PERISTAR CO 4/1,25 TABLET

País: República de Sud-àfrica

Idioma: anglès

Font: South African Health Products Regulatory Authority (SAHPRA)

Disponible des:

Adcock Ingram Limited

Dosis:

See ingredients

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS INDAPAMIDE 1,25 mg PERINDOPRIL TERT-BUTYLAMINE 4,0 mg

Estat d'Autorització:

Registered

Data d'autorització:

2014-02-10

Informació per a l'usuari

1
PROPOSED PATIENT INFORMATION LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU TAKE PERISTAR. THIS
LEAFLET TELLS YOU THE MAIN
POINTS ABOUT THE MEDICINE. IF YOU HAVE ANY QUESTIONS OR ARE WORRIED
ABOUT ANY OF THIS
INFORMATION, PLEASE ASK YOUR DOCTOR OR PHARMACIST.
SCHEDULING STATUS
PROPRIETARY NAME AND (DOSAGE FORM):
PERISTAR 2 (TABLETS)
PERISTAR 4 (TABLETS)
PERISTAR 8
(TABLETS)
(AND DOSAGE FORM) (TABLETS)
WHAT THIS MEDICINE CONTAINS:
Each PERISTAR 2 tablet contains 2 mg perindopril, tert-Butylamine
salt.
Each PERISTAR 4
tablet contains 4 mg perindopril, tert-Butylamine salt.
Each PERISTAR 8
tablet contains 8 mg perindopril, tert-Butylamine salt.
List
of
excipients:
Hydrophobic
colloidal
silica,
lactose
monohydrate,
magnesium
stearate
and
microcrystalline cellulose.
WHAT THIS MEDICINE IS USED FOR:
PERISTAR is indicated for hypertension (high blood pressure) and for
heart failure when it is not
adequately controlled by other medicine.
BEFORE TAKING THIS MEDICINE:
You should not take PERISTAR:

If you are a child (unless otherwise directed by your doctor).

If you are allergic to the product or any of its components.
S3
2
Do not use PERISTAR if you are pregnant or are planning to become
pregnant. Perindopril can pass
through the placenta and may influence the blood pressure of your
baby. Please inform your doctor or
healthcare professional if you are pregnant or planning to become
pregnant.
The following medication may interact with PERISTAR and therefore you
should notify your doctor or
healthcare professional if you are taking medicines that contains any
of the following before taking
PERISTAR:

Diuretics.

Other anti-hypertensives, or

Other agents, including alcohol.
If you are taking medicines on a regular basis, concomitant use of the
medicine may cause undesirable
interactions. Please consult your doctor, pharmacist or other
healthcare professional for advice.
If you are pregnant or breastfeeding your baby consult your doctor,
pharmacist or other health care
professional before using this

Fitxa tècnica

1
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
PERISTAR 2 Tablets
PERISTAR 4 Tablets
PERISTAR 8
Tablets
COMPOSITION
Each PERISTAR 2 tablet contains 2 mg perindopril tert-butylamine salt.
Each PERISTAR 4
tablet contains 4 mg perindopril tert-butylamine salt.
Each PERISTAR 8
tablet contains 8 mg perindopril tert-butylamine salt.
List
of
excipients:
Hydrophobic
colloidal
silica,
lactose
monohydrate,
magnesium
stearate
and
microcrystalline cellulose.
PHARMACOLOGICAL CLASSIFICATION
A 7.1.3 Other hypotensives.
PHARMACOLOGICAL ACTION
Perindopril inhibits angiotensin I converting enzyme (ACE) activity.
It inhibits the conversion of the
relatively inactive angiotensin I to the active angiotensin II.
Angiotensin II is a potent vasoconstrictor
and stimulates the release of aldosterone. Decreased angiotensin II
levels result in a decrease in
vasopressor activity and a reduction in aldosterone secretion, which
may result in small increases in
serum potassium.
It is also thought that ACE inhibition may inhibit degradation of
bradykinin, leading to increased
bradykinin levels.
PHARMACOKINETICS:
Given orally the peak concentration of perindoprilat, the active
metabolite, is reached within 3 to 4 hours
and peak pharmacological activity is obtained within 4 to 6 hours.
Although the oral bioavailability of
2
perindopril (75 %) is not affected by food, the bioavailability of
perindoprilat is reduced by approximately
35 %.
Perindopril is metabolized to perindoprilat and to five other inactive
metabolites.
Perindoprilat is about 10 % to 20 % bound to plasma proteins.
Perindoprilat binds to angiotensin
converting enzyme at both plasma and tissue levels.
About 75 % of an oral dose of perindopril is excreted in the urine as
unchanged drug, as perindoprilat,
and as other metabolites; the remainder is excreted in the faeces. The
elimination of perindoprilat is
biphasic with a distribution half-life of about 5 hours and an
elimination half-life of 25 - 30 hours.
Elimination of perindoprilat is less in the patients with cardiac or
r