Isosorbide mononitrate 10mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
21-04-2023
Summary of Product characteristics
(SPC)
21-04-2023
Active ingredient:
Isosorbide mononitrate
Available from:
Teva UK Ltd
ATC code:
C01DA14
INN (International Name):
Isosorbide mononitrate
Dosage:
10mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02060100; GTIN: 5017007026822
Patient Information leaflet
ISOSORBIDE MONONITRATE
10 MG, 20 MG AND 40 MG TABLETS
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.
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.
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
WHAT ISOSORBIDE MONONITRATE
IS AND WHAT IT IS USED FOR
•
Isosorbide mononitrate belongs to a
group of drugs called nitrates. These
drugs open out blood vessels and allow
more blood to flow through them.
•
Isosorbide Mononitrate is used:
•
in the treatment and prevention of
angina pectoris attacks which is a
chest pain associated with the heart
that usually occurs with exertion.
•
in the treatment of heart failure where
the heart does not pump with enough
force to maintain effective circulation
of the blood around the body.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ISOSORBIDE
MONONITRATE
DO NOT TAKE ISOSORBIDE MONONITRATE IF YOU:
• are allergic (hypersensitive) to isosorbide
mononitrate or any of the other ingredients
of this medicine
• have ever suffered a reaction to medicines
containing nitrates before
• have low blood pressure
• have ever suffered from a heart attack
• have any other problems with your heart or
your blood has stopped circulating around
your body properly (circulatory failure)
• are suffering from “shock” or vascular
collapse
• suffer from glaucoma (loss of vision due to
high pressure in the eye)
• have ever suffered
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Summary of Product characteristics
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.
Excipient(s) with known effect: Each 10 mg tablet contains 40 mg
lactose
monohydrate.
_ _
For the full list of excipients, see section 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
c
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