Lecado 200mg/50mg modified-release tablets

Summary of Product characteristics

                                OBJECT 1
LECADO 200/50 MG MODIFIED-RELEASE TABLETS
Summary of Product Characteristics Updated 08-Feb-2018 | Sandoz
Limited
1. Name of the medicinal product
Lecado 200/50 mg Modified-release Tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 200 mg levodopa and 50 mg
carbidopa (as carbidopa
monohydrate).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablets
Appearance: Orange-brown, round, biconvex tablets
4. Clinical particulars
4.1 Therapeutic indications
Idiopathic Parkinson's disease, in particular to shorten the 'off'
period in patients who have previously
been treated with immediate-release levodopa/decarboxylase inhibitors
or with just levodopa and who
showed motor fluctuations.
Experience with Lecado is limited in patients, who have not been
previously treated with levodopa.
4.2 Posology and method of administration
The daily dose of levodopa/carbidopa should be carefully determined.
Patients should be monitored
closely during the period of dose adjustment, especially with regard
to the occurrence or exacerbation of
nausea and abnormal involuntary movements, such as dyskinesia, chorea
and dystonia. Blepharospasm
could be an early sign of overdosing.
The pharmacokinetic properties of the prolonged-release tablets may be
altered if the tablets are broken or
chewed. Therefore the tablets must be swallowed whole.
Most other medicines, used to treat Parkinson's Disease, except for
levodopa, can be continued during
administration of levodopa/carbidopa. However their dosage may need to
be adjusted.
Sudden withdrawal of Lecado therapy should be avoided wherever
possible.
Since carbidopa prevents the reversal of levodopa effects caused by
pyridoxine, Lecado 200/50 mg can be
administered to patients who receive supplemental pyridoxine (Vitamin
B
6
).
• Starting dose
Patients who have never before received Levodopa therapy
Lecado 100/25 mg is designed for use in patients, who have not
previously had levodopa treatment or to
aid titra
                                
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