Corangin

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Isosorbide mononitrate 40 mg;  
Available from:
Novartis New Zealand Ltd
INN (International Name):
Isosorbide mononitrate 40 mg
Dosage:
40 mg
Pharmaceutical form:
Modified release tablet
Composition:
Active: Isosorbide mononitrate 40 mg   Excipient: Colloidal silicon dioxide Hydrated silica Hypromellose Lactose monohydrate Macrogol 4000 Magnesium stearate Polyvidone 30
Units in package:
Blister pack, 30 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Cambrex Karlskoga AB
Therapeutic indications:
Corangin is indicated for: · Prevention of angina pectoris attacks, and also in cases where symptoms of angina pectoris persist after myocardial infarction. Corangin may be used either as monotherapy or in combination with other antianginal agents (e.g. beta-blockers or calcium antagonists).
Product summary:
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-4571
Authorization date:
1989-07-20

__________________________________________________________________________________________________

Corangin ®

1

Corangin ®

40mg tablet

isosorbide-5-mononitrate

_____________________________________________________________________________________

Consumer Medicine Information

____________________

What is in this leaflet

__________________________________

This leaflet answers somecommon

questions aboutCorangin.

Itdoes notcontain allthe available

information. Itdoes nottake the

place of talking to your doctor or

pharmacist.

Allmedicines have risks and

benefits. Your doctor has weighed

the risks of you having

Corangin againstthe benefitsthey

expect it will provide.

If you have any concerns about

this medicine, ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

________________________

What Corangin is

used for

________________________

Corangin contains the active

ingredientisosorbide-5-

mononitrate. Itbelongs toa class of

medicines know as organic nitrate

vasodilators, meaningthat they

cause blood vesselstowiden.

Widening the blood vesselsmeans

thatblood flow and blood pressure

isimproved, and so the heartdoes

notneed todo as much work and

does notneed as much oxygen.

Corangin isused topreventangina

pectoris andtotreat heart failure. It

is notsuitable for the treatmentof

acute attacks of angina pectoris.

Ask your doctor ifyou have any

questions about why this

medicine has been prescribed for

you.

Your doctor mayhave prescribed it

Corangin isonlyavailable witha

doctor's prescription. Itisnot

addictive.

There isnotenough information to

recommend the use of thismedicine

inchildren.

____________________________

Before you take

Corangin

________________________

When you must not take

it

Do not take Corangin if you have

ever had an allergic reaction to:

isosorbide-5-mononitrate

(the

active ingredientinCorangin)

or anyof the other ingredients

listedat the endofthis leaflet

anyother medicine containing

nitrates or nitrites.

You have low blood pressure

You have recently had a heart

attack or other serious heart

disease, a stroke or a head

injury

Do notuse Corangin if you are

taking Viagra, a medicine for

impotence in men.

If you use these two medicines

together your blood pressure may

fall toa dangerously low level.

Symptomsofanallergic reaction

mayinclude shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue or

other parts of the body;rash, itching

or hives on the skin.

Do not take Corangin after the

expiry date printed on the pack

or ifthe packaging istorn or

shows signs of tampering.

In that case, return the medicine to

your pharmacist.

Before you start to take it

Tellyour doctor ifyou are

pregnant or planning to become

pregnant.

There is limitedinformation

available on the use of this

medicine inpregnancy. Your doctor

can discuss withyou the benefits

and risks involved.

Tell your doctor if you are breast-

feeding.

Breast-feeding isnotrecommended

whileyou are taking Corangin. Itis

notknown ifthe active ingredient,

isosorbide-5-mononitrate, passes

intothe breast milkandcouldaffect

your baby.

Tellyour doctor if:

you have anycardiac or

circulatory diseases

blood enzymedeficiencies

headaches

allergies toany other

medicines, foods, dyes or

preservatives

anyother healthproblems

Your doctor maywanttotake

special precautions if you have any

of the above conditions.

Taking other medicines

Tellyour doctor ifyou are taking

any other medicines, including

medicines that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Somemedicines and Corangin may

interfere with each other. These

include:

Viagra, a medicine for

impotence in men

other medicines for angina

medicines for high blood

pressure or hearttrouble

diureticmedicines, also called

water or fluid tablets

tricyclic

antidepressants,

medicines used to treat

__________________________________________________________________________________________________

Corangin ®

2

depression

medicines for mentaldisorders

dihydroergotamine, a medicine

for migraine

acetylsalicylic acid (aspirin)

medicines used to treat

inflammation called non-

steroidal anti-inflammatory

drugs (NSAIDs)

alcohol

You mayneed totake different

amounts of your medicines or you

mayneed totake different

medicines. Your doctor and

pharmacisthave more information.

