.

The recommended dose is:

• adults and adolescents from 12 years: 10 ml of the oral suspension (equivalent to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 6 hours, if necessary.
• For more intense symptoms, 20 ml of the oral suspension (equivalent to 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride) every 6 to 8 hours, not exceeding the maximum daily dose of 60 ml per day (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride).

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).

Never exceed the maximum daily dose of 60 ml per day (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride).

Extract the recommended dose from the bottle using the dosing syringe contained in the packaging. Release the suspension slowly into the mouth and then take water.

Use in children and adolescents

Ibuprofen/Pseudoephedrine Nutra Essential is contraindicated in children and adolescents under 12 years.

If adolescents need to take this medication for more than 3 days, or if symptoms worsen, they should consult a doctor.

If you take more Ibuprofen/Pseudoephedrine Nutra Essential than you should

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

Overdose symptoms 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, low potassium levels in the blood, chills, and breathing difficulties have been reported.

In case of overdose or accidental ingestion, consult immediately with your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the prospectus of the medication to the healthcare professional.

If you forgot to take Ibuprofen/Pseudoephedrine Nutra Essential

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

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Stop taking Ibuprofen/Pseudoephedrine Nutra Essential and contact your doctor immediately if you notice:

• Signs of a severe allergic reactionsuch as: difficulty breathing or swallowing, unknown lung noises, inflammation in the face, lips, tongue, or throat, skin itching, and hives, skin reactions, including blisters under the skin, palpitations with low blood pressure.
• Signs of intestinal bleedingsuch as: bright red stools (defecations), black tarry stools, vomiting blood or particles that resemble coffee grounds.
• A severe skin reactionknown 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).

Frequency "not known"

• Sudden onset of fever, skin redness, or many small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) that may occur within the first 2 days of treatment with Ibuprofen/Pseudoephedrine Nutra Essential. See section 2.
• Generalized red scaly rash, with bumps under the skin and localized blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno/Pseudoefedrina Nutra Essential if you present these symptoms and seek immediate medical attention. See also section 2.
• Decreased blood flow to the optic nerve (ischemic optic neuropathy).
• The skin becomes sensitive to light.

Consult your doctor if you have any of the following adverse effects, if they worsen, or if you notice any effect not mentioned.

Frequent (may affect up to 1 in 10 people):

• stomach disorders such as stomach discomfort, indigestion, nausea, vomiting, flatulence, diarrhea, constipation, and loss of appetite.

Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, difficulty sleeping, nervousness, irritability, or fatigue
• visual disturbances
• dry mouth, thirst
• stomach pain or ulcer, sometimes with perforation or bleeding, worsening of colitis or Crohn's disease
• skin rashes, hives (erythema), itching, redness, and inflammation.

Rare (may affect up to 1 in 1,000 people):

• tinnitus (ringing in the ears)
• nervousness, tremors, anxiety, agitation, and hallucinations
• worsening of asthma
• inflammation, high blood pressure, palpitations, rapid heartbeat, chest pain, and shortness of breath
• kidney damage, elevated uric acid levels in the blood
• heart rhythm disorders, chest pain

Very rare (may affect up to 1 in 10,000 people):

• infectious inflammation, symptoms of meningitis (headache, fever, stiffness in the neck)
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are: fever, sore throat, superficial ulcers in the mouth, unexplained nosebleeds, and the appearance of bruises
• severe allergic reactions
• psychotic reactions, depression
• kidney failure and kidney disorders, difficulty urinating
• liver disorders
• esophagitis (burning); pancreatitis
• severe skin reactions.

Frequency not known (cannot be estimated from the available data):

• inflammation of the colon due to insufficient blood irrigation (ischemic colitis).

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: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofen/Pseudoephedrine Nutra Essential

Keep this medication out of sight and reach of children.

No special storage conditions are required. This medication should be used within 6 months after opening.

Do not use this medication after the expiration date that appears on the packaging 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 packaging and medications that are no longer needed at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofen/Pseudoephedrine Nutra Essential

The active ingredients are ibuprofen (20 mg/ml) and pseudoephedrine hydrochloride (3 mg/ml).

The other components (excipients) are: sodium benzoate, anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E-422), thaumatin (E-957), orange flavor 052595/A (contains butylhydroxyanisole (E-320), alpha-tocopherol (E307), and flavoring substances and preparations) and purified water.

Appearance of the product and package contents

White-colored suspension with an orange flavor.

It is presented in 150 and 200 ml packages. It includes a 5 ml dosing syringe, graduated in milliliters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Nutra Essential OTC, S.L.

C/ La Granja, nº1, 28108

Alcobendas (Madrid)

Spain

Manufacturer

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

EDEFARM, S.L.

Poligono Industrial Enchilagar del Rullo, 117

Villamarchante (Valencia)

Spain

Date of the last revision of this prospectus: November 2024

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