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TRANGINA XL 60MG TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE

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Trangina XL 60mg tablets
(isosorbide mononitrate)
Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If you have any of the side effects, or if
you notice any not listed, please tell your
doctor or pharmacist.

• have heart problems caused by an inflammation
of the heart, abnormal pressure around the heart or
narrowing of the aortic or mirtal valve.
• have suffered from a heart attack
• have angina that is caused by an enlarged heart
muscle
• have suffered from shock or vascular collapse
(collapse of the blood vesels)
• have sever anaemia
• have suffered from a head injury or bleeding in the
brain
• have suffered from closed-angle glaucoma
• suffer from very low blood pressure

In this leaflet:
1 
What Trangina XL tablets are
and what they are used for
2 
Before you take Trangina XL
tablets
How to take Trangina XL tablets
3 
4 
Possible side effects
5 
How to store Trangina XL
tablets
6 
Further information

• 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

1 W
 hat 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 B
 efore you take Trangina XL
tablets

Check with your doctor or pharmacist before
taking Trangina XL tablets if you:

Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. 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.

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
• have any condition where your blood
pressure is very low or your blood is not
circulating properly (such as shock)
Continued top of next column
AAAG9714 50809844

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Isosorbide mononitrate 60mg, PIL, United Kingdom
item no:

AAAG9714

dimensions: 148 x 210

print proof no:

5

pharmacode:

origination date: 17.6.14
approved for print/date

min pt size:

7.5 pt

originated by:

db

revision date:

24.7.14

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

colours/plates:

Trangina XL Tablets
60mg x 28’s (UK)

1. black

JDE No.:

2.

50809844

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 9248

3.

6.
Non Printing Colours
1. profile
2.
3.

Date Sent:
30/05/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Pregnancy and breastfeeding

If you have been told that you have an intolerance to some
sugars, contact your doctor before taking this medicine, as
it contains lactose.

Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
• headaches, which can be relieved with painkillers and
usually get better after 1-3 weeks of treatment.
• dry or flaky skin rash
• being sick, heartburn
• glaucoma (pressure within the eye)
• flushing, dizziness, weakness, low blood pressure
including fainting on standing, fast or slow heart rate,
temporary low levels of oxygen in the blood, fainting or
passing out and heartburn.
• slow or fast heart beat

Taking Trangina XL tablets with alcohol

Reporting of side effects

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.

Sugar intolerance

You are advised not to drink alcohol with this medicine as
it may increase the blood pressure lowering affect of the
tablets.
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 Trangina XL tablets exactly as your doctor has
told you. If you are not sure, check with your doctor or
pharmacist.
Swallow the tablets whole with water. Do not crush or
chew them.
The usual doses are:
• Adults - 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.
• Children - not recommended.
• Elderly 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 then 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.

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 the tablets

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

4 Possible 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 out of the reach and sight of children.
Do not store above 25°C.
Do not use Trangina XL tablets after the expiry date stated
on the label/carton/bottle. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6 Further 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: June 2014

Like all medicines, Trangina XL tablets can cause side
effects, although not everybody gets them. Please tell your
doctor or pharmacist if you notice any of the following
effects or any not listed.
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 mouth, throat, or airways, resulting in
shortness of breath or difficulty to swallow.

Continued top of next column
AAAG9714 50809844

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Isosorbide mononitrate 60mg, PIL, United Kingdom
item no:

AAAG9714

dimensions: 148 x 210

print proof no:

5

pharmacode:

origination date: 17.6.14
approved for print/date

min pt size:

7.5 pt

originated by:

db

revision date:

24.7.14

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

colours/plates:

Trangina XL Tablets
60mg x 28’s (UK)

1. black

JDE No.:

2.

50809844

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 9248

3.

6.
Non Printing Colours
1. profile
2.
3.

Date Sent:
30/05/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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