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

Package leaflet: Information for the user

Introduction

Package 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 you start taking this medicine because it contains important information for you.

Follow exactly the instructions for administration provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve

  • after 5 days if you are an adult, or
  • after 3 days if you are a child over 7 years of age or an adolescent.

Contents of the leaflet

1. What Ibuprofen/Phenylephrine Nutra Essential is and what it is 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. Storage of Ibuprofen/Phenylephrine Nutra Essential

6. Contents of the pack and other information

1. What Ibuprofeno/Fenilefrina Nutra Essential is and what it is used for

Ibuprofeno/Fenilefrina 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 influenza and the common cold, such as mild to moderate pain, nasal congestion (stuffy nose), and fever, in adults, adolescents, and children over 7 years of age.

You should consult a doctor if your condition 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 of age or an adolescent.

2. What you need to know before taking Ibuprofeno/Fenilefrina Nutra Essential

Do not take Ibuprofeno/Fenilefrina Nutra Essential:

• if you are allergic to ibuprofen, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6), or to acetylsalicylic acid or other analgesics
• if you have ever had a stomach ulcer, perforation, or gastrointestinal bleeding
• if you have previously experienced worsening asthma, skin rash, itchy nasal discharge, or facial swelling after taking ibuprofen, acetylsalicylic acid, or similar medicines
• if you have had gastrointestinal bleeding or perforation while taking NSAIDs (non-steroidal anti-inflammatory drugs)
• if you are currently taking other NSAID analgesics
• if you are taking more than 75 mg of acetylsalicylic acid per day. If you are taking low-dose 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 a blood coagulation disorder
• if you have breathing difficulties
• if you have hyperthyroidism
• if you are taking or have taken within the last 14 days a medicine called 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 of age

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno/Fenilefrina 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 a gastrointestinal disease (such as ulcerative colitis or Crohn's disease)
• you have systemic lupus erythematosus (an immune system disease causing joint pain, skin changes, or other organ disorders)
• you are a smoker
• you are in the first 6 months of pregnancy
• you have an infection; see the "Infections" section below.

The use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially when high doses are taken. Do not exceed the recommended dose or duration of treatment.

Consult your doctor or pharmacist before taking Ibuprofeno/Fenilefrina 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 narrowed 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 Ibuprofeno/Fenilefrina Nutra Essential

Skin reactions

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

Infections

Ibuprofeno Codramol may mask signs of infection such as fever and pain. Therefore, Ibuprofeno Codramol may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and in bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and symptoms of infection persist or worsen, consult a doctor immediately.

Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Ibuprofeno/Fenilefrina Nutra Essential immediately and contact your doctor or emergency medical services immediately if you experience any of these symptoms.

Children and adolescents

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

Taking Ibuprofeno/Fenilefrina Nutra Essential with other medicines

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

To reduce the risk of side effects, do not take this medicine with other NSAIDs (e.g., acetylsalicylic acid, ibuprofen). If you are on low-dose acetylsalicylic acid treatment (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, beclometasone)
• quinolone antibiotics, used to treat bacterial infections (e.g., ciprofloxacin, norfloxacin, levofloxacin)
• anticoagulant medicines (i.e., blood thinners or those preventing clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines for the heart (e.g., cardiac glycosides) or those that reduce blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• medicines used to help eliminate urine (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 termination of pregnancy (e.g., mifepristone)
• medicines used for the treatment of HIV (e.g., zidovudine)

Pregnancy, breastfeeding, and fertility

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

Ibuprofeno/Fenilefrina Nutra Essential belongs to a group of medicines that may affect female fertility. Fertility returns to normal once this medicine is discontinued. It is unlikely that occasional use of Ibuprofeno/Fenilefrina Nutra Essential will affect your chances of becoming pregnant. If you have difficulty becoming pregnant, consult your doctor before taking this medicine.

Do not take ibuprofen during 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 tendency and that of your baby to bleed and may delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno Nutra Essential may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Do not take this medicine during the last 3 months of pregnancy; it is contraindicated.

