Nyzamac SR 60mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

60mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 5028613000441

Patient Information leaflet

D50205-A
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.
-
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 on this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Nyzamac SR Capsules are and what
they are 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 ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Nyzamac SR
Capsules. The active ingredient is isosorbide
mononitrate. Nyzamac SR Capsules belong to a
group of medicines called nitrates.
They are called prolonged-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.
Nyzamac SR Capsules 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 NYZAMAC SR CAPSULES
DO NOT TAKE NYZAMAC SR CAPSULES IF YOU:
•
are under 18 years of age;
•
are allergic to isosorbide mononitrate or any
other medicines known as nitrates (glyceryl
trinitrate, isosorbide dinitrate), or any of the
other ingredients of Nyzamac SR Capsules
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 i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nyzamac SR 60mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 60 mg prolonged-release capsule contains 60 mg of isosorbide
mononitrate.
Excipients with known effect:
Each 60mg capsule contains:
Lactose (180mg/capsule)
Sucrose (57.75 mg/capsule)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release capsules, hard.
The 60mg capsule is a size 1 capsule and has an opaque white cap
printed with “ISMN
SR” in black ink and an opaque white body printed with « 60 » in
black ink, containing
off-white to yellowish microgranules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nyzamac SR capsules are indicated in adults for the prophylactic
treatment of angina
pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
One capsule once daily given in the morning. The dose may be increased
up to 120
mg.
The product must not be given in divided doses as a daily nitrate free
period is
required in order to prevent the development of tolerance. Thus, if
more than one
capsule is needed they must be taken simultaneously.
The dose can be titrated to minimise the possibility of headache by
initiating treatment
by a lower dose for the first two to four days.
Paediatric population
The safety and efficacy of Nyzamac SR Capsules in children have not
been
established.
Elderly:
There is no evidence of a need for routine dose adjustment in the
elderly, but care may
be needed in those patients with increased susceptibility to
hypotension, and in those
with marked hepatic or renal insufficiency.
The lowest effective dose should be used.
There is a risk of tolerance developing to prolonged-release
preparations. In such
patients, intermittent therapy may be more appropriate (see section
4.4).
As with other drugs for the treatment of angina pectoris, abrupt
discontinuation of
therapy may lead to exacerbation of symptoms. When discontinuing
long-term
treatment, the dosage should be reduced gradually over several days