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NYZAMAC SR 60MG CAPSULES

Active substance(s): ISOSORBIDE 5-MONONITRATE / ISOSORBIDE 5-MONONITRATE

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XXX_FRXXXXX_V1_Nyzamac SR Capsules Capsules _XXX_FRXXXXX_V1 15/09/16 22:12 Page1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nyzamac ® SR 40 mg & 60 mg Capsules
Isosorbide Mononitrate

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

- 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 signs of illness 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 Nyzamac SR Capsules is and what it is used for
2. What you need to know before you take Nyzamac SR Capsules
3. How to take Nyzamac SR Capsules
4. Possible side effects
5. How to store Nyzamac SR Capsules
6. Contents of the pack and other information
1. What Nyzamac SR Capsules is and what it is used for
Nyzamac SR Modified-release Capsules contain isosorbide mononitrate which belongs to a
group of medicines called nitrates that act on the cardiovascular system (the heart and
blood vessels). Nyzamac SR Capsules has been given to you by your doctor or pharmacist
to reduce the frequency of your anginal attacks (chest pains). They are called modifiedrelease capsules because they are manufactured in a way that allows the isosorbide
mononitrate to be released and slowly absorbed by your body over a period of several hours.
In angina, isosorbide mononitrate works by opening up the arteries supplying the heart
muscle and this allows more blood and oxygen to reach the muscle, decreasing the
chances of angina (chest pains) occurring when extra strain is placed upon the heart.

2. What you need to know before you take Nyzamac SR Capsules
Do not take Nyzamac SR Capsules:
• if you are taking the drug sildenafil, for the treatment of male erectile
dysfunction (see also: Section 2 - taking other medicines)
• if you are allergic to isosorbide mononitrate, other nitrates (e.g glyceryl trinitrate or
isosorbide dinitrate) or any of the other ingredients in Nyzamac SR Capsules
• if you have suffered a stroke or have any other condition which may affect the blood
supply to your brain
• if you suffer from low blood pressure
• if you suffer from a reduction in red blood cells which can make the skin pale and
cause weakness and breathlessness
• if you have been told that you have a problem with your heart. Ask your doctor if
you are not sure if this applies to you
• to treat an angina attack as it occurs. Your doctor will probably have given you
another tablet to take for sudden attacks.
Take special care with Nyzamac SR Capsules and always tell your doctor or
pharmacist if:
• you suffer from increased pressure in your eyes
• you suffer from an underactive thyroid gland
• you suffer from an abnormally low body temperature
• you suffer from poor health caused by a poor diet
• you suffer from severe liver or kidney disease
• you have been told that you have a narrowing of the valves in your heart
• you become dizzy, light headed or faint when you stand up
• you have suffered from a head injury or bleeding in the brain.
Taking other medicines
Before starting treatment, please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a prescription.
If you have to go to a doctor, dentist or hospital for any reason, tell them that you are
taking Nyzamac SR Capsules.
In particular, tell your doctor or pharmacist if you are taking:
• medicines for the treatment of high blood pressure, such as hydralazine or minoxidil
• medicines to treat the symptoms of depression, such as amitriptyline or imipramine
• medicines to treat a mental condition, such as chlorpromazine or methotrimeprazine
• water tablets, such as frusemide
Taking these types of medicines with Nyzamac SR Capsules can increase the risk of low
blood pressure occurring, especially if you are elderly.
Do not take sildenafil, used for the treatment of erectile dysfunction at the
same time as Nyzamac SR Capsules. If taken at the same time it could cause a
severe fall in blood pressure resulting in collapse, unconciousness and may be fatal.
Taking Nyzamac SR Capsules with alcohol
Do not take Nyzamac SR Capsules at the same time as an alcoholic drink.
Pregnancy, breast-feeding and fertility:
Do not take Nyzamac SR Capsules if you are pregnant, trying to become pregnant or are
breast-feeding.
Driving and using machines:
If you feel faint, dizzy or light headed when you stand up or move suddenly after taking
Nyzamac SR Capsules, then do not drive or operate machinery.
Important information about some of the ingredients of Nyzamac SR Capsules:
Nyzamac SR Capsules contains lactose monohydrate and sucrose. If you have been told
by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
Please read the back of this leaflet



