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Isosorbide Mononitrate Tablets 10mg

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Isosorbide Mononitrate 10mg, 20mg and 40mg tablets


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 you have any of the side effects, or if you notice any not listed, please tell your doctor or pharmacist.

In this leaflet:

H What Isosorbide Mononitrate tablets are and what they are used for

Before you take Isosorbide Mononitrate tablets How to take Isosorbide Mononitrate tablets "4 Possible side effects How to store Isosorbide Mononitrate tablets "6 Further information

T| What Isosorbide Mononitrate tablets are and what they are used for

Isosorbide Mononitrate belongs to a group of medicines called nitrate vasodilators. These work by relaxing the blood vessels of the heart, reducing the strain on the heart making it easier to pump blood.

Isosorbide Mononitrate tablets may be used to:

•    relieve the pain and frequency of angina attacks.

•    help control certain types of heart failure.

Before you take Isosorbide Mononitrate tablets Do not take Isosorbide Mononitrate tablets if you:

•    are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate or any of the ingredients in the tablet (see section 6). An allergic reaction may include a rash, itching or difficulty breathing


•    have any condition where your blood pressure is very low or your blood is not circulating properly

(such as shock)

•    have angina that is caused by an enlarged heart muscle

•    have suffered from a head injury or bleeding in the brain

•    have severe anaemia.

Check with your doctor or pharmacist before taking Isosorbide Mononitrate tablets if you:

•    have glaucoma (increased pressure in the eye)

•    have severe kidney or liver problems

•    have an underactive thyroid gland

•    are undernourished as a result of a poor diet

•    are suffering from hypothermia

•    have an undiagnosed pituitary tumour (brain tumour).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    noradrenaline (norepinephrine) - to treat high blood pressure or heart attack

•    acetylcholine - used in some operations

•    medicines to treat high blood pressure such as ACE inhibitors, beta blockers, alphablockers, angiotensin-II receptor agonists, clonidine, diazoxide, diuretics (water tablets), methyldopa, moxonidine,

•    histamine - to treat allergic reactions

•    sildenafil , tadalafil and vardenafil, used to treat male erection dysfunction, should not be taken if taking nitrate preparations such as Isosorbide Mononitrate tablets because a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal.

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant or breastfeeding speak to a doctor before taking Isosorbide Mononitrate tablets.

Driving and using machines

Isosorbide mononitrate may make you feel dizzy, make sure you are not affected before you drive or operate machinery.


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Sugar intolerance

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

Taking Isosorbide Mononitrate tablets with alcohol

You are advised not to drink alcohol with this medicine as it may increase the blood pressure lowering affect of the tablets.

If you see another doctor or go into hospital, let them know what medicines you are taking.

_3| How to take Isosorbide Mononitrate tablets

Always take Isosorbide Mononitrate tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with water after meals.

The usual doses are:

   Adults

-    Angina: initially 20mg two or three times a day, then a maintenance dose of between 20-120mg a day.

-    Congestive heart failure: 20mg two or three times a day depending on your condition. Your doctor may also be treating you with other drugs.

   Patients with kidney or liver disease - a lower dose may be given.

   Elderly: Dose should be reduced especially in patients with kidney or liver disease.

   Children: Not recommended

If you take more Isosorbide Mononitrate tablets than you should

If you (or someone else) swallow's a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose over excited, flushing, feeling or being sick, cold sweats, feeling dizzy or spinning sensation, fainting or passing out, fast heart beat or fall in blood pressure.

If you forget to take Isosorbide Mononitrate tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking the tablets

Do not stop taking the tablets without talking to your

doctor and follow their advice.

_4| Possible side effects

Like all medicines, Isosorbide Mononitrate tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any not listed.

Contact your doctor at once if you experience symptoms of an allergic reaction skin rash, swelling of the skin of the extremities or face, swelling of lips, tongue, or the mucous membranes in mouth, throat, or airways, resulting in shortness of breath or difficulty to swallow.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    headaches, which can be relieved with painkillers and usually get better after 1-3 weeks of treatment.

•    dry or flaky skin rash

•    being sick, heartburn

•    glaucoma (pressure within the eye)

•    flushing, dizziness, weakness, fainting on standing, fast or slow heart rate, temporary low levels of oxygen in the blood.

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.

How to store Isosorbide Mononitrate tablets

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Do not use Isosorbide Mononitrate tablets after the expiry date stated on the label/carton/bottle. 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. These measures will help to protect the environment.

_6| Further information

What Isosorbide Mononitrate tablets contain

•    The active substance (the ingredient that makes the tablets work) is isosorbide mononitrate. Each tablet contains either 10mg, 20mg or 40mg of the active ingredient.

•    The other ingredients are crospovidone, lactose, magnesium stearate, maize starch, povidone and E460 (10mg and 40mg only).

What Isosorbide Mononitrate tablets look like and contents of the pack

Isosorbide Mononitrate tablets are circular, biconvex, white to off white uncoated tablets.

Pack sizes are 56 tablets


Marketing Authorisation holder and manufacturer

Actavis, Barnstaple, EX32 8NS, UK Date of last revision: June 2014

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Actavis, Barnstaple, EX32 8NS, UK