Active substances: thiocolchicoside, acelofenac; 1 tablet contains acelofenac 100 mg; thiocolchicoside 4 or 8 mg Excipients: MCC, Cross Carmellose Sodium, Colloidal Anhydrous Silicon, Sodium Starch Glycolate, Talcum, Magnesium Stearate.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.
Administration during pregnancy or breast-feeding.
Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.
Aclotol MR is contraindicated in patients who are hypersensitive to any component of this product. It is contraindicated to pregnant women, lactating mother. Should not be used during pregnancy and lactation. Should not be given to children. Stomach and duodenum peptic ulcer in acute stage, severe disorders of liver function (liver insufficiency) and hepatotoxic reaction on usage of the preparation in anamnesis; concurrent usage of potential hepatotoxic agents; severe disorders of kidneys function (creatinine clearance less than 30 mg/min); severe disorders of blood coagulability; Aclotol MR should be prescribed cautiously to people with H/O seizure(thiocolchiside) and porphyria(aceclofenac).
Aclotol MR is a combined drug with a pronounced anti-inflammatory, analgesic, antipyretic and muscle relaxant effect. Pharmacological activity of the drug is due to the properties of acelofenac and thiocolchicoside, which are the components of the drug. Acelofenac has a pronounced anti-inflammatory and analgesic, and a moderate antipyretic effect. Paracetamol has a pronounced analgesic, slight antipyretic and anti-inflammatory effect. The mechanism of action is associated with inhibition of prostaglandin synthesis. Thiocolchicoside binds to GABA-A and strychnine sensitive glycine receptors. Thiocolchicoside acting as a GABA-A receptor antagonist, its myorelaxant effects could be exerted at the supra-spinal level, via complex regulatory mechanisms, although a glycinergic mechanism of action cannot be excluded. The characteristics of the interaction of Thiocolchicoside with GABA-A receptors are qualitatively and quantitatively shared by its main circulating metabolite, the glucuronidated Derivative. Pharmacokinetics. After the intake, the drug is rapidly and completely absorbed. Food has no effect on absorption of the drug. Plasma concentrations of active substances are linearly dependent on the dose; the maximum levels are reached in 60-90 minutes after ingestion. Binding of acelofenac to plasma proteins (mainly albumin) reaches 99.7%. The expected volume of distribution is 0.12-0.17 L/kg. Acelofenac penetrates into synovial liquid, where its maximum concentration is reached 2-4 hours later than in blood plasma. The half-life for elimination from the synovial fluid is 3-6 hours. Acelofenac is metabolized by glucuronidation of unchanged molecule and methoxylation, which forms several phenolic metabolites, the biological activity of which is considerably inferior to the activity of the parent substance. General plasmatic clearance of acelofenac is approximately 300 mL/min. Terminal half-life is 1-2 hours. 60% of the administered dose is excreted in the urine as glucuronic conjugates of unchanged acelofenac; the rest is excreted in the bile and feces. Thiocolchicoside is rapidly absorbed after oral administration, and metabolized into 3 main metabolites. The two main circulating forms were the Thiocolchicoside aglycon and the glucuronidated derivative of Thiocolchicoside, which is active. After repeated administration of the drug, pharmacokinetic parameters of active substances remain unchanged. No accumulation occurs provided the recommended dosage intervals are observed.
Conditions of supply.