“Composition
SPIDOL 400 mg granules for preparation of oral solution with apricot flavor
Active ingredient: arginine salt of ibuprofen, equivalent to ibuprofen 400 mg. Excipients: Aspartame 60 mg Sucrose 1770 mg.
Excipients: L-arginine, sodium bicarbonate, sodium saccharin, aspartame, apricot flavoring, sucrose.
Therapeutic indications
Pain of various origins and nature: headache, toothache, neuralgia, bone and joint and muscle pain, menstrual pain. Auxiliary agent in symptomatic treatment of feverish and flu-like conditions.
Dosage
Adults and children over 12 years of age: 1 film-coated tablet or 1 sachet two to three times a day. The maximum daily dose should not exceed 1200 mg per day. Elderly patients: Elderly patients should adhere to the minimum dosages indicated above. The tablet should be swallowed with a small amount of water. The granules should be dissolved in a glass of water (50-100 ml) and taken immediately after preparation of the solution. When treating elderly patients, the dosage should be carefully established by the physician, who will have to assess the possibility of reducing the dosages indicated above. Impaired liver function: Caution should be exercised when treating patients with impaired liver function. In such patients, periodic monitoring of clinical and laboratory parameters is advisable, especially in case of long-term treatment (see section 4.4). The use of SPIDOL 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. In such patients, periodic monitoring of clinical and laboratory parameters is advisable, especially in case of long-term treatment (see section 4.4). The use of SPIDOL is contraindicated in patients with severe renal impairment.
Contraindications
Hypersensitivity to the active substance or to other chemically related substances and/or to any of the excipients. History of gastrointestinal bleeding or perforation related to previous active treatment or history of recurrent gastric ulcer/bleeding (two or more separate episodes of confirmed ulcer or bleeding). Active and recurrent peptic ulcer. Active gastrointestinal bleeding. Ulcerative colitis and Crohn’s disease. Severe hepatic and/or renal impairment. Severe cardiac impairment. Due to the possibility of cross-allergic reactions with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, the drug is contraindicated in patients who have allergic reactions to these drugs, such as asthma, urticaria, rhinitis, nasal polyposis, angioedema. In case of systemic lupus erythematosus and collagenoses, before using the drug SPIDOL, it is necessary to consult the attending physician. Granules containing aspartame are contraindicated in patients with phenylketonuria. Third trimester of pregnancy.”
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