Sastravi 75mg/18.75mg/200mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Entacapone; Carbidopa; Levodopa

Tilgjengelig fra:

Accord-UK Ltd

INN (International Name):

Entacapone; Carbidopa; Levodopa

Dosering :

200mg ; 18.75mg ; 75mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04090100; GTIN: 5690528464047 5690528464054

Informasjon til brukeren

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SASTRAVI ALL STRENGTHS PIL - UK
Black
BBBA0126
C.Grant
22/11/16
28/11/16
C.Grant
190x380
8pts
Actavis Zdravlje
Serbia
22/11/16
28/11/16
02
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 ingredien

Preparatomtale

OBJECT 1
SASTRAVI 75MG/18.75MG/200MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 24-Feb-2017 | Accord-UK Ltd
1. Name of the medicinal product
Sastravi 75mg/18.75mg/200mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 75mg of levodopa, 18.75mg of
carbidopa (as monohydrate) and 200mg
of entacapone.
Excipient with known effect:
Each film-coated tablet contains 0.54mg lecithin (soya) (E322).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Sastravi 75mg/18.75mg/200mg: Brownish red, oval, biconvex film-coated
tablet of 7.04 x 14.7mm with
“75“ 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