IBUPROFEN/PHENYLEPHRINE NUTRA ESSENTIAL 200 MG/5 MG ORAL SUSPENSION

Introduction

Leaflet: Information for the patient

Ibuprofen/Phenylephrine Nutra Essential 200 mg/5 mg oral suspension

Ibuprofen/Phenylephrine 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, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve
• • after 5 days in adults, or
  • after 3 days in children over 7 years or adolescents.

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. Storage of Ibuprofen/Phenylephrine Nutra Essential
6. 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. This medication 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.

Ibuprofen belongs to a group of medications 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.

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 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, runny nose 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 NSAID analgesics
• 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 7 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 heading "Infections" below.

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, it is possible that ibuprofen may delay the proper 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), 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, beclometasone)
• 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 ability to clot and prolong 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, the lowest dose should be used 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 5.0 mg of sodium benzoate in each sachet.

Ibuprofen/Phenylephrine Nutra Essential contains sodium.

This medication contains 26.9 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to 1.3% 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 leaflet or as indicated by your doctor or pharmacist.

The effective lowest dose should be used 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 for administration by mouth. 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 and flu.

Dose

Adults, elderly patients, and adolescents over 12 years:

Take 2 sachets of the oral suspension every 6-8 hours. Allow at least 4 hours between doses and do not take more than 6 sachets per day.

Children between 10 and 12 years:

Take 1 sachet of the oral suspension every 4-6 hours. Allow at least 4 hours between doses and do not take more than 4 sachets per day.

Children 7-9 years:

Take 1 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.

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 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.

Children under 7 years old cannot 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 7 years 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 cold, and breathing problems have been reported.

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

Secondary effects can be minimized by taking the lowest dose for the shortest time necessary to alleviate 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 immediate medical attention:

• 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
• swelling of the face, tongue, or throat
• reddish, non-elevated, target-like or circular patches 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].
• Widespread rash, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome). Widespread, 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:

• neck stiffness
• 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 unusual bleeding, fever, sore throat, mouth ulcers, flu-like symptoms, and severe fatigue
• decreased blood pressure or irregular heartbeat
• liver problems

Adverse effectsof 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)
• widespread 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.

• the skin becomes sensitive to light.

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).

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 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 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 (5 ml) of the oral solution contains 200 mg of ibuprofen and 5 mg of phenylephrine hydrochloride.
• The other components (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, and with a characteristic orange flavor.

Packaging of 10, 12, and 24 sachets of 5ml

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/