Isosorbide mononitrate 10mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Isosorbide mononitrate

Διαθέσιμο από:

Flamingo Pharma (UK) Ltd

Φαρμακολογική κατηγορία (ATC):

C01DA14

INN (Διεθνής Όνομα):

Isosorbide mononitrate

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02060100; GTIN: 5060464500664

Φύλλο οδηγιών χρήσης

FONTS SIZE :
Generic Name font size : 12 pt.
Composition fonts size : 9 pt.
FONTS : Zurich CnBT
330 mm
160 mm
160 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOSORBIDE MONONITRATE 10 MG TABLETS
ISOSORBIDE MONONITRATE 20 MG TABLETS
ISOSORBIDE MONONITRATE 40 MG TABLETS
ISOSORBIDE MONONITRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1. What Isosorbide mononitrate Tablets are and what are they used for
2. What you need to know before you take Isosorbide mononitrate
Tablets
3. How to take Isosorbide mononitrate Tablets
4. Possible side effects
5. How to store Isosorbide mononitrate Tablets
6. Contents of the pack and other information
Isosorbide mononitrate belongs to a group of medicines
called Organic Nitrates.
1. WHAT ISOSORBIDE MONONITRATE TABLETS ARE AND WHAT ARE THEY USED FOR
DO NOT TAKE ISOSORBIDE MONONITRATE TABLETS:
• if you are allergic (hypersensitive) to isosorbide
mononitrate or any of the other ingredients in the
product (see section 6)
• if you suffer from anaemia (reduction in red blood cells
which can make the skin pale and cause weakness or
breathlessness)
• if you have had a heart attack (myocardial infarction)
• if you have had a brain haemorrhage (bleeding)
• if you have had a head injury (trauma)
• if you have a low blood volume (hypovolaemia)
• if you have very low blood pressure
• if you are suffering from 'shock' as the blood has
stopped circulating properly around your body
(circulatory failure)
• if you take sildenafil

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isosorbide Mononitrate 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains diluted isosorbide mononitrate equivalent to
isosorbide
mononitrate 10 mg.
Excipient(s) with known effect:
Each tablet contains 32.25mg lactose monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Isosorbide mononitrate 10 mg Tablets are white to off white circular,
biconvex
uncoated tablets debossed with ‘I’ and ‘10’ separated by break
line on one side and
plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis and long term management of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
Tablet should be swallowed whole with water.
Isosorbide mononitrate 10 mg Tablets: one tablet twice daily, or three
times daily
_ _
_Adults_:
One tablet to be taken asymmetrically (to allow a nitrate low period)
two or three
times a day. The dosage may be increased up to 120mg per day.
Dosage regime should be designed according to the clinical response of
the patient.
Tablets should be taken after meals, unchewed with water.
The lowest effective dose should be used.
In patients taking one tablet twice daily the second dose should be
taken 8 hours after
the first dosage. If the dose is one tablet three times daily, take
one every 6 hours and
ensure 12 hours treatment-free interval every 24 hours..
_Paediatric population_: The safety and efficacy of Isosorbide
Mononitrate 10mg
Tablets in children has not been established.
_ _
Elderly There is no evidence to suggest that an adjustment of the
dosage is necessary.
Treatment with Isosorbide mononitrate tablets, as with any other
nitrate, should not be
stopped suddenly. Both the dosage and frequency should be tapered
gradually (see
section 4.4)
Method of administration
For oral administration
4.3
CONTRAINDICATIONS
Isosorbide mononitrate tablets should not be given to patients with a
known
sensitivity to isos