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IMDUR 60MG TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE / ISOSORBIDE MONONITRATE / ISOSORBIDE-5-MONONITRATE

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Assessed against UK PIL dated July 2014

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By kariri at

212 Leaflet Imdur 20150716

Other medicines and Imdur

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Imdur Tablets 60mg
(isosorbide mononitrate)

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines that you
buy without a prescription and herbal medicines. This is because
Imdur can affect the way some medicines work and some
medicines can have an effect on Imdur.

Your medicine is known as Imdur Tablets 60mg but will be referred
to as Imdur throughout the following leaflet.

Do not take lmdur if you are taking the following medicines:

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Do not take Imdur if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Imdur.



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 Imdur is and what it is used for
2. What you need to know before you take Imdur



Sildenafil or similar medicines called Phosphodiesterase Type 5
Inhibitors, (used for male impotence).

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 feel dizzy after taking lmdur. If this happens, do not drive
or use any tools or machines.
3. HOW TO TAKE IMDUR
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

3. How to take Imdur
4. Possible side effects

Taking this medicine

5. How to store Imdur



Swallow the tablets whole or broken in half (if this is easier to
swallow).

6. Contents of the pack and other information


Take the tablets with half a glass of water.

1. WHAT IMDUR IS AND WHAT IT IS USED FOR



Do not crush or chew the tablets.

Imdur contains a medicine called isosorbide mononitrate. This
belongs to a group of medicines called 'nitrates'.

How much to take



It is used to prevent chest pain (angina).



The recommended dose is one or two tablets a day.



It works by making the blood vessels relax and widen. This
makes it easier for the heart to pump blood around the body.



Take the medicine in the morning.



Your doctor may ask you to start on a low dose so that you are
less likely to have a reaction to starting Imdur.



The blister strips are marked with the days of the week. If you
are taking two tablets a day, make sure you take one tablet
from each strip marked with the same day of the week.

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 IMDUR
Do not take lmdur:


If you are allergic to isosorbide mononitrate or any of the other
ingredients of this medicine (listed in section 6).



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 Imdur”.

You must not take lmdur for a sudden attack of angina. If you
have a sudden attack, take a glyceryl trinitrate tablet (follow
the instructions given on the label).
Very occasionally, some people see the remains of the tablet in
their bowel motions. This is quite normal and does not mean that
the medicine has not been released.
Use in children
Do not give these tablets to children.
If you take more lmdur than you should

Do not take Imdur if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Imdur.

If you take more lmdur than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you so the
tablets can be identified.

Warnings and precautions

If you forget to take lmdur

Talk to your doctor or pharmacist before taking Imdur if:



If you forget a dose, take it as soon as you remember it.
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.



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 Imdur.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Like all medicines, this medicine can cause side effects, although
not everybody gets them. The following side effects may happen
with this medicine:

What Imdur contains




It contains 60mg of the active ingredient isosorbide mononitrate
in a sustained release formulation.

Headaches.





Feeling sick (nausea).



Feeling dizzy.

The tablets also contain the following inactive ingredients:
sodium aluminium silicate, paraffin (special),
hydroxypropylcellulose LF, magnesium stearate (vegetable
origin), colloidal silicon dioxide, hypromellose 6 CPS, macrogol
6000, titanium dioxide (E171) Cl 77891, and yellow iron oxide
(E172) Cl 77492.

The above problems usually disappear with time.
Other possible side effects:
Common (may affect up to 1 in 10 people)

What Imdur looks like and contents of the pack



Low blood pressure. This may make you feel faint or dizzy.



Faster heartbeat

The tablets are pale yellow, coated and coded A/lD on one side,
with breaklines on each side.



Headache



Feeling dizzy



Feeling sick (nausea).

lmdur 60mg Tablets are available as blister strips each containing
two rows of 7 tablets which have the days of the week shown There
is a total of 28 or 56 tablets per carton.
Product Licence holder

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

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Astrazeneca AB, S-151 85
Södertälje, Sweden.
P

PL 08747/0212

Very rare (may affect up to 1 in 10,000 people)

Leaflet revision date: 16 July 2015



Imdur is a trade mark of the Astrazeneca group of companies.

Pain in muscles

Reporting of 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.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE IMDUR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store your tablets below 30°C



Do not use after the expiry date printed on the carton label or
blister strip.



If the tablets become discoloured or show any other signs of
deterioration, consult your pharmacist before taking them. Any
unused tablets should be returned to your pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.

212 Leaflet Imdur 20150716

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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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