Modisal XL 40mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Isosorbide mononitrate

זמין מ:

Ennogen Pharma Ltd

קוד ATC:

C01DA14

INN (שם בינלאומי):

Isosorbide mononitrate

כמות:

40mg

טופס פרצבטיות:

Modified-release tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 02060100

עלון מידע

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
290312/1
Ennogen
Modisal XL Leaflet
UK
English
180 x 300 mm
9 pt
1 of 2
27
13-06-17
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
Modisal XL 40mg Prolonged Release Tablets
(ISOSORBIDE MONONITRATE)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or nurse.
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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT MODISAL XL 40MG PROLONGED RELEASE
TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MODISAL XL 40MG PROLONGED RELEASE
TABLETS
3.
HOW TO TAKE MODISAL XL 40MG PROLONGED
RELEASE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MODISAL XL 40MG PROLONGED
RELEASE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Modisal XL 40mg Prolonged Release Tablets
contain a medicine called isosorbide mononitrate.
This belongs to a group of medicines called
nitrates that act on your cardiovascular system (the
heart and blood vessels). They work by reducing
the frequency of your angina attacks. They are
called prolonged release tablets because they
have been made in a way that allows the
isosorbide mononitrate to be released and slowly
absorbed by your body over a period of several
hours.
These tablets work by widening the blood vessels
in your heart to allow an increased amount of blood
to flow to areas which need it.
Modisal Tablets are used to prevent angina
pecto

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Modisal XL 40mg Prolonged Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40mg isosorbide mononitrate.
For excipients see 6.1
3
PHARMACEUTICAL FORM
Prolonged Release Tablets
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
One tablet (40mg) once daily given in the morning. The dose may be
increased to two tablets (80mg), the whole dose to be given together.
The
tablets should not be chewed or crushed and should be swallowed with
half
a glass of fluid.
Children:
The safety and efficacy of Modisal XL 40mg Prolonged Release Tablets
has not been established.
Elderly:
No 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.
The lowest effective dose should be used.
Attenuation of effect (tolerance) has occurred in some patients being
treated with
prolonged release preparations. In such patients intermittent therapy
may be
more appropriate (see Section 4.4).
Therapy should not be discontinued suddenly. Both dosage and frequency
should be
tapered gradually (see Section 4.4).
The core of the tablet is insoluble in the digestive juices but
disintegrates into small
particles when all the active substance has been released. Very
occasionally the
matrix may pass through the gastrointestinal tract without
disintegrating and be found
inside the stool, but all active substance has been released.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Severe
cerebrovascular
insufficiency.
Phosphodiesterase
type-5
inhibitors
e.g.sildenafil, tadalafil and vardenafil have been shown to potentiate
the hypotensive
effects of nitrates, and their co-administration with nitrates or
nitric oxide donors is
therefore contraindicated (see section 4.5).
A