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ISMN PIL:005657580315/02........160 X 297mm 3	^28/15 3:12 PM Page 1
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Patient Information Leaflet

ISOSORBIDE MONONITRATE 10MG, 20MG & 40MG TABLETS

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.

1. What Isosorbide Mononitrate is and what it is used for

Isosorbide Mononitrate belongs to a group of medicine called nitrate vasodilators. It works by improving the blood supply to the heart, by enlarging the blood vessels in the heart muscle, reducing the strain on the heart making it easier to pump blood, and is used for preventing the pain in your chest called angina. Isosorbide Mononitrate tablets may be used to help control certain types of heart failure.

2. What you need to know before you take Isosorbide Mononitrate

Do not take Isosorbide Mononitrate tablets and tell

your doctor if you:

•    are allergic (hypersensitive) to Isosorbide Mononitrate or to other nitrates or to any of the other ingredients in your tablets (see section 6). An allergic reaction may include rash, itching or difficulty breathing

•    have very low blood pressure

•    have a low blood volume

•    have glaucoma (increased pressure in the eye)

•    suffer from any serious heart or circulatory (vein/artery) problems, other than angina

•    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

•    are taking sildenafil, tadalafil and vardenafil or any other phosphodiesterase inhibitor

•    are pregnant, planning to get pregnant or breastfeeding (see below pregnancy and breastfeeding)

Warnings and precautions

Talk to your doctor or pharmacist before taking

this tablet if you:

•    have severe kidney or liver problems

•    have an underactive thyroid gland

•    are undernourished as a result of a poor diet

•    are suffering from hypothermia (a very low body temperature)

•    suffer from very poor circulation

Isosorbide mononitrate tablets may give rise to postural hypotension (dizziness on standing or fainting) particularly at the start of treatment or when their dose is changed.

Other medicines and Isosorbide Mononitrate Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, especially:

•    noradrenaline (norepinephrine) to treat high blood

pressure

•    acetylcholine (a neurotransmitter) and histamine

(used for maintenance therapy in patients with acute myeloid leukamia)

•    medicines to treat severe high blood pressure-such

as ACE inhibitors (captopril), beta blockers (atenolol), alpha blockers (prazosin), angiotensin-II receptor agonists (losartan), calcium channel blockers (diltiazepam), , clonidine, diazoxide, diuretics (water tablets such as furosemide), methyldopa, moxonidine

•    alprostadil (used to treat erectile dysfunction)

•    aldesleukin (used to treat kidney cancer)

•    sildenafil, tadalafil or verdenafil 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

•    alcohol, tricyclic antidepressants (used to treat

depression) and neuroleptics (used to treat anxiety)

•    dihydroergotamine (used to treat migraines)

Taking the tablets with alcohol

You are advised not to drink alcohol with this medicine as it may increase the blood pressure lowering effect of the tablets. If this happens, you may feel dizzy or faint.

Pregnancy and breast feeding

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 give you headache, blurred vision or make you feel dizzy or tired, make sure you are not affected before you drive or operate machinary.

Isosorbide Mononitrate tablet contains lactose

Isosorbide Mononitrate tablets contain lactose (a type of sugar). If you have been told that you have intolerance to some sugars contact you doctor before taking this medicine.

3. How to take Isosorbide Mononitrate

Always take isosorbide mononitrate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with little water after meals. Do not chew them.

Doses • 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.

Do not use Isosorbide Mononitrate Tablets to treat an acute angina attack. Your doctor will give you a different medicine such as a GTN (glyceryl trinitrate) spray or tablet for this.

•    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 tablets than you should

If you (or someone else) swallow a lot of the tablets all together, or you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or 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 the tablets

If you forget to take a dose, take the missed dose as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining tablets at the correct times.

If you stop taking the tablets

Do not stop taking the tablets without talking to your doctor and follow their advice. Do not stop taking it just because you feel better. If you stop taking the tablets your condition may get worse.

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, particularly when you first start to take it, although not everybody gets them.

Contact your doctor at once if you experience following symptoms:

•    fainting or collapse

•    allergic reactions; 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: Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

•    tiredness, flushing, dizziness, weakness, low blood pressure, fast or slow heart rate, temporary low levels of oxygen in the blood

Uncommon (may affect up to 1 in 100 people):

•    dry or flaky skin rash

•    Feeling sick or being sick

•    looking pale

•    restlessness

•    excessive sweating

•    worse angina

•    heartburn

•    red or scaly skin (exfoliative dermatitis)

Not known (frequency cannot be estimated from the available data):

•    pituitary apoplexy (bleeding or poor blood supply to the pituitary gland) in patients with undiagonised pituitary tumor. The initial symptoms are sudden headache and rapidly worsening problems with vision including double vision

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 Isosorbide Mononitrate

Keep all the medicines out of the sight and reach of children.

•    Do not use this medicine after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

•    These tablets should be stored in a dry place, below 25°C.

•    Store in the original container.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Isosorbide Mononitrate 10mg, 20mg & 40mg tablets contain:

•    The active substance is isosorbide mononitrate. Each tablet contains 10mg, 20mg or 40mg of the active ingredient.

•    The other ingredients are lactose anhydrous, magnesium stearate and colloidal silicon dioxide. See end of section 2 for further information on lactose.

What Isosorbide Mononitrate tablets look like and contents of the pack:

•    Isosorbide mononitrate 10mg tablets are white biconvex, engraved PV on one side and IS10 on the other.

•    Isosorbide mononitrate 20mg tablets are white biconvex, engraved PV on one side and IS20 on the other.

•    Isosorbide mononitrate 40mg tablets are white biconvex, engraved PV on one side and IS40 on the other.

•    Isosorbide mononitrate 10mg and 40mg Tablets are available in pack sizes of 28, 30, 56, 60, and 100. Isosorbide Mononitrate 20mg Tablets are available in pack sizes of 28, 30, 56, 60, 100 and 500. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex UB6 7HQ.

Telephone: 0208 997 5444 Fax:    0208 997 5433

To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.

PL 04556/0056, 04556/0057 & 04556/0058

Reference: 005657580315/02

This leaflet last revised in March 2015