Imdur 60mg Prolonged Release Film-Coated Tablets
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IMDUR® 60mg Prolonged-release Film-coated Tablets (isosorbide mononitrate)
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.
• The name of this medicine is IMDUR 60mg Prolonged-release Film-coated Tablets but will be referred to as Imdur throughout the remainder of this leaflet.
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 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 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 applies 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 applies 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 applies 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.
• 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.
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.
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
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.
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
• Do not take your tablets after the expiry date shown on the carton and blister strip.
• Store out of the sight and reach of children.
• Do not store above 30°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• If your tablets become discoloured or show any sign of deterioration, return them to your pharmacist (chemist).
6) FURTHER INFORMATION
Each tablet is a yellow, oval, biconvex, prolonged-release, film-coated tablet, scored on both sides, engraved A/ID on one side and contains 60 mg of the active ingredient isosorbide mononitrate.
Each tablet also contains the following inactive ingredients: aluminium silicate, paraffin special, hyprolose, magnesium stearate, colloidal anhydrous silica, hypromellose, macrogol 6000, titanium dioxide (E171) and ferric oxide (E172).
The tablets are made so that they release the medicine slowly over a number of hours.
IMDUR® 60mg Prolonged-release Film-coated Tablets come in blister strips containing 7 tablets, which have the days of the week shown. A pack contains 28 tablets as multiples of the 7 tablet blister strip.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER, U.K.
Repackaged by XXXXXXXXXXXXXXXXXX
IMDUR® 60mg Prolonged-release Film-coated Tablets
PL: 33532/0166
IMDUR® 60mg Prolonged-release Film-coated Tablets are manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
IMDUR® is a registered trademark of the AstraZeneca group of companies
Leaflet date: 4th September 2014 Leaflet code: XXXXXXXXXX