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TRANGINA XL 60MG TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE

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Package leaflet: Information for the patient

Trangina XL 60mg tablets
(isosorbide mononitrate)
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K eep 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 Trangina XL tablets are and what they
are used for
2 What you need to know before you take
Trangina XL tablets
3 How to take Trangina XL tablets
4 Possible side effects
5 How to store Trangina XL tablets
6 Contents of the pack and other information
1 What Trangina XL tablets are and what they

are used for

Isosorbide Mononitrate belongs to a group of medicines
called nitrate vasodilators. These work by relaxing the
blood vessels of the heart, reducing the strain on the heart
making it easier to pump blood.
Trangina XL tablets may be used to:
• prevent angina pectoris (chest pain).

2 What you need to know before you take

Trangina XL tablets

Do not take Trangina XL tablets if you:
• are allergic (hypersensitive) to isosorbide mononitrate,
isosorbide dinitrate, other nitrates or any of the
ingredients in the tablet (see section 6). An allergic
reaction may include a rash, itching or difficulty breathing
• h ave any condition where your blood pressure is very
low or your blood is not circulating properly (such as
shock)

• h ave heart problems caused by an inflammation of the
heart, abnormal pressure around the heart or narrowing
of the aortic or mirtal valve.
• h ave suffered from a heart attack
• h ave angina that is caused by an enlarged heart muscle
• have suffered from shock or vascular collapse (collapse
of the blood vessels)
• have severe anaemia
• have suffered from a head injury or bleeding in the brain
• have suffered from closed-angle glaucoma
• have fluid on the lungs (toxic pulmonary oedema)
• are taking certain medicines such as sildenafil, tadalafil or
vardenafil (also see section: Other medicines and Trangina
XL tablets)

Warnings and precautions

Talk to your doctor or pharmacist before taking Trangina
XL tablets if you:
• are having an angina attack. Trangina XL tablets are not
suitable for treating sudden angina attacks.
• have recently suffered a heart attack, or are suffering
from an under active thyroid gland, low body temperature
(hypothermia), malnutrition (undernourishment from a
poorly balanced diet)
• have severe liver or kidney disease

Other medicines and Trangina XL tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Especially:
• noradrenaline (norepinephrine) – to treat high blood
pressure or heart attack
• acetylcholine – used in some operations
• medicines to treat high blood pressure such as ACE
inhibitors, beta blockers, alphablockers, angiotensin-II
receptor agonists, clonidine, diazoxide, diuretics (water
tablets), methyldopa, moxonidine,
• histamine – to treat allergic reactions
• sildenafil , tadalafil and vardenafil, used to treat male
erection dysfunction, should not be taken if taking
nitrate preparations such as Isosorbide Mononitrate
tablets because a severe and possibly dangerous fall in
blood pressure can occur. This would result in collapse,
unconsciousness and could be fatal.

Trangina XL tablets with alcohol

You are advised not to drink alcohol with this medicine as
it may increase the blood pressure lowering affect of the
tablets.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Isosorbide Mono 60mg x 28’s (UK)

Isosorbide Mononitrate (Trangina XL) 60mg 28 Tablets PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0276

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
21.11.16
24.11.16
S.Anson

Date sent:
n/a
Date received: n/a

Dimensions:
148 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Text Safe Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50914601

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 5795
Date Sent:
10/11/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Pregnancy, breastfeeding and fertility

If you are pregnant, planning to become pregnant or
breastfeeding speak to a doctor before taking Trangina XL
tablets.

Driving and using machines

Trangina XL tablets may make you feel dizzy. Make sure you are
not affected before you drive or operate machinery.

Trangina XL tablets contain lactose

If you have been told that you have an intolerance to some
sugars, contact your doctor before taking this medicine, as it
contains lactose.
If you see another doctor or go into hospital, let them know
what medicines you are taking.

3 How to take Trangina XL tablets
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
Swallow the tablets whole with water. Do not crush or chew
them.
The recommended dose is:
•A
 dults - one tablet in the morning, the dose may be increased
to two tablets (120mg) in the morning. To reduce the possibility
of headaches you may initially be given half a tablet (30mg)
once daily for the first 2-4 days.
•C
 hildren - not recommended.
• E lderly patients with low blood pressure or liver or kidney
disease - your doctor may prescribe you a smaller dose.

If you take more Trangina XL tablets than you should
If you (or someone else) swallow’s a lot of tablets at the same
time, or you think a child may have swallowed any contact
your nearest hospital casualty department or tell your doctor
immediately. Symptoms of an overdose include: pulsing
headache, excitation, flushing, cold sweat, feeling or being sick,
feeling of dizziness or spinning, fainting, fast heart beat, a fall in
blood pressure.

If you forget to take Trangina XL tablets

Do not take a double dose to make up for a forgotten dose. If
you forget to take a dose take it as soon as you remember it and
then take the next dose at the right time.

If you stop taking Trangina XL tablets

Do not stop taking the tablets without talking to your doctor
and follow their advice.

4 Possible side effects

mouth, throat, or airways, resulting in shortness of breath or
difficulty to swallow.
Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
• h eadaches, which can be relieved with painkillers and usually
get better after 1-2 weeks of treatment.
• f eeling sick, being sick, heartburn
•g
 laucoma (pressure within the eye)
• f lushing, dizziness, weakness, low blood pressure including
fainting on standing, temporary low levels of oxygen in the
blood, fainting or passing out.
• s low or fast heart beat

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 Trangina XL tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the
label/carton/bottle. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharacist 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 Trangina XL tablets contain

• The active substance (the ingredient that makes the
tablets work) is isosorbide mononitrate. Each tablet
contains 60mg of the active ingredient.
• The other ingredients are lactose, hypromellose
(E464), glyceryl palmitostearate, maize starch,
magnesium stearate.

What Trangina XL tablets look like and
contents of the pack

Trangina XL tablets are white, oval shaped prolonged
release tablets.
Pack sizes are 28 tablets
Marketing Authorisation holder and
manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision: November 2016

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Contact your doctor at once if you experience symptoms of an
allergic reaction skin rash, swelling of the skin of the extremities
or face, swelling of lips, tongue, or the mucous membranes in
Continued top of next column
50914601 BBBA0276

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Isosorbide Mono 60mg x 28’s (UK)

Isosorbide Mononitrate (Trangina XL) 60mg 28 Tablets PIL - UK
approved for print/date

Proof Round

3

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0276

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
21.11.16
24.11.16
S.Anson

Date sent:
n/a
Date received: n/a

Dimensions:
148 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Text Safe Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50914601

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 5795
Date Sent:
10/11/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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