“Composition
Active ingredients: arginine salt of ibuprofen, equivalent of ibuprofen 400 mg.
Excipients: L-arginine, sodium bicarbonate, crospovidone, magnesium stearate, hydroxypropyl methylcellulose, sucrose, titanium dioxide, polyethyleneglycol.
Directions
Spididol 400 mg – anti-inflammatory and antirheumatic tablets, useful for:
Heart pain.
Toothache.
Neuralgia.
Bone, joint and muscle pain.
menstrual cramps.
Auxiliary agent in the symptomatic treatment of febrile and influenza-like conditions.
Method of administration and dosage
Adults and children over 12 years old: 1 film-coated tablet 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.
When treating elderly patients, the dosage should be carefully established by the physician, who will have to evaluate the possibility of reducing the dosages indicated above.
In patients with renal, hepatic or cardiac impairment, the dosage should be reduced.
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 during long-term treatment.
The use of this drug is contraindicated in patients with severe hepatic impairment.
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 during long-term treatment.
The use of this drug is contraindicated in patients with severe renal impairment.
In adolescents (aged 12 to 18 years): If the drug is used for more than 3 days in adolescents or if symptoms worsen, a physician should be consulted.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time necessary to control symptoms.
Directions for use: Swallow the tablet with a small amount of water.
Patients with more sensitive stomachs are advised to take the drug during meals.
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 treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
History of recurrent peptic ulcer disease/bleeding (two or more separate episodes of confirmed ulcer or bleeding).
Active and recurrent peptic ulcer disease.
Gastrointestinal bleeding.
Other ongoing bleeding, such as cerebrovascular bleeding.
Ulcerative colitis and Crohn’s disease.
Severe liver and/or kidney failure.
Hemorrhagic diathesis.
Severe heart failure (class IV according to NYHA).
Due to the possibility of cross-allergic reactions with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, the drug is contraindicated in patients in whom these drugs cause allergic reactions such as bronchospasm, asthma, urticaria, rhinitis, nasal polyposis, angioedema.
Third trimester of pregnancy.”
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