Provera 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Medroxyprogesterone acetate

Available from:

Pfizer Ltd

ATC code:

L02AB02

INN (International Name):

Medroxyprogesterone acetate

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030200; GTIN: 5013457026900

Patient Information leaflet

Package leaflet: Information for the user
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your
doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Provera Tablets are and what they are used for
2. What you need to know before you take Provera
Tablets
3. How to take Provera Tablets
4. Possible side effects
5 How to store Provera Tablets
6. Contents of the pack and other information
1. What Provera Tablets are and what they are
used for
- This medicine contains medroxyprogesterone
acetate, which is one of a group of medicines
called ‘Progestogens’. Progestogens act like
progesterone, a natural sex hormone.
- Medroxyprogesterone acetate can slow down the
growth of certain tumours which are sensitive to
hormones.
- Provera tablets are used in the treatment of cancer
in the breast, kidney (in men and women) and in
the lining of the womb (endometrial cancer). It is
also used to treat cancer which has spread to
other parts of the body (metastatic cancer) in post
menopausal women (women who have stopped
having their periods).
- It is not expected that Provera Tablets will be used
in children for the above indications. If you are not
certain why you are being given this medicine, ask
your doctor.
- You must talk to a doctor if you do not
feel better
or if you feel worse.
2. What you need to know before you take Provera
Tablets
Do not take Provera Tablets:
- If
you
are
hypersensitive
(allergic)
to
medroxyprogesterone acetate or other similar
hormone medicines or any of the other ingredients
of this medicine (listed in section 6).
- If you have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Provera Tablets 200 mg or Medroxyprogesterone Acetate Tablets 200 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg medroxyprogesterone acetate.
Excipient with known effect:
Each tablet contains 0.278 mg sodium benzoate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Progestogen indicated for the treatment of certain hormone dependant
neoplasms, such as:
1.
Endometrial carcinoma.
2.
Renal cell carcinoma.
3.
Carcinoma of breast in post menopausal women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
Endometrial and renal cell carcinoma
200 - 600 mg daily
Breast carcinoma
400 - 1500 mg daily
The incidence of minor side-effects, such as indigestion and weight
gain,
increases with the increase in dose.
Response to hormonal therapy may not be evident until after at least
8-10
weeks of therapy.
Elderly patients:_ _This product has been used primarily in the older
age group
for the treatment of malignancies. There is no evidence to suggest
that the
older age group is any less prepared to handle the drug metabolically
than is
the younger patient. Therefore, the same dosage, contra-indications,
and
precautions would apply to either age group.
Paediatric population: The product is not anticipated for paediatric
use in the
indications recommended.
Method of administration
For Oral use.
4.3
CONTRAINDICATIONS
Medroxyprogesterone acetate is contraindicated in the following
conditions:
•
thrombophlebitis, thromboembolic disorders, and where there is a high
risk
of developing such manifestations [presence or history of atrial
fibrillation,
valvular
disorders,
endocarditis,
heart
failure,
pulmonary
embolism;
thromboembolic
ischaemic
attack
(TIA),
cerebral
infarction;
atherosclerosis; immediate post surgery period]
•
hypercalcaemia in patients with osseous metastases
•
hypersensitivity to the active substance or to any of the excipients
liste