IMDUR 60 MG TABLETS - patient leaflet, side effects, dosage

Imdur® 60mg Tablets

(isosorbide mononitrate)

PATIENT INFORMATION LEAFLET

Your medicine is available using the above name but will be referred to as Imdur throughout the leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Imdur is and what it is used for

• 2. What you need to know before you take Imdur

• 3. How to take Imdur

• 4. Possible side effects

• 5. How to store Imdur

• 6. Contents of the pack and other 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. what you need to know before you take imdur do not take imdur:

• – If you are allergic to isosorbide mononitrate or any of the other ingredients of this medicine (listed in section 6).

• – If you have ever had a stroke.

• – If you have very low blood pressure.

• – If you have severe anaemia.

• – If you have a heart problem called ‘cardiomyopathy’ or ‘pericarditis’ or you have narrow heart valves.

• – If you are taking sildenafil or similar medicines called Phosphodiesterase Type 5 Inhibitors, (used for male impotence). See the section “Other medicines and Imdur”.

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.

Warnings and precautions

Talk to 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 any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Imdur.

Other medicines and Imdur

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 recommended 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.

Use in children

Do not give these tablets to children.

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 to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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 (may affect up to 1 in 10 people)

• – Low blood pressure. This may make you feel faint or dizzy.

• – Faster heartbeat

• – Headache

• – Feeling dizzy

• – Feeling sick (nausea).

Uncommon (may affect up to 1 in 100 people)

• – Being sick (vomiting)

• – Diarrhoea

Rare (may affect up to 1 in 1,000 people)

• – Fainting

• – Rash

• – Itchy skin

Very rare (may affect up to 1 in 10,000 people)

• – Pain in muscles

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 25°C.

• – Do not use Imdur after the expiry date which is stated on the carton.

The expiry date refers to the last day of that month.

• – If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

• – If your doctor tells you to stop taking this medicine, return any unused tablets to your doctor or pharmacist for safe disposal. Only keep the tablets if they tell you to.

• – Medicines should not be disposed of via wastewater or household waste. This will help to protect the environment.

6. contents of the pack and other information

What Imdur contain

The active substance is isosorbide mononitrate.

Each tablet contains 60mg isosorbide mononitrate in an extended-release formulation.

Each tablet also contains the following inactive ingredients: sodium aluminium silicate, paraffin, hydroxypropyl­cellulose, magnesium stearate, colloidal silica, hypromellose, macrogol, titanium dioxide (E171) and yellow iron oxide (E172).

What Imdur look like and contents of the pack

Imdur 60mg Tablets are pale yellow, oval, biconvex, film-coated tablet, scored on both sides, engraved A/ID on one side.

Imdur come in calendar blister packs of 28 and 98 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Laboratorios Alcala Farma, S.L., Avenida de Madrid, 82, Alcala de Henares, Madrid, 28802, Spain and Procured from within the EU and repackaged by Product Licence holder P.I.E. Pharma Ltd, Harrow, Middlesex HA3 0HD.

P PL 15361/2208

Leaflet revision and issue date (Ref) 09.11.19[12]

Imdur is a trademark of the AstraZeneca AB.