Isosorbide mononitrate 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Almus Pharmaceuticals Ltd

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 05060057401149

Patient Information leaflet

MEDREICH PLC
ISOSORBIDE MONONITRATE 20MG TABLETS
ISOSORBIDE MONONITRATE 40MG TABLETS
MARKETING AUTHORISATION HOLDER AND MANUFACTURER:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : [e-mail]
This leaflet was last approved in July 2013
1210598
Keep out of sight and reach of children.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ISOSORBIDE MONONITRATE TABLETS 40mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40mg 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 “IV”on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1) Prophylaxis of angina pectoris.
2) As an adjunctive treatment in the management of severe acute or
chronic
congestive cardiac failure not responding to cardiac glycosides and/or
diuretics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
It is recommended that the tablets should be swallowed whole with a
little fluid after
meals.
Dosage should be reduced in patients with renal or hepatic impairment.
_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 (_eg_
cardiac
glycosides, diuretics).
_Elderly:_ Dosage requirements may be reduced especially when hepatic
or renal
function is impaired. Also, particular care should be taken due to
susceptibility to
hypotension.
_Children: _Safety and efficacy has not been established.
_Method of Administration _
For oral administration.
4.3
CONTRAINDICATIONS
Known hypersensitivity to iso