PHARMAPRESS 10 mg TABLET

Држава: Јужноафричка Република

Језик: Енглески

Извор: South African Health Products Regulatory Authority (SAHPRA)

Купи Сада

Доступно од:

Pharmacare Limited û Woodmead

Дозирање:

See ingredients

Фармацеутски облик:

TABLET

Састав:

EACH TABLET CONTAINS ENALAPRIL MALEATE 10,0 mg

Статус ауторизације:

Registered

Датум одобрења:

2002-03-06

Информативни летак

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_Page 1 of 17 _
1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S3
PHARMAPRESS 10 MG TABLETS
ENALAPRIL MALEATE
CONTAINS SUGAR: LACTOSE MONOHYDRATE 66,435 MG
PHARMAPRESS 20 MG TABLETS
ENALAPRIL MALEATE
CONTAINS SUGAR: LACTOSE MONOHYDRATE 133,246 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PHARMAPRESS
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse, or other
healthcare provider.
•
PHARMAPRESS has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What PHARMAPRESS is and what it is used for
2.
What you need to know before you take PHARMAPRESS
3.
How to take PHARMAPRESS
4.
Possible side effects
5.
How to store PHARMAPRESS
6.
Contents of the pack and other information
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1.
WHAT PHARMAPRESS IS AND WHAT IT IS USED FOR
PHARMAPRESS belongs to a group of medicines called
Angiotensin-converting enzyme
inhibitors (ACE inhibitors). It works by causing blood vessels to
relax, lowering blood pressure,
and increasing the supply of blood and oxygen to the heart.
PHARMAPRESS is used in adults to:
•
treat high blood pressure (hypertension) including renovascular
hypertension (caused by
high blood pressure due to narrowing of the arteries that carry blood
to the kidneys).
•
the treatment of heart failure (weakening of the heart function),
usually combined with
other medicines used for high blood pressure (diuretics) and medicine
used to treat heart
rhythm problems (digoxin).
•
the treatment of a form of heart failure with no symptoms
(asymptomatic left ventricular
dysfunction). PHARMAPRESS decreases the rate of development of heart
failure with
symptoms and decreases the incidence of hospitalisation for heart
failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHARMAPRESS
DO NO
                                
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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
PHARMAPRESS 10 MG tablets
PHARMAPRESS 20 MG tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of PHARMAPRESS 10 mg contains 10 mg of enalapril maleate.
Contains sugar: Lactose monohydrate 66,435 mg
Each tablet of PHARMAPRESS 20 mg contains 20 mg of enalapril maleate.
Contains sugar: Lactose monohydrate 133,246 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets
PHARMAPRESS 10 mg is a round, pink tablet with bevelled edges,
bisected on one side.
PHARMAPRESS 20 mg is a round, peach tablet with bevelled edges,
bisected on one side.
4. CLINICAL PARTICULARS
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4.1 THERAPEUTIC INDICATIONS
PHARMAPRESS is indicated in:
•
HYPERTENSION
-
All grades of essential hypertension;
-
renovascular hypertension.
•
HEART FAILURE
PHARMAPRESS is indicated for the treatment of symptomatic congestive
heart failure,
usually in combination with diuretics and when appropriate, digoxin.
In these patients,
PHARMAPRESS improves symptoms, increases survival and decreases the
frequency of
hospitalisation.
•
ASYMPTOMATIC LEFT VENTRICULAR DYSFUNCTION
In clinically stable asymptomatic patients with left ventricular
dysfunction (ejection fraction
≤
35 %), PHARMAPRESS decreases the rate of development of overt heart
failure and
decreases the incidence of hospitalisation for heart failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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ESSENTIAL HYPERTENSION
The initial dose is 10 mg to 20 mg depending on the degree of
hypertension and is given once
daily. In mild hypertension the recommended initial dose is 10 mg
daily. For other degrees of
hypertension, the initial dose is 20 mg daily. The usual maintenance
dose is one 20 mg tablet
taken once daily. The dosage should be adjusted according to the needs
of the patient.
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