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ISOKET RETARD 40 TABLETS

Active substance(s): ISOSORBIDE DINITRATE

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isoket

®

retard 40 mg

Tablets

Isosorbide dinitrate

Patient Information Leaflet
Read all of this leaflet carefully before you
start taking 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:
1. What Isoket Retard is for
2. Before you take Isoket Retard­­
3. How to take Isoket Retard
4. Possible side effects
5. How to store Isoket Retard
6. Further information.

CIA77277B 4019287 11/1131 3178

1. What Isoket Retard is for
Isoket Retard 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 Retard is used to prevent and treat angina
pectoris. Angina usually feels like a tight pain in the
chest, neck or arm area. The pain comes
from the heart muscle and is a sign that part of it
is not getting enough oxygen for the amount of
work it is doing.
2. Before you take Isoket Retard
Do not take Isoket Retard if:
• You are allergic to isosorbide dinitrate, other
nitrates or any of the other ingredients of
Isoket Retard (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 heart attack (myocardial

infarction)
• You have had a brain haemorrhage (bleeding)
• You have had a head injury (trauma)
• 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 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 taking
Isoket Retard 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 suffer from very poor circulation
• You have been diagnosed with any of the
following heart conditions: hypertrophic
obstructive cardiomyopathy (HOCM),
constrictive pericarditis, cardiac tamponade,
low cardiac filling pressures, aortic/mitral
valve stenosis and diseases associated with
raised intra-cranial (head) pressure
Taking other Medicines
• Do not take Isoket Retard with
phosphodiesterase inhibitors such as Sildenafil (“Viagra”) used for impotence.
Using Isoket Retard with these
medicines could cause your blood
pressure to fall to a dangerously low level.

You must not stop taking Isoket Retard
to take Sildenafil as this will increase your
chances of having an angina attack.
Tell your doctor if you are taking any of the
following medicines:
• Medicines to lower your blood pressure.
• Tricyclic antidepressants (used to treat
depression) and neuroleptics (used to treat
anxiety).
• Ergotamine used for migraine.
• Sapropterin used for phenylketonuria (PKU).
• Any other medicine, including medicines
obtained without a prescription.
If any of the above applies to you, talk to your
doctor.
Using Isoket Retard 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.
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 Retard. 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 Retard
This medicine contains lactose. If you have an
intolerance to some sugars, tell your doctor
before taking this medicine.

4019287_GI_MON_Isoket40_GBR_CIA77277B.indd 1

12.08.15 13:57

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany

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!

Product Name

Isoket

Print Colours

Techn. Colours

Artwork Studio

Aesica Id.-No.

4019287

black

techn. info

PT Approval

external Id.-No.

CIA77277B / GBR

Dimensions

140 x 260 mm

Operator

Sorek

Creation Date

12.08.2015

Dispatched to

Date

Operator

Palladio

Manufacturing Site

8 pt.

Linespacing

Approver

Artwork Information
Fontsize Bodytext

9 pt.

Technical Changes

Amended by

Modific. Date
Edition No.

01

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

R

3. How to take Isoket Retard
Always take Isoket Retard exactly as your doctor
has told you.
Important:Your doctor will choose the
dose that is right for you. Your dose will
be shown clearly on the label that your
pharmacist puts on your medicine. If it
does not, or you are not sure, ask your
doctor or pharmacist.
Remember:You should not chew the tablets,
swallow them whole with a glass of water.
Adults
• The usual dose is one or two tablets per day.
If you are taking two tablets, it is important to
take the second tablet six to eight hours after
the first. Taking the tablets in this way allows a
period of time (when you are sleeping) when
no tablets are taken. This is called a “nitrate
low” period and is needed to make sure your
medicine remains effective.
Children
This medicine is not suitable for children.
If you take more Isoket Retard than you
should
Do not take more Isoket Retard than you should.
If you accidentally take too much, immediately
contact the nearest hospital casualty department
or your doctor.
Too much Isoket Retard may cause your blood
pressure to fall too low, making you feel sick,
faint and dizzy. A very large overdose could
cause a coma or collapse and require immediate
resuscitation.

If you forget to take Isoket Retard
Do not take a double dose to make up for a missed
dose. Take your next dose at the usual time.
If you stop taking Isoket Retard
Do not stop taking Isoket Retard without first
talking to your doctor. You should keep taking your
medicine until your doctor tells you to stop. Do not
stop taking it just because you feel better. If you stop
taking the tablets your condition may get worse.
If you have any further questions about the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Isoket Retard can cause side
effects, although not everybody gets them.
Seek immediate medical help if you have any
of the following symptoms:
• Swelling of the face or throat, causing
difficulty in breathing or wheezing
• Fainting or collapse
• Swelling or blistering of the skin, mouth,
eyes and genitals (Stevens-Johnson
syndrome).
Very common side effects (affects more than
1 in 10 people):
• Mild headaches at the start of treatment.
Usually they disappear after a few days.
Common side effects (affects less than
1 in 10 people):
• Dizziness
• Tiredness
• Feeling weak
• Fast heartbeat
They may occur for the first few days of treatment
or after your dosage has been increased.

Uncommon side effects (affects less than
1 in 100 people):
• Feeling sick or being sick
• Skin rashes or flushing
• Looking pale
• Excessive sweating
• Restlessness
• Worse angina.
Very rare side effects (affects less than
1 in 10,000 people)
• Heartburn
• Red or scaly skin (exfolilative dermatitis)
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

What Isoket Retard looks like
Isoket Retard is a white tablet marked with IR/40
on the front and SCHWARZ PHARMA on the
back. They come in blister packs of 50, 56, 60,
84 and 90 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
UCB Pharma Ltd, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK
Manufacturer
Aesica Pharmaceuticals GmbH,
Alfred Nobel Strasse 10,
D-40789, Monheim, Germany
This leaflet was last updated August 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 Road,
Slough, Berkshire, SL1 3WE, UK.

5. How to store Isoket Retard
Keep out of the reach and sight of children.
Do not use Isoket Retard 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.
Medicines should not be disposed of via waste­
water or household waste. Return any medicine
you no longer need to your pharmacist.
6. Further information
What Isoket Retard contains
The active substance is isosorbide dinitrate 40 mg.
The other ingredients are lactose monohydrate,
talc, polyvinyl acetate, magnesium stearate and
potato starch.

CIA77277B 4019287 11/1131 3178

4019287_GI_MON_Isoket40_GBR_CIA77277B.indd 2

12.08.15 13:57

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany

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!

Product Name

Isoket

Print Colours

Techn. Colours

Artwork Studio

Aesica Id.-No.

4019287

black

techn. info

PT Approval

external Id.-No.

CIA77277B / GBR

Dimensions

140 x 260 mm

Operator

Sorek

Creation Date

12.08.2015

Dispatched to

Date

Operator

Palladio

Manufacturing Site

8 pt.

Linespacing

Approver

Artwork Information
Fontsize Bodytext

9 pt.

Technical Changes

Amended by

Modific. Date
Edition No.

01

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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