Muscopocket Ibuprofen 400 mg 12 sachets

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

Muscopocket Ibuprofen 400 mg 12 sachets it is a medicine based on ibuprofen, active ingredient belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), indicated for symptomatic treatment of pain and fever. Its formulation in oral powder in sachets It represents a practical solution for adults and adolescents over 12 years of age and with a body weight over 40 kg, offering simple intake and rapid relief from the most common symptoms.

Muscopocket Ibuprofen 400 mg is indicated in case of mild or moderate pain of different origins, such as headache, toothache, menstrual pain, muscle and joint pain, as well as in the presence of back pain, feverish states and painful symptoms associated with flu syndromes. Thanks to the analgesic, anti-inflammatory and antipyretic action of ibuprofen, the product helps to combat pain, inflammation and fever in a targeted way.

The sachet formulation allows you to dissolve the contents in water or take it directly into your mouth, making it particularly convenient even when away from home. Muscopocket 400 mg it is therefore a versatile solution for occasional use, designed for those looking for an effective and practical medicine for the management of painful and feverish disorders of daily life.

INDICATIONS

Why is Muscopocket Ibuprofen 400 mg 12 sachets used? What is it for?

Ibuprofen-based drug (NSAID), indicated for the symptomatic treatment of mild or moderate pain of various origins (headache, toothache, menstrual, muscle and joint pain, back pain) and feverish states, even in the case of flu syndromes.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Muscopocket Ibuprofen 400 mg 12 sachets not be used and what side effects can it cause?

What you need to know before taking the medicine
Do not take MuscoPocket:
- if you are allergic (hypersensitive) to ibuprofen, to other drugs from the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin or to any other component of this medicine (listed in section 6). Reactions indicating allergy could 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 haemorrhage 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 or blood clotting disorders, or are taking anticoagulants (medicines used to "thinning" the blood). If you need to use anticoagulant drugs at the same time, your 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.

Possible side effects
As with all medicines, this medicine can cause side effects, although not everybody gets 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 contact a doctor immediately if you experience:
- allergic reactions such as skin rashes, swelling of the face, wheezing or difficulty breathing;
- vomiting with blood or with an appearance similar to coffee grounds;
- blood in the stool or bloody diarrhea;
- severe stomach pain - 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 accumulation of fluid in the arms or legs.

Talk to your doctor if you get any of the following side effects, if they get worse, or if you notice any effects not listed.

The frequencies shown below are for 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, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in the stool, bloody vomiting;
- headache, dizziness, fatigue.

Uncommon (may affect up to 1 in 100 people):
- sneezing, stuffy 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 the intake of ibuprofen must be stopped;
- tingling or tingling sensation, drowsiness;
- difficulty sleeping, feeling of anxiety;
- acne, hives, itching, small bruises on the skin or inside the mouth, nose or ears, sensitivity of the skin to light;
- vision disorder. In this case the doctor must be informed immediately and the intake of ibuprofen 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 (accumulation of fluids inside the body (edema) and accumulation of proteins in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, accumulation of fluid within the body (edema), and generally feeling unwell can be signs of kidney disease and even kidney failure. If any of the above symptoms occur, stop administering MuscoPocket and consult your doctor immediately.

Rare (may affect up to 1 in 1,000 people):
- feeling of depression or confusion;
- symptoms of aseptic meningitis with stiff neck, headache, feeling of nausea, vomiting, fever or clouded consciousness have been observed during treatment with ibuprofen. 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 fatigue, bleeding from the nose and skin, unusual and unexplained bruising and bruising of unknown cause. In these cases it is necessary to immediately stop therapy and consult a doctor;
- reversible toxic amblyopia (reduction of vision);
- dizziness, tinnitus/tinnitus (beats or ringing in the ear);
- liver damage;
- water 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);
- damage to the optic nerve.

