BI PRETERAX 5MG/1.25MG TABLET Film Coated Tablet 5+1.25

国: タンザニア

言語: 英語

ソース: Tanzania Medicinces & Medical Devices Authority

有効成分:

Perindopril,Indapamide

から入手可能:

LES LABORATOIRES SERVIER, FRANCE

ATCコード:

Agents acting on the renin-angiotensin system, ACE

INN（国際名）:

Perindopril+Indapamide

投薬量:

5+1.25

医薬品形態:

Film Coated Tablet

製:

: Les Laboratoires Servier Industrie (LSI), FRANCE

製品概要:

Physical description: white, rod shaped film coated tablet; Local technical representative: Harleys (T) Limited (4194)

認証ステータス:

Registered/Compliant

承認日:

2022-09-21

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1.NAME OF THE MEDICINAL PRODUCT
Bi Preterax 5mg/1.25mg film-coated tablets
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril
arginine and 1.25 mg indapamide.
Excipient with known effect: 71.33 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.PHARMACEUTICAL FORM
Film-coated tablet.
White, rod-shaped film-coated tablet.
4.CLINICAL PARTICULARS
1.
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults, bi Preterax 5mg/1.25mg
film-coated tablet is
indicated in patients whose blood pressure is not adequately
controlled on perindopril alone.
2.
POSOLOGY AND METHOD OF ADMINISTRATION
Prescription Only Medicine
Posology
One bi Preterax 5mg/1.25mg film-coated tablet per day as a single
dose, preferably to be
taken in the morning, and before a meal.
When possible individual dose titration with the components is
recommended. bi Preterax
5mg/1.25mg film-coated tablet should be used when blood pressure is
not adequately
controlled on Preterax 2.5mg/0.625mg film-coated tablet (where
available).When clinically
appropriate, direct change from monotherapy to bi Preterax 5mg/1.25mg
film-coated tablet
may be considered.
Special populations
Elderly (see section 4.4)
Treatment should be initiated after considering blood pressure
response and renal function.
Renal impairment (see section 4.4)
In
severe
renal
impairment
(creatinine
clearance
below
30
ml/min),
treatment
is
contraindicated.
In
patients
with
moderate
renal
impairment
(creatinine
clearance
30-60
ml/min),
it
is
recommended to start treatment with the adequate dosage of the free
combination.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification
is
required.
Usual
medical
follow-up
will
include
frequent
monitoring
of
creatinine
and
potassium.
Hepatic impairment (see sections 4.3, 4.4 and 5.2)
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic