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ISOKET 0.5 MG/ML SOLUTION FOR INFUSION OR INJECTION

Active substance: ISOSORBIDE DINITRATE

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®

0.5 mg/ml

solution for infusion or injection
Isosorbide Dinitrate

PIL_ISDN_GB_BOTTLE_50ML_0.05MG_MU1 10/999 2022

In this leaflet:
1. What Isoket is for
2. Before you use Isoket
3. How to use Isoket
4. Possible side effects
5. How to store Isoket
6. Further information.
1. What Isoket is for
Isoket belongs to a group of medicines
called organic nitrates. Organic nitrates
work by widening the blood vessels in
your heart to allow an increased amount
of blood to flow to areas which need it.
Isoket is used to treat heart failure (heart
problems that can cause shortness of
breath or ankle swelling) and angina
pectoris.

Angina usually feels like a tight pain in the
chest, neck or arm area.
It is also used sometimes during surgical
procedures on the heart.
2. Before you use Isoket
Do not use Isoket if:
• You are allergic to isosorbide dinitrate,
other nitrates or any of the other
ingredients of Isoket (see section 6)
• You suffer from anaemia (reduction in
red blood cells which can make the skin
pale and cause weakness or
breathlessness)
• You have had a brain haemorrhage
(bleeding)
• You have had a head injury (head
trauma) or raised intracranial pressure
(high pressure within your skull)
• You have a low blood volume
(hypovolaemia)
• You have very low blood pressure
• Your blood has stopped circulating
around your body properly (circulatory
failure)
• You have cardiogenic shock (your heart
is not delivering enough oxygen around
your body)
• You have constrictive pericarditis
(inflammation of the sack-like covering
of the heart)

• You have cardiac tamponade or
hypertrophic obstructive cardiomyopathy
(conditions which affect the ability of
your heart to function as a pump)
• You have aortic or mitral valve stenosis
(narrowing of the heart valves)
• You have an eye disease called glaucoma
• You take sildenafil (“Viagra”) or any
other phosphodiesterase inhibitor.
If any of the above applies to you talk to
your doctor or pharmacist.
Check with your doctor before using
Isoket if:
• You have hypothyroidism (an underactive
thyroid gland which can cause tiredness
or weight gain)
• You are malnourished (severely
underfed)
• You have liver or kidney disease
• You suffer from hypothermia (a very low
body temperature)
• You have other heart problems or a
family history of heart problems
• You suffer from orthostatic syndrome,
(where you may have a rapid heart rate
and light-headedness on standing)

Print Colours

Aesica Id.-No.



external Id.-No.

PIL_ISDN_GB_BOTTLE_
50ML_0.05MG_MU1

/ GBR/IRL

Dimensions

140 x 520 mm

Operator

Peggy Nathaus

Creation Date

09.06.2015

Note:

black

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Techn. Colours

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Manufacturing Site

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Fontsize Bodytext

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Technical Changes

Amended by

Modific. Date
Edition No.

01

isoket

®

The following information is intended
for medical or healthcare
professionals only.
It supplements the information provided
above in section 3.

0.5 mg/ml

solution for infusion or injection
Isosorbide Dinitrate

Posology and method of
administration
Adults, including the elderly
Intravenous route
Isoket 0.5 mg/ml is intended for
intravenous administration by slow infusion
via a syringe pump.
A dose of between 2mg and 12mg per
hour is usually satisfactory. However,
dosages up to 20mg per hour may be
required. In all cases the dose administered
should be adjusted to the patient response.
Intra-coronary Route
The usual dose is 1mg given as a bolus
injection prior to balloon inflation. Further
doses may be given not exceeding 5mg
within a 30 minute period.

Incompatibilities
Isoket contains isosorbide dinitrate in
isotonic solution and is compatible with
commonly employed infusion fluids, such
as sodium chloride solution, 5-30% glucose
solution, Ringer’s solution and solutions
containing albumin. No incompatibilities
have so far been demonstrated.
Isoket is compatible with glass infusion
bottles and infusion packs made from
polyethylene.
Isoket may be infused slowly using a
syringe pump with glass or plastic syringe.
The use of PVC giving sets and containers
should be avoided since significant losses
of the active ingredient by adsorption can
occur.
Rev. September 2011

Children
The safety and efficacy of Isoket has not
yet been established in children.
Admixtures are stable for approximately
24 hours at room temperature in the
recommended containers.
Open ampoules or bottles should be used
immediately and any unused drug
discarded.

09.06.15 15:15

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

Isoket

Tell your doctor if you are taking any
of the following medicines:
• Medicines to lower your blood
pressure. They could increase the effect
of Isoket and lower your blood pressure
too much.
• Tricyclic antidepressants (used to treat
depression) and neuroleptics (used to
treat anxiety). These may also increase
the effect of Isoket.
• Dihydroergotamine (used to treat
migraine). This could increase your
blood pressure too much.
• Any other medicine, including medicines
obtained without a prescription.
• Sapropterin used for phenylketonuria
(PKU).
If any of the above applies to you, talk to
your doctor or nurse.
Using Isoket with food and drink
Do not drink alcohol. It could increase the
effect of Isoket and lower your blood
pressure too much. If this happens, you
may feel dizzy or faint.

PIL_ISDN_GB_BOTTLE_50ML_0.05MG_MU1.indd 1

Product Name

Taking other Medicines
• Do not take Isoket with
phosphodiesterase inhibitors such
as Sildenafil (“Viagra”) used for
impotence. Using Isoket with these
medicines could cause your blood
pressure to fall to a dangerously
low level.

