Provera

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Medroxyprogesterone acetate 10mg;  

Available from:

Pfizer New Zealand Limited

INN (International Name):

Medroxyprogesterone acetate 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Medroxyprogesterone acetate 10mg   Excipient: Calcium stearate Lactose monohydrate Liquid paraffin Maize starch Purified talc Purified water Sucrose

Units in package:

Blister pack, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Valdepharm

Therapeutic indications:

PROVERA low dosage (2.5mg, 5mg and 10mg tablets) are indicated for: · diagnosis of primary and secondary amenorrhoea · treatment of dysfunctional (anovulatory) uterine bleeding · opposition of endometrial effects of estrogen in menopausal women being treated with estrogen (hormone replacement therapy [HRT]) · treatment of endometriosis.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 60 months from date of manufacture stored at or below 30°C

Authorization date:

1987-11-23

Patient Information leaflet

PROVERA

MEDROXYPROGESTERONE ACETATE TABLETS 2.5MG, 5MG, 10MG, 100 MG, 200 MG
TABLETS
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 YOUR MEDICINE.
You may need to read it again.
WHAT PROVERA IS
USED FOR
PROVERA is a progestogen which
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

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 (the lining of the
womb).
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.
Your doctor may have prescribed
PROVERA for another purpose.
Ask your doctor or pharmacist if
you have any questions about why
PROVERA has been prescribed for
you.
This medicine is available only with
a doctor's p

Summary of Product characteristics

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Page 1 of 14 NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
PROVERA
®
2.5 mg, 5 mg, 10 mg, 100 mg and 200 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROVERA tablet contains 2.5 mg, 5 mg, 10 mg, 100 mg and 200 mg of
medroxyprogesterone
acetate (MPA) as the active ingredient.
MPA is a progestogen and a derivative of progesterone. It is a white
to off-white, odourless
crystalline powder, stable in air, melting between 200 and 210°C. It
is freely soluble in
chloroform, soluble in acetone and dioxane, sparingly soluble in
ethanol and methanol, slightly
soluble in ether and insoluble in water. MPA is 6

-methyl-3,20-dioxopregn-4-en-17

-yl
acetate.
EXCIPIENT(S) WITH KNOWN EFFECT
PROVERA 2.5 mg, 5 mg and 10 mg tablets:
•
Lactose monohydrate,
•
Sucrose,
PROVERA 100 mg and 200 mg tablets:
•
Isopropyl alcohol,
Sodium benzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
PROVERA 2.5 mg tablets are orange, circular, scored one side, marked
U64 on the other.
PROVERA 5 mg tablets are blue, circular, scored one side and marked
286 on both sides of the
score line, marked U on the other.
PROVERA 10 mg tablets are white, circular, scored marked UPJOHN 50.
PROVERA 100 mg tablets are white, scored, marked U467.
PROVERA 200 mg tablets are white, scored, marked U320.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROVERA 2.5 MG, 5 MG AND 10 MG TABLETS
are indicated for
:
•
diagnosis of primary and secondary amenorrhoea
Version: pfdprovt10220
Supersedes: pfdprovt10519
Page 2 of 14
•
treatment of dysfunctional (anovulatory) uterine bleeding
•
opposition of endometrial effects of estrogen in menopausal women
being treated with
estrogen (hormone replacement therapy [HRT])
•
treatment of endometriosis.
PROVERA 100 MG AND 200 MG TABLETS
are indicated as adjunctive and/or palliative treatment
of recurrent and/or metastatic endometrial or renal carcinoma and, in
the treatment of
hormonally-dependent, recurrent breast cancer in post-