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ETIMONIS XL 50MG CAPSULES

Active substance(s): ISOSORBIDE MONONITRATE DILUTED IN LACTOSE / ISOSORBIDE MONONITRATE DILUTED IN LACTOSE / ISOSORBIDE MONONITRATE DILUTED IN LACTOSE

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PATIENT INFORMATION LEAFLET

of methemoglobin, a form of haemoglobin, is produced) occurs rarely.
Symptoms associated with methemoglobinaemia include: restlessness,
shallow breathing, altered state of mind, irregular heartbeat, blueish
discolouration of the skin and mucus membranes and circulatory failure.

IMO LA 50mg CAPSULES
(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 on this leaflet. See Section 4.

PHARMACODE
TO BE
INSERTED

WHAT IS IN THIS LEAFLET
1. What IMO LA is and what it is used for
2. What you need to know before you take IMO LA
3. How to take IMO LA
4. Possible side effects
5. How to store IMO LA
6. Contents of the pack and other information

1.

WHAT IMO LA IS AND WHAT IT IS USED FOR

The name of your medicine is IMO LA 50mg Capsules. IMO LA 50mg
Capsules contain the active substance isosorbide mononitrate.
Isosorbide mononitrate belongs to a group of medicines called nitrates.
Isosorbide mononitrate works by improving the blood supply to the heart
by enlarging the blood vessels in the heart muscle.
IMO LA 50mg Capsules are used to:
• Prevent symptoms of angina (chest pain) from happening
Angina usually occurs as a pain or tightness in the chest although it may
be felt in the neck or arm. The pain happens when the muscle of the heart
does not receive enough oxygen for the work it has to do.

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMO LA

Do not take IMO LA 50mg Capsules if you:
• are under 18 years of age
• are allergic to isosorbide mononitrate or any other medicines known as
nitrates (glyceryl trinitrate, isosorbide dinitrate)
• are anaemic (suffering from a low iron content in your body)
• have an eye disease called glaucoma (raised pressure in the eye)
• have very low blood pressure
• suffer from acute circulatory failure or hypovolaemia (low blood
volume)
• have severe cerebrovascular insufficiency - obstruction of one or more
arteries that supply blood to the brain which could lead to a stroke
• have a heart valve disorder or suffer from low cardiac filling pressures
• have had a recent severe head injury (and since had migraines and
headaches), cerebral haemorrhage (bleeding in the brain) or a disease
which is accompanied by increased pressure in the brain
• suffer from a condition called hypertrophic obstructive cardiomyopathy
(HOCM)
• suffer from a condition called constrictive pericarditis (inflammation of
the heart lining) or cardiac tamponade (where the fluid around the heart
puts pressure on the heart)
• are taking Viagra® (sildenafil), tadalafil or vardenafil- which belong to a
group of medicines called phosphodiesterase type- 5 inhibitors, to treat
male erectile dysfunction. Taking IMO LA 50mg Capsules with these
medicines could cause a severe and possibly dangerous fall in blood
pressure. This would result in collapse, unconsciousness and it could
be fatal.
Take special care with this medicine if you:
• have recently had a heart attack
• suffer from low blood pressure
• suffer from liver or kidney disease
• suffer from underactive thyroid gland (hypothyroidism)
• suffer from hypothermia (becoming excessively cold)
• suffer from malnutrition (severe lack of food)
Talk to your doctor or pharmacist if any of the above applies to you.
Taking other medicines
Your medicine may interfere with other medicines that you are taking.
Please inform your doctor or pharmacist if you are taking, or have recently
taken, any other medicine even those not prescribed.
In particular, the following types of drugs can interact with IMO LA 50mg
Capsules:
• medicines for high blood pressure e.g. beta blockers, calcium channel

If you forget to take your medicine
If you remember within 8 hours take the forgotten dose immediately.
If you remember after 8 hours take the dose at the usual time. DO NOT
take a double dose to make up for the dose you have missed.
If you stop taking this medicine
Do not stop taking this medicine without first talking to your doctor. Do not
stop taking it just because you feel better. If you stop taking the capsules
your condition may get worse.

4.
blockers, aldesleukin, angiotensin II receptor antagonists, ACE
inhibitors.
• diuretics (water tablets)
• vasodilators (used in the treatment of cold hands and feet)
• medicines to treat male erectile problems (sildenafil, alprostadil)
• tricyclic antidepressants (used to treat depression)
• neuroleptics (used to treat anxiety)
• dihydroergotamine (used to treat migraine)
• noradrenaline, acetylcholine and histamine
Pregnancy and breast-feeding
If you are pregnant, or think you may be pregnant, or you are
breast-feeding do NOT take this medicine without consulting your doctor.
Driving and using machines
This medicine may cause blurred vision or may make you feel dizzy or
tired. If you are affected, do not drive or operate machinery.
Drinking alcohol with this medicine
Alcohol may interact with this medicine causing your blood pressure to
become low.
Important information about some of the ingredients in IMO LA 50mg
Capsules
IMO LA 50mg Capsules contain lactose and sucrose. If you have been
told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3.

