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CHEMYDUR 60XL

Active substance(s): ISOSORBIDE 5-MONONITRATE

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Chemydur XL 60mg
Modified Release Tablets
102402/LF/1
Leaflet
148 x 210 mm
Great Britain
TBC
TBC
100%
Black & Cutter
14/03/2014
8 pt
5
AMCo
CNC

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Package leaflet: Information for the patient
102402/LF/1

Chemydur® 60XL Tablets
Isosorbide-5-mononitrate




Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
• Please 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 only. Do not
pass it on to others. It may harm them, even if their
symptoms 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 Chemydur 60XL Tablets are and what they are used
for.
2. What you need to know before you take Chemydur 60XL
Tablets.
3. How to take Chemydur 60XL Tablets.
4. Possible side effects.
5. How to store Chemydur 60XL Tablets.
6. Contents of the pack and other information.
1. WHAT CHEMYDUR 60XL TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Chemydur 60XL Tablets. The
active ingredient is isosorbide-5-mononitrate. Chemydur 60XL
Tablets belong to a group of medicines called nitrates.
Chemydur 60XL Tablets are used in adults to prevent angina
(chest pain) and work by opening up blood vessels and
reducing the pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHEMYDUR
60XL TABLETS
Do not take Chemydur 60XL Tablets if you:
• are allergic to isosorbide-5-mononitrate or any of the other
ingredients of Chemydur 60XL Tablets listed in section 6
(allergic reactions include mild symptoms such as itching
and/or rash. More severe symptoms include swelling of the
face, lips, tongue and/or throat with difficulty in swallowing
or breathing);
• have any inflammation of the heart such as pericarditis;
• have been diagnosed with any of the following heart
conditions
- Low cardiac filling pressure
- Cardiac tamponade
- Hypertrophic obstructive cardiomyopathy;
• have had any serious damage to your heart, such as a
cardiomyopathy or have narrow heart valves;
• suffer from severe anaemia (low levels of red blood cells in
the blood);
• have a low volume of blood in your body (hypovolaemia);
• have a head injury or bleeding of the brain;
• have closed-angle glaucoma (high pressure in the eyes);





have low blood pressure (hypotension);
have decreased blood supply to the brain (cerebrovascular
insufficiency);
are taking a medicine called Viagra (sildenafil) used for
male erectile dysfunction.

Warnings and precautions
Talk to your doctor or pharmacist before taking Chemydur 60XL
Tablets if you:
• have recently had a heart attack;
• have an underactive thyroid gland (hypothyroidism);
• have angina due to other causes (such as a large heart
muscle), or have an increased circulatory volume;
• have a head injury or bleeding of the brain;
• develop low blood pressure (hypotension), a slow heart
rate (bradycardia), or worsening of your angina;
• are at risk of having a stroke;
• have liver or kidney problems, especially if you are elderly;
• have cirrhosis of the liver;
• have a poor diet;
• have poor circulation;
• have consumed alcohol as this may lead to low blood
pressure (hypotension);
• feel that you are developing a tolerance to Chemydur 60XL
Tablets;
• have a very low body temperature (hypothermia).
If you have an attack of angina whilst taking Chemydur, do not
stop taking your Chemydur 60XL Tablets. Your doctor will
provide another medicine to treat your condition.
Children
Chemydur 60XL Tablets are not suitable for use in children.
Other medicines and Chemydur 60XL Tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken, or might take any other medicines, including
medicines obtained without a prescription.
It is especially important to tell your doctor if you are taking;
• medicines used to treat high blood pressure (e.g. propranolol,
furosemide);
• medicines used to treat heart failure (e.g. nifedipine, ramipril);
• medicines used in the treatment of erectile dysfunction (e.g.
sildenafil);
• any medication which may cause a lowering of your blood
pressure (e.g. causing dizziness or light-headedness,
especially on standing);
• medicines such as noradrenaline, which are used to treat
high blood pressure or a heart attack;
• acetylcholine, which is used during some operations;
• medicines such histamine, which is used to treat allergic
reactions;
• medicines used to treat migraines (e.g. ergotamine).
Chemydur 60XL Tablets with food, drink and alcohol
You should avoid alcohol while taking Chemydur 60XL as it may
increase the feeling of dizziness you may experience.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. The safety of
Chemydur 60XL Tablets during pregnancy or whilst
breast-feedng has not been established.
Driving and using machines
You can drive while taking Chemydur 60XL Tablets but do not
drive until you know how the tablets affect you. They may give
you low blood pressure or make you feel dizzy, if they affect you
in this way, do not drive or operate any machinery.






looking pale;
weakness;
tiredness;
cold perspiration.

