Medicinal Products

ALEVETABS 220 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Naproxen
laboratory: Bayer Healthcare

Coated tablet
box of 24
All forms

Indication

They are limited, in the adult and the child from 15 years, to the symptomatic treatment of painful affections of light intensity to moderate and / or febrile states.

Dosage ALEVETABS 220 mg film-coated tablet box of 24

They are limited, in the adult and the child from 15 years, to the symptomatic treatment of painful affections of light intensity to moderate and / or febrile states.

Against indications

This medicine is contraindicated in the following cases:

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

· A history of allergy or asthma triggered by sodium 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.

Alevetabs 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

· Most commonly reported gastrointestinal disorders such as epigastralgia, usually mild or moderate, nausea, vomiting, abdominal bloating and exceptionally ulcers, gastrointestinal bleeding and / or perforation. These digestive haemorrhages are all the more frequent as the dosage used is high.

Hypersensitivity reactions

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

· Respiratory: asthma. The onset of asthma attack in some subjects may be related to an allergy to acetylsalicylic acid or an NSAID. In this case, this medicine is contraindicated.

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

Effects on the central nervous system

· Headache, dizziness, insomnia, tinnitus, hearing problems, difficulty concentrating, disturbances in ideation, visual disturbances.

Skin reactions

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

Renal effects

· Hydrosoduced retention, hyperkalemia (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 sections Warnings and Precautions ).

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

Other

· Eosinophilic pneumonia.

· Ulcerative stomatitis.

· Aseptic meningitis.

· Possible occurrence of mild peripheral edema in patients with compromised cardiac function.

Some biological modifications could be observed

· Hematologic: granulocytopenia, thrombocytopenia, aplastic and hemolytic anemia.

· Hepatic: jaundice, unusually severe hepatitis; some cases of transient and reversible changes in liver function tests have been reported.

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