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ISIB 60XL PROLONGED RELEASE TABLETS

Active substance(s): ISOSORBIDE MONONITRATE

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155mm

Package leaflet: Information for the user

Warnings and precautions
• If you have labile (unsteady) circulation.
Speak with your doctor as treatment may
be started with a 30mg dose.
• If you suffer from an under-active thyroid gland.
• If you have hypoxaemia (low oxygen level in
your blood, due to lung disease for example).
• If you suffer from hypothermia (symptoms
include shiver, abnormal drowsiness, confusion).
• If you suffer from malnutrition
• If you suffer from severe liver or renal disease
Talk to your doctor or pharmacist before taking
ISIB 60 XL if:
• You have ever had any serious damage to
your heart, such as a heart attack or
operation.
If any of the above apply to you, or you are not
sure, talk to your doctor or pharmacist before
taking ISIB 60 XL.
Other medicines and ISIB 60 XL
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines. This
is because ISIB 60 XL can affect the way some
medicines work and some medicines can have an
effect on ISIB 60 XL.
Do not take ISIB 60 XL if you are taking the
following medicines:
Sildenafil or similar medicines called Phosphodiesterase
Type 5 inhibitors (used for male impotence).
If you take one of these drugs for erectile
dysfunction, taking nitrate preparations such as
ISIB 60 XL as well can cause a severe and
possible dangerous fall in blood pressure.
This could result in fainting, or even worse, in
a heart attack.
Do not take ISIB 60 XL if any of the above apply
to you.
If you are not sure, talk to your doctor or
pharmacist before taking ISIB 60 XL.
The following medicines may interfere with the
way ISIB 60 XL works:
• noradrenaline (norepinephrine) (used to treat
sharp and severe drop in blood pressure)
• acetylcholine (used to shrink the pupil of
the eye during cataract surgery and other
types of eye surgery)
• histamine (used mostly as a diagnostic
agent in some medical conditions)
• any drugs used to treat high blood pressure
(e.g. beta-blockers, calcium channel
blockers, vasodilators, angiotensin II
receptor antagonists, ACE inhibitors).
Taking ISIB 60 XL with alcohol
Avoid drinking alcohol while taking ISIB 60 XL, as the
side-effect of low blood pressure may be worse than
normal and you may feel dizzy or faint.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
You may get headache or feel dizzy after taking
ISIB 60 XL. If this happens, do not drive or use
any tools or machines.
ISIB 60 XL contains lactose and sucrose
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicinal product.

FPO

Read all of this leaflet carefully before you
start taking ISIB 60 XL 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 ISIB 60 XL is and what it is used for
2. What you need to know before you take
ISIB 60 XL
3. How to take ISIB 60 XL
4. Possible side effects
5. How to store ISIB 60 XL
6. Contents of the pack and other
information
1. WHAT ISIB 60 XL IS AND WHAT IT IS
USED FOR
ISIB 60 XL Prolonged Release Tablets (referred
to as ISIB 60 XL throughout this leaflet)
contains an active substance called Isosorbide
Mononitrate. This belongs to a group of
medicines called 'nitrates'.
• It is used to prevent chest pain (angina).
Angina is a crushing pain or tightness in the
chest, although the pain may also be felt in
the neck or arm. The pain happens when the
muscle in the heart does not receive enough
oxygen for the work it has to do. ISIB 60 XL
works by improving the supply of blood
and oxygen to the heart muscle. The tablets
will release your medicine slowly and will treat
your condition throughout the day.
• It works by making the blood vessels
relaxed and widen. This makes it easier for
the heart to pump blood around the body.
The tablets are made so that they release the
medicine slowly over a number of hours.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ISIB 60 XL
Do not take ISIB 60 XL:
DO NOT use these tablets to treat sudden
chest pain (acute angina). Instead seek
immediate medical attention. These tablets
work too slowly to treat this and are only used
to prevent symptoms of angina from happening.
• If you are allergic (hypersensitive) to
isosorbide mononitrate or any of the other
ingredients of ISIB 60 XL (listed in
Section 6: Further information).
• If you have ever had a stroke.
• If you have very low blood pressure.
• If you have severe anaemia.
• If you have a heart problem called
'cardiomyopathy' or 'pericarditis' or you have
narrow heart valves.
• If you are taking sildenafil or similar medicines
called Phosphodiesterase Type 5 inhibitors,
(used for male impotence). See the section
"Other medicines and ISIB 60 XL".
Do not take ISIB 60 XL if any of the above
apply to you.
If you are not sure, talk to your doctor or
pharmacist before taking ISIB 60 XL.

