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Imdur 60mg Prolonged Release Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Imdur® 60mg Prolonged-release, Film-coated Tablets

isosorbide mononitrate

The name of this product is Imdur® 60mg Prolonged-release, Film-coated Tablets but will be referred to as Imdur throughout this 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.

•    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.

In this leaflet:

1.    What Imdur is and what it is used for

2.    Before you take Imdur

3.    How to take Imdur

4.    Possible side effects

5.    How to store Imdur

6.    Further information

1 . What Imdur is and what it is used for

Imdur 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 Imdur

Do not take Imdur if:

•    You are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients of Imdur (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 Inhibitor, (used for male impotence). See the section “Taking other medicines”.

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.

Take special care with Imdur

Check with your doctor or pharmacist before taking Imdur if:

•    You have ever had any serious damage to your heart, such as 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.

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 Imdur can affect the way some medicines work and some medicines can have an effect on Imdur.

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

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

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 Im dur.'

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 whether this medicine is suitable for you.

Driving and using machines

You may feel dizzy after taking Imdur. If this happens, do not drive or use any tools or machines.

3 . How to take Imdur

Always take Imdur 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 chew or crush 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 Imdur.

You must not take Imdur 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 Imdur than you should

If you take more Imdur 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 Imdur

•    If you forget a dose, take is 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 dose 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, Imdur 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, 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.

5 . How to store Imdur

•    Keep your medicine in a safe place where children cannot see or reach it.

•    Do not store above 30°C.

•    Do not use Imdur after the expiry date which is stated on the carton and blister strips. The expiry date refers to the last day of that month.

•    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.

6 . Further information

What Imdur contains

•    The active substance is isosorbide mononitrate. Each tablet contains 60mg of the active substance.

•    The other ingredients are aluminium silicate, paraffin special, hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol, titanium dioxide (E171) and yellow iron oxide (E172).

What Imdur looks like and contents of the pack

Imdur 60mg Prolonged-release, Film-coated Tablets are yellow, oval, bi-convex tablets, scored on both sides and marked A/ID on one side. They come in blister strips containing 7 tablets, which have the days of the week shown. A pack contains 28 tablets as 4 blister strips.

Manufacturer

AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield,

Cheshire, SK10 2NA, UK.

Imdur 60mg Prolonged-release Film-coated tablets PL 39467/0004    | P |

Procured from within the EU by Product License holder: PilsCo Ltd., 10-16 Colvilles Place, East Kilbride, G75 0SN, UK.

This medicine has been repackaged by TBC This leaflet was last revised on 25/06/2014

Imdur is a registered trademark of the AstraZeneca group of companies