MUSCOPOCKET*OS 12SACHETS 400MG

Ibuprofen Nutra Essential 400 mg oral powder in sachet

What it is and what it is used for
Ibuprofen Nutra Essential contains ibuprofen as an active ingredient and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine can be used by adults and adolescents over 12 years of age (weighing over 40 kg) for the symptomatic relief of occasional mild to moderate pain, such as headaches, toothaches, menstrual pain, muscle pain (contractures) or back pain (lumbago), as well as to treat feverish states.

What you need to know before taking the medicine
Do not take Ibuprofen Nutra Essential:
- if you are allergic (hypersensitive) to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or any other component of this medicine (listed in paragraph 6). Reactions indicating an allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, difficulty breathing or asthma;
- if you suffer from severe liver or kidney disease;
- if you have had an ulcer or bleeding in the stomach or duodenum or have suffered from a perforation of the digestive system;
- if you vomit blood;
- if you have black stools or bloody diarrhea;
- if you suffer from bleeding disorders or blood clotting disorders, or are taking anticoagulants (medicines used to thin the blood). If it is necessary to use anticoagulant drugs at the same time, the doctor will perform blood clotting tests;
- if you have severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
- if you suffer from severe heart failure;
- if you are in the third trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking:
- if you have edema (fluid retention);
- if you suffer or have suffered from any heart disorder or have high blood pressure;
- if you suffer from asthma or any other respiratory disorder;
- if you are receiving ibuprofen treatment as it can mask fever, which is an important sign of infection, making diagnosis difficult;
- if you suffer from kidney or liver disease, are over 60 years old or need to take the medicine for a prolonged period (more than 1-2 weeks), your doctor may need to perform regular check-ups. Your doctor will indicate the frequency of these check-ups;
- if you have had or develop an ulcer, bleeding or perforation of the stomach or duodenum, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of combining it with a medicine for stomach protection;
- if you are simultaneously taking medicines that alter blood clotting such as oral anticoagulants, antiplatelet agents such as acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of bleeding such as corticosteroids and selective serotonin reuptake inhibitor antidepressants;
- if you suffer or have suffered from Crohn's disease (a chronic disease in which the immune system attacks the intestine causing inflammation that usually causes bloody diarrhea) or ulcerative colitis, as medicines like Ibuprofen Nutra Essential can worsen these conditions;
- if you are being treated with diuretics (medicines used to increase urine production) because your doctor needs to monitor your kidney function;
- if you suffer from systemic lupus erythematosus (a chronic disease of the immune system that can affect various vital organs, the nervous system, blood vessels, skin and joints) as aseptic meningitis (inflammation of the meninges, the membranes that protect the brain and spinal cord, non-bacterial) may occur;
- if you suffer from acute intermittent porphyria (a metabolic disease that affects the blood and can cause symptoms such as reddish urine, blood in the urine or liver disease), the doctor will evaluate whether ibuprofen treatment is appropriate or not;
- if you suffer from headaches after prolonged treatment, you should not take the medicine in higher doses;
- this medicine can cause allergic reactions;
- if you take the medicine after major surgery, your doctor will need to monitor your situation more closely;
- if you have chickenpox;
- if you have an infection, see the Infections section below.

Side effects can be minimized by using the lowest effective dose for the shortest possible time needed to control symptoms.

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), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop taking Ibuprofen Nutra Essential and consult your doctor immediately if you experience any skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very severe skin reaction. See paragraph 4.

Cardiovascular precautions
Medicines like ibuprofen may be associated with a slight increase in the risk of heart attacks or strokes. This risk is more likely to occur when high doses are used. Do not exceed the recommended doses or duration of treatment.
Before taking Ibuprofen Nutra Essential, you should discuss the treatment with your doctor or pharmacist if:
- you have heart problems, including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowing or blockage of arteries) or any type of stroke (including a mini-stroke or transient ischemic attack TIA);
- you have high blood pressure, diabetes, high cholesterol;
- a family history of heart disease or stroke;
- you are a smoker.

Children and adolescents
In dehydrated children and adolescents, there is a risk of kidney damage.

