Dazonay 75mg/18.75mg/200mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levodopa; Carbidopa; Entacapone

Available from:

Rowex Ltd

ATC code:

N04BA; N04BA03

INN (International Name):

Levodopa; Carbidopa; Entacapone

Dosage:

75mg/18.75mg/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:

2016-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAZONAY 50 MG/12.5 MG/200 MG FILM-COATED TABLETS
DAZONAY 75 MG/18.75 MG/200 MG FILM-COATED TABLETS
DAZONAY 100 MG/25MG/200 MG FILM-COATED TABLETS
DAZONAY 125 MG/31.25 MG/200 MG FILM-COATED TABLETS
DAZONAY 150 MG/37.5 MG/200 MG FILM-COATED TABLETS
DAZONAY 175 MG/43.75 MG/200 MG FILM-COATED TABLETS
DAZONAY 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 symptoms 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 Dazonay is and what it is used for
2.
What you need to know before you take Dazonay
3.
How to take Dazonay
4.
Possible side effects
5.
How to store Dazonay
6.
Contents of the pack and other information
1.
WHAT DAZONAY IS AND WHAT IT IS USED FOR
Dazonay contains three active substances (levodopa, carbidopa and
entacapone) in one film-coated tablet.
Dazonay 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 anti-Parkinson effects of levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAZONAY
DO NOT TAKE DAZONAY IF YOU
-
are allergic to levodopa, carbidopa or entacapone, 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 (combinations of
selective MAO-A and

Summary of Product characteristics

Health Products Regulatory Authority
01 July 2020
CRN009FVL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dazonay 75mg/18.75mg/200mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of
carbidopa anhydrous(as 20.24 mg carbidopa monohydrate)
and 200 mg of entacapone.
Excipient with known effect
Each film-coated tablet of 75 mg levodopa/18.75 mg carbidopa
anhydrous/200 mg entacapone contains 124 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light brownish red coloured, oval shaped, biconvex film coated tablets
debossed "75" on one side and plain on the other side.
Size: 14.1 mm x 8.2 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dazonay 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 Dazonay 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 Dazonay 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
Dazonay 150 mg/37.5 mg/200mg equals 375 mg of
ca