Medicinal Products

ADVILMED 400 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Ibuprofen
laboratory: Pfizer Sante Familiale

Coated tablet
Box of 20
All forms

Indication

· Symptomatic treatment of mild to moderate pain and / or febrile conditions.

· Dysmenorrhea after etiological research.

· Treatment of mild to moderate migraine attack, with or without aura.

· Treatment of moderate pain in osteoarthritis (hip, knee).

Posology ADVILMED 400 mg Coated tablet Box of 20

Administration mode

Oral way.

Swallow the tablet without chewing it, with a large glass of water.

Dosage

The occurrence of side effects can be minimized by using the lowest possible dose for the shortest duration of treatment required to relieve symptoms (see Warnings and Precautions section ).

RESERVED FOR ADULTS (over 15 years).

dysmenorrhea:

1 400 mg tablet per dose, repeat if necessary every 6 to 8 hours, not exceeding 3 tablets at 400 mg per day (ie 1200 mg per day), starting at the onset of menses and for a duration of 1 at 3 days.

Migraine crisis:

1 400 mg tablet to be taken as soon as possible from the beginning of the migraine attack

Painful conditions and / or febrile states:

1 400 mg tablet per dose, repeat if necessary every 6 to 8 hours, not to exceed 3 400 mg tablets per day (ie 1200 mg per day).

Pain in osteoarthritis (hip, knee)

1 400 mg tablet per dose, repeat if necessary every 6 to 8 hours, not to exceed 3 400 mg tablets per day (ie 1200 mg per day).

Elderly

As age does not alter the kinetics of ibuprofen, the dosage should not need to be changed according to this parameter. However precautions must be taken (see section Warnings and precautions for use ).

Frequency and timing of administration

The tablets are best taken during meals.

Systematic catches prevent fever or pain from oscillating. They should be spaced at least 6 hours.

Against indications

This medicine is contraindicated in the following situations:

· Beyond 24 weeks of amenorrhea (5 months pregnant) (see section on Pregnancy and breastfeeding ),

· Hypersensitivity to ibuprofen or any of the excipients of the product,

· History of asthma triggered by ibuprofen or other substances of similar activity such as: other NSAIDs, acetylsalicylic acid,

· History of bleeding or digestive perforation during previous NSAID treatment,

· Gastrointestinal haemorrhage, cerebrovascular hemorrhage or other progressive haemorrhage,

· Progressive peptic ulcer, history of peptic ulcer or recurrent haemorrhage (2 or more episodes, or more, of haemorrhage or ulceration objectivized),

· Severe liver failure,

· Severe renal insufficiency,

· Severe heart failure,

· Systemic lupus erythematosus.

Adverse effects Advilmed

Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used at high doses (2400 mg per day) over a long course of treatment, may be associated with a slight increase in the risk of arterial thrombotic event (eg, myocardial infarction or stroke) (see Warnings and Precautions for Use section ).

The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, can occur, especially in the elderly (see section Warnings and precautions for use ).

Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melena, hematemesis, exacerbation of rectocolitis or Crohn's disease (see Warnings and Precautions for Use section ) reported following administration of NSAIDs. Less frequently, gastritis has been observed.

Edema, hypertension and heart failure have been reported in combination with NSAID therapy.

Gastrointestinal effects

Gastrointestinal disorders such as nausea, vomiting, gastralgia, dyspepsia, transit disorders, digestive ulcerations with or without haemorrhage, occult or non-occult haemorrhage have usually been reported. These are all the more frequent as the dosage used is high and the duration of treatment extended.

Hypersensitivity reactions

· Dermatological: rashes, rash, pruritus, edema, urticaria, aggravation of chronic urticaria.

· Respiratory: The onset of asthma attacks in some subjects may be related to an allergy to acetylsalicylic acid or a nonsteroidal anti-inflammatory drug (see section 4.3 ).

· General: anaphylactic shock, angioedema.

Skin effects

Very rarely bullous reactions (Stevens-Johnson syndrome, Lyell syndrome) have been observed.

Effects on the central nervous system

Ibuprofen may exceptionally be responsible for vertigo and headache.

Other

· Some rare cases of visual disturbances have been reported,

· Oliguria, renal failure,

· The discovery of aseptic meningitis with ibuprofen should result in systemic lupus erythematosus or connective tissue disease.

Some biological modifications could be observed

· Hepatic: rarely elevated transaminases, exceptional cases of hepatitis.

· Haematological: agranulocytosis, haemolytic anemia.

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