PARACETAMOL/IBUPROFEN NUTRA ESSENTIAL 500 mg/200 mg GRANULES

Introduction

Package Leaflet: Information for the Patient

Paracetamol/Ibuprofen Nutra Essential 500 mg/200 mg Granules

Read the entire package 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 package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package 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 side effects not listed in this package leaflet. See section 4.
• You must not take this medication for more than 3 days.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Package Leaflet

1. What is Paracetamol/Ibuprofen Nutra Essential and what is it used for
2. What you need to know before taking Paracetamol/Ibuprofen Nutra Essential
3. How to take Paracetamol/Ibuprofen Nutra Essential
4. Possible side effects
5. Storage of Paracetamol/Ibuprofen Nutra Essential
6. Package Contents and Additional Information

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

Paracetamol/Ibuprofen Nutra Essential contains two active substances (that make the medication work). These are ibuprofen and paracetamol.

Ibuprofen belongs to a group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). Paracetamol works differently from ibuprofen, but both active substances work together to reduce pain.

Paracetamol/ibuprofen is used for the symptomatic occasional treatment of mild to moderate pain. This medication is especially indicated for pain that has not been relieved by ibuprofen or paracetamol alone.

Paracetamol/ibuprofen is used in adults over 18 years of age.

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

Do not take Paracetamol/Ibuprofen Nutra Essential if:

• you are allergic to ibuprofen, paracetamolor to any of the other components of this medication (included in section 6),
• you are taking any other medication that contains paracetamol,
• you have a history of allergic reactions (e.g., bronchospasm, angioedema, asthma, rhinitis, or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• you have an active or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or bleeding confirmed),
• you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• you have a cerebrovascular hemorrhage or other active bleeding,
• you suffer from blood coagulation disorders,
• you suffer from severe heart, liver, or kidney failure,
• you are severely dehydrated, caused by vomiting, diarrhea, or insufficient fluid intake,
• you are in the last 3 months of pregnancy,
• you are under 18 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Paracetamol/Ibuprofeno Nutra Essential if:

? you are an elderly patient,

? you have asthmaor have suffered from asthma,

? you have kidney, heart, liver, or intestinal problems, hepatitis, or difficulty urinating,

? you are being treated concomitantly with medications that affect liver function,

? you are allergic to other substances,

? you have stomach acid, indigestion, stomach ulcers, or any other stomach problem,

? you have a tendency to bleed,

? you have Gilbert's syndrome(a rare hereditary metabolic disorder with possible signs such as yellowing of the skin or the whites of the eyes),

? you have systemic lupus erythematosus(SLE), a condition of the immune system that affects connective tissue and causes joint pain, skin changes, and disorders of other organs or other mixed connective tissue disease,

? you have gastrointestinal disorders or chronic inflammatory bowel disease(e.g., ulcerative colitis, Crohn's disease),

? you have an infection; consult the section "Infections" below,

? you have a deficiencyof a certain enzyme called glucose-6-phosphate dehydrogenase,

? you have a hereditary or acquired genetic disorder of certain enzymes that manifests with neurological complications or skin problems and occasionally both, i.e., porphyria,

? you have hemolytic anemia,

? you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there may be a higher risk of allergic reactions,

? you suffer from chronic alcoholism,

? you have low weightor chronic malnutrition,

? you have a total body water deficiency(dehydration),

? you have recently had major surgery,

? you are in the first 6 months of pregnancyor are breastfeeding,

? you are planning to become pregnant.

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

Consult your doctor if any of the above warnings apply to you, or if you have experienced them in the past. You may need to avoid this medication or reduce the dose.

Side effects can be minimized by using the minimum effective dose for the shortest time necessary to control symptoms. Do not take this medication for more than 3 days.

Concomitant use with NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see below "Other medications and Paracetamol/Ibuprofeno Nutra Essential") and should be avoided.

Warning: taking higher doses than the recommended doses does not provide greater pain relief, but causes the risk of severe liver damage. Therefore, do not exceed the maximum daily dose of paracetamol. Do not take other medications that also contain paracetamol (see also the section "Do not take Paracetamol/Ibuprofeno Nutra Essential" above). Symptoms of liver damage usually occur for the first time after a couple of days. Therefore, it is essential to consult a doctor immediatelyif you have taken more than recommended. See also section 3 "If you take more Paracetamol/Ibuprofeno Nutra Essential than you should".

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

You should discuss your treatment with your doctor or pharmacist before taking this medication if:

? you have heart problems, such as heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs and feet due to narrow or blocked arteries) or any type of stroke (including 'mini-stroke' or transient ischemic attack "TIA"),

? you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Skin Reactions

Severe skin reactions have been reported with paracetamol/ibuprofen treatment. Stop taking this medication and go to the doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

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. Interrupt treatment with Paracetamol/Ibuprofeno Nutra Essential and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

Paracetamol/ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 immediately.

