IBUPROFEN/PHENYLEPHRINE NUTRA ESSENTIAL 40 mg/mL + 1 mg/mL ORAL SUSPENSION

Introduction

Leaflet: information for the user

Ibuprofen/Phenylephrine Nutra Essential 40 mg/ml + 1 mg/ml oral suspension

Ibuprofen/Phenylephrine hydrochloride

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

Follow the administration instructions of the medicine 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, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve
  • after 5 days if you are an adult, or
  • after 3 days if you are a child over 7 years or an adolescent.

Contents of the leaflet

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

5 Conservation of Ibuprofen/Phenylephrine Nutra Essential

1. Package contents and additional information

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

Ibuprofen/Phenylephrine Nutra Essential contains ibuprofen and phenylephrine hydrochloride. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and is effective against pain (including headache), inflammation, and can also reduce fever. Phenylephrine hydrochloride is a nasal decongestant that relieves nasal congestion.

This medicine is indicated for the relief of symptoms associated with flu and colds, such as mild or moderate pain, nasal congestion (stuffy nose), and to reduce fever, in adults, adolescents, and children over 7 years.

You should consult a doctor if it worsens or does not improve, after 5 days if you are an adult, or after 3 days if you are a child over 7 years or an adolescent.

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

Do not take Ibuprofen/Phenylephrine Nutra Essential:

• if you are allergic to ibuprofen, phenylephrine hydrochloride, or any of the other components of this medicine (listed in section 6), or to acetylsalicylic acid or other analgesics
• if you have ever had an ulcer, perforation, or bleeding in the stomach
• if you have had worsening of asthma, skin rash, nasal secretion with itching, or facial swelling when taking ibuprofen, acetylsalicylic acid, or similar medicines
• if you have had gastrointestinal bleeding or perforation when taking NSAIDs (non-steroidal anti-inflammatory drugs)
• if you are taking other analgesic NSAIDs
• if you are taking more than 75 mg of acetylsalicylic acid per day. If you are taking low doses of acetylsalicylic acid (up to 75 mg per day), consult your doctor or pharmacist before taking this medicine
• if you have severe liver or kidney problems
• if you have severe heart problems (severe heart failure), high blood pressure, or blood coagulation disorder
• if you have breathing difficulties
• if you have hyperthyroidism
• if you are taking or have taken in the last 14 days a medicine called a monoamine oxidase inhibitor (usually used to treat depression)
• if you are in the last 3 months of pregnancy (see also section 2 "Pregnancy, breastfeeding, and fertility")
• if you are under 7 years old

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen/Phenylephrine Nutra Essential 40 mg/ml + 1 mg/ml oral suspension if:

• you have or have had asthma
• you have kidney, heart, liver, or intestinal problems
• you have high cholesterol or have previously had a heart attack or stroke
• you have any gastrointestinal disease (such as ulcerative colitis or Crohn's disease)
• you have systemic lupus erythematosus (a disease of the immune system that causes joint pain, skin changes, or other organ disorders)
• you are a smoker
• you are in the first 6 months of pregnancy
• If you have an infection; see the "Infections" heading later.

Taking anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke, especially when taken in high doses. Do not exceed the recommended dose or treatment duration.

Consult your doctor or pharmacist before taking Ibuprofen/Phenylephrine Nutra Essential 40 mg/ml + 1 mg/ml oral suspension if you:

• have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrow or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
• have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Special caution is recommended with Ibuprofen/Phenylephrine Nutra Essential

Skin reactions

Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Ibuprofen/Phenylephrine Nutra Essential treatment. Discontinue treatment with Ibuprofen/Phenylephrine Nutra Essential and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen 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 medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Ibuprofen/Phenylephrine Nutra Essential immediately and contact your doctor or the emergency medical service immediately if you notice any of these signs.

Children and adolescents

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

Taking Ibuprofen/Phenylephrine Nutra Essentialwithother medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

To reduce the risk of side effects, do not take this medicine with other NSAIDs (e.g., acetylsalicylic acid, ibuprofen). If you are taking low doses of acetylsalicylic acid (up to 75 mg per day), consult your doctor or pharmacist before taking this medicine.