HOW TO TAKE IMO LA

If this medicine is from your doctor or pharmacist, do exactly as they have
told you. Otherwise, follow the instructions below. Check with your doctor
or pharmacist if you are not sure.
Swallow the capsule whole with a glass of water. Do not chew the
capsule.
Dosage
Adults
The usual adult dose is 50mg per day, taken in the morning.
Your doctor may increase this dose to 100mg, to be taken as a single
dose.
Your doctor may start you on a lower dose for the first two to four days
and slowly increase to minimise the possibility of headache.
The tablets should NOT be chewed or crushed and should be swallowed
with half a glass of fluid.
Children
IMO LA 50mg Capsules are NOT recommended for children under 18
years of age.
If you take more of your medicine than you should
If you take more capsules than you should, contact your nearest casualty
department or tell your doctor or pharmacist IMMEDIATELY. Take this
leaflet and any remaining capsules with you.
Symptoms of overdose include: headache, low blood pressure, feeling
sick, being sick, sweating, cold sweating, excitation, rapid heartbeat,
dizziness, warm flushed skin, blurred vision and fainting. A rise in
pressure in the brain with confusion and decrease in neurological
functions sometimes occur.
Methemoglobinaemia (is a blood disorder in which an abnormal amount

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What IMO LA 50mg Capsules contain
The active ingredient is isosorbide mononitrate. Each capsule contains
50mg of isosorbide mononitrate.
Other ingredients: lactose monohydrate, sucrose, maize starch, bleached
dewaxed shellac, dewaxed shellac, talc, copolymer of methacrylic acid
and methyl methacrylate (1:1) and copolymer of ethyl acrylate, methyl
methacrylate and trimethylammonioethyl methacrylate chloride (1:2:0.1).
The capsule shells are made of gelatin and also contain the colouring
agent titanium dioxide (E171).
The black printing ink contains shellac, propylene glycol, ammonium
hydroxide, potassium hydroxide and black iron oxide (E172).
What IMO LA 50mg Capsules look like and contents of the pack
The capsules are white and are printed in black with “ISMN SR” and “50”.
The capsules are available in boxes of 28, 30, 56 or 60 capsules.

POSSIBLE SIDE EFFECTS

Like all medicines, IMO LA 50mg Capsules can cause side effects,
although not everybody gets them.
If you experience the following side effects, you should STOP taking
your medicine and tell your doctor IMMEDIATELY or go to your
nearest casualty department.
• Skin troubles such as rash or itching
• Wheezing or shortness of breath
These may be signs of an allergic reaction.
Very Common (may affect more than 1 in 10 people):
• headache, which may be throbbing - this usually becomes less after a
few days of treatment

Marketing authorisation holder
Athlone Pharmaceuticals Ltd., Ballymurray, Co. Roscommon, Ireland.
Distributor
Almus Pharmaceuticals,
43 Cox Lane, Chessington, KT9 1SN, UK
PL 30464/0059
This leaflet was last revised: September 2014.

Common (may affect up to 1 in 10 people):
• dizziness or feeling light-headed
• lowered blood pressure (feeling light-headed, dizzy and a speeding up
of the heart rate when standing up. Also feeling of weakness,
drowsiness or increased heart rate)
Uncommon (may affect up to 1 in 100 people):
• nausea
• vomiting
• flushing
• skin rashes
• heartburn
• paleness, sweating and restlessness – if your blood pressure drops
severely, leading to passing out (collapse). Worsening of angina
symptoms can occur if blood pressure drops severely.
Rare (may affect up to 1 in 1,000 people)
• increase in your heart rate (tachycardia)
• decrease in your heart rate (paroxysmal bradycardia)
These symptoms generally disappear during long-term treatment
Not known (frequency cannot be estimated from the available data)
• muscle pain
• weakness
• inadequate supple of oxygen in the body (hypoxia)
• restlessnes
• sleepiness
• pituitary haemorrhage
• itching and allergic dermatitis
• Skin peeling
• Diarrhoea
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 IMO LA

DO NOT take the capsules after the expiry date printed on the container.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 25°C. Store in the original pack.
Return any left over medicine to your pharmacist.

A0076a/Lt2

DIMENSIONS 210 x 297 mm
REVISED ARTWORK FOR MHRA APPROVAL
VERSION: 2 (KENT/ATHLONE)

Client:

Almus UK

Project:

9910 / A / UK
Isosorbide Mononitrate
LA Capsules 50mg

DRAFT ISSUE: 1
REASON FOR CHANGE: SAFETY TEXT UPDATE

Item(s):

Colours used:

PMS
280

Patient Information Leaflet

SUPPLIER ISSUE DATE: 22.12.2014

PHARMA CODE TBA
ALMUS CODE A0076a/Lt2

Checked by: Paul Adams
Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams
This scale measures 100mm when artwork is 100%
0
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Date: 22.12.2014
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Lower Test Studios
Sheardley Lane, Droxford
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+44 (0)1489 878780
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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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