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MODISAL XL 40MG PROLONGED RELEASE TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE / ISOSORBIDE 5-MONONITRATE / ISOSORBIDE 5-MONONITRATE

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Artwork No.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

290312/1

Colours Used

Customer

Ennogen

Black

Description

Modisal XL Leaflet

Keyline

Market

UK

Language

English

Size

180 x 300 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

27

Date

13-06-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Modisal XL 40mg Prolonged Release Tablets
(Isosorbide mononitrate)

Suffer from high pressure in the eye (closed
Read all of this leaflet carefully before you start
!
angle glaucoma)
taking this medicine because it contains
Have very low blood pressure
!
important information for you.
!
Have low blood volume
!
Keep this leaflet. You may need to read it
Are taking riociguat e.g. Adempas for
!
again.
!
pulmonary hypertension. (See section, Other
If you have any further questions, ask your
medicines and Modical XL 40mg Prolonged
doctor or pharmacist or nurse.
!
Release Tablets)
This medicine has been prescribed for you
Have had an acute (short-lived) heart attack
!
only. Do not pass it on to others. It may harm
(myocardial infarction)
them, even if their signs of illness are the same
!
Are suffering from shock or vascular collapse
as yours.
!
which causes the blood to stop circulating
If you get any side effects, talk to your doctor,
around your body (acute circulatory failure)
or pharmacist or nurse. This includes any
!
Have had severe disruption of blood and
possible side effects not listed in this leaflet.
oxygen supply to the brain (cerebrovascular
See section 4.
insufficiency) resulting in a stroke.
What is in this leaflet:
Warnings and precautions:
1. What Modisal XL 40mg Prolonged Release
Talk to your doctor, or pharmacist or nurse before
Tablets are and what they are used for
taking Modisal Tablets if you:
2. What you need to know before you take
Suffer from an underactive thyroid gland or you
Modisal XL 40mg Prolonged Release
!
are taking thyroxine
Tablets
Suffer from an abnormally low body
3. How to take Modisal XL 40mg Prolonged
!
temperature
Release Tablets
Suffer from poor health as a result of a poor
4. Possible side effects
!
diet
5. How to store Modisal XL 40mg Prolonged
Suffer from severe liver or kidney disease
Release Tablets
!
!
Have been told by your doctor that you have an
6. Contents of the pack and other information
intolerance to some sugars (see Modisal XL
1. WHAT MODISAL XL 40MG PROLONGED
40mg Prolonged Release Tablets contain
RELEASE TABLETS ARE AND WHAT THEY
lactose)
ARE USED FOR
!
Are intending to drink alcohol as it may cause
severe low blood pressure
!
Have recently suffered from a heart attack.
Modisal XL 40mg Prolonged Release Tablets
contain a medicine called isosorbide mononitrate.
Modisal Tablets should not be used for the relief
This belongs to a group of medicines called
of sudden attacks of angina. Your doctor will have
nitrates that act on your cardiovascular system (the
given you another medicine to treat these sudden
heart and blood vessels). They work by reducing
attacks.
the frequency of your angina attacks. They are
called prolonged release tablets because they
You should not just stop treatment with these
have been made in a way that allows the
tablets. If you wish to stop taking them you should
isosorbide mononitrate to be released and slowly
see your doctor first (see section 3, How to take).
absorbed by your body over a period of several
hours.
Other medicines and Modisal XL 40mg
Prolonged Release Tablets:
These tablets work by widening the blood vessels
Tell your doctor or pharmacist if you are taking,
in your heart to allow an increased amount of blood
have recently taken or might take any other
to flow to areas which need it.
medicines.
Modisal Tablets are used to prevent angina
Modisal Tablets may lower blood pressure so tell
pectoris.
your doctor if you are taking any other medicines
Angina usually feels like a tight pain in the chest,
that may lower your blood pressure, such as:
arm or neck area. The pain comes from the heart
!
Beta-blockers e.g. atenolol
muscle and is a sign that part of it is not getting
!
Diuretics e.g. furosemide
enough oxygen for the amount of work it is doing.
!
ACE-inhibitors e.g. ramipril
2. WHAT YOU NEED TO KNOW BEFORE YOU
!
Calcium channel blockers e.g. nifedipine
TAKE MODISAL XL 40MG PROLONGED
!
Vasodilators e.g. hydralazine
RELEASE TABLETS
!
Angiotensin II receptor antagonists e.g.
losartan
!
Aldesleukin used to treat certain types of
Do not take Modisal XL 40mg Prolonged
cancer
Release Tablets if you:
!
!
Alcohol
Are taking the drug Sildenafil, or similar
!
Dihydroergotamine (used to treat migraine).
products for the treatment of male erectile
dysfunction (see section Other medicines and
Taking these types of medicines with Modisal
Modisal XL 40mg Prolonged Release Tablets)
!
Tablets can increase the risk of low blood pressure
Are allergic to isosorbide mononitrate, other
occurring, especially if you are elderly.
nitrates (e.g. glyceryl trinitrate) or any of the
other ingredients of this medicine (listed in
Do not take Modisal XL 40mg Prolonged Release
section 6)
!
Tablets if you are taking riociguat, e.g. Adempas for
Suffer from increased intracranial pressure
pulmonary hypertension. When taken together, a
(high pressure within your skull, e.g. from a
fall in blood pressure can occur.
blow to your head) or cerebral haemorrhage bleeding from a ruptured blood vessel in the
Do not take Modisal Tablets at the same time as
brain
!
Sildenafil or Alprostadil, used for the treatment
Have been diagnosed with any of the following:
of male erectile dysfunction. If taken at the
hypertrophic obstructive cardiomyopathy
same time it could cause a severe fall in blood
(HOCM), constrictive pericarditis, cardiac
pressure resulting in collapse,
tamponade or aortic/mitral valve stenosis
!
unconsciousness and may be fatal.
Suffer from anaemia, a reduction in red blood
cells which can make the skin pale and cause
you to feel weak and breathless