XXX_FRXXXXX_V1_Nyzamac SR Capsules _XXX_FRXXXXX_V1 15/09/16 22:34 Page2

3. How to take Nyzamac SR Capsules
Always take Nyzamac SR Capsules exactly as your doctor or pharmacist has told you to.
You should check with your doctor or pharmacist if you are not sure.
The label on the carton will tell you how many capsules you should take and when. It is
very important that you take your capsules regularly. Do not stop treatment even if
you feel better unless told to do so by your doctor.
Nyzamac SR Capsules is formulated so that you only have to take your capsules once a
day. It is important that you take your capsules at the same time each day, preferably
in the morning. Your capsule must be swallowed whole with a glass of water. Do not
break or chew your capsules.
Adults and the elderly: the usual dose is 40 mg or 60 mg once a day. Your doctor may
decide to increase your dose to a maximum of 120 mg of Nyzamac SR Capsules once a day.
If you are elderly and suffer from low blood pressure, liver or kidney disease, your doctor
may prescribe a lower dose for you to take.
Do not stop taking your medicine until your doctor tells you.
Children must not take this medicine.
If you take more Nyzamac SR Capsules than you should
If you accidentally take more Nyzamac SR Capsules than you should, contact your
nearest casualty department or tell your doctor or pharmacist immediately. Remember to
take the pack and any remaining capsules with you.
If you forget to take Nyzamac SR Capsules
Do not worry. Simply leave out that dose completely and then take your next dose at
the right time. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Nyzamac SR Capsules can cause side effects, although not everyone
gets them.
If you experience a headache when you first start taking your capsules, contact your
doctor or pharmacist immediately. Your doctor or pharmacist may need to adjust your
dose.
The following side effects do not usually last long and are most likely to occur when you
first start to take your medicine or if your dose has been increased. If they continue or if
you are worried, contact your doctor or pharmacist immediately:
• light headedness when you stand up or move suddenly
• faintness
Also, some people experience:
• flushing
• dry skin rashes
• dizziness
• feeling sick
• itchy skin
If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
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 YellowCard 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 Nyzamac SR Capsules
• Keep this medicine out of the sight and reach of children.
• Do not store above 25oC. Store in the original packaging.
• Do not use Nyzamac SR Capsules after the expiry date which is stated on the blister
and carton. 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
protect the environment.

6. Contents of the pack and other information
What Nyzamac SR Capsules contains:
The active substance in your capsules is isosorbide mononitrate. Each capsule
contains 40 mg or 60 mg of isosorbide mononitrate.
The other ingredients are lactose monohydrate, sucrose, maize starch, shellac (E904),
talc, copolymer of methacrylic acid and methyl methacrylate and copolymer of ethyl
acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride, gelatine,
titanium dioxide (E171) and iron oxide (E172).
What Nyzamac SR Capsules looks like and the contents of the pack:
Nyzamac SR Capsules SR 40 mg and 60 mg are white with “ISMN SR” and “40” or “60”
printed on the capsule in black ink respectively. They are available in blister packs of
28 capsules.
Marketing Authorisation Holder:
Ethypharm, 194, Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud Cedex, France.
Manufacturer:
Ethypharm, Z.I de Saint Arnoult, 28170 Châteauneuf-en-Thymerais, France.
For any information about this medicine, please contact the local representative of the
Marketing Authorisation Holder: United Kingdom: Ethypharm UK Ltd
Medical information tel: +44(0)1483662805
This leaflet was last revised in 01/2017

C11287

Expand Transcript

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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