SPC changes
Mirapexin
The summaries of product characteristics for Mirapexin (pramipexole;
Boehringer Ingelheim) have been updated to include an additional indication
for the symptomatic treatment of moderate to severe idiopathic restless
legs syndrome. The recommended starting dose for RLS is 0.088mg of base
(0.125mg of salt) taken once a day, two to three hours before bedtime.
The dose may be increased, if needed, every four to seven days up to
a maximum of 0.54mg of base (0.75mg of salt). If treatment is interrupted
for more than a few days, Mirapexin should be reintroduced from the starting
dose and titrated. The SPCs say that, when used for RLS at a dose not
exceeding 0.54 mg of base, Mirapexin can be discontinued without tapering,
but rebound symptoms cannot be excluded. The SPCs now contain information
about augmentation phenomena (where, with dopaminergic treatment, symptoms
of RLS can worsen, begin earlier in the day or spread to involve other
extremities). The undesirable effects sections of the SPCs have been
updated and now include adverse reactions for Mirapexin use in RLS (for
example, common [>=5 per cent] nausea, headache, fatigue). See SPCs.
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