ISOTARD 25XL CAPSULES

Active substance: ISOSORBIDE 5-MONONITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Isotard 25XL and 50XL Capsules
(Isosorbide-5-mononitrate)

Read all of this leaflet carefully because it contains important information for
you.
This medicine is available without prescription. However, you still need to take
Isotard carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects gets serious, or if you notice any side effect not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Isotard is and what it is used for
2. Before you take Isotard Capsules
3. How to take Isotard Capsules
4. Possible side effects
5. How to store Isotard Capsules
6. Further information

1.

WHAT ISOTARD IS AND WHAT IT IS USED FOR

Isotard Capsules are one of a group of medicines known as nitrates. They are used to
help prevent an attack of angina (chest pain). They are not suitable for the relief of an
angina attack.

2.

BEFORE YOU TAKE ISOTARD CAPSULES

Do not take Isotard Capsules
- if you are allergic (hypersensitive) to isosorbide-5-mononitrate or any of the other
ingredients (listed in section 6) of Isotard
- if you are suffering a heart attack or have recently had a heart attack
- if you suffer from severe anaemia (severe reduction in red blood cells)
- if you are suffering from a head injury
- if you are suffering from bleeding in the brain (brain haemorrhage)
- if you suffer from very low blood pressure (severe hypotension)
- if you suffer from low circulating blood volume (hypovolaemia)
Talk to your doctor before taking this product if any of the above apply to you.
Take special care with Isotard Capsules
- if you are pregnant
- if there is a chance you might become pregnant
- if you are breast-feeding
- if you suffer from liver problems
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if you suffer from kidney problems
if you suffer from glaucoma (glaucoma is the name given to a group of eye
conditions that affect vision)
- if you suffer from an under-active thyroid gland (a condition known as
hypothyroidism)
- if you suffer from hypothermia (very low body temperature)
- if you suffer from malnutrition (severe lack of food)
If any of the above apply to you, it is important that you tell your doctor or pharmacist
before taking Isotard and they will decide what to do. It may still be safe for you to
take Isotard.
Taking other medicines
Do not take Viagra (sildenafil – for male erectile dysfunction) while you are taking
Isotard. Taking Viagra while you are taking Isotard could cause a severe and possibly
dangerous fall in blood pressure. This could result in collapse, unconsciousness and
could be fatal.
It is important that you inform your doctor or pharmacist if you are taking medicines
that can lower your blood pressure.
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Taking Isotard Capsules with alcohol
Do not drink alcohol while taking Isotard Capsules.
Pregnancy and breast-feeding
You should not use Isotard Capsules during pregnancy or while breast-feeding unless
your doctor thinks it is essential. Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
Isotard Capsules may make you feel faint or dizzy. You should not drive or operate
machinery until you know how they affect you.
Important information about some of the ingredients of Isotard Capsules
These capsules contain sucrose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicine.

3.

HOW TO TAKE ISOTARD CAPSULES

This product should be taken orally (by mouth). You must swallow the capsules
whole with a drink of water. The capsules must not be crushed or chewed.
The usual dose of Isotard for adults is one or two capsules to be taken in the morning.
If this product has been prescribed by your doctor the label on the carton will tell you
how many capsules you should take and when. Always take Isotard Capsules exactly

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as your doctor has told you. You should check with your doctor or pharmacist if you
are not sure.
Elderly patients or patients with low blood pressure, kidney or liver disease may be
advised to take a lower dose.
The capsules should not be given to children.
If you take more Isotard Capsules than you should
If you take too many capsules, contact your nearest hospital casualty department or
doctor immediately. Take this leaflet and any remaining capsules with you.
If you forget to take Isotard Capsules
If you forget to take your capsule(s), take your recommended dose as soon as you
remember and then carry on as normal. Do not take a double dose to make up for a
forgotten dose.
If you stop Isotard Capsules
Do not stop taking Isotard Capsules without consulting your doctor. Stopping your
medicine suddenly may lead to your condition getting worse.
If you have an angina attack (chest pain) despite taking Isotard Capsules, your doctor
will supply you with another medicine for this. Do not stop taking your Isotard
Capsules.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Isotard Capsules can cause side effects, although not everybody
gets them.
In rare cases, some patients feel faint and collapse after taking their first dose of the
medicine. If this occurs, tell your doctor immediately.
Headaches may occur when this treatment is first started, but these usually disappear
after 1-2 weeks. Dizziness, tiredness, nausea (feeling sick), vomiting, stomach upsets,
flushing (when your face, ears, neck and, occasionally, your upper chest, becomes red
in colour), uneven heart beat and a fast heart beat may also occasionally occur.
If you consider any of these side effects to be serious or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

5.

HOW TO STORE ISOTARD CAPSULES

Keep out of the reach and sight of children.

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Do not use Isotard Capsules after the expiry date, which is stated on the carton and
blister foil. The expiry date refers to the last day of that month.
Do not use Isotard Capsules if you notice that the packaging or any of the capsules are
damaged.
This product does not require any special storage conditions.
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 Isotard Capsules contain
The active substance is called isosorbide-5-mononitrate.
Isotard Capsules come in two different strengths of capsule:
- Isotard 25XL Capsules, which contain 25mg of isosorbide-5-mononitrate per
modified-release capsule.
- Isotard 50XL Capsules, which contain 50mg of isosorbide-5-mononitrate per
modified-release capsule.
As well as the active substance the pellets inside the capsule shells also contain other
ingredients: sucrose, maize starch, shellac, povidone, poly (-o-ethyl) cellulose and
talc.
The capsule shells are made of gelatin and may contain, depending on the strength of
the capsule, the following colourings: titanium dioxide (E171), yellow iron oxide
(E172), red iron oxide (E172), black iron oxide (E172) and erythrosine (E127).
The ink on the capsule shells contains: shellac, propylene glycol, strong ammonia
solution, potassium hydroxide, titanium dioxide (E171), povidone and sodium
hydroxide.
What Isotard capsules look like and the contents of the pack
- Isotard 25XL Capsules are hard gelatin capsules, which have a brown cap and a
white body, with “ISM 25” overprinted in white ink.
- Isotard 50XL Capsules are hard gelatin capsules, which have a brown cap and a
red body, with “ISM 50” overprinted in white ink.
Isotard 25XL and 50XL Capsules are packaged in calendar/blister packs containing
28 capsules.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
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UK

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last approved in September 2012.
The following date should be inserted below the in-house PX code on the mock-up:
“dd/mm/yy”

1.3.1 Package Leaflet
Date of revision: 26 October 2012

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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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