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 20 mg

Pharmaceutical form:

TABLET

Composition:

ISOSORBIDE MONONITRATE 20 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Withdrawn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 PHARMACE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
MONOSORDIL
®
Isosorbide-5- Mononitrate
ANTIANGINAL
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.
SUMMARY OF PRODUCT CHARACTERISTICS
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