Volina 3 mg0.03 mg film-coated tablets

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

DROSPIRENONE; ETHINYLESTRADIOL

Mevcut itibaren:

PAHANG PHARMACY SDN. BHD.

INN (International Adı):

DROSPIRENONE; ETHINYLESTRADIOL

Paketteki üniteler:

21tablet Tablets; 63tablet Tablets

Tarafından üretildi:

Gedeon Richter Plc

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VOLINA FILM-COATED TABLETS
Drospirenone (3 mg) and Ethinylestradiol (0.03 mg)_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What _Volina _is used for
2.
How _Volina_ works
3.
Before you use _Volina_
4.
How to use _Volina_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Volina_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _VOLINA_ IS USED FOR
Volina is a contraceptive pill and is
used to prevent pregnancy.
HOW _VOLINA_ WORKS
The contraceptive effect of Volina is
based on the interaction of various
factors, the most important of which are
seen as the inhibition of ovulation and
the changes in the endometrium.
BEFORE YOU USE _VOLINA _
-
_When you must not use it _

if you have (or have ever had) a
blood clot in a blood vessel of your
legs (deep vein thrombosis, DVT),
your lungs (pulmonary embolus,
PE) or other organs

if you know you have a disorder
affecting your blood clotting – for
instance, protein C deficiency,
protein S deficiency, antithrombin-
III deficiency, Factor V Leiden or
antiphospholipid antibodies.

if you need an operation or if you
are off your feet for a long time (see
section ‘Blood clots’)

if you have ever had a heart attack
or a stroke

if you have (or have ever had)
angina pectoris (a condition that
causes severe chest pain and may be
a first sign of a heart attack) or
transient ischaemic attack (TIA –
temporary stroke symptoms)

if you have any of the following
diseases that may increase your risk
of a clot in the arteries:
-
severe diabetes with blood vessel
damage
-
very high blood pressure
-
a very high level of fat in the
blood (cholesterol or triglycerides)
-
a condition known as
hyperhomocysteinaemia

if you have (or have ever had) a
type of migraine called ‘migraine
with aura’

if you have (or have ever had) a
liver disease and your liver function
is still not normal

if your kidneys are not working well
(renal failure)

if you ha

Ürün özellikleri

PACKAGE INSERT
BRAND OR PRODUCT NAME
Volina 3 mg /0.03 mg film-coated tablets
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each film-coated tablet contains 3 mg drospirenone and 0.03 mg
ethinylestradiol.
Excipients with known effect: Each film-coated tablet contains 48.17
mg of lactose monohydrate and
0.07 mg of soya lecithin.
PRODUCT DESCRIPTION
White or almost white, round, biconvex film-coated tablet. Engraving
on one side: “G63”, other side is
without engraving. Diameter approximately 6.0 mm.
_Tablet core: _
Lactose monohydrate
Pregelatinised maize starch
Maize starch
Povidone K-25
Magnesium stearate
_Film-coating: _
Polyvinyl alcohol
Titanium dioxide (E171)
Talc (E553b)
Macrogol 3350
Lecithin (soya)
PHARMACODYNAMICS/ PHARMACOKINETICS
_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: Sex hormones and modulators of the genital
system; Progestogens and
estrogens, fixed combinations, ATC code: G03AA12
Mechanism of action
The contraceptive effect of Volina is based on the interaction of
various factors, the most important of
which are seen as the inhibition of ovulation and the changes in the
endometrium.
Volina is a combined oral contraceptive with ethinylestradiol and the
progestogen drospirenone. In a
therapeutic dosage, drospirenone also possesses antiandrogenic and
mild antimineralocorticoid
properties. It has no estrogenic, glucocorticoid and
antiglucocorticoid activity. This gives drospirenone
a pharmacological profile closely resembling the natural hormone
progesterone.
_PHARMACOKINETIC PROPERTIES _
-
Drospirenone
Absorption
Orally administered drospirenone is rapidly and almost completely
absorbed. Maximum
concentrations of the active substance in serum of about 38 ng/ml are
reached at about 1-2 h after
single ingestion. Bioavailability of drospirenone is between 76 and
85%. Concomitant ingestion of
food has no influence on the bioavailability of drospirenone.
Distribution
After oral administration, serum drospirenone levels decrease in two
phases, with terminal half-lives
of 31 h. Drospirenone is