Rarely, these side effects can occur:
• rash and itching;
• pain in your muscles or joints;
• drowsiness;
• feeling sick, being sick and diarrhoea;
• sensitivity to light;
• fainting or collapse;
• low levels of oxygen in the blood;
• bleeding in the brain;
• your angina may worsen.

Chemydur 60XL Tablets contain lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
Very rarely, these side effects can occur:
this medicinal product.
• red or scaly skin (exfoliative dermatitis).
3. HOW TO TAKE CHEMYDUR 60XL TABLETS
Always take Chemydur 60XL Tablets exactly as your doctor has Reporting of side effects
told you. You should check with your doctor or pharmacist if If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
you are not sure.
The recommended dose for adults is 1 or 2 tablets a day, taken You can also report side effects directly via the Yellow Card
Scheme, website: www.mhra.gov.uk/yellowcard. By reporting
in the morning.
A dose of half a tablet may be prescribed for the first 2-4 days. side effects you can help provide more information on the
safety of this medicine.
The tablets should be swallowed with half a glass of water.
Do not crush or chew the tablets.
If Chemydur 60XL Tablets are taken frequently and for long If Chemydur 60XL Tablets are taken frequently and for long
periods the effectiveness of the drug may decrease. If you periods the effectiveness of the drug may decrease. If you
notice that your tablets are no longer working as well at notice that your tablets are no longer working as well at
relieving the pain as they have done before, consult your relieving the pain as they have done before, consult your
doctor.
doctor.
If you take more Chemydur 60XL Tablets than you should
If you take more Chemydur 60XL than you should, contact your
doctor or nearest hospital emergency department immediately.
Take this leaflet and any remaining tablets with you. Symptoms
of overdose include headache, feeling over-excited, flushing,
cold perspiration, feeling sick, being sick, feeling dizzy, fainting,
a fast heart beat, low blood pressure, confusion, shortness of
breath and unconciousness.

5. HOW TO STORE CHEMYDUR 60XL TABLETS
Do not use after the expiry date which is stated on the pack. The
expiry date refers to the last day of that month.
Store your medicine in a dry place below 25°C. Keep it out of
direct sunlight.
KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF
CHILDREN.

6. CONTENT OF THE PACK AND OTHER INFORMATION
If you forget to take Chemydur 60XL Tablets
What Chemydur 60XL Tablets contain
If you forget to take a dose, just take the next dose at the usual Each tablet contains 60 mg of the active substance
time. DO NOT take a double dose.
isosorbide-5-mononitrate.
The other ingredients are: polyethylene glycol 4000,
If you stop taking Chemydur 60XL Tablets
Ask your doctor before stopping treatment with Chemydur hydroxypropyl methylcellulose, stearic acid, talc, purified
60XL, as treatment should be reduced gradually over several siliceous earth, lactose, carnauba wax, magnesium stearate and
the colourings titanium dioxide (E171) and yellow iron oxide
days and you must be monitored carefully by your doctor.
(E172).
4. POSSIBLE SIDE EFFECTS
Like all medicines, Chemydur 60XL Tablets can cause side What Chemydur 60XL Tablets look like and contents of the
pack
effects, although not everyone gets them.
Headaches may occur when treatment is first started, but this Chemydur 60XL Tablets are oval, cream-coloured tablets with a
score line on both sides and a crown and `60` on one side.
usually disappears after 1 to 2 weeks of treatment.
They are packaged in blister packs of 28, 30, 56, 60 and
100 tablets.
Other side effects include:
Not all packs sizes may be marketed.
• feeling dizzy;
• low blood pressure when standing up (postural
Marketing Authorisation Holder and Manufacturer
hypotension), which may make you feel sick or dizzy;
responsible for release:
• slow heart beat;
Amdipharm UK Limited,
• fast heart beat;
Capital House,
• flushing;
85 King William Street,
• restlessness;
London EC4N 7BL, UK
Chemydur is a registered trademark of Amdipharm mercury
international Limited.
This leaflet was last revised in March 2014.

Signature ..........................................................................
Name ................................................................................
Date ...................................................................................

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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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