Gastrointestinal Symptoms

Severe gastrointestinal side effects (affecting the stomach and intestine) have been reported with the use of NSAIDs, including ibuprofen. These can occur with or without warning symptoms. The risk of these side effects is higher in patients with a history of stomach or intestinal ulcers, particularly if there was also bleeding or perforation. Elderly patients have a higher risk of gastrointestinal side effects. You should discuss any history of gastrointestinal problems with your doctor and remain alert to any unusual abdominal symptoms, such as nausea, vomiting, diarrhea, constipation, indigestion, abdominal pain, black stools, or vomiting blood.

Prolonged Use of Analgesics

Prolonged use of analgesics for headaches can worsen them. If you experience or suspect this situation, you should inform your doctor and interrupt treatment.

Regular use of analgesics, particularly in combination with several pain-relieving medications, can cause permanent kidney damage with a risk of kidney failure, a condition called analgesic nephropathy. This risk may increase under physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

Vision Problems

If you notice any vision problems after using paracetamol/ibuprofeno, stop using the medication and consult a doctor.

Other Considerations

In general, habitual intake of analgesics, particularly in combination with several analgesic active substances, can lead to permanent kidney damage with a risk of kidney failure. Therefore, it should be avoided.

Children and Adolescents

This medication is contraindicated in children and adolescents (under 18 years of age).

Other Medications and Paracetamol/Ibuprofeno Nutra Essential

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

Do not take this medication with other types of analgesics at the same time unless your doctor indicates so (see section "Warnings and Precautions"). Do not take other medications that contain paracetamol, such as some medications for colds and flu or pain.

This medication can affect other medications or be affected by them. For example:

• medicaments anticoagulants(used to thin blood/prevent clotting, such as acetylsalicylic acid, warfarin, and ticlopidine).

• medications that reduce high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• medications for treating epilepsy or convulsions (e.g., phenytoin).
• chloramphenicol, an antibiotic used to treat ear and eye infections.
• probenecid and sulfinpyrazone, medications used for the treatment of gout.
• zidovudine, a medication used to treat HIV (the virus that causes acquired immunodeficiency disease).
• medications used to treat tuberculosis, such as isoniazid.
• diuretics (to help urinate).
• lithium or ISRS, a medication used for the treatment of mania and some types of depression.
• methotrexate, a medication used for the treatment of arthritis and some types of cancer.
• corticosteroid tablets, such as prednisone, cortisone.
  • medicaments antiemetics(e.g., metoclopramide, domperidone),
  • acetylsalicylic acid, salicylates, or other NSAIDs (including COX-2 inhibitors like celecoxib or etoricoxib),
  • medications that decrease gastric emptying,
  • medications for treating bacterial infections called aminoglycosides,
  • antimycoticmedications that inhibit the liver enzyme CYP2C9 (e.g., voriconazole, fluconazole),
  • other medications thatare known to affect the liveror induce liver microsomal enzymessuch as alcohol and antiepileptic medications (e.g., carbamazepine, phenobarbital, lorazepam),
  • ginkgo biloba(a herbal medication) may increase the risk of bleeding with NSAIDs,

• medications for high cholesterol, for example: colestyramine, a medication used to reduce increased serum lipid levels.
• tacrolimus or cyclosporin, immunosuppressive medications used after organ transplantation.
• sulfonylureas, a medication used to treat diabetes.
• some antibiotics (such as quinolone or cotrimoxazole antibiotics)
• cardiac glycosides (e.g., digoxin), medications to strengthen the heart.
• mifepristone (to interrupt pregnancy)
• flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and that can occur especially in case of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Other medications may also affect or be affected by treatment with paracetamol/ibuprofen. Therefore, you should always seek advice from your doctor or pharmacist before taking paracetamol/ibuprofen with other medications.

Your doctor and pharmacist will have more information about these medications and how to act.

Taking Paracetamol/Ibuprofeno Nutra Essential with Food, Drinks, and Alcohol

To reduce the likelihood of side effects, take Paracetamol/Ibuprofeno with food.

Do not drink alcoholic beverages during treatment with this medication. The combination of alcohol with this medication can cause liver damage. The intoxicating effect of alcohol does not increase when taking this medication.

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.

Pregnancy

Do not take paracetamol/ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It can cause kidney and heart problems in your baby. It may increase the risk of bleeding in you and your baby during delivery, delay delivery, or prolong it more than expected. You should not take paracetamol/ibuprofen during the first 6 months of pregnancy unless it is 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 time possible. If taken for more than a few days from 20 weeks of pregnancy, Paracetamol/Ibuprofeno Nutra Essential may cause kidney problems in the fetus that can 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 monitoring.

