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Imdur 60mg Tablets

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161 Leaflet Imdur 20140710

PACKAGE LEAFLET: INFORMATION FOR THE USER IMDUR 60mg TABLETS

(isosorbide mononitrate)

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

• 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 lmdur. If this happens, do not drive or use any tools or machines.

3. HOW TO TAKE IMDUR

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 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 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

6. FURTHER INFORMATION


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

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.

What Imdur contains

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

•    The tablets also contain the following inactive ingredients: sodium aluminium silicate, paraffin special, magnesium stearate, hydroxypropylcellulose, colloidal silicon dioxide, hydroxypropylmethylcellulose, polyethylene glycol 6000, titanium dioxide (E171) and yellow iron oxide (E172).

What Imdur looks like and contents of the pack

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

Imdur 60mg Tablets are available in blister packs of 30 or 60 tablets.

Product Licence holder

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 either of the below manufacturers-

•    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.

[P]    PL No: 08747/0161

Leaflet revision date: 10 July 2014

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

161 Leaflet Imdur 20140710

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 OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 30°C. Store in original package to protect from light and moisture.

•    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.