Isosorbide mononitrate 40mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Isosorbide mononitrate

Boleh didapati daripada:

Arrow Generics Ltd

Kod ATC:

C01DA14

INN (Nama Antarabangsa):

Isosorbide mononitrate

Dos:

40mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 02060100

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ISOSORBIDE MONONITRATE 20 MG TABLETS
ISOSORBIDE MONONITRATE 40 MG TABLETS
Isosorbide mononitrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, tell 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 is and what it is used for
2.
What you need to know before you take Isosorbide mononitrate
3.
How to take Isosorbide mononitrate
4.
Possible side effects
5.
How to store Isosorbide mononitrate
6.
Contents of the pack and other information
1.
WHAT ISOSORBIDE MONONITRATE IS AND WHAT IT IS USED FOR
Isosorbide mononitrate belongs to a group of medicines called organic
nitrates. Organic nitrates work
by widening the blood vessels in your heart to allow an increased
amount of blood to flow to areas
which need it.
Isosorbide mononitrate is used to prevent angina pectoris. Angina
usually feels like a tight pain in the
chest, neck or arm area. The pain comes from the heart muscle and is a
sign that part of it is not
getting enough oxygen for the amount of work it is doing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOSORBIDE MONONITRATE
_ _
DO NOT TAKE ISOSORBIDE MONONITRATE
-
if you are allergic to the isosorbide mononitrate or to any of the
other ingredients of this
medicine (listed in section 6).
-
if you suffer from severe disorders of the heart muscle or the
pericardium causing severe
impairment of the heart function is severely impaired (called
constrictive pericarditis,
pericardial tamponade or restrictive cardiomyopathy); You have been
diagnosed with any of
the following heart

Ciri produk

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