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ISOSORBIDE MONONITRATE 40MG TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE / ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE DILUTED IN LACTOSE / ISOSORBIDE 5-MONONITRATE / ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE DILUTED IN LACTOSE / ISOSORBIDE-5-MONONITRATE DILUTED IN LACTOSE 80/20 / ISOSORBIDE 5-MONON

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Package leaflet: Information for the patient

Angitate® 20 mg Tablets
Angitate® 40 mg Tablets
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. See section 4.
What is in this leaflet
1. What Angitate® is and what it is used for
2. What you need to know before you take Angitate®
3. How to take Angitate®
4. Possible side effects
5. How to store Angitate®
6. Contents of the pack and other information

1. What Angitate® is and what it is used for
This medicine contains an active ingredient called Isosorbide Mononitrate, which 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.
Isosorbide Mononitrate 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.
Angitate® 20 mg and 40 mg Tablets can also be used to treat congestive heart failure. Heart
failure can happen when the heart muscle is not strong enough to pump the blood around
the body. It may cause problems with breathing and swelling of the legs.

Do not take this medicine:
• If you are allergic to isosorbide mononitrate, other nitrates or to any of the other
ingredients of this medicine (listed in section 6)
• If you suffer from severe anaemia (reduction in red blood cells which can make the skin
pale and cause weakness or breathlessness)
• If you have had a heart attack (myocardial infarction)
• If you have had a brain haemorrhage (bleeding)
• If you have had a head injury (trauma)
• If you have a low blood volume (hypovolaemia)
• If you have severely low blood pressure (hypotension)
• If your blood has stopped circulating around your body properly (circulatory failure)
• If you are suffering from “shock” or vascular collapse
• If you take sildenafil (“Viagra”) or any other phosphodiesterase inhibitor
• If you have an eye disease called glaucoma
• If you have been diagnosed with any of the following heart conditions: hypertrophic
obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade,
low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with
raised intra-cranial (head) pressure
• If you take products that contain riociguat a medicine used in treating pulmonary
hypertension.
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 ®:
• If you have an underactive thyroid gland
• If you are malnourished (severely underfed)
• If you have liver or kidney disease
• If you suffer from hypothermia (a very low body temperature)
• If you suffer from very poor circulation.
Other medicines and Angitate ®
• Do not take Angitate ® with phosphodiesterase inhibitors such as Sildenafil,
Tadalafil, Alprostadil and Vardenafil used for impotence. Using Angitate ® 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.
• Do not take Angitate ® with products that contain riociguat a medicine used in
treating pulmonary hypertension.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines to lower your blood pressure. Especially, the following:
• Medicines which lower blood pressure, such as beta blockers (atenolol, propranolol),
calcium channel blockers (nifedipine, diltiazem), vasodilators (glyceryl trinitrate,
methyldopa), angiotensin receptor blockers (olmesartan medoxomil, candesartan
cilexetil)
• Tricyclic antidepressants (used to treat depression) such as amitriptyline,
clomipramine, and neuroleptics (used to treat anxiety)
• Dihydroergotamine (a drug to treat migraine). The hypertensive effect of this drug may
be strengthened
• Sapropterin containing medicines (used to treat phenylketonuria or tetrahydrobipterin
deficiency)
• Aldesleukin (a drug to treat metastastic cancer of the kidney).
If any of the above applies to you, talk to your doctor.
Taking Angitate ® with food and drink
Do not drink alcohol. It could increase the effect of Isosorbide Mononitrate 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 this medicine.
Your doctor will decide whether you should take this medicine.
Driving and using machines
Angitate® 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 ® tablets contain Lactose
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 this medicine exactly 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.
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2. What you need to know before you take Angitate®

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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.
• Swallow the tablets whole with a drink of water.
• Your doctor may increase your dose, up to a maximum of 120 mg per day.
Do not use Angitate® 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.
The elderly
No dose adjustment is necessary.
Children
This medicine is not suitable for children.
If you take more Angitate ® than you should
Too much Isosorbide mononitrate may cause your blood pressure to fall too low, making
you feel sick, faint and dizzy. A very large overdose could cause a coma or collapse and
require immediate resuscitation. If you have taken more of this medicine than you should,
contact your doctor or the nearest hospital casualty department immediately. Take the
medicine carton with you. Your doctor or pharmacist will then know exactly what you
have taken.
If you forget to take Angitate ®
If you have forgotten to take your medicine, take it as soon as you remember. However,
if it is nearly time for the next dose, you must skip the dose you have missed.
Do not take a double dose to make up for a forgotten dose.
If you stop using Angitate ®
Carry on using your medicine until your doctor says you can stop. Do not stop using it just
because you feel better. If you stop using the tablets, your condition may get worse.
This medicine must be taken regularly. It does not work if you take it only when you suffer
symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
• Fainting or collapse
Very common (may affect more than 1 in 10 people)
• Headaches
Common (may affect up to 1 in 10 people)
• Dizziness
• Sleepiness
• Feeling weak
• Fast heartbeat
• Lowering of blood pressure when standing up
They may occur for the first few days of treatment or after your dosage has been
increased.

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Uncommon (may affect up to 1 in 100 people)
• Fainting or collapse
• Feeling sick or being sick
• Skin rashes
• Looking pale
• Flushing
• Excessive sweating
• Restlessness
• Increase in chest pain/angina.
Very rare (may affect up to 1 in 10,000 people)
• Heartburn
Not known (frequency cannot be estimated from the available data)
• Red or scaly skin (exfoliative dermatitis)
• Low blood pressure
• Swelling of the skin
You may also suffer with increase chest pain due to a lack of oxygen to the heart muscle
and areas around the chest.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Angitate®
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date on the carton. The expiry date refers to
the last day of that month.
• Store below 25°C. Store in the original package in order to protect from moisture and
light.
• 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 ® Tablets contain
• The active substance is isosorbide mononitrate 20 mg or 40 mg.
• The other ingredients are lactose monohydrate, anhydrous lactose, colloidal silicon
dioxide and magnesium stearate.
What Angitate tablets look like
• Angitate® 20 mg Tablets are white to off-white, biconvex tablets, marked ‘IMN’ and
‘20’ on one side with a score line in between and the other side with ‘BL’.
• Angitate® 40 mg Tablets are white to off-white, biconvex tablets, marked with ‘IMN
and ‘40’ on one side with a score line 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
This leaflet was last revised in February 2017.
Angitate ® 20 mg Tablets; PL 17907/0523
Angitate ® 40 mg Tablets; PL 17907/0524

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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