PACKAGE LEAFLET: INFORMATION FOR THE USER

ANGITATE™ TABLETS 10MG

(Isosorbide Mononitrate)

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.

What is in this leaflet:

B1. What Angitate™ is and what it is used for

B2. What you need to know before you take Angitate™ y* How to take Angitate™

[4. Possible side effects [5. How to store Angitate™

16 Contents of the pack and other information

1. What Angitate™ is and what it is used for

•    Angitate™ belongs to a group of medicines called organic nitrates.

•    Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it.

•    Angitate™ is used to prevent angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing.

2. What you need to know before you take Angitate™

Do not take Angitate^TM if:

•    you are allergic (hypersensitive) to isosorbide mononitrate, other nitrates or any of the other ingredients of Angitate^TM (see section 6)

•    you suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)

•    you have had a heart attack (myocardial infarction)

•    you have had a brain haemorrhage (bleeding)

•    you have had a head injury (trauma)

•    you have a low blood volume (hypovolaemia)

•    you have very low blood pressure

•    your blood has stopped circulating around your body properly (circulatory failure)

•    you take sildenafil or any other phosphodiesterase inhibitor.

•    you are suffering from “shock” or vascular collapse

•    you have an eye disease called glaucoma

•    you have been diagnosed with any of the following heart conditions: hypertrophic obstructive cardiomyopathy (HOCM) (thickness of the heart muscle abnormally increased), constrictive pericarditis (inflammation of the membranes around the heart), cardiac tamponade (increased fluid around the heart), low cardiac filling pressures, narrowing of heart valve (aortic/ mitral valve stenosis and diseases associated with raised intra-cranial (head) pressure.

If any of the above applies to you talk to your doctor or pharmacist.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Angitate^TM if:

•    you have an underactive thyroid gland

•    you are malnourished (severely underfed)

•    you have liver or kidney disease

•    you suffer from hypothermia (a very low body temperature)

•    you suffer from very poor circulation Other medicines and Angitate^TM

•    Do not take Angitate™ with phosphodiesterase inhibitors such as Sildenafil used for impotence. Using Angitate^TM with these medicines could cause your blood pressure to fall to a dangerously low level. You must not stop taking Angitate™ to take Sildenafil as this will increase your chances of having an angina attack.

Tell your doctor if you are taking any of the following medicines:

•    Anti-hypertensives such as ACE inhibitors (e.g. captopril, enalapril), beta-blockers (e.g. atenolol), Calcium channel blockers, vasodilators, alprostadil, Aldesleukin and angiotensin II receptor antagonists

•    Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety).

•    Ergotamine used for migraine.

•    Any other medicine, including medicines obtained without a prescription.

Angitate^TM with food, drink and alcohol

Do not drink alcohol. It could increase the effect of Angitate^TM and lower your blood pressure too much. If this happens, you may feel dizzy or faint.

Pregnancy, breast-feeding and fertility

If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking Angitate^TM. Your doctor will decide whether you should take this medicine.

Driving and using machines

Angitate^TM may give you a headache, blurred vision or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.

Angitate^TM contains Lactose

Angitate Insert

Same Size Artwork 130 x 260 mm

Version 001-----280511    Version 011----030912

Version 002-—100611 Version 003—100611 (new size)

Version 004-—270611 Version 005-—310811 Version 006-—270112 Version 007—070112 (new size)

Version 008-----170112 (TM added)

Version 009-----270312 Version 010-----200812

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Angitate™

Always take Angitate^TM as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Important:

•    Your doctor will choose the dose that is right for you.

•    Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

•    Swallow the tablets whole with a drink of water

Adults

•    The usual adult dose is one tablet two or three times a day

•    Your doctor will tell you when you should take your tablets. You will need to have a period of time (usually when you are sleeping) when no tablets are taken. This is called a “nitrate low” period and is needed to make sure your medicine remains effective

•    Your doctor may increase your dose, up to a maximum of 120 mg per day.

Do not use Angitate^TM to treat an actual angina attack. Your doctor will give you a different medicine such as a GTN (glyceryl trinitrate) spray or tablet for this.

Children

This medicine is not suitable for children.

If you take more Angitate^TM than you should

Do not take more Angitate^TM than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor.

If you forget to take Angitate^TM

Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

If you stop taking Angitate^TM

Do not stop taking Angitate^TM without first talking to your doctor. You should keep taking your medicine until your doctor tells you to stop. 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Angitate^TM can cause side effects, although not everybody gets 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.

Seek immediate medical help if you have any of the following symptoms:

•    Fainting or collapse

Very common side effects (affects more than 1 in 10 people):

•    Throbbing headaches at the start of treatment. Usually they disappear after a few days.

Common side effects (affects less than 1 in 10 people):

•    Low blood pressure

•    Drowsiness

•    Dizziness

•    Tiredness

•    Feeling weak

•    Fast heartbeat

They may occur for the first few days of treatment or after your dosage has been increased.

Uncommon side effects (affects less than 1 in 100 people):

•    Fainting or collapse

•    Feeling sick or being sick

•    Flushing.

•    Skin rashes

•    Looking pale

•    Excessive sweating

•    Restlessness

•    Worse angina.

Very rare side effects (affects less than 1 in 10,000 people):

•    Heartburn

•    Red or scaly skin (exfolilative dermatitis).

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

5. How to store Angitate™

•    Keep out of the reach and sight of children.

•    Do not use Angitate™ after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

•    Store below 25⁰C.

•    Do not throw away any medicines via waste water 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 Angitate™ 10 mg tablets contain

•    The active substance is isosorbide mononitrate 10 mg.

•    The other ingredients are lactose mono hydrate, compressible sugar, colloidal silicon dioxide and magnesium stearate.

What Angitate™ 10 mg tablets look like and contents of the pack

•    White to off-white flat beveled edge tablet marked ‘IMN and 10’on one side with a scoreline in between and the other side with ‘BL’.

•    They come in blister packs of 14, 28, 30, 56 and 60 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, UK Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

Email:    info@bristol-labs.co.uk

Angitate™ Tablets 10mg, PL 17907/0311 This leaflet was last revised in September 2012

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