Very rare (may affect up to 1 in 10,000 people):
- high blood pressure, heart failure, heart attack;
- inflammation of the pancreas;
- very serious 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):
- worsening of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine causing inflammation which usually causes bloody diarrhoea).
You may experience a serious skin reaction known as DRESS syndrome. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell);
- generalized red and scaly rash, with subcutaneous bumps and blisters located mainly in the skin folds, on the torso and upper limbs, which is accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis. Stop taking MuscoPocket if these symptoms occur and contact a doctor immediately.

PREGNANCY AND BREASTFEEDING

Can Muscopocket Ibuprofen 400 mg 12 sachets be used during pregnancy and breastfeeding?

Precautions during pregnancy and in women of childbearing age
Since the administration of medicines such as MuscoPocket has been associated with an increased risk of suffering from congenital anomalies/abortions, its administration is not recommended in the first and second trimester of pregnancy unless considered strictly necessary. In these cases the doses and duration will be limited to the minimum possible.
In the third trimester the administration of Ibuprofen is contraindicated.
For patients of childbearing age it should be considered that medicines such as MuscoPocket have been associated with a reduction in the ability to conceive.

WARNINGS

What are the warnings of Muscopocket Ibuprofen 400 mg 12 sachets?

Warnings and precautions
Talk to your doctor or pharmacist before taking MuscoPocket:
- 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 treatment with ibuprofen as it can mask fever, which is an important sign of infection, making it difficult to diagnose;
- if you suffer from kidney or liver disease, are over 60 years old or need to take the medicine for a long time (more than 1-2 weeks), your doctor may need to check you regularly. Your doctor will advise you on the frequency of these checks;
- if you have had or develop an ulcer, bleeding or perforation of the stomach or duodenum, which may be manifested by severe or persistent abdominal pain and/or black stools, or even without any previous warning symptoms. This risk is greater when using high doses and prolonged treatments, in patients with a history of peptic ulcers and in the elderly. In these cases your doctor will take into account the possibility of combining a medicine to protect the stomach;
- if you simultaneously take drugs that alter blood coagulation such as oral anticoagulants, antiplatelet agents such as acetylsalicylic acid. You should also report to your doctor the use of other drugs 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 which usually causes bloody diarrhoea) or ulcerative colitis, as medicines such as MuscoPocket can make these conditions worse;
- if you are being treated with diuretics (medicines used to increase urine production) because your doctor needs to monitor the functioning of your kidneys;
- if you suffer from systemic lupus erythematosus (chronic disease of the immune system which can affect various vital organs, the nervous system, blood vessels, skin and joints) because 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 (metabolic disease which affects the blood and can cause symptoms such as reddish urine, blood in the urine or liver disease), your doctor will consider whether treatment with ibuprofen 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 rigorously;
- if you have chickenpox;
- if you have an infection, see the "Infections" paragraph below.

Side effects can be limited 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 treatment with ibuprofen. Stop taking MuscoPocket and see your doctor immediately if you have any skin rashes, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See paragraph 4.

Cardiovascular precautions
Medicines such as ibuprofen may be associated with a slightly increased risk of suffering from heart or brain attacks. This risk is more likely to occur when high doses are used. Do not exceed the recommended doses or duration of treatment.

Before taking MuscoPocket, you should discuss your treatment with your doctor or pharmacist if:
- have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA");
- have high blood pressure, diabetes, high cholesterol;
- a family history of heart disease or stroke;
- he is a smoker.

Children and adolescents
There is a risk of kidney damage in dehydrated children and adolescents.

Infections
MuscoPocket can mask signs of infection, such as fever and pain. As a result, MuscoPocket may delay proper treatment of the infection, thereby increasing the risk of complications. This has occurred in cases of bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine if you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

Elderly
Older adults taking NSAIDs are at greater risk of side effects, particularly those relating to the stomach and intestines. For more information, see section 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 intestines), particularly in the early stages of treatment.
There is risk of renal impairment in dehydrated older adults.

FORMAT

What is the format of Muscopocket Ibuprofen 400 mg 12 sachets?

DRUG LEGAL TEXT

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