Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Entacapone; Carbidopa; Levodopa
Accord-UK Ltd
Entacapone; Carbidopa; Levodopa
200mg ; 18.75mg ; 75mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100; GTIN: 5690528464047 5690528464054
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. 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 Baca dokumen lengkap
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 Baca dokumen lengkap