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Imdur 60 Mg Tablets

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|2. Before you take lmdu


PACKAGE LEAFLET: INFORMATION FOR THE USER

IMDUR® 60 mg Tablets (isosorbide mononitrate)

This medicine is called Imdur 60 mg Tablets but it

will be referred to as Imdur through the remainder of

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 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 foi

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.

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 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 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 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 breastfeeding. 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 Imdu

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.

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 lmdur 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, 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

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 lmdu

•    Keep out of the sight and reach of children

•    Do not store above 30°C.

•    Protect from light. Protect from moisture.

•    Do not use lmdur after the expiry date which is stated on the carton. 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 60mg Tablets contain

•    The active substance is isosorbide mononitrate. Each tablet contains 60mg of the active substance in an extended-release formulation (Durules®).

•    The other ingredients are aluminium sodium silicate, paraffin, hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol 6000, titanium dioxide (E171) and yellow iron oxide (E172).

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

lmdur 60mg Tablets are pale yellow, oval, scored both sides and coded with ‘A' above and ‘ID' below it on one side. They come in blister strips containing 10 tablets.

A pack contains 30 or 60 tablets as multiples of the 10 tablet blister strip.

Manufacturer

AstraZeneca AB, Gartunavagen, S-151 85 Sodertalje, Sweden

AstraZeneca AB, Mariehemsvagen 8, S-906 54 Umea, Sweden

Biofabri, S.L., La Relva, s/n, Porrino, 36400 Pontevedra, Spain

Procured from within the EU and repackaged by Mediwin Ltd. PL Holder Mediport Ltd.

13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA,

United Kingdom.

§    PL: 18980/0820

lmdur and Durules are Trade marks of the AstraZeneca group of companies.

Date of Leaflet preparation: 05/12/2014

PIL_0820_S0008