Medicinal Products

BI-PROFENID LP 100 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Ketoprofen
laboratory: Sanofi-Aventis France

Breakable sustained release tablet
Box of 100
All forms

Indication

They come from the analgesic and anti-inflammatory activity of ketoprofen, from 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 (or related syndromes, such as Fiessinger-Leroy-Reiter syndrome and psoriatic arthritis),

o some painful and debilitating arthrosis;

· Short-term symptomatic treatment of acute episodes:

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

o microcrystalline arthritis,

o arthrosis,

o low back pain,

o radiculalgia,

o acute post-traumatic benign conditions of the musculoskeletal system.

Dosage BI-PROFENID LP 100 mg Break-off tablet with prolonged release Box of 100

Administration mode :

Oral way.

The tablets are to be swallowed as is with a large glass of water, if possible during a meal or failing with a snack.

Dosage:

The occurrence of adverse effects may be minimized by using the lowest possible dose for the shortest duration necessary to relieve symptoms (see Warnings and Precautions ).

The maximum daily dose is 200 mg daily. The benefit / risk ratio should be carefully evaluated before starting treatment at a daily dose of 200 mg and the use of higher doses is not recommended (see also section Warnings and precautions for use )

· Long-term symptomatic treatment: 1 to 2 tablets at 100 mg daily, ie 100 to 200 mg daily;

· Short-term symptomatic treatment of acute episodes: 2 tablets at 100 mg daily, ie 200 mg daily.

Frequency of administration:

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

Populations at risk:

· Patients with renal impairment and elderly patients : It is recommended to reduce the initial dosage and then adapt it if necessary according to the renal tolerance.

· Hypovolemic patients: see section Warnings and precautions for use

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 ketoprofen or any of the excipients of the product,

· A history of hypersensitivity reactions such as bronchospasm, asthma, rhinitis, urticaria or other allergic reactions to ketoprofen, acetylsalicylic acid or other NSAIDs. Severe, rarely fatal, anaphylactic reactions have been reported in these patients (see section 4.8 ).

· 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 hemorrhage (2 or more distinct episodes of haemorrhage or ulceration objectivized),

· Severe liver failure,

· Severe renal insufficiency,

· Severe heart failure .

This medicine is contraindicated in patients with wheat allergy (other than celiac disease).

BI-Profenid LP 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 ).

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.

Edema, hypertension and heart failure have been reported in combination with NSAID therapy. Very rarely bullous reactions (Stevens-Johnson syndrome, Lyell syndrome) have been observed.

Adverse events were classified according to their incidence using the following classification:

Very common (≥1 / 10) frequent (≥1 / 100, <1/10); uncommon (≥1 / 1000, <1/100); rare (≥1 / 10000, <1/1000); very rare (<1 / 10, 000); indeterminate frequency (can not be estimated based on available data).

Gastrointestinal disorders

· Frequent: dyspepsia, nausea, abdominal pain, gastric pain, vomiting,

· Uncommon: diarrhea, constipation, flatulence, gastritis,

· Rare: stomatitis, peptic ulcer, colitis,

· Indefinite frequency: exacerbation of colitis and Crohn's disease, gastrointestinal haemorrhage and perforation.

At the dose of 200 mg per day, oral ketoprofen causes an increase in occult digestive blood losses: these are all the more frequent as the dosage used is high and the duration of treatment extended.

Immune system disorders

· Not known: Quincke's edema, anaphylactic reactions (including anaphylactic shock).

Skin and subcutaneous tissue disorders

· Infrequent: rash, rash, pruritus,

· Not known: urticaria, worsening of chronic urticaria, photosensitivity, alopecia and bullous dermatoses (Stevens-Johnson syndrome and Lyell's syndrome).

Respiratory, thoracic and mediastinal disorders

· Rare: asthma attack,

· Not known: bronchospasm, especially in subjects with allergies to aspirin and other NSAIDs, rhinitis.

Nervous system disorders

· Uncommon: headache, dizziness, drowsiness,

· Rare: paresthesia,

· Undetermined frequency: convulsions, taste disturbances.

Psychiatric disorders

· Frequency not known: mood disorders.

Eye disorders

· Rare: visual blur.

Affections of the ear and labyrinth

· Rare: tinnitus.

Renal and urinary disorders

· Not known: water-soluble retention, hyperkalemia (see Warnings and Precautions and Interactions with other medicinal products and other forms of interaction ) sections.

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

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

Abnormalities of renal function.

Blood and lymphatic system disorders

· Rare: anemia due to haemorrhage, leukopenia,

· Not known: agranulocytosis, thrombocytopenia, medullary insufficiency.

Hepatobiliary disorders

· Rare: increased transaminase levels, hepatitis, increased bilirubin due to liver disorders.

Heart conditions

· Uncommon: edema,

· Not known: heart failure.

Vascular disorders

· Not known: hypertension, vasodilation.

General conditions and anomalies at the administration site

· Uncommon: fatigue,

· Rare: weight gain.

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