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Imdur 60mg Prolonged Release Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

(isosorbide mononitrate}

Your medicine is known by the above name, 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 get 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 Inhibitors, (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 a heart attack or operation.

If the above applies 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 Inhibitors, (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 Imdur. 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 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 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 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.

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 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, 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.

Rarely you may have a rash or itching.

Very rarely you may have muscle pain.

Do not be concerned by this list of possible side effects, you may not get any of them.

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.

5. How to store Imdur

   Keep out of the sight and reach of children

•    Do not store above 30°C

•    Do not use after the last day of the month shown in the expiry date on the carton and blister

•    If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.

•    Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer require or medicines that have expired. These measures will help to protect the environment.

6. Further information

What Imdur contains

•    Each prolonged release tablet contains 60 mg of isosorbide mononitrate as the active substance.

•    The other ingredients are: aluminium silicate, paraffin special, hydroxyproylcellulose, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol 6000, titanium dioxide and yellow iron oxide.

What Imdur looks like and contents of the pack

Indur 60mg Prolonged Release Film-Coated Tablets are yellow, oval biconvex, film coated tablets, scored on both sides, engraved ‘A/ID' on either side of the score line on one side of the tablet.

Imdur 60mg Prolonged Release Film-Coated Tablets are supplied as a calendar blister pack of 28 tablets.

Who manufactured your medicine

Manufactured by AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom.

Procured from within the EU and repackaged by Product Licence Holder C&N Medical Limited, Unit G2, RD Park, Stephenson Close, Hoddesdon, EN11 0BW, United Kingdom.

Imdur 60mg Prolonged Release Film-Coated Tablets    PL 40775/0002


Leaflet date: 29th October 2012

Imdur® is a registered trademark of the AstraZeneca group of companies.