Monosordil

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISOSORBIDE MONONITRATE

Available from:

Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece

ATC code:

C01DA14

INN (International Name):

ISOSORBIDE MONONITRATE 60 mg

Pharmaceutical form:

MODIFIED-RELEASE CAPSULE

Composition:

ISOSORBIDE MONONITRATE 60 mg

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Withdrawn

Authorization date:

2007-01-10

Patient Information leaflet

MONOSORDIL
®
Isosorbide-5- Mononitrate
Antianginal
1.
CHARACTERISTICS OF THE PHARMACEUTICAL PRODUCT
1.1.
MONOSORDIL
® Tablets 20 mg/tab
Modified release capsules 60 mg/cap
1.2.
COMPOSITION: Active ingredient: Isosorbide-5-Mononitrate Excipients:
MONOSORDIL
®
_TABLETS 20 MG/TAB_:
Lactose Monohydrate, Mannitol, Starch Maize,
Povidone, Magnesium Stearate, Sodium Starch Glycollate.
MONOSORDIL
®
_MODIFIED RELEASE CAPSULES 60 MG/CAP_:
Neutral pellets (sucrose+starch maize 75:25), Lactose Monohydrate,
Ethyl cellulose, Stearic Acid, Talc.
_Empty capsule synthesis: Cap_: Titanium Dioxide CI 77891, E171,
Erythrosine CI 45430 E127, Patent
Blue V CI 42051, E131, Gelatine.
_Body_: Erythrosine CI 45430 ,E127, Gelatine.
1.3.
DOSAGE FORMS: Tablets, Modified release capsules.
1.4.
CONTENT OF ACTIVE INGREDIENT:
MONOSORDIL
® _tablets 20 mg/tab_: Each tablet contains 20 mg
Isosorbide-5-Mononitrate.
MONOSORDIL
®
_modified release capsules 60 mg/cap_: Each capsule contains 60mg
Isosorbide-5-
Mononitrate.
1.5.
DESCRIPTION- PACKAGING:
MONOSORDIL
® 20MG tablets are white, biconvex scored on one side. 50 tablets per
pack.
MONOSORDIL
®
MODIFIED RELEASED 60MG CAPSULES have a light pink transparent body and
an opaque pink cap containing white pellets. 14 capsules per pack.
1.6.
THERAPEUTIC CATEGORY: Nitrates
1.7.
LICENCE HOLDER: ELPEN PHARMACEUTICAL CO. INC.
95, Marathonos Ave.
Pikermi, Attica, 190 09, Greece
Tel: [phone] - 9
Fax: [phone]
1.8.
MANUFACTURER: ELPEN PHARMACEUTICAL CO. INC.
95, Marathonos Ave.
Pikermi, Attica, 190 09, Greece
Tel: [phone] - 9
Fax: [phone]
2.
WHAT THE PATIENT MUST KNOW ABOUT THE DRUG PRESCRIBED BY THE DOCTOR
2.1.
GENERAL INFORMATION:
Relaxation of vascular smooth muscle via stimulation of intracellular
cyclic guanosine monophosphate
production is the principal pharmacologic effect of nitrates.
Dilation of the post capillary vessels, including large veins,
promotes peripheral pooling of
blood and decreases venous return to the heart, reducing left
ventricular end-diastolic pr

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
MONOSORDIL
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 CONTENT OF ACTIVE INGREDIENT:
MONOSORDIL
®
_tablets 20 mg/tab_: Each tablet contains 20 mg
Isosorbide-5-Mononitrate.
MONOSORDIL
®
_modified release capsules 60 mg/cap_: Each capsule contains 60mg
Isosorbide-5-Mononitrate.
3.
PHARMACEUTICAL FORM
Tablets, Modified release capsules.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ACUTE ANGINA:
For relief of acute anginal episodes.
ANGINA PROPHYLAXIS:
Prophylaxis and long-term management of recurrent angina.
CHRONIC MYOCARDIAL INSUFFICIENCY:
Reduction of cardiac workload in patients with acute myocardial
infarction.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage is prescribed by the doctor according to the needs of each
individual, the severity of the case
and the overall picture of the patient.
MONOSORDIL
® TABLETS 20MG
_: _
Usually treatment is started with 20 mg 2-3 times daily. Up to 120 mg
daily, may be administered.
MONOSORDIL
® MODIFIED RELEASE CAPSULES 60MG
_: _Usually 1 capsule per day is sufficient. If need be up
to 120 mg daily, may be administered.
4.3.
CONTRAINDICATIONS
Hypersensitivity or idiosyncrasy to nitrates; severe anaemia; early
MI. Since nitrates increase
intracranial pressure, they are contraindicated in patients with head
trauma or cerebral haemorrhage.
Also, in cases of glaucoma or hypotension. Phosphodiesterase type 5
inhibitors (eg sildenafil,
tadalafil,
verdenafil),
hypovolaemia,
hypertrophic
obstructive
cardiomyopathy
(HOCM),
constrictive pericarditis, cardiac tamponade, low cardiac filling
pressures and aortic/mitral valve
stenosis.
Page 2 of 6
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
4.4.1
Since
MONOSORDIL
®
can cause postural hypotension it is suggested that the patient be
seated for a
while after taking the drug.
4.4.2.
Prolonged use may produce nitrate dependence. In this case withdrawal
from the drug should
be gradual. It is also known that tolerance to nitrat