Isosorbide mononitrate 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Accord-UK Ltd

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 5012617009654

Patient Information leaflet

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Isosorbide Mononitrate Tablets
10, 20, 40mg x 56 (UK)
148x210 (Reel Fed)
50989937
Leaflet for Blisters
3220
T. Hull
25/03/20
approved for print/date
PROOF ROUND
Technical
Approval
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
NON PRINTING COLOURS
COLOURS
1.
2.
3.
4.
5.
6.
1.
2.
3.
[e-mail]
G. Worth
14/05/2020
23/06/2020
G. Worth
148x210
7.25pt
Accord Barnstaple
n/a
n/a
ISOSORBIDE MONONITRATE ALL STRENGTHS TABLET PIL - UK
Black
profile
BBBA8209
3
* 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.
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
German GTIN 14
(incorporating PZN):
_Continued over page_
_Continued top of next column_
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 ISOSORBIDE MONONITRATE TABLETS
ARE AND WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ISOSORBIDE MONONITRATE TABLETS
3
HOW TO TAKE ISOSORBIDE MONONITRATE
TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ISOSORBIDE MONONITRATE
TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT ISOSORBIDE MONONITRATE TABLETS
ARE AND WHAT THEY ARE USED FOR
Isosorbide Mononitrate belongs to a gr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ISOSORBIDE MONONITRATE TABLETS 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Isosorbide mononitrate
3.
PHARMACEUTICAL FORM
White to off-white, uncoated tablets.
White to off-white, circular, biconvex uncoated tablets impressed
“C” on one
face and the identifying letters “IO” on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isosorbide mononitrate tablets are indicated for use in the treatment
and
prophylaxis of angina pectoris and as adjunctive therapy in congestive
heart
failure which does not respond adequately to cardiac glycosides and/or
diuretics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
_Angina_
Usually 20mg, two or three times daily. Patients already accustomed to
prophylactic nitrate therapy may normally be transferred directly to a
therapeutic dose of isosorbide mononitrate. For patients not already
receiving
prophylactic nitrate therapy, it is recommended that the initial
dosage should
be 20mg twice daily.
The maintenance dose in individual patients is usually between
20-120mg
daily.
_Congestive cardiac failure_
In severe congestive cardiac failure doses of 20mg, two or three times
daily
may be employed depending on individual requirements. The optimum
dosage is best determined by continuous haemodynamic monitoring. The
use
of isosorbide mononitrate tablets in severe congestive cardiac failure
should be
regarded as an adjunctive therapy to more conventional treatment (e.g.
cardiac
glycosides, diuretics).
For those previously treated with isosorbide dinitrate in conventional
form, the
dosage of isosorbide mononitrate should be the same initially.
Isosorbide
mononitrate is effectively twice as potent as sustained release forms
of
isosorbide dinitrate and patients transferred from such treatment
should
receive isosorbide mononitrate at half the previous dosage.
Therapy should not be discontinued suddenly. Both dosage and frequency
should be tapered gradually (see sec