Paracetamol/ibuprofen may make it difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems conceiving.

Breastfeeding

Only small amounts of ibuprofen and its metabolites pass into breast milk. This medication can be taken during breastfeeding if used at the recommended dose and for the shortest time possible.

Fertility

This product belongs to a group of medications (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of treatment.

Driving and Using Machines

This medication can cause dizziness, fatigue, drowsiness, and visual disturbances in some people. This should be taken into account in situations where a high level of alertness is required, for example, during driving. Be careful when driving or using machines until you know how this medication affects you.

Paracetamol/Ibuprofeno Nutra Essentialcontains aspartame (E-951), mannitol (E-421), isomalt (E-953), and sodium.

This medication contains 16.43 mg of aspartamein each sachet, equivalent to 14.94 mg/g. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains isomalt(E-953). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium(1 mmol) per sachet; this is, essentially "sodium-free".

3. How to take Paracetamol/Ibuprofeno Nutra Essential

Follow 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.

Adults over 18 years: the recommended dose is 1 sachetup to 3 times a day. Open the sachet and pour the contents directly onto the tongue. The granulate disperses quickly in saliva and is swallowed.

Leave at least 6 hours between doses.

If one sachet does not control the symptoms, you can take up to a maximum of 2 sachets up to three times a day. Leave at least 6 hours between doses.

Do not take more than six sachets in a 24-hour period(equivalent to 1,200 mg of ibuprofen and 3,000 mg of paracetamol per day).

To reduce the likelihood of adverse effects, it is recommended to take paracetamol/ibuprofeno with food.

Use in elderly patients

No special dose modifications are required. There is a greater risk of serious adverse reactions. The lowest possible dose should be used for the shortest possible time.

Use in children and adolescents

Its use is contraindicated in children and adolescents under 18 years of age.

It may be necessary to reduce your dose to a maximum of 4 sachets per day if:

• you have kidney problems,
• you have liver problems,
• you weigh less than 50 kg,
• you suffer from chronic malnutrition,
• you regularly drink alcohol (chronic alcoholism),
• you are not sufficiently hydrated.

If any of the above applies to you, talk to your doctor before taking paracetamol/ibuprofeno (see also section 2 "Warnings and precautions").

Only for oral use and for short-term use.

Do not take this medication for more than 3 days.

If your symptoms worsen or persist, consult your doctor.

The effective lowest dose should be used for the shortest time necessary for symptom relief.

If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

If you take more Paracetamol/Ibuprofeno Nutra Essential than you should

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

The symptoms may include nausea, stomach pain, vomiting (which may be streaked with blood), gastrointestinal bleeding, headache, ringing in the ears, confusion, and eye tremor (nystagmus) or, more rarely, diarrhea. Additionally, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (high potassium levels in the blood), increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, somnolence, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling of cold in the body, and respiratory problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Talk to a doctor immediately if you have taken too much medication, even if you feel well.The reason is that an excessive amount of paracetamol can cause severe late liver damage, which can be fatal. Even if there are no signs of discomfort or poisoning, you may need urgent medical attention. Liver damage can become irreversible in case of late intervention. To avoid liver damage, it is essential to obtain medical treatment as soon as possible.

If you forgot to take Paracetamol/Ibuprofeno Nutra Essential

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as you remember and then take the next dose at least 6 hours later.

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.

Regarding the following adverse effects, it should be noted that they depend largely on the dose and vary from patient to patient.

The most frequently observed adverse effects are of a gastrointestinal nature. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatal, especially in elderly patients. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, stomatitis, ulcerative exacerbation of colitis, and Crohn's disease have been reported. Less frequently, gastritis has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose range and duration of use.

Cases of edema, high blood pressure, and heart failure have been reported in association with AINE treatment.

STOP TAKING the medication and inform your doctor if you experience:

• Reddish, non-raised, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

• signs of intestinal bleeding (severe stomach pain, vomiting blood or liquid that looks like coffee grounds, blood in the stool, black tarry stools).

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

• symptoms of aseptic meningitis, inflammation of the brain lining such as: stiffness in the neck, headache, nausea, or vomiting, fever, or loss of consciousness,
• severe allergic reactions. The symptoms may include: swelling of the face, tongue, or larynx, difficulty breathing, rapid heartbeat, low blood pressure (anaphylaxis, angioedema, or severe shock),
• respiratory reactivity including asthma, worsening of asthma, wheezing, difficulty breathing,
• severe forms of skin reactions, such as blistering reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis,
• worsening of severe existing skin infections (you may notice rash, blisters, and skin discoloration, fever, drowsiness, diarrhea, and nausea), or worsening of other infections, such as chickenpox or herpes zoster or severe infection with destruction (necrosis) of the skin, subcutaneous tissue, and muscle, blisters, and skin peeling.

