Provera HD

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Medroxyprogesterone acetate 200mg;  

Available from:

Pfizer New Zealand Limited

INN (International Name):

Medroxyprogesterone acetate 200 mg

Dosage:

200 mg

Pharmaceutical form:

Tablet

Composition:

Active: Medroxyprogesterone acetate 200mg   Excipient: Docusate sodium Gelatin hydrolysate Isopropyl alcohol Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Purified water Sodium benzoate Sodium starch glycolate

Units in package:

Blister pack, PVC/Al/PVC, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Valdepharm

Therapeutic indications:

PROVERA 100mg and 200mg 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-menopausal women.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al/PVC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

PROVERA® HD 
MEDROXYPROGESTERONE ACETATE 100MG AND 200MG TABLETS 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Provera HD (high 
dose) tablets.  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 HD 
tablets against the benefits they are 
expected to have for you. 
If you have any concerns about 
using this medicine, ask your doctor 
or pharmacist. 
Keep this leaflet with your 
medicine.  You may need to read it 
again. 
WHAT PROVERA HD 
TABLETS ARE USED FOR 
Provera HD tablets contain a 
progestogen which comes from 
progesterone, a natural sex 
hormone.  Provera HD tablets are 
used to treat the symptoms of 
recurrent or metastatic cancer 
(cancer which has spread to other 
parts of the body).  The types of 
cancer in which Provera HD tablets 
may be of use are breast cancer, 
kidney cancer and endometrial 
cancer, which is cancer of the lining 
of the uterus (womb). 
However, your doctor may have 
prescribed Provera HD tablets for 
another purpose.  Ask your doctor 
or pharmacist if you have any 
questions about why Provera HD 
tablets have been prescribed for 
you. 
This medicine is available only with 
a doctor's prescription. 
BEFORE YOU TAKE PROVERA 
HD TABLETS 
WHEN YOU MUST NOT TAKE IT 
DO NOT TAKE PROVERA HD TABLETS IF 
YOU HAVE OR HAVE HAD ANY OF THE 
FOLLOWING MEDICAL CONDITIONS 
UNLESS ADVISED OTHERWISE BY YOUR 
DOCTOR: 

unusual or irregular vaginal 
bleeding 

any lumps in your breast 

any bleeding or discharge from 
your nipples 

you pass blood when you 
urinate. 
Do not take Provera HD tablets if 
you have an allergy to 
medroxyprogesterone acetate or to 
any of the ingredients listed at the 
end of this leaflet.�

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
α
-methyl-3,20-dioxopregn-4-en-17
α
-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
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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-me