QuestionPosted on: September 28 2021
Magistral preparation with Mexiletin
Mexiletine HCl is approved by the European Medicines Agency for use in the EU. There is currently no medicine on the market in Belgium with this active ingredient.
Mexiletine Hydrochloride is a medicine used to treat symptoms of myotonia in patients with non-dystrophic myotonic disorders, a group of inherited muscle disorders. Non-dystrophic means that patients with this condition do not suffer from muscle breakdown. Patients with non-dystrophic myotonic disorders experience muscle stiffness and pain because their muscles relax slowly after contraction. Myotonic disorders are rare and Mexiletine Hydrochloride was designated an 'orphan medicine' on 19 November 2014.
Because this licensed raw material is now available to Belgian pharmacists, doctors can prescribe Mexiletine HCl capsules magisterially and thus help patients with this orphan disease in an affordable way. At the request of the FAGG/AFMPS, this raw material, which is regarded as an essential medicine, was introduced on the market.
The dosage is 167 mg per capsule and is dosed at 1 to 3 capsules per day.
Unfortunately, as this is an orphan disease, we are unable to do any major marketing communications and hope for your help in getting this message to the right doctors. Pharmacists can obtain this raw material from Magis Pharma BV.