If you have not toldyour doctor

about any of these things, tell

him/her before you take

Corangin.

___________________________

How to take Corangin

____________________

Follow all directions given to you

by your doctor or pharmacist

carefully.

Theymaydiffer fromthe

information contained inthis

leaflet.

Yourdoctor will tell youhowmany

Corangin tablets to take each day.

Corangin ispresented inthe formof

divitabs. These are divisible slow-

relase tablets, whichallow the

dosage to be increased or decreased

stepwise, so that it can be more

closelyadapted toindividual

requirements.

How much to take

The adultdose isusuallyone tablet

of Corangin 40mg once dailyand

increased as required byadding ½

of a 40mg tablet. Tablets can be

takeneither inthe morningor

evening depending on whattime of

day the angina attacks occur.

Swallow the table witha full glass

of water or other liquid.

If you forgettotake a dose of this

medicine, butremember todo so

within2 hours, take the missed dose

rightaway witha full glass ofwater

or other liquid. Then go back to

your regular dosing schedule.

However, if you do notremember

until later, skipthe misseddose and

then go back toyour regular dosing

schedule. Do notdouble the doses.

If you take too much

Tellyour doctor ifyou have any

of the following symptoms, which

may point to possible signs of

overdosage.

feeling of extreme pressure in

the head

unusuallightheadedness,

dizziness or faintness

shortness of breath, rapid

breathing

blueness around the mouth and

at extremities due tolackof

oxygen

weak and unusuallyfast

heartbeat.

____________________________

While you are taking

Corangin

____________________

Things you must do

Follow your doctor's instructions

carefully and keep all

appointments.

Tell your doctor immediately if

you become pregnant while

having treatment with Corangin.

Your doctor can discuss withyou

the risks oftakingit while youare

pregnant.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Corangin.

Tellany other doctor, dentist or

pharmacist who treats you that

you are taking Corangin.

Things you must not do

Donot givethis medicine to

symptoms seem to be the same as

yours.

Do not use it to treat any other

complaints unless your doctor

tells you to.

Things to be careful of

Be careful driving, operating

machinery or doing jobs that

require you to be alert until you

know how Corangin affects you.

Be careful when drinking alcohol

while youare usingCorangin

TTS.

If you drink alcoholwhileyou are

using it,your blood pressure may

drop, making you feeldizzyor

faint.

___________________________

Side effects

________________________

Tell your doctor or pharmacist as

soon as possible ifyou do not feel

well while youare taking

Corangin.

Allmedicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medicaltreatmentifyou getsome

of the side effects.

If you are over 65 years old, you

should be especially careful and

report any side effects promptly

to your doctor.

As people grow older, theyare

more likely toget side effects from

medicines.

Do not be alarmed by these lists

of possible side effects. You may

not experience any of them. Ask

your doctor or pharmacist to

answer any questions you may

have.

Tellyour doctor ifyou notice any

of the following side effects and

they worry you:

faintness

dizziness and/or

lightheadedness upon standing

__________________________________________________________________________________________________

Corangin ®

3

flushing – these normallyoccur

at the start of treatment

headache – these normally

occur at the start of treatment

nausea,

vomiting

allergic skinreactions suchas

rash

Tell your doctor immediately or

go to the Accident and

Emergency Department at your

nearest hospitalifyou notice any

of the following:

signs of allergy such as rash,

itching or hives on the skin;

swelling of the face, lips,

tongue or other partof the

body;shortness of breath,

wheezing or troubled breathing

collapse

symptomsof angina getworse

chest pain

The above side effects maybe

serious. You mayneed urgent

medicalattention.

Tellyour doctor ifyou notice

anything else that ismaking you

feel unwell.

Somepeople mayhave other side

effects notyetknown or mentioned

inthis leaflet. Some side effects can

onlybe found bylaboratorytesting.

___________________________

After taking Corangin

________________________

Storage

Store the medicine ina cooldry

place. .

Do notstore Corangin or any

other medicine inthe bathroom

or near a sink.

Do not leave it in the car or on

window sills.

Keep the medicine where children

cannot reach it.

A locked cupboard atleastone-and-

a-halfmetres above the ground isa

good place to store medicines.

