Medicinal Products

APRANAX 550 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Naproxen
laboratory: Roche

Divisible coated tablet
Box of 16
All forms

Indication

They arise from the anti-inflammatory activity of naproxen, the importance of the manifestations of intolerance to which the drug results 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:
. chronic inflammatory rheumatism, including rheumatoid arthritis, ankylosing spondylitis or related syndromes such as Fiessinger-Leroy-Reiter syndrome and psoriatic arthritis,
. some disabling and painful arthroses;
- short-term symptomatic treatment of acute attacks of:
. abarticular rheumatism such as scapulohumeral periarthritis, tendonitis, bursitis,
. arthrosis,
. low back pain,
. radicular pain,
. acute post-traumatic benign conditions of the musculoskeletal system;
- Short-term symptomatic treatment of pain during inflammatory manifestations in stomatology. In this indication, the risks involved, in particular the extension of a concomitant septic process, are those of NSAIDs. They must be evaluated in relation to the expected analgesic benefit.
- dysmenorrhea after etiological research.

Dosage APRANAX 550 mg Breakable film-coated tablet Box of 16

Administration mode

Oral way.

The tablets are swallowed as is, with a large glass of water, preferably at mealtimes.

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 ).

· Rheumatology, gynecology:

o Attack treatment: 2 tablets at 550 mg, ie 1100 mg per day.

o Maintenance treatment: 1 tablet at 550 mg, or 550 mg per day.

· Stomatology: 1/2 to 2 tablets daily, ie 275 mg to 1100 mg per 24 hours.

Elderly

· Clinical and biological monitoring is recommended in case of high dosage. One study has shown that in the elderly, the plasma concentration of free naproxen ion is doubled even though the total plasma concentration is unchanged.

· Dosage reduction should be considered if there is a decrease in renal elimination.

Frequency of administration

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

Against indications

This medicine is contraindicated in the following cases:

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

· A history of allergy or asthma triggered by taking naproxen or other substances of similar activity such as other NSAIDs, acetylsalicylic acid,

Hypersensitivity to any of the excipients,

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

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

· Severe hepatocellular insufficiency,

· Severe renal insufficiency,

· Severe heart failure,

· Child under 15 years old.

Apranax 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.

Gastrointestinal effects

· Mostly reported gastrointestinal disorders such as epigastralgia, often mild or moderate, nausea, vomiting, abdominal meteorism, dyspepsia, diarrhea, constipation, ulcerative stomatitis.

· Exceptionally observed: ulcers, haemorrhage and / or gastrointestinal perforation. These digestive haemorrhages are all the more frequent as the dosage used is high.

· A few isolated cases of oesophagitis, colitis and pancreatitis have also been reported.

Hypersensitivity reactions

· Dermatological: rash, hives, aggravation of chronic urticaria, pruritus.

· Respiratory: asthma. The onset of asthma attacks in some subjects may be related to an allergy to acetylsalicylic acid or an NSAID (see section 4.3 ).

· General: Quincke's edema, vasculitis, anaphylactoid reactions to the components.

Skin reactions

· Pruritus, hair loss, photosensitivity reactions including rare cases of "pseudoporphyries" have been observed.

· Purpura, erythema polyphoma, fixed pigmented erythema, erythema nodosum and lichen planus have been reported rarely.

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

Effects on the central nervous system

· Mostly reported: headache, dizziness, drowsiness.

· Have also been reported: insomnia, difficulty concentrating, disordered ideation, aseptic meningitis.

Kidney manifestations

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

· 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.

Ophthalmic effects

· Visual disturbances, exceptionally papillitis, retrobulbar optic neuritis and papilledema.

Effects on the hearing aid

· Hearing disorders, especially tinnitus.

Cardiovascular effects

· Moderate peripheral edema has been reported in patients with compromised cardiac function, aggravation of congestive heart failure and hypertension.

Effects on the respiratory system

· Eosinophilic pneumonia.

Hematological manifestations

Leucopenia (mainly granulocytopenia), thrombocytopenia, medullary aplasia and haemolytic anemia.

Liver manifestations

· Some cases of transient and reversible changes in liver biological parameters, jaundice, unusually severe hepatitis (including one case of fatal outcome) have been reported.

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