FPO

300mm

Prolonged Release Tablets (Isosorbide Mononitrate)

300mm

155mm

3. HOW TO TAKE ISIB 60 XL
Always take this medicine as described in this
leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.
Taking this medicine
• The tablets can be divided into equal doses.
• Take the tablets with half a glass of water.
• Do not crush or chew the tablets.
How much to take
• The recommended dose is one or two
tablets a day.
• Take the medicine in the morning.
Your doctor may ask you to start with a low dose
so that you are less likely to have a reaction to
starting ISIB XL 60.
You must not take ISIB XL 60 for a sudden
attack of angina. If you have a sudden attack,
take a glyceryl trinitrate tablet (follow the
instructions given on the label).
Use in Children
Do not give these tablets to children.
Elderly
If you are an elderly person, your dosage should
be the same as above, unless you suffer from low
blood pressure or have a severe liver or kidney
disorder – in any case you should follow your
doctor's instructions. If you are already taking
medication such as beta-blockers or calcium
channel blockers, let your doctor or pharmacist
know, as he/she may need to adjust your dose of
ISIB 60 XL or existing treatment (see Section 2
"Other medicines and ISIB 60 XL").
If you take more ISIB 60 XL than you should
If you take more ISIB XL 60 than you should, talk
to your doctor or go to a hospital straight away.
Take the medicine pack with you so the tablets
can be identified.
Symptoms of an overdose can include:
pounding headache, excitation, cold sweat,
nausea (feeling sick), vomiting (being sick),
vertigo (a feeling of dizziness or "spinning"),
fainting, racing pulse.
If you forget to take ISIB 60 XL
• If you forget a dose, take it as soon as you
remember. However, if it is nearly time for
the next dose, skip the missed dose.
• Do not take a double dose to make up for
a forgotten dose.
If you have further questions on the use of
this medicine, ask your doctor or pharmacist.
If you stop taking ISIB 60 XL
Do not suddenly stop taking ISIB 60 XL
tablets, as this could make your angina worse.
If your treatment is to be stopped this should be
done gradually. Be sure to follow your doctor's
instructions. Ask your doctor or pharmacist any
further questions you may have.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects may happen with this
medicine:
• Headaches
• Feeling sick (nausea)
• Feeling dizzy
The above problems usually disappear with time.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Low blood pressure. This may make you feel
faint and dizzy especially when getting up
from a lying or sitting position, but this
usually disappears in time on continued use.
1239850111
TR1292856

• Tachycardia (fast heart beat).
• Headache
• Feeling dizzy
• Feeling sick (nausea).
Uncommon (may affect up to 1 in 100
people)
• Being sick (vomiting).
• Diarrhoea
Rare (may affect up to 1 in 1,000 people)
• Fainting
• Rash
• Itchy skin
Very rare (may affect up to 1 in 10,000
people)
• Pain in muscles
Reporting side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 or
search for MHRA Yellow Card in the Google Play
or Apple App Store. By reporting side effects
you can help provide more information on the
safety of this medicine.
5. HOW TO STORE ISIB 60 XL
• Keep this medicine out of the sight and
reach of children.
• Do not store above 25°C.
• Do not transfer them to another container.
Do not use this medicine after the expiry
date which is stated on the carton.
The expiry date refers to the last day of
that month.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines you
no longer use. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What ISIB 60 XL contains
• The active substance is isosorbide
mononitrate. Each tablet contains 60mg of
the active substance.
• The other ingredients are Hydroxypropyl
methylcellulose 2208, lactose,
compressible sugar (composed of sucrose
and maltodextrin), magnesium stearate,
silica colloidal anhydrous, ferric oxide yellow
E-172.
What ISIB 60 XL looks like and contents of
the pack
ISIB 60 XL tablets are light yellow, biconvex,
oval-shaped, scored on both sides and marked
"DX 31" on one side. ISIB 60 XL is available in
packs of 28 tablets in foil blister strips (2 blister
packs of 14 tablets).
Marketing Authorisation Holder and
Manufacturer:
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton
Fields, Daventry, Northamptonshire NN11 8PB, UK.
This leaflet was last revised in December 2017.
ISIB®, Alliance and associated devices are registered
trademarks of the Alliance Pharma PLC group.
© Alliance Pharmaceuticals Limited 2017.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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