Skip to Content

NYZAMAC SR 40MG CAPSULES

Active substance(s): ISOSORBIDE 5-MONONITRATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

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 modified-release 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
breastfeeding.
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.

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.
Please read the back of this leaflet

D50045-B

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

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
Modified-release Capsules 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:
Macarthys Laboratories Limited
TA Martindale Pharma, Bampton Road,
Harold Hill, Romford, Essex, RM3 8UG,
United Kingdom.
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)1483 662805
This leaflet was last revised in February 2018.

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.

D50045

D50045-B

+ 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.

Hide