Medicinal Products

ADVILCAPS 200 mg

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

Soft capsule
Box of 16
All forms

Indication

This medicine contains a nonsteroidal anti-inflammatory drug: ibuprofen.

It is indicated, in the adult and the child of more than 20 kg (approximately 6 years), in the short treatment of the fever and / or pains such as:

· headache,

· influenza States,

· dental pains,

· Body aches

· painful periods.

Posology ADVILCAPS 200 mg Soft Capsule Box of 16

Administration mode

Oral way.

Swallow the soft capsule, without chewing, with a large glass of water, preferably during a meal.

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 ).

ADAPTED TO THE ADULT AND TO THE CHILD FROM 20 KG (about 6 years).

Painful and / or febrile conditions

In children, the usual dose is 20 to 30 mg / kg / day in 3 doses per day (without exceeding 30 mg / kg / day).

In children from 20 to 30 kg (approximately 6 to 11 years): 1 capsule (200 mg), to be renewed if necessary after 6 hours. In all cases, do not exceed 3 capsules per day (600 mg).

In adults and children over 30 kg (approximately 11-12 years): 1 to 2 capsules (200 mg to 400 mg), to be renewed if necessary after 6 hours.

In all cases, do not exceed 6 capsules per day (1200 mg).

Elderly: As age does not affect 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 of administration

Systematic catches prevent pain or fever oscillations.

They should be spaced at least 6 hours.

Duration of the treatment

If the pain persists for more than five days or if it worsens, or if the fever persists for more than three days or if a new disorder occurs, the patient is advised to seek medical advice.

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.

The use of tablets or capsules is contraindicated in children under 6 years of age because it can lead to a miscarriage.

Advilcaps side effects

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 ulcerative colitis or Crohn's disease (see Warnings and precautions for use ) have been reported following the 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, 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, Quincke's edema.

Skin effects

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

Exceptionally occurrence of severe infectious skin and soft tissue complications during chickenpox (see Warnings and Precautions for Use section ).

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: transient increase in transaminases, exceptional cases of hepatitis.

· Hematologic: agranulocytosis, haemolytic anemia.

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