Do not use this medicine during the first 6 months of pregnancy unless advised otherwise by your doctor.

Consult your doctor or pharmacist BEFORE taking this medicine if you are breastfeeding.

Driving and use of machines

No adverse effects of this medicine on the ability to drive or operate machinery are known.

Ibuprofeno/Fenilefrina Nutra Essential oral contains liquid maltitol (E-965). If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Ibuprofeno/Fenilefrina Nutra Essential oral 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 exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult 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 immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Instructions for use

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

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

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension; ensure that you have shaken the bottle well before administering the medication.

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

Dosage

Children between 7 and 12 years of age:

The recommended dose, calculated according to the child's weight and age, is indicated in the following table:

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

Adults, elderly patients, and adolescents over 12 years of age:

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

Duration of treatment

This medicine is intended only for short-term use. Take the lowest effective 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 of age and adolescents:

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

If symptoms do not improve or worsen, consult your doctor.

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

Children under 7 years of age must not take this medicine.

If you take more Ibuprofen/Phenylephrine Nutra Essential than you should, or if a child under 7 years of age has accidentally taken this medicine, contact your doctor or go to the nearest hospital to obtain information about the risk or actions to be taken.

Symptoms may include nausea, stomach pain, vomiting (possibly bloody), headache, tinnitus, confusion, and involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold in the body, and breathing difficulties have been reported.

In case of overdose or accidental ingestion, seek immediate medical attention even if you feel well, or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested.

If you forget to take Ibuprofen/Phenylephrine Nutra Essential

Refer to the instructions above on how to take this medicine and do not take more than advised.

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

If you have any further 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 everyone will experience them.

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

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

• signs of gastrointestinal bleeding, such as:

• bright red stools, tarry stools

• vomiting blood or dark particles that look like coffee grounds

• signs of a severe allergic reaction, such as:

• difficulty breathing or unexplained wheezing

• dizziness or rapid heartbeat

• severe skin reactions, such as itching, skin rashes with redness, peeling, 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:

• neck stiffness

• headache

• feeling unwell or sick

• fever or confusion. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) may be more likely to be affected.

Stop taking this medicine and contact your doctor if you experience the following uncommon side effects, which may affect up to 1 in 100 people:

• indigestion, heartburn, or discomfort
• stomach (abdominal) pain or other abnormal stomach problems

Tell your doctor if you experience any of the following side effects, if they worsen, or if you notice any unlisted effect:

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

• allergic reactions such as skin rashes (urticaria), itching, peeling

• headache, dizziness, tinnitus (ringing in the ears)

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

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

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

• blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms, and severe fatigue

• low blood pressure or irregular heartbeat

• liver problems

• Adverse effects for which frequency cannot be estimated from available data (frequency not known):

• worsening of asthma or bronchospasm

• swelling (edema), high blood pressure, heart failure, or heart attack

• worsening of colitis or Crohn’s disease

• difficulty urinating (in men only)

• widespread red, scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen/Phenylephrine Nutra Essential if you develop these symptoms and seek immediate medical attention. See also section 2.

• skin becomes sensitive to light

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Discontinue treatment with and seek immediate medical attention if you notice any of the following symptoms:

• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may 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).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Medicines such as 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen/Phenylephrine Nutra Essential

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen/Phenylephrine Nutra Essential

• The active substances are ibuprofen and phenylephrine hydrochloride. Each millilitre (ml) of 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 flavour 052595/A (containing butylated hydroxyanisole (E-320), alpha-tocopherol (E-307), flavouring substances and flavouring preparations), and purified water.

Nature of the product and pack contents

Oral suspension, viscous, free from foreign particles, white in appearance, with a characteristic orange aroma.

Pack sizes of 100 ml and 150 ml: polyethylene terephthalate (PET) bottle, low-density polyethylene (LDPE) adapter, high-density polyethylene (HDPE) child-resistant safety cap, plus an oral dosing 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 most recent revision of this product information: November 2024

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