IBUPROFEN/PHENYLEPHRINE NUTRA ESSENTIAL 400 MG/10 MG ORAL SUSPENSION

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

Do not take Ibuprofeno/Phenylephrine Nutra Essential:

• if you are allergic to ibuprofen, phenylephrine hydrochloride, or any of the other components of this medication (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 medications
• 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 medication
• 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 medication 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 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen/Phenylephrine hydrochloride 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
• you have diabetes
• you have glaucoma
• you have prostate enlargement
• you have an infection; see the "Infections" heading below.

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, it is possible that ibuprofen may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and in 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.

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 syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofen/Phenylephrine and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

With ibuprofen, signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using this medication immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Taking anti-inflammatory/analgesic medications 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 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.

Children and adolescents

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

Other medications and Ibuprofen/Phenylephrine Nutra Essential

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

To reduce the risk of side effects, do not take this medication 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 medication.

This medication may affect or be affected by other medications.

Avoid taking this medication with the following medications:

• 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 medications (i.e., blood thinners or prevent blood clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• heart medications (e.g., glycosides) or medications that lower blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, angiotensin II receptor antagonists like losartan)
• medications used to help you urinate (diuretics)
• medications used for temporary suppression of the immune system (e.g., methotrexate, cyclosporine, tacrolimus)
• medications used to treat mania or depression (e.g., lithium or SSRIs)
• medications used for abortion (e.g., mifepristone)
• medications 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 medication.

Ibuprofen/Phenylephrine hydrochloride belongs to a group of medications that may affect female fertility. Fertility returns to normal when you stop taking this medication. 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 medication.

Inform your doctor if you become pregnant while taking this medication DO NOT take this medication 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 the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.

DO NOT take this medication during the first 6 months of pregnancy unless absolutely necessary and indicated by your doctor.

If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest possible time.

From the 20th week of pregnancy, this medication may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

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

Driving and using machines

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

Ibuprofen/Phenylephrine Nutra Essential contains liquid maltitol (E-965).

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

Ibuprofen/Phenylephrine Nutra Essential contains sodium benzoate (E-211).

This medication contains 10.0 mg of sodium benzoate in each sachet.

Ibuprofen/Phenylephrine Nutra Essential contains sodium.

This medication contains 53.7 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to 2.7% of the maximum recommended daily sodium intake for an adult.

3. How to take Ibuprofen/Phenylephrine Nutra Essential

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

Use the lowest effective dose for the shortest necessary time 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 in sachets for oral administration. It can be administered directly or diluted in water.

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

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

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

Dose

Adults, elderly patients

Take one sachet of the oral suspension every 6-8 hours. Allow at least 4 hours between doses and do not take more than 3 sachets per day.

Adolescents and children over 12 years old

Take one sachet of the oral suspension every 6-8 hours. Allow at least 4 hours between doses and do not take more than 3 sachets per day.

Children under 12 years old

The use of this medication is not recommended for children under 12 years old.

Treatment duration

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

Adults:

DO NOT take Ibuprofen/Phenylephrine Nutra Essential for more than 5 days.

Children over 12 years old and adolescents:

DO NOT take Ibuprofen/Phenylephrine Nutra Essential for more than 3 days.

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

Children under 12 years old MUST NOT take this medication.

If you take more Ibuprofen/Phenylephrine Nutra Essentialthan you should:

If you have taken more of this medication than you should or a child under 12 years old has taken this medication accidentally, contact your doctor or go to the nearest hospital for advice on the risk or actions to be taken.

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 medication and the amount ingested.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may be bloody), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movements. Agitation, somnolence, disorientation, or coma may also occur. In some cases, patients develop seizures. At high doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in urine, low potassium levels in the blood, feeling of cold in the body, and breathing problems have been reported.

Additionally, the prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. In asthmatic patients, worsening of asthma may occur. Additionally, hypotension and decreased respiration may occur.

If you forget to take Ibuprofen/Phenylephrine Nutra Essential

Consult the previous instructions on how to take this medication 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 medication, 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 adverse 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 medical help immediately:

• signs of intestinal bleeding,such as:
• • stools of bright red color, tarry stools
  • vomiting blood or with dark particles that look like coffee grounds
• signs of severe allergic reaction, such as:
• • unexplained difficulty breathing or wheezing
  • dizziness or rapid heartbeat
  • swelling of the face, tongue, or throat
  • red patches, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
  • generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome). Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
• 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 rare adverse 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 adverse effects, if they worsen, or if you notice any effect not described in this leaflet:

• Rare adverse effectsthat may affect up to 1 in 100 people:
• • allergic reactions such as skin rashes (hives), itching, peeling
  • headache, dizziness, tinnitus (ringing in the ears)

• Very 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 effects of unknown frequency (frequency cannot be estimated from available data):
• • 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 immediate medical attention. See also section 2.
  • chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.
  • skin becomes sensitive to light.

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

Medicines like Ibuprofen/Phenylephrine Nutra Essential 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 is not listed 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 the sight and reach of children.

Do not use this medicine after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This 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 sachet (10ml) of the oral solution contains 400mg of ibuprofen and 10mg of phenylephrine hydrochloride.

• The other ingredients (excipients) are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), glycerol (E-422), thaumatin (E-957), orange flavor (containing butylhydroxyanisole (E-320)), and purified water.

Appearance of the Product and Package Contents

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

Packaging of 12 and 20 sachets of 10ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

NUTRA ESSENTIAL OTC, S.L.

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 this Leaflet: December 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/