Disposal

If you no longer need Corangin

or it has passed its expiry date,

return any unused medicine to

____________________

Product description

________________________

What it looks like

Corangin is a white capsule shaped

divisible (scored) slow-release

tablet with convex faces imprinted

withCG/CG on one side and

EDE/EDE on the other. Packs

containing 30 tablets

Ingredients

Corangin tablets contain 40mg

isosorbide-5-mononitrate of the

active ingredientincluding the

following:

Silicagel

Aerosil200

Lactose

Magnesiumstearate

Hydroxypropyl-

methylcelluslose

Polyethylenglycol400

Polyvinylpyrrolidon K 30

Sponsor

Corangin issupplied inNew

Zealand by:

NovartisNew Zealand Limited

NovartisNew Zealand Limited

Private Bag 65904

MairangiBay

Auckland

BuildingG, 5Orbit Drive

Rosedale

Auckland 0632

Telephone 0800 652 422

®= Registered Trademark

This leaflet was prepared on 23

June 2009 based on the currently

approved datasheetfor thisproduct

NEW ZEALAND DATA SHEET

CORANGIN ®

Isosorbide-5-mononitrate

Trade name

CORANGIN ® 40 mg and 60 mgslow release divisible tablets

Description and composition

Pharmaceutical forms

Slow-release tablets ,divisible (Divitabs ®

), containing 40 or 60 mgisosorbide-5-mononitrate.

Active substance

Isosorbide-5-mononitrate. One tablet contains 40 mg or 60 mg.

Active moiety

Isosorbide-5-mononitrate.

Excipients

Tablets(40 mg, 60 mg): silicagel, aerosil 200, lactose, magnesium stearate, Methocel

K 100 M premium (hydroxypropyl-methylcellulose), polyethylenglycol 4000,

polyvinylpyrrolidon K 30.

Indications

Corangin is indicated for:

Long termtreatment of ischemic heart disease,

Prevention of angina pectoris attacks,and also in cases wheresymptomsof angina pectoris

persist after myocardial infarction. Corangin may be used either as monotherapy or in

combination with other antianginal agents(e.g. beta-blockers orcalciumantagonists).

Treatment for chronic heart failure, in combination with digitalis or other positive-inotropic

agents and/or diuretics.

Dosage and administration

General rules

Corangin is not intended for the immediate relief ofacute attacks ofangina pectoris; ifthey

occur, the additional use ofrapid-acting nitrate preparationsis indicated.

Development of tolerance or attenuation of effect may occur withall long-acting nitrates in

individual patients on continuoustreatment. This can be reversed with low-nitrate blood

levels (as observed with Corangin atthe end of thedosing interval).

Angina pectoris

The starting dose should be 1tablet of Corangin 40 mgonce dailyand increased asrequired,

either by adding one-half of a 40mg tablet or changing to the 60 mgtablet. Depending on the

time of day at which the angina pectoris attacks occur in the individual patient, the slow-

release tablet can be taken eitherin the morning or in the evening.

Iftreatment with Corangin in angina pectorispatients isto bediscontinued, an abrupt

cessation should be avoided: if a change toanother product is envisaged, a period of

overlapping treatment should be considered.

Chronic heart failure

In chronic heart failure, it is recommended thattreatment be started in hospital and the

patient’s hemodynamic status monitored; treatment should also be continued in hospital until

the required maintenance dose has been established. The optimal dose should be determined

based on the clinical response and tolerability,with careful monitoring for signs of

overdosage such as hypotension and tachycardia.

Dosage and administrationin special populations

Pediatrics

No information is available on the use of Corangin in children.

Geriatrics(aged 65 years or above)

In elderly patients, Corangin should be startedat a low dose and with caution due to the

higher likelihood of orthostatic or postural hypotension.

Renal impairment

No dose adjustment of Corangin is requiredinpatients with renal impairment (see Clinical

pharmacology ).

Hepatic impairment

No dose adjustment of Corangin is requiredin patients with hepatic impairment (see Clinical

pharmacology ).

Method of administration

Corangin is taken orally and can be administered with or without food (see Clinical

Pharmacology ).

Corangin is presented in the formof Divitabs.These are divisible slow-release tablets, which

allow the dosage to beincreased or decreased stepwise, so that it can bemore closely adapted

to individual requirements. Even ifthe two halves of the tablet are ingested separately, the

prolonged duration of action remains unchanged.

Contraindications

Known hypersensitivity to nitrates.

Acute circulatory failure associated with marked hypotension(shock, states of collapse).

Conditions associated with elevated intracranial pressure.

Myocardial insufficiency due to obstruction (e.g. in the presence of aortic or mitral valve

stenosis or of constrictive pericarditis).

Concomitant use of Corangin and phosphodiesterase type 5 (PDE5) inhibitors such as

sildenafil is contraindicated, because PDE5 inhibitors may amplify the vasodilatory effects

of Corangin resulting insevere hypotension.

