Isosorbide mononitrate 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ISOSORBIDE MONONITRATE
10MG, 20MG & 40MG 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 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 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
medicine called nitrate vasodilators. It works by
improving the blood supply to the heart, by
enlarging the blood vessels in the heart muscle,
reducing the strain on the heart making it easier to
pump blood, and is used for preventing the pain in
your chest called angina. Isosorbide Mononitrate
tablets may be used to help control certain types of
heart failure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ISOSORBIDE MONONITRATE
DO NOT TAKE Isosorbide Mononitrate tablets and TELL
your doctor if you:
•
are ALLERGIC (hypersensitive) to Isosorbide
Mononitrate or to other nitrates or to any of the
other ingredients in your tablets (see section 6).
An allergic reaction may include rash, itching or
difficulty breathing
•
have very low blood pressure
•
have a low blood volume
•
have glaucoma (increased pressure in the eye)
•
suffer from low cardiac filling pressure or any
serious heart or circulatory (vein/artery)
problems, other than angina
•
blood is not circulating properly (such as shock)
•
have angin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isosorbide mononitrate 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of isosorbide mononitrate.
Excipient with known effect: 5 mg of lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
TABLET
ISOSORBIDE MONONITRATE 20MG TABLETS:
White to off white, round, flat, bevelled edge uncoated tablets,
debossed with ‘AS’ on
one side and break line on the other side. The tablets can be divided
in to equal
halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The usual dose of Isosorbidemononitrate is 1 tablet of
Isosorbidemononitrate 20 mg, taken
asymmetrically (to allow a nitrate low period) 2 to 3 times daily. If
result is not adequate, the
dose may be increased to 1 tablet of Isosorbidemononitrate 40 mg, 2 to
3 times daily.
The dosage may be increased to 120mg per day.
Dosage regime should be designed according to the clinical response of
the patient.
The lowest effective dose should be used.
In patients taking isosorbidemononitrate twice daily, the second dose
should be taken 8 hours
after the 1st dosage. If the dose is one three times daily, take one
every 6 hours. This provides
a nitrate-free period of 6 – 8 hours.
The maximum dose is 3 tablets isosorbidemononitrate 40 mg per day.
In order to prevent possible initial undesirable effect, it may be
adequate to initiate treatment
with possible lowest dose and slowly increase to the required dose.
To prevent tolerance, it is recommended that the dosage be kept as low
as possible and that a
sufficiently long nitrate-free interval is ensured to restore
sensitivity (first dose in the morning
and last dose late in the afternoon, e.g. at 8 am and 15 pm).
The duration of application is decided by the treating physician.
Treatment with isosorbidemononitrate, as with any other nitrate,
should not be stopped
suddenly. Both