Following the change of the manufacturing plant, the sewage and the shape of some Sinemet tablets will be adapted from June. This medicine is used by 45,000 patients in France.
Some tablets of essential drug for Parkinson's disease, Sinemet, will be adjusted from June for the 100 mg dose and mid-July for the doses at 250 mg, following a manufacturing plant change, and Warned Thursday, 23 t May the drug agency (ANSM). The adjustments are about the faeces, which facilitate the absorption of the drug, and the shape of the tablets that pass from round to oval.
Sinemet is a levodopa-based drug, a molecule that compensates for dopamine deficiency in the brain, typical of this pathology. It also contains another molecule, carbideopa, which prevents rapid degradation of leopodo before it reaches the brain. The change is not about the active substances (levodopa / carbidopa) and their concentration, which remain the same, than the dose and the number t of tablets to use.
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Learn from Levothyrox
Currently, of the 200,000 patients with Parkinson's disease in France, 45,000 take Sinemet. Others are treated with Modopar, an alternative to Sinemet. "The adjustment is about 40,000 patients (those taking the 100 mg dose and 250 mg, Ed)," said Dr Philippe Vella, director of neurological drugs in the ANSM. This change will not influence the effectiveness and tolerance of these drugs, says the ANSM. The new tablets are the same as those already used by thousands of European patients, for example in Germany, Spain and Italy.
To prevent the formula change from being noticed by patients as happened with the new Levothyrox formula, the boxes will carry a warning label in red letters on a yellow background. They'll be labeled the first six months of marketing with the talk "Composition and new presentation – Ask the information sheet for your pharmacist / doctor". In addition, pharmacists will give patients an information document when distributing new Sinemet boxes and a letter from ANSM has been sent to health professionals.
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At the end of August 2018, the MSD laboratory had announced a long stock of some portions of this "big drug", the Sinemet. According to Dr. Vella, was torn to plan to start over seven months. ANSM imposed a fine of 348,000 euros on the manufacturer, the MSD laboratory, for this lack of supply.
According to the ANSM, the stock was often due to "production difficulties". For this reason, the MSD laboratory decided to give the best to manufacture in the US to move it to Italy, at the factory where it was insured until 2012 for France. "It was necessary to modify the manufacturing process in the new tools and thus the composition of the tablets," he said the Agence du médicament. Marketing has already started in the UK.