Avoid taking this medicine with the following medicines:

• corticosteroids, used to treat asthma and various inflammatory disorders (e.g., prednisolone, beclomethasone)
• quinolone antibiotics, used to treat bacterial infections (e.g., ciprofloxacin, norfloxacin, levofloxacin)
• anticoagulant medicines (i.e., thin the blood or prevent blood clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• heart medicines (e.g., glycosides) or medicines that lower blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, angiotensin II receptor antagonists like losartan)
• medicines used to help you urinate (diuretics)
• medicines used for temporary suppression of the immune system (e.g., methotrexate, cyclosporine, tacrolimus)
• medicines used to treat mania or depression (e.g., lithium or SSRIs)
• medicines used for abortion (e.g., mifepristone)
• medicines used to treat HIV (e.g., zidovudine)

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 this medicine.

Ibuprofen/Phenylephrine Nutra Essential belongs to a group of medicines that may affect female fertility. Fertility returns to normal when you stop taking this medicine. It is unlikely that if you take Ibuprofen/Phenylephrine Nutra Essential only occasionally, it will affect your chances of becoming pregnant. If you have problems becoming pregnant, consult your doctor before taking this medicine.

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 delivery 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 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 checks.

Do not take this medicine in the last 3 months of pregnancy, it is contraindicated.

Do not use this medicine in the first 6 months of pregnancy unless your doctor advises you to do so.

Consult your doctor or pharmacistBEFOREtaking this medicine if you are breastfeeding.

Driving and using machines

No adverse effects of this medicine on the ability to drive and use machines are known.

Ibuprofen/Phenylephrine Nutra Essential oral suspension contains maltitol liquid (E-965).If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Ibuprofen/Phenylephrine Nutra Essential oral suspension contains sodium.This medicine contains less than 23 mg of sodium (1 mmol) per ml; this is, essentially "sodium-free".

3. How to take Ibuprofen/Phenylephrine Nutra Essential

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

Method of administration

Ibuprofen/Phenylephrine Nutra Essentialis an oral suspension. It can be administered directly or diluted in water.

1. Shake the bottle before use.
2. Insert the syringe into the hole in the cap.
3. Invert the bottle and withdraw the required dose.
4. Administer the contents of the syringe directly into the mouth or into a spoon.

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension; make sure you have shaken the bottle well before administering the medicine.

Patients with stomach upset should take the medicine with milk and/or during meals.

Dose

Children between 7 and 12 years:

The recommended dose calculated based on the child's weight and age is indicated in the following table:

The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours. Do not take more than the maximum daily dose indicated in the table.

Adults, elderly patients, and adolescents over 12 years:

Take 10 ml of the oral suspension every 8 hours. The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours. Do not take more than 30 ml in 24 hours.

Treatment duration

This medicine is for short-term use only. Take the lowest dose for the shortest time necessary to relieve your symptoms.

Adults:

Do not take Ibuprofen/Phenylephrine Nutra Essential for more than 5 days.

Children over 7 years and adolescents:

Do not take Ibuprofen/Phenylephrine Nutra Essential for more than 3 days.

If it does not improve, or worsens, consult your doctor.

It is important to drink plenty of fluids when you have a cold or flu.

Children under 7 years should not take this medicine.

If you take more Ibuprofen/Phenylephrine Nutra Essentialthan you should or if a child under 7 years has taken this medicine accidentally, contact your doctor or go to the nearest hospital for advice on the risk or actions to be taken.

The symptoms may include nausea, stomach pain, vomiting (which may be bloody), headache, ringing in the ears, confusion, and involuntary eye movements. At high doses, somnolence, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported.

In case of overdose or accidental ingestion, go immediately to a medical center even if you feel well, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forgot to take Ibuprofen/Phenylephrine Nutra Essential

Consult the previous instructions on how to take this medicine and do not take more than advised.

