Isosorbide mononitrate 40mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Isosorbide mononitrate

Disponible desde:

IVAX Pharmaceuticals UK Ltd

Código ATC:

C01DA14

Designación común internacional (DCI):

Isosorbide mononitrate

Dosis:

40mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02060100

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANGITATE
® 20 MG TABLETS
ANGITATE
® 40 MG TABLETS
Isosorbide Mononitrate
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 Angitate
®
is and what it is used for
2 .
What you need to know before you take Angitate
®
3 .
How to take Angitate
®
4 .
Possible side effects
5 .
How to store Angitate
®
6 .
Contents of the pack and other information
1. WHAT ANGITATE
® IS AND WHAT IT IS USED FOR
This medicine contains an active ingredient called Isosorbide
Mononitrate, which 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.
Angitate
®
20 mg and 40 mg Tablets can also be used to treat congestive heart
failure. Heart
failure can happen when the heart muscle is not strong enough to pump
the blood around
the body. It may cause problems with breathing and swelling of the
legs.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGITATE
®
DO NOT TAKE THIS MEDICINE:
•
If you are allergic to isosorbide mononitrate, other nitrates or to
any of the other
ingredients of this medicine (listed in section 6)
•
If you suffer from severe anaemia (reduction in red blood c

Ficha técnica

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