Spididol 400mg anti-inflammatory 12 coated tablets

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

Diuretics, ACE inhibitors and angiotensin II antagonists:
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking SPIDIDOL concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Prothrombin time should be closely monitored during the first few weeks of combined treatment and the dosage of anticoagulants may need to be adjusted.

Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Decreased efficacy of thiazide diuretics may occur, possibly due to sodium retention associated with renal prostaglandin synthetase inhibition.
The hypotensive effect of beta-blockers can be reduced.
The association with aspirin or other NSAIDs should be avoided, ibuprofen can in fact reduce the cardioprotective effect of acetylsalicylic acid if taken at the same time.
Experimental data indicate that ibuprofen may inhibit the effects of low-dose aspirin on platelet aggregation when the drugs are administered concomitantly.
However, the paucity of the data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen

Isolated cases of elevated plasma levels of digoxin, phenytoin and lithium as a result of combined therapy with ibuprofen are reported in the literature.

Technical data sheet (RCP) Composition:
One film-coated tablet contains:
Active principle
Ibuprofen arginine salt, equivalent to ibuprofen 400 mg

Excipients:
Sucrose 16.7 mg
Spiridol in packs of 12 tablets 400 mg

METHOD OF USE
Adults and children over 12 years: 1 film-coated tablet or 1 sachet, two – 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 the preparation of the solution.
In the treatment of elderly patients, the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
Hepatic insufficiency: caution should be used in the treatment of patients with impaired hepatic function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment (see section 4.4). The use of SPIDIDOL is contraindicated in patients with severe hepatic insufficiency (see section 4.3).
Renal insufficiency: caution should be adopted in the treatment of patients with impaired renal function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment (see section 4.4). The use of SPIDIDOL is contraindicated in patients with severe renal insufficiency (see section 4.3).
In adolescents (aged ≥ 12 to <18 years): if use of the medicinal product is necessary for more than 3 days in adolescents, or if symptoms worsen, a doctor should be consulted.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

Spiridol in packs of 12 tablets 400 mg