Sastravi 200mg/50mg/200mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levodopa; Carbidopa; Entacapone

Available from:

Actavis Group PTC ehf

ATC code:

N04BA; N04BA03

INN (International Name):

Levodopa; Carbidopa; Entacapone

Dosage:

200 mg/50 mg/200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopa and dopa derivatives; levodopa, decarboxylase inhibitor and COMT inhibitor

Authorization status:

Marketed

Authorization date:

2014-09-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
SASTRAVI 50 MG/12.5 MG/200 MG FILM-COATED TABLETS
SASTRAVI 75 MG/18.75 MG/200 MG FILM-COATED TABLETS
SASTRAVI 100 MG/25 MG/200 MG FILM-COATED TABLETS
SASTRAVI 125 MG/31.25 MG/200 MG FILM-COATED TABLETS
SASTRAVI 150 MG/37.5 MG/200 MG FILM-COATED TABLETS
SASTRAVI 175 MG/43.75 MG/200 MG FILM-COATED TABLETS
SASTRAVI 200 MG/50 MG/200 MG FILM-COATED TABLETS
levodopa/carbidopa/entacapone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Sastravi is and what it is used for
2.
What you need to know before you take Sastravi
3.
How to take Sastravi
4.
Possible side effects
5.
How to store Sastravi
6.
Contents of the pack and other information
1.
WHAT SASTRAVI IS AND WHAT IT IS USED FOR
Sastravi contains three active substances (levodopa, carbidopa and
entacapone) in one film-coated
tablet. Sastravi is used for the treatment of Parkinson’s disease.
Parkinson’s disease is caused by low levels of a substance called
dopamine in the brain. Levodopa
increases the amount of dopamine and hence reduces the symptoms of
Parkinson’s disease. Carbidopa
and entacapone improve the antiparkinson effects of levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SASTRAVI
_ _
DO NOT TAKE SASTRAVI IF YOU
-
are allergic to levodopa, carbidopa or entacapone, soya, peanut or any
of the other ingredients of
this medicine (listed in section 6)
-
have narrow-angle glaucoma (an eye disorder)
-
have a tumour of the adrenal gland
-
are taking certain medicines for treating depression

Summary of Product characteristics

Health Products Regulatory Authority
30 November 2020
CRN008HJQ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sastravi 200mg/50mg/200mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of levodopa, 50 mg of
carbidopa (as monohydrate)and 200 mg of entacapone.
Excipient with known effect:
Each film-coated tablet contains 0.83 mg lecithin (soya) (E322).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Brownish red, oval, biconvex film-coated tablet of 8.21 x 17.2 mm with
“200” marked on one side and “LEC” on the opposite
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sastravi is indicated for the treatment of adult patients with
Parkinson’s disease and end-of-dose motor fluctuations not
stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The optimum daily dose must be determined by careful titration of
levodopa in each patient. The daily dose should be
preferably optimised using one of the seven available tablet strengths
(50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.5 mg/200 mg,
175 mg/43.75 mg/ 200 mg or
200 mg/50 mg/200 mg levodopa/carbidopa/entacapone).
Patients should be instructed to take only one Sastravi tablet per
dose administration. Patients receiving less than 70-100 mg
carbidopa a day are more likely to experience nausea and vomiting.
While the experience with total daily dose greater than
200 mg carbidopa is limited, the maximum recommended daily dose of
entacapone is 2,000 mg and therefore the maximum
dose is 10 tablets per day for the Sastravi strengths of 50 mg/12.5
mg/200 mg, 75 mg/18.75 mg/200 mg,
100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Ten tablets of Sastravi
150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day. According to
this daily carbidopa dose, the maximum
recommended daily 175 mg/43.75 mg