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FASTUMDOL ANTINFIAMMATORIO 25mg- Sachet and Tablets



Therapeutic indications:

Short term symptomatic treatment of acute pain of mild to moderate intensity, such as acute musculo-skeletal pain, dysmenorrhoea and dental pain

Composition

Each sachet of granules for oral solution contains dexketoprofen 25 mg, as dexketoprofen trometamol.
Other excipients: Ammonium glycyrrhizinate, Neohesperidin-dihydrochalcone, Quinoline yellow (E-104), Lemon aroma, Sucrose, Silica, colloidal hydrated.
Each Sachet contains: 2,40 – 2,44 g of Sucrose eith colloidal silicia
Each tablet contains: dexketoprofen 25 mg as dexketoprofen trometamol Others excipients: Maize starch, microcrystalline cellulose, sodium starch glycollate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Special Warnings and Controindications

FASTUMDOL ANTINFIAMMATORIO granules must not be administered in the following cases:

  • patients hypersensitive to the active substance, to any other NSAID, or to any of the excipients listed in section 6.1
  • patients in whom substances with a similar action (e.g. acetylsalicylic acid, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioedema.
  • known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates
  • patients with history of gastrointestinal bleeding or perforation related to previous NSAIDs therapy
  • patients with active peptic ulcer/gastrointestinal haemorrhage, or any history of gastrointestinal bleeding, ulceration or perforation.
  • patiens with chronic dyspepsia.
  • patients who have other active bleedings or bleeding disorders.
  • patients with Crohn’s disease or ulcerative colitis.
  • patients with severe heart failure.
  • patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml/min).
  • patients with severely impaired hepatic function (Child-Pugh score 10-15).
  • patients with haemorrhagic diathesis and other coagulation disorders.
  • patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
  • during the third trimester of pregnancy and lactation period (see section 4.6). Administer with caution in patients with a history of allergic conditions.

The concomitant use of FASTUMDOL ANTINFIAMMATORIO with other NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Fot the entrire list of special precautions for use, please read Product internal leaflet.

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