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

Product Description

Composition:

SPIDIDOL 400 mg granules for oral solution, mint-anise flavour. One sachet contains: Active ingredient: Ibuprofen, arginine salt, equivalent to 400 mg of ibuprofen.

Excipients:

Granules for oral solution, mint-anise flavour: Arginine, Sodium bicarbonate, Sodium saccharin, Aspartame, Mint flavour, Anise flavour, Sucrose.

Therapeutic indications:

Pains 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 cross-allergic 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, angioedema. • In case of systemic lupus erythematosus and collagen diseases, the doctor must be consulted before using SPIDIDOL. • The granules, as they contain aspartame, are contraindicated in patients with phenylketonuria. • Third trimester of pregnancy (see section 4.6).

Dosage

Adults and children over 12 years: 1 film-coated tablet or 1 sachet, two or three times a day. 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. In the treatment of elderly patients, the dosage must be carefully established by the physician who will evaluate a possible reduction of the dosages indicated above. Hepatic impairment: caution should be exercised when treating patients with reduced liver function. In these patients, periodic monitoring of clinical and laboratory parameters is advisable, especially in case of 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 reduced renal function. In these patients, periodic monitoring of clinical and laboratory parameters is advisable, especially in case of prolonged treatment (see section 4.4). The use of SPIDIDOL is contraindicated in patients with severe renal impairment (see section 4.3).