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

290312/1

Colours Used

Customer

Ennogen

Black

Description

Modisal XL Leaflet

Keyline

Market

UK

Language

English

Size

180 x 300 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

27

Date

13-06-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Modisal XL 40mg Prolonged Release Tablets
with food, drink and alcohol:
If you drink alcohol while taking Modisal Tablets it
can increase the risk of low blood pressure
occurring, especially if you are elderly with light
headedness and dizziness on standing. You
should not drink alcohol while taking this
medicine.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you
might be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
Pregnancy
This medicine should only be used during
pregnancy if your doctor thinks the benefits
outweigh the possible risks.
Breast-feeding
This medicine should only be used whilst breastfeeding if your doctor thinks the benefits outweigh
the possible risks.
Driving and using machines:
Do not drive or operate machinery when taking
Modisal Tablets if you develop low blood pressure
(you may experience this as dizziness, tiredness or
feeling sick) or if you have blurred vision.
Modisal XL 40mg Prolonged Release Tablets
contain lactose:
If you have been told by your doctor that you have
an intolerance to some sugars you should not take
this medicine.
3. HOW TO TAKE MODISAL XL 40mg
PROLONGED RELEASE TABLETS
Always take this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
These tablets should be taken whole, with a glass
of water. They should not be crushed or chewed.
Adults and the elderly
One tablet (40mg) once daily in the morning.
This may be increased to two tablets (80mg) daily,
taken at the same time, if necessary.
If you are elderly and suffer from low blood
pressure, liver or kidney disease, your doctor may
prescribe a lower dose for you to take.
Use in Children
These tablets are unsuitable for children.
If you take more Modisal XL 40mg Prolonged
Release Tablets than you should
If you take too many tablets by mistake, contact
your nearest hospital casualty department or tell
your doctor immediately. Take your tablet pack with
you.
If you have taken more tablets than you should,
symptoms may include low blood pressure,
headache and confusion, feeling excited, cold
sweats, sensation that you, or the environment
around you, is moving or spinning, feeling sick,
being sick, restlessness, warm flushed skin,
blurred vision, fainting, fast heart rate, palpitations
and a blood disorder in which an abnormal amount
of methemoglobin is produced.
If you forget to take Modisal XL 40mg
Prolonged Release Tablets
Do not take a double dose to make up for a
forgotten dose. Take your next dose at the normal
time. If you have trouble remembering to take the
tablets, tell your doctor or pharmacist.

Quality Control (QC)

Production

Most side effects are dose-dependent. The most
common side effect is headache. This side effect
occurs in more than 10% of patients at the
beginning of treatment. The headache usually
disappears after 1 - 2 weeks of treatment.

Very Common Side Effects (may affect more than
1 in 10 people )
!
headache.

Uncommon Side Effects (may affect up to 1 in 100
people)
!
worsening angina (tight pain in the chest, neck
or arm area)
!
collapse
!
fainting
!
slow heart rate.

Not known (frequency cannot be estimated from
the available data)
!
feeling sick
!
flushing
!
being sick
!
excessive sweating
!
diarrhoea
!
dizziness
!
drowsiness
!
restlessness
!
tiredness
!
pale skin
!
low blood pressure
!
low blood pressure on standing
!
sudden slow heart rate
!
increase in heartbeat
!
redness and peeling of the skin
!
muscle pain.
Medicine should be stopped immediately and
medical attention sought if any of the
symptoms occur.
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 MODISAL XL 40MG
PROLONGED RELEASE TABLETS
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the label. The expiry date refers
to the last day of that month.
Do not store above 25°C. Store in the original
package.
In case of any visible signs of deterioration, you
should discard the package.
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 Modisal XL 40mg Prolonged Release
Tablets contain:
Modisal Tablets contain the active substance
isosorbide mononitrate 40mg in each tablet.
The other ingredients are:
Stearic acid, carnauba wax, hypromellose, lactose
monohydrate, magnesium stearate, talc, purified
siliceous earth, macrogol 4000, titanium dioxide
(E171), yellow iron oxide (E172).

If you stop taking Modisal XL 40mg Prolonged
Release Tablets
These tablets should not be discontinued suddenly
but should be tapered gradually. Consult your
doctor on how to stop taking these tablets.

What Modisal Tablets look like and contents of
the pack:
Modisal Tablets are round, cream coloured tablets
marked IM40 on one side and plain on the other
side.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Modisal Tablets are available in packs of 28, 30,
56, 60 or 100. Not all pack sizes are sold.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everyone gets them.

Marketing Authorisation Holder and
Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.

Seek immediate medical help if you have any of
This leaflet was last revised in June 2017.
the following symptoms:
!
allergic reactions (including rashes).

Expand Transcript

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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