Monomax XL 60mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Isosorbide mononitrate

Saadav alates:

Chiesi Ltd

ATC kood:

C01DA14

INN (Rahvusvaheline Nimetus):

Isosorbide mononitrate

Annus:

60mg

Ravimvorm:

Modified-release tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02060100; GTIN: 5028613002360

Infovoldik

0108006113/01
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOMAX
®
XL 60 MG 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 MONOMAX IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONOMAX
3. HOW TO TAKE MONOMAX
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MONOMAX
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MONOMAX IS AND WHAT IT IS USED FOR
Monomax XL Prolonged-release Tablets contain isosorbide mononitrate
which
belongs to a group of medicines called nitrates that act on the
cardiovascular
system (the heart and blood vessels). Monomax has been given to you by
your
doctor or pharmacist to reduce the frequency of your anginal attacks
(chest pains).
They are called prolonged-release tablets because they are
manufactured in a way
that allows the isosorbide mononitrate to be released and slowly
absorbed by your
body over a period of several hours.
In angina, isosorbide mononitrate works by opening up the arteries
supplying
the heart muscle and this allows more blood and oxygen to reach the
muscle,
decreasing the chances of angina (chest pains) occurring when extra
strain is
placed upon the heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONOMAX
Do not take Monomax:
• IF
YOU
ARE
TAKING
THE
DRUG,
SILDENAFIL
OR
SIMILAR
MEDICINES
CALLED
PHOSPHODIESTERASE TYPE 5 INHIBITORS, FOR THE TREATMENT OF MALE
ERECTILE
DYSFUNCTION (see also: Section 2 - Taking other medicines)
• if you are allergic to isosorbide mononitrate, other nitrates (e.g
glyceryl

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MONOMAX XL 60 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 60mg of isosorbide mononitrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release tablets
White, oval convex tablets with a score line between” SL” and”
60 “, which
are embossed on one side
4.1.
THERAPEUTIC INDICATIONS
For the prophylactic treatment of angina pectoris
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Oral use
Tablets may be taken with or without food, and should be swallowed
whole and not
chewed.
Posology
_ _
_Adults_: Usual adult dose is one isosorbide mononitrate XL 60 mg
tablet per day (taken
in the morning). If necessary, the dosage may be increased to 120 mg
once daily (i.e. 2
x 60mg tablets taken in the morning). The dosage can be titrated to
minimise the
possibility of headache by initiating treatment with 30mg (half a
tablet), for the first
two to four days.
_ _
_Paediatric Population_: Safety and efficacy in children have not been
established.
_ _
_Older People_: There is no evidence of a need for routine dosage
adjustment in older
people, but special care may be needed in those with increased
susceptibility to
hypotension or marked hepatic or renal insufficiency.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
This product should not be given to patients with a known sensitivity
to nitrates and a
known hypersensitivity to the constituents of the tablets.
Relative contraindications to the use of isosorbide mononitrate are
severe cerebral
vascular insufficiency and hypotension
Sildenafil has been shown to potentiate the hypotensive effects of
nitrates, and its co-
administration with nitrates or nitric oxide donors is therefore
contraindicated.
Isosorbide mononitrate is contraindicated in patients with
constrictive cardiomyopathy
and pericarditis, aortic stenosis, cardiac tamponade, mitra