Precautions during pregnancy and in women of childbearing potential
Since the administration of medicines such as Ibuprofen Nutra Essential has been associated with an increased risk of congenital anomalies/miscarriages, its administration is not recommended in the first and second trimesters of pregnancy except in cases where it is considered strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.
In the third trimester, Ibuprofen administration is contraindicated.
For patients of childbearing age, it should be considered that medicines such as Ibuprofen Nutra Essential have been associated with a reduction in fertility.

Infections
Ibuprofen Nutra Essential can mask signs of infection, such as fever and pain. Consequently, Ibuprofen Nutra Essential can delay adequate treatment of infection, thus increasing the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine in the presence of an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Elderly
Elderly people taking NSAIDs are at increased risk of side effects, particularly those related to the stomach and intestines. For more information, see paragraph 4 Possible side effects.
If you have a history of gastrointestinal toxicity, particularly if you are elderly, report any unusual abdominal symptoms (especially bleeding in the stomach or intestine), particularly in the early stages of treatment.
There is a risk of kidney impairment in dehydrated elderly people.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them. The incidence of side effects is lower in short treatments and if the daily dose is lower than the maximum recommended dose.
Stop taking this medicine and seek immediate medical attention if you experience:- Allergic reactions such as skin rash, facial swelling, wheezing or difficulty breathing;
- Vomiting with blood or with a coffee ground-like appearance;
- Blood in stools or bloody diarrhea;
- Severe stomach ache;
- Blisters or severe peeling of the skin;
- Severe or persistent headache;
- Yellowing of the skin (jaundice);
- Signs of severe hypersensitivity;
- Swelling of the extremities or fluid accumulation in the arms or legs.

Consult your doctor if you experience any of the following side effects, if they worsen or if you notice any effect not listed.
The frequencies shown below refer to short-term use of maximum daily doses of 1,200 mg of oral ibuprofen: Common (may affect up to 1 in 10 people):
-gastrointestinal bleeding, especially in elderly patients;
- nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, bloody vomiting, headache, dizziness, fatigue.

Uncommon (may affect up to 1 in 100 people):
- sneezing, blocked or runny nose or itchy nose (rhinitis);
- hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with lowering of blood pressure and photosensitivity reactions). In this case, the doctor must be informed immediately and ibuprofen intake must be stopped;
- tingling or prickling sensation, drowsiness;
- difficulty sleeping, feeling anxious;
- acne, urticaria, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitization to light;
- visual disturbance. In this case, the doctor must be informed immediately and ibuprofen intake must be stopped;
- hearing problems;
- difficulty breathing, wheezing or coughing, asthma or worsening of asthma;
- inflammation of the stomach lining, gastrointestinal ulcers, in some cases with bleeding and perforation, ulcerative stomatitis;
- hepatitis, yellowing of the skin or eyes, reduced liver function;
- nephrotic syndrome (fluid accumulation in the body (edema) and protein accumulation in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation in the body (edema) and a general feeling of malaise may be signs of kidney disease and even kidney failure. If any of the above symptoms occur, stop taking Ibuprofen Nutra Essential and consult your doctor immediately.

Rare (may affect up to 1 in 1,000 people):
- feeling depressed or confused;
- symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or blurred consciousness have been observed during ibuprofen treatment. If such symptoms appear, contact a doctor immediately;
- leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (the first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, bleeding from the nose and skin, unusual and unexplained bruises and ecchymoses of unknown cause. In these cases, therapy must be stopped immediately and a doctor consulted;
- reversible toxic amblyopia (reduced vision);
- dizziness, tinnitus (ringing or sounds in the ear);
- liver damage;
- fluid retention (edema);
- anaphylactic reaction (in case of generalized hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur;
- optic nerve damage.

Very rare (may affect up to 1 in 10,000 people):
- high blood pressure, heart failure, heart attack;
- inflammation of the pancreas;
- very severe bullous reactions including Stevens Johnson syndrome (widespread erosions affecting the skin and mucous membranes and purple lesions, preferably on the trunk);
- toxic epidermal necrolysis (mucosal lesions and painful lesions with necrosis and detachment of the skin);
- erythema multiforme (skin lesion);
- liver failure.

Frequency not known (frequency cannot be estimated from the available data):
- aggravation of colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine causing inflammation that usually causes bloody diarrhea).
A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
- generalized red and scaly skin rash, with subcutaneous bumps and blisters located mainly in the skin folds, on the trunk and upper limbs, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Nutra Essential if these symptoms occur and consult a doctor immediately.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.