PIL_ISDN_GB_BOTTLE_50ML_0.05MG_MU1 10/999 2022

isoket

Patient Information Leaflet
Read all of this leaflet carefully before
you start using this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• In this leaflet, Isoket 0.5 mg/ml solution
for infusion or injection will be called
Isoket.

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

R

Pregnancy and breast-feeding
If you are pregnant, trying to become
pregnant or breast-feeding, ask your
doctor or pharmacist for advice before
taking Isoket. Your doctor will decide
whether you should take this medicine.
Driving and using machines
Isoket may give you a headache, or make
you feel dizzy or tired. If this happens to
you, do not drive or operate machinery.
Warnings about the ingredients in
Isoket
Isoket 0.5 mg/ml contains 3.54 mg/ml
sodium and may not be suitable for people
on a controlled sodium diet. Tell your
doctor or pharmacist before taking Isoket
if this applies to you.
3. How to use Isoket
Important:
Your doctor will choose the dose that
is right for you. If you have any
questions ask your doctor.
Isoket is for intravenous infusion (injected
into a vein) and intracoronary injection
(injected directly into the artery serving
the heart).
Your doctor or nurse may dilute Isoket
with saline (salt water) or glucose solution
before it is given to you.
PIL_ISDN_GB_BOTTLE
_50ML_0.05MG_MU1 10/999 2022

PIL_ISDN_GB_BOTTLE_50ML_0.05MG_MU1.indd 2

Print Colours

Isoket

Aesica Id.-No.



external Id.-No.

PIL_ISDN_GB_BOTTLE_
50ML_0.05MG_MU1

/ GBR/IRL

Dimensions

140 x 520 mm

Operator

Peggy Nathaus

Creation Date

09.06.2015

Note:

black

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Techn. Colours

Artwork Studio

Date

Operator

Palladio

Manufacturing Site

9 pt

Linespacing

Approver

PT Approval
Dispatched to
Artwork Information
Fontsize Bodytext

9,5 pt

Technical Changes

Amended by

Modific. Date
Edition No.

01

Children
This medicine is not suitable for children.
If you have any further questions about the
use of this medicine, ask your doctor or
pharmacist.
If you think you have been given too
much Isoket
As this medicine will be given to you by a
doctor or nurse, it is unlikely that you will
be given too much or too little.
An overdose of Isoket may cause your
blood pressure to be too low resulting in
paleness, sweating, weak pulse, fast
heartbeat, light-headedness on standing,
headache, weakness, dizziness, feeling sick,

being sick and diarrhoea. If you have any
concerns about this tell your doctor or
nurse.
4. Possible side effects
Like all medicines Isoket can cause side
effects, although not everybody gets them.
• headache
• feeling sick
• have a faster heart beat (tachycardia)
• A reduced blood flow to the brain and
heart, causing you to feel faint or dizzy.
• drowsiness
• weakness
• light-headedness on standing
• fainting.
• symptoms of angina (chest pain) may be
increased.
• skin rash or flushing,
• heartburn
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
5. How to store Isoket
Keep out of the reach and sight of
children.
Do not use Isoket after the expiry date on
the carton. The expiry date refers to the
last day of that month.

This medicine does not require any special
storage conditions.
Once diluted, the product must be used
immediately.
Medicines should not be disposed of via
wastewater or household waste. Return
any medicine you no longer need to your
pharmacist.
6. Further information
What Isoket contains
The active substance is isosorbide
dinitrate.
Isoket contains 0.5 milligrams of isosorbide
dinitrate in each ml of solution.
The other ingredients are sodium chloride,
water for injections and hydrochloric acid
and sodium hydroxide for pH adjustment.
What Isoket looks like
Isoket is a solution for infusion and
injection. It is a clear solution.
In Ireland
Isoket 0.5 mg/ml comes in glass bottles
containing 25 mg of isosorbide dinitrate in
50 ml of solution.
In the UK
Isoket 0.5 mg/ml comes in a glass bottle or
syringe. The bottles contain 25 mg of
isosorbide dinitrate in 50 ml of solution.
Each syringe contains 5 mg of isosorbide
dinitrate in 10 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma Ltd, 208 Bath Rd, Slough,
Berkshire, SL1 3WE, UK
Manufacturer
UCB Pharma GmbH, Alfred Nobel Strasse
10, D-40789, Monheim, Germany
This leaflet was last updated May 2015
If this leaflet is difficult to see or read
or you would like it in a different
format, please contact UCB Pharma
Ltd, 208 Bath Rd, Slough, Berkshire,
SL1 3WE, UK

PIL_ISDN_GB_BOTTLE
_50ML_0.05MG_MU1 10/999 2022

09.06.15 15:15

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

Product Name

Adults
• When this medicine is given
intravenously (injected into a vein), the
usual dose will be between 2 mg and
12 mg per hour, although sometimes as
much as 20 mg per hour is necessary.
• When used during surgical procedures
on the heart the usual dose is 1 mg
injected directly into the heart.
Further doses may be given if your
doctor thinks it necessary
As this medicine is used in hospital, your
heart beat (pulse) and blood pressure will
be carefully monitored whilst you are being
given Isoket. This is to make sure that your
medicine is working properly and that the
dose you are taking is right for you.

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

V

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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