Medicinal Products

ARTHROCIN 200 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Sulindac
laboratory: Gerda

Tablet breackable
Box of 30
All forms

Indication

They arise from the anti-inflammatory activity of sulindac, the importance of the manifestations of intolerance to which the drug gives rise and from 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,

o some painful and debilitating arthrosis;

· Short-term symptomatic treatment of acute attacks of:

o Abarticular rheumatism, such as scapulohumeral periarthritis, tendonitis, bursitis,

o arthrosis.

Dosage ARTHROCIN 200 mg scored tablet Box of 30

Administration mode

Oral way.

The tablets are swallowed as is, with a large glass of water, 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 ).

Long-term symptomatic treatment of certain chronic inflammatory rheumatism and certain painful and disabling arthrosis : the initial dose is 200 to 400 mg / day. The dosage may be adapted according to the response of the patient to the treatment.

Short-term symptomatic treatment of acute attacks of rheumatic fever and osteoarthritis : 2 tablets at 200 mg, or 400 mg per day.

The total daily dose of sulindac should not exceed the maximum recommended dose above 400 mg / day.

Frequency of administration

The dosage is to be divided into 1 or 2 doses per day.

Against indications

This medicine is contraindicated in the following cases:

· 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 any of the excipients,

· 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.

Arthrocin undesirable 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.

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.

Hypersensitivity reactions:

Hypersensitivity reactions have been described, which may include general signs (fever, anaphylaxis, angioedema), cutaneous signs (rash, pruritus, allergic vasculitis), pulmonary signs (asthma attack, especially in some people with allergies to aspirin and other nonsteroidal anti-inflammatory drugs), renal signs, hematologic abnormalities, abnormalities of one or more liver tests. Deaths have occurred in some patients.

Hepatic effects:

Elevations of liver enzymes and cases of hepatitis and / or jaundice with or without fever may occur, in most cases, within the first three months of treatment. In some patients, the test results are consistent with the diagnosis of cholestatic hepatitis.

Effects on the central nervous system:

Headaches, vertigo, exceptional sensory hallucinations. Visual disturbances (blurred vision, diplopia) have been described.

Renal effects:

Hematuria, proteinuria, crystalluria, acute renal failure.

Hematological effects:

Thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, medullary aplasia.

Various effects:

Epistaxis, gynecomastia.

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