Warnings and precautions

Cardiac and vascular disorders

In cases of recent myocardial infarction or acute heart failure, Corangin should only be used

cautiously under strict medical surveillance and/or hemodynamic monitoring.

Patients with angina pectoris,myocardial infarction, or cerebral ischemia frequently suffer

fromabnormalities of the small airways (especially alveolar hypoxia). Under these

circumstances vasoconstriction occurs within thelung to shift perfusion fromareas of alveolar

hypoxia to better ventilated regions of the lung. As a potentvasodilator, isosorbide-5-

mononitrate could reverse this protective vasoconstriction and thus result in increased

perfusion of poorly ventilated areas, worsening ofthe ventilation/perfusion imbalance, and a

further decrease in the arterial partial pressure of oxygen.

Treatment discontinuation

When transferring the patient on long-termtherapy to another formof medication,Corangin

should be gradually withdrawn and overlapping treatment should be started to avoid the risk

of angina pectoris.

Driving and using machines

As syncope and dizziness are the known adversedrug reactions associated with the use of

Corangin, patients should not drive a vehicle or operate a machine or performtasks that

require alertness if they experience these symptoms.

Adverse drug reactions

Table 7.1 presents adverse drug reactions observed frommixed sources including clinical

trials and post-marketing spontaneous reports.

Table 0-1 Tabulated summaryof adverse drugreactions

Cardiac disorders

Unknown

Syncope, orthostatic hypotension, tachycardia, dizziness, flushing

Gastrointestinal disorders

Unknown

Vomiting, nausea

Nervous system disorders

Unknown

Headache

Like other nitrate preparations,Corangin may frequently give rise to headache, which is due

to cerebral vasodilatation and is dose dependent. Headaches, however, usually regress after a

few days despite continuation of the therapy.Flushing, syncope, dizziness, and orthostatic

hypotension, which may be associated with reflex-induced tachycardia, have rarely been

reported.

Interactions

Interactionsresultingin a contraindication

Sildenafil

Concomitant use of Corangin and PDE5 inhibitors suchas sildenafil is contraindicated;

because sildenafil may amplifythe vasodilatory effects of Corangin resulting in severe

hypotension (see Contraindications ).

Interactionsto be considered

Antihypertensive drugs

Concomitant treatment with other vasodilators, calciumantagonists, ACE inhibitors, beta-

blockers, diuretics, antihypertensives, may potentiate the blood-pressure-lowering effect of

Corangin.

CNS depressants

Tricyclic antidepressants,or major tranquilizers, as wellas the consumption of alcohol, may

potentiate the blood-pressure-lowering effect of Corangin.

Dihydroergotamine

Concurrent administration of Coranginwith dihydroergotamine may increase the

bioavailability of dihydroergotamine. This warrants special attention inpatients with coronary

artery disease, because dihydroergotamine antagonizes the effect of nitrates and may lead to

coronary vasoconstriction.

Non-steroidal anti-inflammatory drugs (NSAIDS)

The possibility that acetylsalicylic acid andNSAIDS might diminish the therapeutic response

to Corangin cannot be excluded.

Women of child bearing potential, pregnancy,breast-feeding and

fertility

Women of child bearing potential

There is nodata supportinganyspecialrecommendations in women of child-bearing

potential.

Pregnancy

There is a limited amount ofdatafromtheuse of isosorbide-5-mononitrate in pregnant

patients. Limited animalstudies do not indicate director indirectharmful effects with respect

to reproductive toxicity. Corangin should be given to a pregnantwoman only if clearly needed

and the benefit outweighs the risk.

Breast-feeding

Itis not known whether the active substance passes into the breast milk. Thebenefitsforthe

mother must be weighed against the risks for the child.

Fertility

There is no data available on the effect ofisosorbide-5-mononitrate on fertility in humans.

Overdosage

Signs and symptoms

High doses of isosorbide-5-mononitrate may leadto more pronounced systemic side effects,

e.g. to a marked hypotension or to syncope. Excessive dosage of all nitrates may, on rare

occasions, provoke methemoglobinemia.

Treatment

Overdosage should be treated symptomatically.

Clinical pharmacology

Pharmacotherapeutic group, ATC

Pharmaco therapeutic group: Vasodilator (ATC code C01DA14)

Mechanism of action

Nitrates are prodrugs that are sources of nitric oxide (NO). NO activatesthe soluble isoform

of guanylyl cyclase,thereby increasing intracellular levels of cyclic guanosine

monophosphate (cGMP). In turn, cGMP promotesthe dephosphorylation ofthe myosin light

chain and the reductionof cytosolic calciumwhich leads to the relaxation of smooth muscle

cells, ultimately leading to vasodilation .

