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MODISAL XL 40MG PROLONGED RELEASE TABLETS

Active substance(s): 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.

22

Date

02-12-15

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)

Read all of this leaflet carefully before you start
cells which can make the skin pale and cause
taking this medicine because it contains
you to feel weak and breathless
!
important information for you.
Suffer from high pressure in the eye (closed
!
Keep this leaflet. You may need to read it
angle glaucoma)
!
again.
Have very low blood pressure
!
If you have low blood volume.
!
If you have any further questions, ask your
doctor or pharmacist or nurse.
!
This medicine has been prescribed for you
Warnings and precautions:
only. Do not pass it on to others. It may harm
Talk to your doctor, or pharmacist or nurse before
them, even if their signs of illness are the same
taking Modisal Tablets if you:
!
as yours.
Are sensitive to the effects of low blood
!
If you get any side effects, talk to your doctor,
pressure; Modisal Tablets should not be used
or pharmacist or nurse. This includes any
for example, by patients with existing low blood
possible side effects not listed in this leaflet.
pressure, shock, reduced thyroid function
See section 4.
(hypothyroidism), anaemia, cerebral perfusion
disorders or elevated intracranial pressure,
What is in this leaflet:
patients who faint as a result of reduced
1. What Modisal XL 40mg Prolonged Release
perfusion (vascular collapse)
!
Tablets are and what they are used for
Suffer from an underactive thyroid gland or you
2. What you need to know before you take
are taking thyroxine
!
Modisal XL 40mg Prolonged Release
Suffer from an abnormally low body
Tablets
temperature
!
3. How to take Modisal XL 40mg Prolonged
Suffer from poor health as a result of a poor
Release Tablets
diet
!
4. Possible side effects
Suffer from severe liver or kidney disease
5. How to store Modisal XL 40mg Prolonged
!
Have been told by your doctor that you have an
Release Tablets
intolerance to some sugars (see Modisal XL
6. Contents of the pack and other information
40mg Prolonged Release Tablets contain
lactose)
1. WHAT MODISAL XL 40MG PROLONGED
!
Are intending to drink alcohol as it may cause
RELEASE TABLETS ARE AND WHAT THEY
severe low blood pressure
ARE USED FOR
!
Have recently suffered from a heart attack
!
Suffer from very poor circulation.
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
pectoris.
Angina usually feels like a tight pain in the chest,
arm or neck 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.

Modisal Tablets may lower blood pressure so tell
your doctor if you are taking any other medicines
that may lower your blood pressure, such as:
!
Beta-blockers e.g. atenolol
!
Diuretics e.g. furosemide
!
ACE-inhibitors e.g. ramipril
!
Calcium channel blockers e.g. nifedipine
2. WHAT YOU NEED TO KNOW BEFORE YOU
!
Vasodilators e.g. hydralazine
TAKE MODISAL XL 40MG PROLONGED
!
Angiotensin II receptor antagonists e.g.
RELEASE TABLETS
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
!
Sapropterine containing medicines for the
dysfunction (see section Other medicines and
treatment of hyperphenylalaninaemia (HPA)
Modisal XL 40mg Prolonged Release Tablets)
!
Tricyclic antidepressants used to treat
!
Are allergic (hypersensitive) to isosorbide
depression e.g.amitriptyline and neuroleptics to
mononitrate, other nitrates (e.g. glyceryl
treat psychosis (delusions, hallucinations
trinitrate) or any of the other ingredients in
and/or disordered thought) such as
Modisal Tablets (listed in section 6)
phenothiazines e.g fluphenazine.
!
Suffer from increased intracranial pressure
(high pressure within your skull, e.g. from a
Taking these types of medicines with Modisal
blow to your head) or cerebral haemorrhage Tablets can increase the risk of low blood pressure
bleeding from a ruptured blood vessel in the
occurring, especially if you are elderly.
brain
!
Have been diagnosed with any of the following:
Do not take Modisal Tablets at the same time as
hypertrophic obstructive cardiomyopathy
Sildenafil or Alprostadil, used for the treatment
(HOCM), constrictive pericarditis, cardiac
of male erectile dysfunction. If taken at the
tamponade or aortic/mitral valve stenosis
same time it could cause a severe fall in blood
!
Suffer from anaemia, a reduction in red blood
pressure resulting in collapse,
unconsciousness and may be fatal.

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.

22

Date

02-12-15

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 breastfeeding:
Modisal Tablets should only be used in pregnancy
or breastfeeding under close supervision of a
doctor.
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:
Modisal Tablets contain lactose monohydrate. 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

Quality Control (QC)

Production

Most side effects are dose-dependent. The most
common side effect is headache. This side effect
occurs in approximately 25% of patients at the
beginning of treatment. The headache usually
disappears within about a week.

Very Common Side Effects (affects more than 1
user in 10)
!
headache.

Common Side Effects (affects 1 to 10 users in 100)
!
dizziness (including dizziness on standing up)
!
drowsiness
!
tiredness
!
feeling weak
!
low blood pressure
!
increase in heartbeat

Uncommon Side Effects (affects 1 to 10 users in
1000)
!
worsening angina (tight pain in the chest, neck
or arm area)
!
vomiting
!
diarrhoea
!
nausea
!
skin rashes
!
itching

Rare Side Effects (affects 1 to 10 users in 10,000)
!
fainting.

Always take Modisal Tablets exactly as your doctor
has instructed you. You should check with your
doctor or pharmacist if you are unsure.

Very Rare (affects less than 1 user in 10,000)
!
upset stomach
!
indigestion

These tablets should be taken whole, with a glass
of water. They should not be crushed or chewed.

Medicine should be stopped immediately and
medical attention sought if any of the
symptoms occur.

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.
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 nausea (feeling sick),
vomiting (being sick), restlessness, confusion,
warm flushed skin, blurred vision, headache,
fainting, dizziness (caused by low blood pressure hypotension), fast heart beats and palpitations.
A very large overdose could cause a coma or
collapse and require immediate resuscitation.
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.
If you forget to take Modisal XL 40mg
Prolonged Release Tablets:
If you have forgotten to take a dose, leave out that
dose completely. Take your next dose at the
normal time. If you have trouble remembering to
take the tablets, tell your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everyone gets them.

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
Check the expiry date printed on the label or side
of the box. Do not use after the expiry date 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.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.
Keep out of the sight and reach of children.
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).
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.

Seek immediate medical help if you have any of
Modisal Tablets are available in packs of 28, 30,
the following symptoms:
56, 60 or 100. Not all pack sizes are sold.
!
skin rashes
!
itching
Marketing Authorisation Holder and
!
excessive sweating
Manufacturer
!
allergic skin reaction
Ennogen Pharma Limited
!
flushing
Unit G4, Riverside Industrial Estate,
!
fainting or collapse
Riverside Way, Dartford, DA1 5BS, UK.
!
difficulty in breathing
This leaflet was last revised November 2015.

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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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