Spididol 400mg granules for oral solution - analgesic anti-inflammatory 12 sachets apricot flavour

Product Description

Composition

SPIDIDOL 400 mg granules for oral solution, apricot flavor. One sachet contains: Active ingredient: Ibuprofen arginine salt, equivalent to ibuprofen 400 mg. Excipients: Aspartame 60 mg, Sucrose 1770 mg.

 Excipients

Granules for oral solution, apricot flavor: L-Arginine, Sodium bicarbonate, Sodium saccharin, Aspartame, Apricot flavor, Sucrose.

Therapeutic indications

Pain of various origins and natures: headache, toothache, neuralgia, bone, joint and muscle pain, menstrual pain. Adjuvant in the symptomatic treatment of fever and influenza.

Contraindications

Hypersensitivity to the active substance or to other closely related substances from a chemical point of view and/or to any of the excipients. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding). Active and recurrent peptic ulcer. Active gastrointestinal bleeding. Ulcerative colitis and Crohn's disease. Severe hepatic and/or renal insufficiency. Severe cardiac insufficiency. Due to the possibility of allergic cross-reactions with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, the product is contraindicated in patients in whom these drugs induce allergic reactions such as asthma, urticaria, rhinitis, nasal polyps, and angioedema. In case of systemic lupus erythematosus and collagen diseases, consult your doctor before using SPIDIDOL. The granules, as they contain aspartame, are contraindicated in patients with phenylketonuria. Third trimester of pregnancy.

Dosage

Adults and children over 12 years: 1 film-coated tablet or 1 sachet, two to three times daily. The maximum daily dose should not exceed 1200 mg per day. Elderly: Elderly patients should adhere to the minimum dosages indicated above. The tablet should be swallowed with a little water. The granules should be dissolved in a glass of water (50–100 ml) and taken immediately after preparing the solution. When treating elderly patients, the dosage should be carefully determined by the physician, who will evaluate a possible reduction in the dosages indicated above. Hepatic impairment: Caution should be exercised when treating patients with impaired hepatic function. Periodic monitoring of clinical and laboratory parameters is recommended in these patients, especially during prolonged treatment (see section 4.4). The use of SPIDIDOL is contraindicated in patients with severe hepatic impairment (see section 4.3). Renal impairment: Caution should be exercised when treating patients with impaired renal function. Periodic monitoring of clinical and laboratory parameters is recommended in these patients, especially during prolonged treatment (see section 4.4). The use of SPIDIDOL is contraindicated in patients with severe renal impairment (see section 4.3).