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

• a severe skin reaction known as DRESS syndrome (frequency not known). The symptoms of DRESS include: skin rash, fever, lymph node inflammation, and an increase in eosinophils (a type of white blood cell),
• red, scaly, widespread rash, with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you develop these symptoms and seek immediate medical attention. See also section 2.

Other possible adverse effects

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

• gastrointestinal disorders such as stomach pain, heartburn, indigestion, nausea, vomiting, gas, and constipation, diarrhea, mild gastrointestinal bleeding that can cause anemia in exceptional cases,
• elevated alanine aminotransferase, elevated gamma-glutamyltransferase, and abnormal liver function tests with paracetamol,
• swelling and fluid retention, swelling of ankles or legs (edema); fluid retention usually responds quickly to discontinuation of the combination,
• increased levels of creatinine and urea in the blood.

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

• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability, or fatigue,
• urticaria, itching,
• inability to empty the bladder completely (urinary retention),
• thick mucus in the respiratory tract,
• various types of rash,
• gastrointestinal ulcers, potentially with bleeding and perforation or gastrointestinal bleeding, worsening of colon inflammation (colitis) and digestive tract (Crohn's disease), ulcerative stomatitis, gastritis,
• decrease in hemoglobin and hematocrit, increase in aspartate aminotransferase, increase in alkaline phosphatase in blood, increase in creatine phosphokinase in blood, increase in platelet count (blood clotting cells).

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

• abnormal dreams,
• kidney tissue damage (particularly with long-term use),
• high uric acid levels in the blood (hyperuricemia),
• abnormal skin sensation (tingling, numbness).

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

• blood disorders (agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, and thrombocytopenia). The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising, and nosebleeds,
• optic neuritis and somnolence, aseptic meningitis in patients with existing disorders (such as systemic lupus erythematosus and mixed connective tissue disease), the symptoms include stiffness in the neck, headache, nausea, vomiting, fever, or loss of consciousness,
• visual disturbances; in this case, you should stop using this medication and consult a doctor,
• hearing loss, ringing in the ears, sensation of spinning (vertigo), confusion, psychotic reactions, hallucinations, depression,
• fatigue, general malaise,
• increased sweating, sensitivity to light, exfoliative dermatitis,
• rash with red spots on the skin (purpura),
• hair loss,
• high blood pressure, vasculitis,
• esophageal inflammation, pancreatic inflammation, formation of intestinal structures similar to a diaphragm,
• liver problems, dysfunction, liver damage (particularly with long-term use), liver failure, acute hepatitis, yellowing of the skin and/or the whites of the eyes, also called jaundice; in paracetamol overdose, it can cause acute liver failure, liver failure, liver necrosis, and liver damage,
• nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic renal failure,
• rapid or irregular heartbeats, also called palpitations, tachycardia, arrhythmia, and other cardiac arrhythmias, heart failure (which causes difficulty breathing, swelling), myocardial infarction.

Not known(cannot be estimated from the available data):

• the skin becomes sensitive to light.

Medications like paracetamol/ibuprofeno may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (see section 2).

Reporting of adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if it is possible adverse effects that do 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 Paracetamol/Ibuprofeno Nutra Essential

Keep this medication out of sight and reach of children.

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.

Do not store at a temperature above 25°C.

Keep in the original packaging to protect it from light.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications 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 medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol/Ibuprofeno Nutra Essential

• The active ingredients are paracetamol and ibuprofeno. Each sachet contains 500 mg of paracetamol and 200 mg of ibuprofeno.

The other components (excipients) are: calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), glycerol distearate (Type I), mannitol (E-421), isomalt (E-953), sodium croscarmellose, sodium starch glycolate type A (from potato), silicon dioxide, ethylcellulose, hypromellose, macrogol, lemon flavor, strawberry flavor, flavoring (contains aspartame).

Product appearance and package contents

Sachets

Each package contains 10 or 20 single-dose polyester/aluminum/polyethylene sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Nutra Essential OTC, S.L.

C/ La Granja, 1, 3rd floor

28108, Alcobendas (Madrid)

Spain

Manufacturer

Farmalider, S.A.

C/ Aragoneses, 2

28108, Alcobendas (Madrid)

Spain

or

Edefarm, S.L.

Enchilagar del Rullo Industrial Estate, 117

46191, Valencia

Spain

Date of the last revision of this prospectus: April 2025

Other sources of information:

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/