Disopyramide Phosphate Capsules BP 100mg
Riik: Malta
keel: inglise
Allikas: Medicines Authority
Infovoldik
(PIL)
11-06-2024
Toote omadused
(SPC)
11-06-2024
Toimeaine:
DISOPYRAMIDE
Saadav alates:
Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
ATC kood:
C01BA03
INN (Rahvusvaheline Nimetus):
DISOPYRAMIDE 100 mg
Ravimvorm:
CAPSULE
Koostis:
DISOPYRAMIDE 100 mg
Retsepti tüüp:
POM
Terapeutiline ala:
CARDIAC THERAPY
Volitamisolek:
Withdrawn
Loa andmise kuupäev:
2006-11-10
Infovoldik
Customer
Code & Job Title
Colours
Dimensions
DB job No.
Date
Version
Artwork By
Generics
Fix-a-Form
-
52x101mm
-
25.8.99
1
Danny
112211112
PEEL HERE
BUT DO NOT REMOVE
DISOPYRAMIDE
PHOSPHATE
CAPSULES BP
84 Capsules
EACH CAPSULE CONTAINS:
Disopyramide
Phosphate BP
equivalent to 100 mg
of Disopyramide.
ALSO CONTAINS:
lactose.
DOSAGE:
Take as
directed by the
physician. For further
information see leaflet.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN.
Store below 25
°
C.
Keep the container
tightly closed.
PL 4569/0026 POM DG-Q35
Generics [UK] Ltd,
Potters Bar, Herts, EN6 1TL.
100
MG
84 Capsules
DISOPYRAMIDE
PHOSPHATE
CAPSULES BP
112211
112
100
MG
COLOURS:
Black & 60/80% tint
Blue PMS 307
Dk Green PMS 348
Lt Green PMS 376
Text free area
Lot/Exp do not print
APPROVED TO PRINT:
Marketing
Registration
Production
Customer
Quality Assurance
Generics [UK] Limited, Design Department
Albany Gate, Darkes Lane, Potters Bar, Herts, EN6 1AG
CUSTOMER:
GUK
DESIGNER:
Maria Toumazou
PRODUCT:
Disopyramide capsules 100 mg x 84
ITEM CODE:
DG-Q35
PHARMACODE:
608
DIMENSIONS:
52 x 101 mm (Denny's tweeked profile)
PROOF NO & DATE:
3 23/11/04
REVISION:
Further MDSG text changes. Amending date in
header box.
SUPERSEDES:
DG-Q30
ARTWORK FOR SUBMISSION
KEEP ALL MEDICATION OUT OF THE REACH AND
SIGHT OF CHILDREN.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE.
• Keep this leaflet.
You may need to read it again. • If you have further
questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and
you should not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
YOUR MEDICINE
Your medicine is in the form of a capsule. There are two
Lugege kogu dokumenti
Toote omadused
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Disopyramide Phosphate Capsules BP 100mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule
contains 128.90 mg Disopyramide Phosphate BP equivalent to
Disopyramide 100mg.
For a full list of excipients, see 6.1
3.
PHARMACEUTICAL FORM
Capsule
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Maintenance of normal rhythm following conversion by parenteral
drugs or electroconversion.
Prevention of arrhythmias after myocardial infarction.
Treatment of persistent ventricular and
atrial extrasystoles, paroxysmal supraventricular
tachycardia, Wolff-Parkinson-White syndrome.
Suppression of arrhythmias during surgical procedures.
Control of arrhythmias following the use of digitalis or similar
glycosides.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only. The capsules should be swallowed
whole and not chewed or opened.
Adults: 300-800mg in divided doses adjusted according to the
response of the patient.
Heart Failure: In determining the intervals between administration
of Disopyramide capsules it
should be borne in mind that whilst the elimination
half-life in normal volunteers is approximately
seven hours, in patients with heart failure, half life values
of 12 hours or more have been recorded.
Impaired Renal Function: (Disease state of the elderly): Standard
capsules should be used in
patients in renal failure. A reduced dosage,
preferably accompanied by assay of Disopyramide
plasma levels in cases of
severe renal failure (creatinine clearance <8ml/min) is
recommended. The
following table may be helpful as a guide.
_Creatinine Clearance _
_(ml/min) _
_Dosage 100 or 150mg capsules _
Page 2 of 7
Normal Normal
Dosage
20 - 60
100mg 8 hourly or
150mg 12 hourly
8 – 20
100
Lugege kogu dokumenti
