Isotard 40XL tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Evolan Pharma AB

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

40mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 5038903000211

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOTARD 25 MG XL
®
TABLETS
ISOTARD 40 MG XL
®
TABLETS
ISOTARD 50 MG XL
®
TABLETS
ISOTARD 60 MG XL
®
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 Isotard XL is and what it is used for
2.
What you need to know before you take Isotard XL
3.
How to take Isotard XL
4.
Possible side effects
5.
How to store Isotard XL
6.
Contents of the pack and other information
1.
WHAT ISOTARD XL IS AND WHAT IT IS USED FOR
Isotard tablets contain the active substance isosorbide mononitrate
(ISMN). ISMN belongs to
a group of medicines called organic nitrates.
Isotard XL prolonged release tablets are used to prevent attacks of
angina (chest pain). Isotard
XL works by opening up blood vessels and reducing the pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOTARD XL
DO NOT TAKE ISOTARD XL:

if you are allergic to isosorbide mononitrate or any of the other
ingredients of this
medicine (listed in section 6)

if you suffer from increased intracranial pressure (high pressure
within your skull, e.g.
from a blow to your head) or cerebral haemorrhage – bleeding from a
ruptured blood
vessel in the brain

if you are taking sildenafil or similar products e.g. Viagra for male
erectile dysfunction

if you are taking riociguat e.g. Adempas for pulmonary hypertension

if you have been diagnosed with any of the following: hypertrophic
obstructive
cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade or
aortic/mitra

Summary of Product characteristics

OBJECT 1
ISOTARD XL
Summary of Product Characteristics Updated 11-Jul-2016 | Kyowa Kirin
Ltd
1. Name of the medicinal product
Isotard 25 mg XL, 40 mg XL, 50 mg XL and 60 mg XL Tablets.
2. Qualitative and quantitative composition
Each tablet contains 25 mg, 40 mg, 50 mg or 60 mg of isosorbide
mononitrate (ISMN).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets (prolonged release).
Isotard 25 mg XL, 40 mg XL and 50 mg XL tablets are round, biconvex,
cream coloured tablets marked
IM25, 40 or 50 on one side, as appropriate.
The Isotard 60 mg XL tablets, only, are oval, cream coloured tablets
scored on both sides but with '6
(score) 0' on one side. The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Isotard XL is indicated in adults and the elderly for prophylactic
treatment of angina pectoris.
4.2 Posology and method of administration
Adults:
One tablet, once daily given in the morning. The dose may be increased
to two tablets, the whole dose to
be given together (dose range 25 to 120 mg).
For Isotard 60 mg XL only, the dose can be titrated to minimise the
possibility of headache by initiating
treatment with half a tablet (30 mg) for the first two to four days.
The tablets should not be chewed or crushed and should be swallowed
with half a glass of fluid.
Children:
The safety and efficacy of Isotard XL ISMN prolonged release tablets
has not been established.
Elderly:
No need for routine dosage adjustment in the elderly has been found,
but special care may be needed in
those with increased susceptibility to hypotension or marked hepatic
or renal insufficiency.
The lowest effective dose should be used.
Attenuation of effect (tolerance) has occurred in some patients being
treated with prolonged release
preparations. In such patients intermittent therapy may be more
appropriate (see Section 4.4).
Therapy should not be discontinued suddenly. Both dosage and frequency
should be tapered gradually
(see Section 4.4).
The core of the tablet is insolubl