SORMON

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

ISOSORBIDE-5-MONONITRATE

Commercializzato da:

Generics (UK) Limited

Codice ATC:

C01DA14

INN (Nome Internazionale):

ISOSORBIDE-5-MONONITRATE

Dosaggio:

60 Milligram

Forma farmaceutica:

Tablet Prolonged Release

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

isosorbide mononitrate

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1999-08-23

Foglio illustrativo

PAGE 2 OF 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORMON 60 MG PROLONGED-RELEASE TABLETS
(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 Sormon is and what it is used for
2.
What you need to know before you take Sormon
3.
How to take Sormon
4.
Possible side effects
5.
How to store Sormon
6.
Contents of the pack and other information
1.
WHAT SORMON IS AND WHAT IT IS USED FOR
Sormon contains isosorbide mononitrate which belongs to a family of
medicines known as nitrates.
These medicines allow the blood vessels around the heart to relax and
widen, allowing more blood to
flow to the heart and around the body. Your medicine is in the form of
a ‘prolonged-release’ tablet,
which slowly releases the medicine into your body.
Sormon can be used to help prevent angina (a muscle cramp of the
heart). However, Sormon is NOT a
suitable treatment for the relief of acute angina. If you suffer from
an acute attack of angina, a more
suitable medicine should be taken. Do not stop taking Sormon without
first consulting your doctor or
pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SORMON
DO NOT TAKE SORMON:

if you are allergic to isosorbide mononitrate, other nitrates, or any
of the other ingredients of this
medicine (listed in section 6).

if you have heart conditions such as swelling of the lining that
surrounds the heart, problems with
your heart muscle or valves.

if you are taking sildenafil or similar medicines called
“phosphodiesterase type-5 inhibitors”

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sormon 60 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 60 mg isosorbide mononitrate.
Excipient with known effect:
Each tablet contains 0.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet (tablet).
Pale yellow, elliptical, film-coated tablets (13.1 x 7.1 mm), embossed
with ‘IM’ breakline ‘60’ on one side and
breakline on the reverse
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Sormon_ are intended for prophylactic therapy.
Dosage should be adjusted individually and monitored according to
clinical response.
_ADULTS_
_When initiating therapy in new patients,_ the dose can be titrated to
reduce the frequency of headache by administering
30 mg (half a tablet) for the first 2-4 days.
_The usual dosage_ is 60 mg to be taken in the morning.
When necessary, the dose may be increased to 120 mg daily to
be taken in the morning.
There is a risk of tolerance developing when nitrate therapy is given.
For this reason, it is important that_ Sormon_ are
taken once a day to achieve an interval with low nitrate
concentration, thereby reducing the risk of tolerance
development.
When necessary the product may be used in combination with
beta-adrenoceptor blockers and calcium antagonists.
_PAEDIATRIC POPULATION_
The safety and efficacy of_ Sormon_ in children has not been
established.
_OLDER PEOPLE_
No evidence of a need for routine dosage adjustment in the elderly has
been found, but special care may be needed in
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