Sormon 60 mg Prolonged-release Tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Isosorbide-5-mononitrate

Disponibbli minn:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Kodiċi ATC:

C01DA; C01DA14

INN (Isem Internazzjonali):

Isosorbide-5-mononitrate

Dożaġġ:

60 milligram(s)

Għamla farmaċewtika:

Prolonged-release tablet

Żona terapewtika:

Organic nitrates; isosorbide mononitrate

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1999-08-23

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOSORBIDMONONITRAT MYLAN 60 MG 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 Isosorbidmononitrat Mylan is and what it is used for
2.
What you need to know before you take Isosorbidmononitrat Mylan
3.
How to take Isosorbidmononitrat Mylan
4.
Possible side effects
5.
How to store Isosorbidmononitrat Mylan
6.
Contents of the pack and other information
1.
WHAT ISOSORBIDMONONITRAT MYLAN IS AND WHAT IT IS USED FOR
Isosorbidmononitrat Mylan 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.
Isosorbidmononitrat Mylan can be used to help prevent angina (a muscle
cramp of the heart). However,
Isosorbidmononitrat Mylan 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 Isosorbidmononitrat
Mylan without first consulting your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOSORBIDMONONITRAT MYLAN
DO NOT TAKE ISOSORBIDMONONITRAT MYLAN:
-
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 c

Karatteristiċi tal-prodott

HealthProductsRegulatoryAuthority
18April2019
CRN008ZSJ
Page1of6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sormon60mg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_
_Sormon_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_Sormon_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effica