Medicinal Products

ANTADYS 100 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Flurbiprofen
laboratory: Theramex

Coated tablet
Box of 15
All forms

Indication

They come from the anti-inflammatory activity of flurbiprofen, the importance of the manifestations of intolerance to which the drug gives rise, and its place in the range of anti-inflammatory products currently available.

They are limited, in adults and children from 15 years old, to:

· Long-term symptomatic treatment:

o chronic inflammatory rheumatism, including rheumatoid arthritis, ankylosing spondylitis or related syndromes, such as Fiessinger-Leroy-Reiter syndrome and psoriatic arthritis;

o some painful and disabling arthrosis.

· Short-term symptomatic treatment of acute attacks of:

o Abarticular rheumatism such as scapulohumeral periarthritis, tendinitis, bursitis;

o arthrosis;

o back pain;

o radiculalgia.

· Dysmenorrhea after etiological research.

Dosage ANTADYS 100 mg Film-coated tablet Box of 15

Administration mode

Oral way.

The tablets are swallowed as is without chewing, with a glass of water, preferably during meals.

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 ).

· Rheumatic conditions:

o treatment of attack: 1 tablet with 100 mg, 3 times a day or 300 mg / day,

o maintenance treatment: 1 100 mg tablet, 1 to 2 times daily, ie 100 to 200 mg / day.

· Dysmenorrhoea: 1 tablet at 100 mg, 2 to 3 times a day, ie 200 to 300 mg / day from the beginning of the pain until the disappearance of the symptoms.

Against indications

This medicine is contraindicated in the following situations:

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

· History of allergy or asthma triggered by the use of this drug or substances of similar activity such as other NSAIDs, acetylsalicylic acid,

· History of allergy to other components of the tablet,

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

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

· Severe hepatocellular insufficiency,

· Severe renal insufficiency,

· Severe heart failure,

· Child under 15 years old.

This drug is generally not recommended in combination with:

· Oral anticoagulants,

· Other NSAIDs (including high-dose salicylates),

· Heparins (parenteral route),

· Lithium,

· Methotrexate (used at doses greater than 20 mg / week),

· The pemetrexed.

Antadys side effects

Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially when used at high doses and over a long period of time) may be associated with a small increase in the risk of arterial thrombotic events (eg, infarction myocardial or cerebrovascular accident) (see Warnings and Precautions for Use section ).

Gastrointestinal effects:

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 the administration of NSAIDs. Less frequently, gastritis has been observed.

Cardiovascular effects

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

Rarely have been reported: elevation of blood pressure, tachycardia, chest pain, arrhythmia, palpitations, hypotension, congestive heart failure.

Hypersensitivity reactions

· General: anaphylactic reaction, Quincke's edema.

· Respiratory: the onset of asthma attack may be observed in some subjects, particularly allergic to aspirin and other non-steroidal anti-inflammatory drugs.

Skin reactions

Very rarely bullous reactions (including Stevens-Johnson syndrome and Lyell's syndrome) have been observed.

Have also been reported: rash, urticaria and worsening of chronic urticaria, pruritus, purpura.

Cases of photosensitization have been exceptionally reported.

Renal effects

· Functional acute renal failure (ARF) in patients with risk factors (see Warnings and Precautions section ).

· Organic kidney damage that can result in ARI: isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.

Effects on the central nervous system

· Dizziness, headache.

Other

· Hydrosoduced retention, hyperkalemia (see sections Warnings and precautions for use and Interactions with other medicinal products and other forms of interaction ).

· Rarely, sight disorders.

· Increased transaminases.

· Exceptionally: agranulocytosis, haemolytic anemia, thrombocytopenia.

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