Isosorbide mononitrate 10mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Isosorbide mononitrate

Tillgänglig från:

The Boots Company Plc

ATC-kod:

C01DA14

INN (International namn):

Isosorbide mononitrate

Dos:

10mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 02060100

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOSORBIDE MONONITRATE TABLETS 10MG
ISOSORBIDE MONONITRATE TABLETS 20MG
ISOSORBIDE MONONITRATE TABLETS 40MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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.
• You must talk to a doctor if you do not feel better or if you feel
worse.
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. Content of the pack and other information
1. WHAT ISOSORBIDE MONONITRATE TABLETS ARE AND WHAT THEY ARE USED FOR
Isosorbide Mononitrate Tablets belong to a group of medicines called
nitrate vasodilators. These work by
relaxing the blood vessels of the heart, reducing the strain on the
heart making it easier to pump blood.
Isosorbide Mononitrate Tablets are 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
TABLETS
Do not take Isosorbide Mononitrate Tablets if:
• you are allergic (hypersensitive) to isosorbide mononitrate,
isosorbide dinitrate or any of the other
ingredients of Isosorbide Mononitrate Tablets (see section 6). An
allergic reaction may include a rash,
itching or difficulty breathing
• you have severe anaemia (reduction in red blood cells which can
ma

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isosorbide Mononitrate 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of isosorbide mononitrate.
(50mg isosorbide mononitrate: lactose 20:80)
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet
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
For oral administration.
Adults
The recommended dosage is from 20 to 120 mg isosorbide-5-mononitrate
daily in divided doses. The majority of patients will require a dosage
in the
range of 40 to 60 mg daily in divided doses. The tablets should be
taken with
fluid and swallowed whole without chewing.
The lowest effective dose should be used.
For patients who have not previously received prophylatic nitrate
therapy an
initial dosage of 10 mg isosorbide mononitrate (1 tablet) daily for 2
days
followed by a dosage of 20 mg (1 tablet morning and evening) for a
further 3
days is recommended. Subsequently the daily dosage may be increased to
the
normal prophylatic level. Patients already accustomed to chronic
nitrate
therapy normally may be transferred directly to a therapeutic dose.
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 section 4.4).
Children
The safety and efficacy of isosorbide mononitrate has not been
established in
children.
The elderly
There is no evidence to suggest that an adjustmen