Monigen XL 60 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Viatris UK Healthcare Ltd

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

60mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100

Patient Information leaflet

PAGE 1 OF 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MONIGEN XL 60
PROLONGED-RELEASE 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 Monigen XL 60 is and what it is used for
2.
What you need to know before you take Monigen XL 60
3.
How to take Monigen XL 60
4.
Possible side effects
5.
How to store Monigen XL 60
6.
Contents of the pack and other information
1.
WHAT MONIGEN XL 60 IS AND WHAT IT IS USED FOR
Monigen XL 60 contains isosorbide mononitrate which belongs to a
family of medicines
known as nitrates. These medicines allow the blood vessels around the
heart to relax and
widen, allowing more blood to flow to the heart and around the body.
Your medicine is in the
form of a ‘prolonged release’ tablet, which slowly releases the
medicine into your body.
Monigen XL 60 can be used to help prevent angina (a muscle cramp of
the heart). However,
Monigen XL 60 is
NOT
a suitable treatment for the relief of acute angina. If you suffer
from an
acute attack of angina, a more suitable medicine should be taken. Do
not stop taking
Monigen XL 60 without first consulting your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONIGEN XL 60
DO NOT TAKE MONIGEN XL 60:
•
if you are allergic to isosorbide mononitrate, other nitrates, or any
of the other ingredients
of this medicine (listed in section 6).
•
if you have heart conditions such as swelling of the lining that
surrounds the heart,
problems with your heart muscle or valves.
•
if you are taking si

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Monigen XL 60 prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 60 mg isosorbide mononitrate.
Excipient with known effect:
Each tablet contains 0.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release-tablet (tablet).
Pale yellow, elliptical, film-coated tablets (13.1 x 7.1 mm), embossed
with ‘IM’
breakline ‘60’ on one side and breakline on the reverse
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monigen XL 60 _are intended for prophylactic therapy. Dosage should
be adjusted
individually and monitored according to clinical response.
_Adults _
When initiating therapy in new patients, the dose can be titrated to
reduce the
frequency of headache by administering 30 mg (half a tablet) for the
first 2-4 days.
The usual dosage is 60 mg to be taken in the morning. When necessary
the dose may
be increased to 120 mg daily to be taken in the morning.
There is a risk of tolerance developing when nitrate therapy is given.
For this reason it
is important that _Monigen XL 60_ are taken once a day to achieve an
interval with low
nitrate concentration, thereby reducing the risk of tolerance
development.
When necessary the product may be used in combination with
beta-adrenoceptor
blockers and calcium antagonists._ _
_ _
_Paediatric population _
The safety and efficacy of _Monigen XL 60_ in children has not been
established.
_ _
_Older people _
No evidence of a 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.
Method of administration
For oral use.
The tablet is divisible; however, whether administered whole or
divided, it is not to be
chewed or crushed and s