Medicinal Products

APRANAX 500 mg

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

Suppository
Box of 12
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,
. acute post-traumatic benign conditions of the musculoskeletal system;
- dysmenorrhea after etiological research.

Dosage APRANAX 500 mg suppository Box of 12

Mode of administration:
Rectal way.
The choice of the rectal route is determined solely by the convenience of administering the drug.
Dosage:
- Attack treatment : 1 suppository at night in addition to oral forms.
- Maintenance treatment : 1 suppository per day.
Duration of administration:
The use of the rectal route should be as short as possible because of the risk of local toxicity added to oral risks.

Against indications

CONTRAINDICATED:
This medicine is contraindicated in the following cases:
- a history of allergy or asthma triggered by taking naproxen or substances of similar activity such as other NSAIDs, aspirin,
- hypersensitivity to any of the excipients,
- evolving gastroduodenal ulcer, digestive haemorrhage,
- severe hepatocellular insufficiency,
- severe renal insufficiency,
- severe uncontrolled heart failure,
- recent history of proctitis or rectorrhagia,
- child under 15,
- from the 6th month of pregnancy: during the 3rd trimester, all prostaglandin synthesis inhibitors can expose the fetus to cardiopulmonary toxicity (pulmonary arterial hypertension with premature closure of the ductus arteriosus), renal dysfunction up to renal failure with oligoamnios; the mother and the child, at the end of pregnancy, to a possible lengthening of the bleeding time. As a consequence, apart from extremely limited obstetric use and which warrant specialized supervision, the prescription of NSAIDs is contraindicated from the 6th month.
NOT RECOMMENDED :
- Breast-feeding: NSAIDs passing into breast milk, as a precaution, should be avoided in women who are breastfeeding.
- This medication should be avoided if treated with another nonsteroidal anti-inflammatory drug, with an oral anticoagulant, with lithium, with aspirin at analgesic, antipyretic or anti-inflammatory doses, with methotrexate. doses greater than 20 mg per week, with low molecular weight and related heparins and unfractionated heparins (at curative doses and / or in the elderly) (see section on interactions).

Apranax side effects

- Gastrointestinal effects:
. Of particular note were gastrointestinal disorders such as epigastralgia, often mild or moderate, nausea, vomiting, abdominal meteorism, dyspepsia, diarrhea, constipation, ulcerative stomatitis.
. Exceptionally, ulcers, haemorrhages and / or gastrointestinal perforations have been observed. These digestive haemorrhages are all the more frequent as the dosage used is high.
. Some isolated cases of esophagitis, colitis and pancreatitis have also been reported.
. Risk of local toxicity, related to the route of administration, all the more frequent and intense as the duration of treatment is prolonged, the rate of administration and the high dosage. Rectal burns, pain, pruritus may occur.
- Hypersensitivity reactions:
. Dermatological : rash, urticaria, aggravation of chronic urticaria, pruritus,
. Respiratory : asthma. The occurrence of an asthma attack in certain subjects may be related to an allergy to aspirin or to an NSAID (see section contraindications),
. General : Quincke's edema, vasculitis, anaphylactoid reactions to components.
- Skin reactions:
. Pruritus, hair loss, photosensitivity reactions including rare cases of "pseudoporphyries" have been observed.
. Purpura, erythema multiforme, fixed pigmented erythema, erythema nodosum and lichen planus have been reported rarely.
. The occurrence of bullous dermatoses (Stevens-Johnson and Lyell syndrome) is quite exceptional.
- Effects on the central nervous system:
. The main findings were headache, dizziness, somnolence.
. Insomnia, concentration difficulties, ideation disorders, aseptic meningitis have also been reported.
- Kidney manifestations:
. Hydrosoduced retention, hyperkalemia with possibility of edema (see warnings and precautions for use and interactions).
. Functional acute renal failure (ARF) in patients with risk factors (see section on warnings and precautions for use).
. Organic kidney disease that may result in ARI: isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.
- Ophthalmic effects:
Visual disorders, 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 worsening congestive heart failure and hypertension.
- Effects on the respiratory system:
Eosinophilic pneumonia.
- Hematological manifestations:
Leukopenia (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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