Pharmacodynamics (PD)

Likeother nitrates, isosorbide-5-mononitrateissuitable forthe chronic treatment ofischemic

heart disease and heart failure.In angina pectoris, its fundamental mechanismof action is

primarily based on an increasein venous capacitance (venous pooling) leading to a decreased

return of blood to the heart. Owing to this phenomenon, left-ventricularend-diastolic pressure

(preload) and hence filling volume diminishes, resultingin a decreased myocardial oxygen

requirement at rest andespeciallyduring exercise, with an improvementin exercisecapacity

in patients with angina pectoris. In the coronary arterial circulation,isosorbide-5-mononitrate

dilates both extramural conductance and small resistance vessels.The drug appears to cause a

redistribution of coronary blood flow to theischemic subendocardiumby selectively dilating

large epicardial vessels.It also produces relaxation of vasospasm,whether spontaneous or

induced by ergometrine.

In addition, isosorbide-5-mononitrate exerts a dose-dependent dilating effect on the arteriolar

vascular bed, as a result of which systemic vascular resistance (afterload) and left-ventricular

systolic wall tension decrease, leading toa reduction in myocardial oxygen consumption.

In chronic heart failure the dilating action exerted by isosorbide-5-mononitrate on the veins

lowers the elevated left-ventricular filling pressure, while atthe sametime cardiacoutput

either remains unchanged or increases slightly.

Isosorbide-5-mononitrate proves effective especially in patients with severe heart failure

showing prominent signs and symptomsof venous pulmonary congestion due to a pronounced

increase inleft-ventricular fillingpressure. If an increase in cardiac output is desired,

combined treatment with an arterial vasodilator is recommended.

The duration of action of isosorbide-5-mononitrate is longer than thatof its parent compound.

A therapeutic efficacysimilar tothat of isosorbide dinitrate may be achieved with

approximately half the dose.

Pharmacokinetics (PK)

Absorption

Isosorbide-5-mononitrate is rapidly and completely absorbed fromthe conventional dosage

forms. Unlike isosorbide dinitrate, isosorbide-5-mononitrate isfree fromfirst-pass

metabolism in theliver, anditsbioavailabilitytherefore showslower inter-individual

variability. AUC values assessed byreferenceto the plasma levels increase linearlywith the

dose.

With Corangin, the peakconcentrations attainedare approximately 60% lower than after

administration of the samedose in conventional dosage forms. Peak concentrations are

reached 4-8 hours after ingestion of Corangin and in less than 1 hour after administration of

conventional formulations. The amount absorbedfromsustained-release formulations such as

Corangin is slightly reduced (by 10-20%) in comparison with conventional formulations. No

accumulation of isosorbide-5-mononitrate was seenafter repeated once-daily administration

in normal volunteers or in patients. The results of pharmacokinetic studies suggest that no

alterations ofthe dosage should be necessary inpatients with coronaryheart disease, renal

failure, or hepatic cirrhosis. Ingestion of food has been reported to have only a negligible

effect on the absorption of isosorbide-5-mononitrate.

Distribution

The volume of distribution of isosorbide mononitrate is approximately 0.6 L/kg, which is

close to the total body water. The plasmaprotein binding of isosorbide mononitrate is

negligible.

Biotransformation/ Metabolism

Isosorbide mononitrate is almost completelymetabolized in the liver. The resulting

metabolites are inactive.

Elimination

Isosorbide mononitrate is excreted via the kidneys almostexclusively in the formof

metabolites.Approximately 2% is excreted via the kidneys in unchanged form. Mean half-

lives of isosorbide-5-mononitrate calculated after administration of conventional formulations

range between 4.0 and 4.8 hours.

Clinical studies

No recent clinical trials have been conducted with Corangin.

Non- clinical safetydata

Several in vitro and in vivo test systems revealed no evidence of mutagenic activity of

isosorbide-5-mononitrate. A dietary carcinogenicity study in rats gave no evidence of a

carcinogenic potential of isosorbide-5-mononitrate. The effect of Corangin on reproduction

and embryonic, fetal and/or postnatal development has been insufficiently investigated in

animals.

Pharmaceutical information

Incompatibilities

None known.

Special precautions for storage

Store at below 25°C. Protect frommoisture.

Corangin should be kept out of the reach of children.

Instructions for use and handling

PVC/PE/PVDC blisters of30 tablets

Medicines classification

Prescription Medicine

Name and address

Novartis New Zealand Limited

Private Bag 65904

Mairangi Bay

Auckland 0754

Building G, 5 Orbit Drive

Rosedale

Auckland 0632

Telephone: 09 361 8100

Date of preparation

21 October 2011

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