Do not take Imdur if you are taking the following

medicines:

PACKAGE LEAFLET: INFORMATION FOR THE USER IMDUR® 60 MG TABLETS

(isosorbide mononitrate)

This medicine will be referred to as Imdur throughout 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 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

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.

Do not take Imdur if:

•    You are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients of Pertil Retard (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 Pertil Retard 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 Imdur can affect the way some medicines work and some medicines can have an effect on Imdur.

• 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.

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 Pertil Retard.

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.

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

Manufacturer

This product is manufactured by:

AstraZeneca Farmaceutica Spain, SA, O Porrino (Pontevedra) Spain

It is procured from within the EU. Product Licence holder: G Pharma Ltd, Dakota Avenue, Salford M50 2PU.

PL NO: 16369/0891

Imdur® 60mg Tablets    07/07/2014

‘Imdur' is a registered trademark of AstraZeneca AB.

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

Expiry

Do not take the tablets after the date printed on the blister label, container, or carton.

Storage

•    Do not store above 30°C.

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

•    If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist for advice.

•    Only keep the tablets if your doctor tells you to.

•    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.

What Imdur contains

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

•    The tablets also contain the following inactive ingredients: aluminium silicate, paraffin special, hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, macrogol, titanium dioxide (E171), yellow iron oxide (E172) and hypromellose.

What Imdur looks like and contents of the pack

Imdur 60mg Tablets are pale yellow, oval-shaped tablets, marked

on one side with “A” score line “ID” and with a score line on the

reverse. The tablets are made so that the medicine is

released slowly over a number of hours. They are available in a

plastic bottle with plastic screw cap incorporating a tamper-evident

seal of 60 tablets, or a carton containing 60 tablets.

PACKAGE LEAFLET: INFORMATION FOR THE USER PERTIL RETARD ® 60 MG TABLETS

(isosorbide mononitrate)

This medicine will be referred to as Pertil Retard throughout 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 Pertil Retard is and what it is used for

2.    Before you take Pertil Retard

3.    How to take Pertil Retard

4.    Possible side effects

5.    How to store Pertil Retard

6.    Further information

Pertil Retard 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 Pertil Retard if:

•    You are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients of Pertil Retard (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 Pertil Retard if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Pertil Retard.

Take special care with Pertil Retard

Check with your doctor or pharmacist before taking Pertil Retard 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 Pertil Retard.

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

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

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

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 Pertil Retard. If this happens, do not drive or use any tools or machines.

Always take Pertil Retard 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 Pertil Retard.

You must not take Pertil Retard 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 Pertil Retard than you should

If you take more Pertil Retard 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 Pertil Retard

•    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.

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

Manufacturer

This product is manufactured by:

AstraZeneca Farmaceutica Spain, SA, O Porrino (Pontevedra) Spain

It is procured from within the EU. Product Licence holder:

G Pharma Ltd, Dakota Avenue, Salford M50 2PU.

PL NO: 16369/0891    I——

Pertil Retard 60mg Tablets    07/07/2014

‘Pertil Retard' is a registered trademark of AstraZeneca AB.

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 Pertil Retard

Expiry

Do not take the tablets after the date printed on the blister label, container, or carton.

Storage

•    Do not store above 30°C.

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

•    If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist for advice.

•    Only keep the tablets if your doctor tells you to.

•    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.

What Pertil Retard contains

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

•    The tablets also contain the following inactive ingredients: aluminium silicate, paraffin special, hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, macrogol, titanium dioxide (E171), yellow iron oxide (E172) and hypromellose.

What Pertil Retard looks like and contents of the pack Pertil Retard 60mg Tablets are pale yellow, oval-shaped tablets, marked on one side with “A” score line “ID” and with a score line on the reverse. The tablets are made so that the medicine is released slowly over a number of hours. They are available in a plastic bottle with plastic screw cap incorporating a tamper-evident seal of 60 tablets, or a carton containing 60 tablets.