Emforal 10 Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

PROPRANOLOL HYDROCHLORIDE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

C07AA05

INN (Διεθνής Όνομα):

PROPRANOLOL HYDROCHLORIDE 10 mg

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

PROPRANOLOL HYDROCHLORIDE 10 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

BETA BLOCKING AGENTS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2007-02-15

Φύλλο οδηγιών χρήσης

 
REMEDICA

LIMASSOL INDUSTRIA ESTATE, AHARNON STREET, P.O.BOX 51706, 3508
LIMASSOL – CYPRUS – EU

                          TEL.:
[phone], FAX: [phone], ΒΙΟΜΗΧΑΝΙΚΉ ΠΕΡΙΟΧΉ ΛΕΜΕΣΟΎ, ΛΕΜΕΣΌΣ – ΚΎΠΡΟΣ- ΕΕ_ _

Ref: P18-0171PILE-02-final maquet 

PATIENT INFORMATION LEAFLET 

           EMFORAL 

       PROPRANOLOL HYDROCHLORIDE 
EMFORAL 10  
FILM-COATED TABLETS 10MG 
EMFORAL 40 
FILM-COATED TABLETS 40MG 
EMFORAL 80 
FILM-COATED TABLETS 80MG 
PLEASE READ CAREFULLY THIS LEAFLET BEFORE YOU START TAKING THE 
MEDICINE.  
-  
Keep this leaflet in a safe place. You may need to read it again.

-  
If you have any questions ask your doctor or your pharmacist.   
- 
This medicine was prescribed for you personally and you should not 
pass it on to others. It can be harmful, even when their symptoms 
are the same as yours.  
COMPOSITION: 
_Active substance:_
 Propranolol Hydrochloride 
_Excipients for Emforal 10, 40 and 80:_
 Lactose, Maize Starch, Povidone, 
Microcrystalline Cellulose, Sodium Starch Glycollate,
Colloidal Silicon 
Dioxide, Magnesium Stearate, Talc, Hypromellose, Macrogol 400, 
Titanium Dioxide, Carmoisine E122, Brilliant
Blue E133, Red Iron Oxide 
E172. 
MARKETING LICENCE HOLDER & MANUFACTURER: 
Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU. 
MARKETING LICENCE NUMBER: 
Emforal 10:  19733 
Emforal 40:  19730 
Emforal 80:  19732 

1.  
WHAT IS EMFORAL AND WHAT ARE ITS USES 
Propranolol, the active substance of Emforal, belongs
to the group of 
medicines that are named beta-adrenergic blockers or,
more commonly, 
beta-blockers (β-blockers). 
Beta-blockers affect the respond in some neural impulses to some
parts 
of the body. As a consequent, beta-blockers reduce heart’s needs
for 
blood and oxygen, reducing thus its effort. 
INDICATIONS: 
Emforal is ind

Αρχείο Π.Χ.Π.

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SUMMARY OF PRODUCT CHARACTERISTICS 

_1. NAME OF THE MEDICINAL PRODUCT _
Emforal 10 Tablets 

_2. QUALITATIVE AND QUANTITATIVE COMPOSITION _
Each Emforal Tablet 10 mg contains 10 mg Propranolol
Hydrochloride. 
For excipients see 6.1. 

_3. PHARMACEUTICAL FORM _
Film-coated Tablets. 

_4. CLINICAL PARTICULARS _
_4.1. THERAPEUTIC INDICATIONS _
Emforal is indicated in: 
a) 
The control of hypertension. 
b) 
The management of angina pectoris. 
c) 
The long-term prophylaxis against a reinfarction after recovery
from acute myocardial 
infarction. 
d) 
The control of most forms of cardiac dysrhythmia. 
e) 
The prophylaxis of migraine. 
f) 
The management of essential tremor. 
g) 
Relief of situational anxiety and generalised anxiety symptoms,
particularly those of somatic 
type. 
h) 
Prophylaxis of upper gastro-intestinal bleeding in
patients with portal hypertension and 
oesophageal varices. 
i) 
The adjunctive management of thyrotoxicosis and thyrotoxic crisis. 
j) 
Management of hypertrophic obstructive cardiomyopathy. 
k) 
Management of phaeochromocytoma preoperatively (with
an alpha blocker). 

_4.2. POSOLOGY AND METHOD OF ADMINISTRATION  _
Emforal reduces heartbeat and if bradycardia occurs the dosage must
be reduced. Emforal should 
preferably be administered before meals. 
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_Hypertension_: The starting dose for adults is 80 mg twice daily.
The dose may be increased according 
to the response of the patient. The usual dose range is 160-320
mg daily. Concurrent use of diuretics or 
other antihypertensives may further reduce blood pressure. 
_Angina, Migraine and Essential Tremor: _The usual initial dose for
adults is 40 mg two or three times 
daily. The dose may be increased by the same amount at weekly
intervals according to the response of 
the patient. An adequate response in migraine and essential tremor
may be obtained with 80-160 mg 
daily and in an