PROVERA Medroxyprogesterone acetate 10mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

medroxyprogesterone acetate, Quantity: 10 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; calcium stearate; liquid paraffin; sucrose; purified talc; maize starch

Administration route:

Oral

Units in package:

15 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. Carcinoma: Palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma. 2. Endometriosis: For use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful. 3. Secondary Amenorrhoea proven not due to pregnancy: In amenorrhoea associated with a poorly developed proliferative endometrium, conventional oestrogen therapy may be employed in conjunction with medroxyprogesterone acetate. 4. Abnormal Uterine Bleeding: In the absence of organic pathology. 5. Adjunct to Oestrogen Therapy: Combination hormone replacement therapy should only be used in non-hysterectomised women.

Product summary:

Visual Identification: White, circular (about 7.14mm diameter) tablets embossed "Upjohn 50" on one side and single scored on the other.; 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:

1993-01-07

Patient Information leaflet

PROVERA
®
_Medroxyprogesterone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROVERA. 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 PROVERA
against the benefits it 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 PROVERA IS
USED FOR
PROVERA is a progestogen that
comes from progesterone, a natural
sex hormone. PROVERA works in a
similar way to progesterone.
PROVERA is used to treat:
•
endometriosis - a condition in
which tissue similar to the lining
of the uterus (womb) grows
outside the uterus, causing pain
and bleeding. PROVERA helps to
stop the growth of this tissue
•
secondary amenorrhoea (a lack of
menstrual periods not due to
pregnancy). PROVERA, with or
without an estrogen, helps to re-
establish a regular menstrual
cycle
•
abnormal bleeding from the
uterus, when the lining of the
uterus breaks down during the
menstrual cycle rather than at the
end, resulting in vaginal spotting
or bleeding. PROVERA helps to
re-establish a regular menstrual
cycle
•
certain types of cancer including
cancer of the breast, kidney and
endometrium
•
PROVERA, in combination with
an estrogen containing medicine,
is used to relieve symptoms of
menopause in women with an
intact uterus. This is called
hormone replacement therapy
(HRT). PROVERA is used to
protect the lining of the uterus
while the estrogens relieve the
symptoms of menopause.
PROVERA is not suitable as a
HRT treatment in women who
have undergone a hysterectomy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PROVERA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
PROVERA
_WHEN YOU MUST

Summary of Product characteristics

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Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
PROVERA
®
(MEDROXYPROGESTERONE
ACETATE) TABLETS
1.
NAME OF THE MEDICINE
Medroxyprogesterone acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROVERA tablets contain 2.5 mg, 5 mg, 10 mg, 100 mg, 200 mg, 250 mg or
500 mg
medroxyprogesterone acetate as the active ingredient.
EXCIPIENT(S) WITH KNOWN EFFECT:
Lactose monohydrate (2.5, 5 and 10 mg tablets)
Sodium benzoate (100, 200, 250 and 500 mg tablets)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
2.5 mg tablets: orange, circular, scored on one side, marked U64 on
the other side.
5 mg tablets: pale blue, circular, scored on one side and marked 286
on both sides of the score
line, marked U on the other side.
10 mg tablets: white, circular, scored on one side, marked UPJOHN 50
on the other side.
100 mg tablets: white, scored, marked U467.
200 mg tablets: white, scored, marked U320.
250 mg tablets: white, scored, marked U403.
500 mg tablets: white, capsule-shaped, marked UPJOHN 717 on one side
only.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CARCINOMA
Palliative treatment of recurrent and/or metastatic breast or renal
cell cancer and of inoperable
recurrent or metastatic endometrial carcinoma.
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Supersedes: pfpprovt10317
Page 2 of 14
ENDOMETRIOSIS
For use in the treatment of visually proven (laparoscopy)
endometriosis where the required
end-point of treatment is pregnancy, or for the control of symptoms
when surgery is
contraindicated or has been unsuccessful.
SECONDARY AMENORRHOEA PROVEN NOT DUE TO PREGNANCY
In amenorrhoea associated with a poorly developed proliferative
endometrium, conventional
estrogen therapy may be employed in conjunction with
medroxyprogesterone acetate.
ABNORMAL UTERINE BLEEDING IN THE ABSENCE OF ORGANIC PATHOLOGY
ADJUNCT TO ESTROGEN THERAPY
Combination hormone replacement therapy should only be used in
non-hysterectomised
women (see Section 4.4 Special warnings and prec