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. You may suffer from one of the known side effects of NSAIDs (see below).

If you notice any of the following adverse effects at any time during treatment, STOPtaking this medicine and seek medical help immediately:

• Signs of intestinal bleeding,such as:

• bright red stools, tarry stools
• vomiting blood or dark particles that resemble coffee grounds

• Signs of severe allergic reaction,such as:

• unexplained difficulty breathing or wheezing
• dizziness or rapid heartbeat
• severe skin reactions, such as itching, skin rash with redness, scaling, blisters (e.g., Stevens-Johnson syndrome)
• swelling of the face, tongue, or throat

• Signs of kidney problems,such as:

• urinating more or less than usual
• cloudy urine or blood in the urine
• back pain and/or swelling (especially in the legs)

• Signs of aseptic meningitis,such as:

• stiff neck
• headache
• feeling unwell
• fever or disorientation. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) may be more prone to being affected.

Stop taking this medicine and inform your doctor if you experience the following uncommon side effectsthat may affect up to 1 in 100 people:

• indigestion, acidity, or discomfort
• stomach pain (abdomen) or other abnormal stomach problems

Tell your doctor if you have any of the following side effects, if they worsen, or if you notice any effect not described:

• Uncommon adverse effectsthat may affect up to 1 in 100 people:

• allergic reactions such as skin rashes (hives), itching, scaling
• headache, dizziness, tinnitus (ringing in the ears)

• Rare adverse effectsthat may affect up to 1 in 1,000 people:

• flatulence (gas), diarrhea, constipation, and vomiting

• Very rare adverse effectsthat may affect up to 1 in 10,000 people:

• blood disorder resulting in unexplained bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms, and severe fatigue
• decreased blood pressure or irregular heartbeat
• liver problems

• Adverse effectsfor which the frequency cannot be estimated from the available data (unknown frequency):

• worsening of asthma or bronchospasm
• swelling (edema), high blood pressure, heart failure, or heart attack
• worsening of colitis and Crohn's disease
• difficulty urinating (in men only)
• generalized red scaly rash, with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen/Phenylephrine Nutra Essential if you experience these symptoms and seek medical attention immediately. See also section 2.
• skin becomes sensitive to light.
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Interrupt treatment with and seek medical attention immediately if you notice any of the following symptoms:

• Red, non-raised, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Medicines like Ibuprofen/Phenylephrine Nutra Essential 40 mg/ml + 1 mg/ml oral suspension may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. See section 2 "Warnings and Precautions".

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 leaflet. 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 medicine.

5. Storage of Ibuprofen/Phenylephrine Nutra Essential

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the 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. Package Contents and Additional Information

Composition of Ibuprofen/Phenylephrine Nutra Essential

• The active ingredients are ibuprofen and phenylephrine hydrochloride. Each milliliter (ml) of the oral solution contains 40 mg of ibuprofen and 1 mg of phenylephrine hydrochloride.

• The other components (excipients) are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate (E-331), sodium saccharin, sodium chloride, hypromellose 15 cP, xanthan gum, liquid maltitol (E-965), glycerol (E-422), thaumatin (E-957), orange flavor 052595/A (which contains butylhydroxyanisole (E-320), alpha-tocopherol (E-307), flavoring substances, and flavoring preparations) and purified water.

Appearance of the Product and Package Contents

Oral suspension, viscous, free of foreign substances, white and with a characteristic orange flavor.

Packages of 100 and 150 ml: polyethylene terephthalate (PET) bottle, low-density polyethylene (LDPE) adapter, and child-resistant high-density polyethylene (HDPE) cap, plus oral syringe (5 ml).

Marketing Authorization Holder and Manufacturer

Farmalider S.A.

C/ La Granja, 1, 3ºB

28108 Alcobendas – Madrid

Spain

Manufacturer

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117,

46191 Villamarchante - Valencia

Spain

or

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas - Madrid

Spain

Date of the Last Revision of thisLeaflet: November 2024

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/