VALETTE ethinyloestradiol / dienogest tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dienogest, Quantity: 2 mg; ethinylestradiol, Quantity: 0.03 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Dienogest,ethinylestradiol

Pharmaceutical form:

Tablet, sugar coated

Composition:

Excipient Ingredients: calcium carbonate; ferric oxide; macrogol 6000; glycol montanate; glycerol; sucrose; lactose monohydrate; maize starch; povidone; titanium dioxide; purified talc; magnesium stearate

Administration route:

Oral

Units in package:

1 x (21 active & 7 placebo), 1 x (21 active & 7 placebo) (sample pack), 3 x (21 active & 7 placebo), 4 x (21 active & 7 placebo), 2 x (21 active & 7 placebo)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Valette is indicated for use as an oral contraceptive and in the treatment of mild to moderate acne in women who seek oral contraception.

Product summary:

Visual Identification: larger round brown coated tablet.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-03-02

Patient Information leaflet

Valette CMI VX1.0
1
RESTRICTED
VALETTE
®
(VAL·ETTE)
_dienogest and ethinylestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Valette. It does not contain all
the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Valette against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS, OR
ARE UNSURE ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST FOR MORE ADVICE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT VALETTE IS
USED FOR
Valette is a combined oral
contraceptive, commonly
known as a ‘birth control pill’
or ‘the Pill’.
Valette is used to prevent
pregnancy.
It is also used to treat mild to
moderate acne in women
seeking oral contraception.
You may also experience the
following benefits:
•
more regular and lighter
periods potentially resulting
in a decreased risk in
anaemia (iron deficiency)
•
a decrease in period pain
•
reduction of greasiness in
skin and hair
Some conditions such as pelvic
inflammatory disease, ovarian
cysts, ectopic pregnancy
(where the foetus is carried
outside of your womb), lumpy
breasts and cancer of the uterus
(womb) and ovaries may be
less common in women taking
Valette.
When taken correctly, it
prevents you from
becoming pregnant in several
ways, including:
•
inhibiting ovulation (egg
release)
•
changing the cervical mucus
consistency, making it more
difficult for the sperm to
reach the egg
When the Pill is taken by
women under close observation
in clinical trials, it is more than
99% effective in preventing
pregnancy. However, in real
life the Pill is around 92%
effective. This is because pills
might be missed, or taken with
medicines that may interfere
with their effectiveness, or may
not be absorbed due to
vomiting and diarrhoea.
Like all oral contraceptives,
Valette is intended to prevent
pregnancy. It does not protect
ag

Summary of Product characteristics

VALETTE PI VX2.0
1
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AUSTRALIAN PRODUCT INFORMATION
VALETTE
®
(DIENOGEST AND ETHINYLESTRADIOL)
1
NAME OF THE MEDICINE
VALETTE (Dienogest and Ethinylestradiol)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VALETTE is a combined oral contraceptive (COC) preparation containing
the synthetic progestogen,
dienogest and the synthetic estrogen, ethinylestradiol as the active
substances.
VALETTE tablets are contained in blister packs. Each blister contains
21 white active tablets
containing dienogest 2 mg and ethinylestradiol 30 μg, followed by 7
brown placebo tablets
Excipients with known effect: lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The small active tablets are small round white glossy coated tablets
The inactive tablets are large round brown coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VALETTE is indicated for use as an oral contraceptive and in the
treatment of mild to moderate
acne in women who seek oral contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately 1% per
year. The failure rate may increase when pills are missed or taken
incorrectly.
Tablets must be taken in the order directed on the package every day
at about the same time with
some liquid as needed. Tablet taking is continuous. One tablet is to
be taken continuously for 28
consecutive days. Each subsequent pack is started the day after the
last tablet of the previous
pack. Withdrawal bleeding usually starts on Day 2-3 after starting the
brown placebo tablets (last
row) and may not have finished before the next pack is started.
HOW TO START VALETTE
_No preceding hormonal contraceptive use (in the past month) _
Tablet-taking has to start on Day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual
bleeding). The women should be instructed to take a white active
tablet from the green section of
VALETTE PI VX2.0
2
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the pack, corresponding to that