ISOSORBIDE DINITRATE TABLETS BP 10MG

Active substance: ISOSORBIDE DINITRATE

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65 mm

Read all of this leaflet carefully before you start taking this medicine.

83.6mm

Isosorbide Dinitrate
10mg and 20mg Tablets
Pharmacode
Position

• If you have any further questions, ask your doctor or pharmacist.
• Keep this leaflet. You may need to read it again.
• This medicine has been prescribed for you. Do not • If you have any of the side effects, or if you notice any not listed,
please tell your doctor or pharmacist.
pass it on to others. It may harm them, even if their
symptoms are the same as yours.

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





2. Before you take Isosorbide Dinitrate
tablets




Do not take Isosorbide Dinitrate tablets
if you:

• are allergic (hypersensitive) to isosorbide
dinitrate, isosorbide mononitrate 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)
• suffer from haemorrhage (problems with
bleeding)
• are dehydrated due to illness such as diarrhoea
or being sick
• have heart problems such as heart valve
problems, inflammation of the heart surface,
build up of fluid under the surface of the heart or
progressive heart failure due to long term lung
disease
• have angina that is caused by an enlarged heart
muscle
• have raised pressure in your head
• have severe anaemia.

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
calcium channel blockers (e.g. nifedipine)
• tricyclic antidepressants (e.g. amitriptyline)
• phenothiazines (e.g. chlorpromazine) – to treat
mental illness
• histamine – to treat allergic reactions
• sildenafil, tadalafil or vardenafil, used to treat
male erection dysfunction, should not be taken
if taking nitrate preparations such as Isosorbide
Dinitrate tablets because a severe and possibly
dangerous fall in blood pressure can occur. This
would result in collapse, unconsciousness and
could be fatal.

Pregnancy and breastfeeding

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

to eye mark centre line on following sheet - 210± 0.5mm

• have glaucoma (increased pressure in the eye)
• have any serious damage to your heart (such as
after a heart attack or operation)
• have been told you suffer from deficiency
of an enzyme called glucose 6 phosphate
dehydrogenase (G6PD). This condition is
sometimes called “Favism” (it is a form of anaemia
that is more common in Mediterranean people,
attacks may occur after eating certain foods, such
as broad beans)
• have severe kidney or liver problems
• have an underactive thyroid gland
• are undernourished as a result of a poor diet
• are suffering from hypothermia
• have suffered from a head injury or bleeding in
the brain.

1. What Isosorbide Dinitrate tablets are
and what they are used for

Isosorbide Dinitrate 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.
Isosorbide Dinitrate tablets may be used to:
• relieve the pain and frequency of angina attacks.
• help control certain types of heart failure.

Check with your doctor or pharmacist
before taking Isosorbide Dinitrate tablets if
you:



Taking Isosorbide Dinitrate tablets with
alcohol

Common (occurs in less than 1 in 10 users):
• a decrease in blood pressure, dizziness or
faintness when standing up due to low blood
pressure, a racing heart beat, drowsiness,
dizziness and weakness may also occur
(especially when Isosorbide Dinitrate tablets
are used for the first time or when your dose is
increased).
• swelling of the hands, ankles or feet.

You are advised not to drink alcohol with this
medicine.





Sugar intolerance



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.



Uncommon (occurs in less than 1 in 100 users):
• feeling or being sick.
• worsening of angina due to very low blood
pressure.
• collapsing with slow or irregular heart beat and
fainting.

3. How to take Isosorbide Dinitrate
tablets

















Always take Isosorbide Dinitrate tablets exactly as
your doctor has told you. If you are not sure, check
with your doctor or pharmacist.
Swallow the tablets with water.
The usual doses are:
• Adults
• Angina: 30-120mg daily in divided doses
• Heart failure: 40-160mg daily in divided doses.
Your doctor may also be treating you with other
drugs.
The maximum daily dose is 240mg in divided
doses.
• Elderly
• a lower dose may be given particularly if you
have kidney or liver disease.

If you take more Isosorbide Dinitrate
tablets than you should

Very rare (occurs in less than 1 in 10, 000 users):
• shallow and slow breathing causing low oxygen
in the blood and a risk of heart attack in patients
with heart disease.
• increased pressure in the eye (angle closure
glaucoma).
• a type of tumour that affects the pituitary, may
cause headaches or vision problems.

5. How to store Isosorbide Dinitrate
tablets




If you (or someone else) swallow 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 Isosorbide Dinitrate
tablets

6. Further information

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.



4. Possible side effects





Keep out of the reach and sight of children.
Store below 25°C, in a dry place.
Do not use Isosorbide Dinitrate 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.

Like all medicines, Isosorbide Dinitrate tablets can
cause side effects, although not everybody gets
them.
Contact your doctor immediately if you notice
signs of: allergic skin reactions, skin that is red,
flaky or peeling (exfoliative dermatitis), severe form
of skin rash with flushing, fever, blisters or ulcers
(Stevens-Johnson Syndrome) and swelling of the
face, lips, tongue or throat (angioedema).
Please tell your doctor or pharmacist if you
notice any of the following effects or any not listed:





What Isosorbide Dinitrate tablets contain

• The active substance (the ingredient that makes
the tablets work) is isosorbide dinitrate. Each
tablet contains either 10mg or 20mg of the active
ingredient.
• The other ingredients are magnesium stearate,
maize starch, lactose, polyvidone.

What Isosorbide Dinitrate tablets look like
and contents of the pack
Isosorbide Dinitrate tablets are circular, white to off
white uncoated tablets
Pack size 56

Marketing Authorisation holder and manufacturer
Actavis, Barnstaple, EX32 8NS, UK

Pharmacode
Position



Date of last revision: May 2009

65 mm

Very common (occurs in more than 1 in 10 users):
• headache (especially when you first start taking
Isosorbide Dinitrate tablets).
• flushing.

Actavis, Barnstaple, EX32 8NS, UK

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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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