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Imdur 60mg Prolonged Release Film-Coated Tablets

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PACKAGE LEAFLET INFORMATION FOR THE USER

lmdur® 60 mg prolonged-release film-coated Tablets

(isosorbide mononitrate)

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.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Imdur 60 mg prolonged-release film-coated Tablets, but will be referred to as Imdur.

In this leaflet:

1.    What lmdur is and what it is used for

2.    Before you take lmdur

3.    How to take lmdur

4.    Possible side effects

5.    How to store lmdur

6.    Further information

1. What lmdur is and what it is used for

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

•    It is used to prevent chest pain (angina).

•    It works by making the blood vessels relax 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.Before you take lmdur

Do not take lmdur if:

•    You are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients of lmdur (listed in Section 6: Further information).

•    You have ever had a stroke.

•    You have very low blood pressure.

•    You have severe anaemia.

•    You have a heart problem called 'cardiomyopathy' or 'pericarditis' or you have narrow heart valves.

•    You are taking sildenafil or similar medicines called Phosphodiesterase Type 5 Inhibitors, (used for male impotence). See the section ''Taking other medicines".

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

Take special care with lmdur

Check with your doctor or pharmacist before taking lmdur 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 lmdur.

Taking other medicines

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

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

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

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

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, may become pregnant or are breast-feeding. Your doctor will decide if this medicine is suitable for you.

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 lmdur

Always take lmdur exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Do not give these tablets to children.

Taking this medicine

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

•    Take the tablets with half a glass of water.

•    Do not crush or chew the tablets.


How much to take

•    The usual dose is one or two tablets a day.

•    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 lmdur.

•    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.

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.

If you take more lmdur than you should

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.

If you forget to take lmdur

•    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 (two doses at the same time) to make up for a forgotten dose.

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

pharmacist.

4.Possible side effects

Like all medicines, lmdur 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 (affect less than 1 in 10 people)

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

•    Faster heartbeat

•    Headache

•    Feeling dizzy

•    Feeling sick (nausea).

Uncommon (affect less than 1 in 100 people)

•    Being sick (vomiting)

•    Diarrhoea

Rare (affect less than 1 in 1,000 people)

•    Fainting

•    Rash

•    Itchy skin

Very rare (affect less than 1 in 10,000 people)

•    Pain in muscles

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme: (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 lmdur

•    Keep out of the sight and reach of children.

•    Do not store above 30°C.

•    Do not take your tablets after the expiry date shown on the carton and blister strip.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

•    If your tablets become discoloured or show any signs of deterioration, consult your pharmacist who will tell you what to do.

6.Further information

What lmdur Tablets 60 mg contain

•    Each tablet contains isosorbide mononitrate 60 mg in a prolonged-release formulation.

•    Each tablet also contains the following inactive ingredients: aluminium silicate, paraffin special, hyprolose, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol 6000, titanium dioxide (E171) and yellow iron oxide (E172).

What lmdur Tablets 60 mg look like and contents of the pack

lmdur Tablets 60 mg are yellow, oval, biconvex tablets scored on both sides, engraved ‘A' and ‘ID' on one side and plain on the reverse.

Imdur Tablets 60 mg come in calendar blister strips containing 7 tablets, which have the days of the week shown. The pack contains 28 tablets.

Manufacturer

lmdur Tablets 60 mg are manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.

Procured from within the EU. Product Licence Holder: S.C.A.C. Ltd., Unit 2a, Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP. Repackaged by Cross Healthcare Ltd., Unit 2a, Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP.

PL: 30984/0026    Imdur® 60 mg prolonged-release film-coated Tablets    |P|

Leaflet prepared: 09 February 2015

lmdur® is a registered trade mark of AstraZeneca AB.