PROMETRIUM 200 progesterone 200 mg soft capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

progesterone, Quantity: 200 mg

Available from:

Besins Healthcare Australia Pty Ltd

INN (International Name):

progesterone

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: glycerol; lecithin; titanium dioxide; Gelatin; purified water; Sunflower Oil

Administration route:

Oral

Units in package:

30 capsules, 15 capsules, 90 capsules, 84 capsules, 14 capsules, 56 capsules, 28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PROMETRIUM 100 mg and 200 mg, soft capsules are indicated for:,Treatment of menstrual irregularities,- In women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea (see dosage and administration),Hormone replacement therapy,- Hormone replacement therapy ? adjunctive use with an oestrogen in postmenopausal women with an intact uterus

Product summary:

Visual Identification: Slightly yellow, ovoid soft capsule containing whitish oily suspension; 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:

2016-06-20

Patient Information leaflet

PROMETRIUM 100 AND 200 MG, SOFT CAPSULE
CONSUMER INFORMATION
CMI _PROMETRIUM 100+200_0222
Page 1 of 5
CONSUMER MEDICINE INFORMATION
PROMETRIUM 100 AND 200 MG
Progesterone (micronised) 100 and 200 mg, soft capsule
_(For oral use) _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Prometrium.
The leaflet 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 Prometrium against
the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT PROMETRIUM IS
USED FOR
Prometrium is provided as a
soft capsule that contains the
natural female hormone,
progesterone for oral use.
Prometrium is for women for
the treatment of menstrual
abnormalities or secondary
amenorrhoea (no menstrual
periods) and as hormone
replacement therapy (HRT) in
combination with estrogen in
postmenopausal women with
an intact uterus (womb).
Your doctor may have
prescribed Prometrium for
another purpose. Ask your
doctor if you have any
questions why this medicine
has been prescribed for you.
Prometrium is available only
with a doctor’s prescription.
This medicine is not addictive.
This medicine is not a
contraceptive.
BEFORE YOU TAKE
PROMETRIUM
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE PROMETRIUM IF
YOU HAVE AN ALLERGY TO:
•
ANY MEDICINE
CONTAINING
PROGESTERONE
•
ANY OF THE INGREDIENTS
LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic
reaction may include:
•
skin rash, itching or
hives
•
swelling of the face,
lips, tongue or other
parts of the body
•
shortness of breath,
wheezing or difficulty
breathing
DO NOT TAKE PROMETRIUM IF
YOU HAVE OR HAVE HAD ANY OF
THE FOLLOWING CONDITIONS:
•
if you are allergic to
soya
•
unusual vaginal
bleeding that has not
been evaluated by your
doctor
•
known missed
abortions o

Summary of Product characteristics

PROMETRIUM 100 AND 200, SOFT CAPSULE
PRODUCT INFORMATION
PI-v1-11-21
1/14
AUSTRALIAN PRODUCT INFORMATION - PROMETRIUM 100 AND 200
(PROGESTERONE) SOFT CAPSULES
1.
NAME OF THE MEDICINE
Progesterone
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
Prometrium capsules contain the active ingredient: Progesterone
(micronised) 100 mg or 200 mg.
Excipient with known effect: Soyabean lecithin.
For the full list of excipients, see section 6.1 List of Excipients
3.
PHARMACEUTICAL FORM
Prometrium 100: Round, slightly yellow, soft capsule containing a
whitish oily suspension.
Prometrium 200: Ovoid slightly yellow, soft capsule, containing a
whitish oily suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prometrium 100 and 200, soft capsules are indicated for:
_TREATMENT OF MENSTRUAL IRREGULARITIES _
•
In women with menstrual abnormalities or secondary amenorrhoea due to
normogonadotrophic
amenorrhoea (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION)
_HORMONE REPLACEMENT THERAPY _
•
Hormone replacement therapy – adjunctive use with an estrogen in
postmenopausal women
with an intact uterus
4.2
DOSE AND METHOD OF ADMINISTRATION
In
women
receiving
estrogen
replacement
therapy
with
intact
uterus,
the
adjunctive
use
of
progesterone at a dose of 200 mg daily at bedtime should be
administered for twelve days in the last
half of each therapeutic cycle (beginning on day 15 of the cycle and
ending on day 26). Withdrawal
bleeding may occur in the following week. Alternatively, 100 mg can be
given at bedtime from day
1 to day 25 of each therapeutic cycle, withdrawal bleeding being less
with this treatment schedule.
In women with secondary amenorrhoea, the treatment may be given as a
single daily dose of 400
mg (2 capsules 200 mg) at bedtime for 10 days. Prior to use for this
indication, other causes of
secondary amenorrhoea such as outflow obstruction, pregnancy,
prolactinoma, thyroid disorders,
pituitary and hypothalamic disorders should be excluded.
The standard daily dosage regimen is 200 to 300 mg of progesterone
taken