Isorem 10mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISOSORBIDE DINITRATE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

C01DA08

INN (International Name):

ISOSORBIDE DINITRATE 10 mg

Pharmaceutical form:

TABLET

Composition:

ISOSORBIDE DINITRATE 10 mg

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2007-02-15

Patient Information leaflet

page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOREM 10 MG TABLETS
Isosorbide dinitrate
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 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 Isorem is and what it is used for
2.
What you need to know before you take Isorem
3.
How to take Isorem
4.
Possible side effects
5.
How to store Isorem
6.
Contents of the pack and other information
1.
WHAT ISOREM IS AND WHAT IT IS USED FOR
Isorem contains the active substance isosorbide dinitrate.
Isorem is a medicine used to treat circulatory system disorders in the
coronary arteries
and belongs to the group of organic nitrates. Organic nitrates extend
the blood vessels
and thus allow for an increased blood flow to the point where the
blood flow is limited.
Therapeutic indications:
Isorem is used for the prevention and long-term treatment of heart
pain due to poor
circulation in the coronary arteries (angina pectoris).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOREM
DO NOT TAKE ISOREM
•
if you are allergic
to isosorbide dinitrate or any of the other ingredients of this
medicine (listed in section 6).
•
in the event of acute circulatory failure (shock collapse).
•
in case of shock due to heart failure (cardiogenic shock), unless a
sufficiently high
filling pressure in the heart (left ventricular pressure, end
diastolic pressure) is not
ensured, by means of appropriate measures.
•
if you suffer from cardiomyopathy with narrowing of the inside of the
heart
(hypertrophic
obstructive
cardiomyopathy),
restrictive
pericarditis
(constrictive
pericarditis

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Isorem 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
diluted
isosorbide
dinitrate
equivalent
to
10 mg
isosorbide
dinitrate.
Excipient(s) with known effect:
Each tablet contains 101,5 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, N.C., scored tablets with Remedica’s logo on one side.
The score line is only there to help you break the tablet if you have
difficulty swallowing
it whole.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis and treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Unless otherwise specified, take 2 times daily 1-2 Isorem tablets
(equivalent to 2 times
10 mg-20 mg isosorbide dinitrate). For higher nitrate demands, the
daily dose can be
increased to 3 times 1-2 tablets (corresponds to 3 times 10 mg-20 mg
isosorbide
dinitrate). When you receive 2 4 tablets a day, you have to maintain a
break from the
treatment lasting 12 hours every 24 hours without nitrate.
_Elderly_
The available data do not indicate that the dose should be adjusted
for the elderly.
_Children and adolescence _
The safety and efficacy of isosorbide dinitrate in children has not
yet been established.
Method of Administration
Oral administration.
Page 2 of 8
The tablets should be swallowed without being chewed and with
sufficient amount of
fluids (e.g. 1 glass of water). Treatment should be initiated at a
lower dose and slowly
increased to the desired dose. The duration of use is decided by the
attending physician
4.3
CONTRAINDICATIONS
Isorem should not be taken in the following cases:
•
hypersensitivity to the active substance, other nitrates or to any of
the excipients
listed in section 6.1.
•
acute circulatory insufficiency (shock, collapse).
•
cardiac shock unless a sufficiently high final diastolic pressure is
ensured by
appropriate measures.
•
hypertrophic obstructive cardiomyopathy.
•
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