Imdur 60mg Tablets
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2) BEFORE YOU TAKE IMDUR
Imdur® 60 mg Tablets
(isosorbide mononitrate)
Patient Information Leaflet
The name of your medicine is Imdur® 60 mg Tablets.
Throughout this leaflet it will be referred to as Imdur®.
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 FO
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 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 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®.
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®.
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.
continued overleaf
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.
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
Manufacturers
AstraZeneca 151 85 Sodertalje, Sweden.
AstraZeneca AB, Mariehemsvagen 8, S-906 54 Umea Sweden.
Biofabri S.L, La Relva S/N, Porrino, 36400 Pontevedra, Spain.
Imdur® 60 mg Tablets
PL No: 18067/0188 P
Imdur® is a registered trademark of the AstraZeneca group of companies.
This leaflet was last revised on 27th July 2014.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
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 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.
• Imdur® 60 mg Tablets should be stored below 30°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.
• 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.
• If you notice any deterioration or discolouration of the tablets, please tell your pharmacist immediately.
6) FURTHER INFORMATION
What Imdur® 60 mg Tablets contain
Each tablet contains 60 mg of the active substance isosorbide mononitrate.
Each tablet also contains: aluminium silicate,
hydroxypropylcellulose, magnesium stearate, silicon dioxide, paraffin, hypromellose, macrogol 6000, titanium dioxide (E171) and yellow ferric oxide (E172).
What Imdur® 60 mg Tablets look like and the contents of the pack
Imdur tablets are yellow oval bi-convex film coated tablets; half scored on both sides and marked A ID on one side.
Each cardboard carton contains 60 tablets that are presented as four blister strips of 15 tablets contained in each strip, or six blister strips of 10 tablets contained in each strip.
Product Licence Holder
500389/PL1g
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.