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ISOSORBIDE DINITRATE TABLETS BP 10MG

Active substance: ISOSORBIDE DINITRATE

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Isosorbide Dinitrate
10mg and 20mg Tablets
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 • If you have any of the side effects, or if you notice any not listed,
pass it on to others. It may harm them, even if their
please tell your doctor or pharmacist.
symptoms are the same as yours.

In this leaflet:
1.  hat Isosorbide Dinitrate tablets are
W
and what they are used for
2.  efore you take Isosorbide Dinitrate
B
tablets
3.  ow to take Isosorbide Dinitrate
H
tablets
4. Possible side effects
5.  ow to store Isosorbide Dinitrate
H
tablets
6. Further information

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

• 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.




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.





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AAAG9613 50809799

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Taking Isosorbide Dinitrate tablets with alcohol



Sugar intolerance

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.

You are advised not to drink alcohol with this medicine.




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.



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

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.





5. How to store Isosorbide Dinitrate tablets





If you take more Isosorbide Dinitrate tablets than
you should

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.
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.

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:

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.

6. Further information


If you forget to take Isosorbide Dinitrate tablets

4. Possible side effects


By reporting side effects you can help provide more
information on the safety of this medicine.





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
Date of last revision: June 2014

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

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Actavis, Barnstaple, EX32 8NS, UK
AAAG9613 50809799

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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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