Provera 5 mg Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Medroxyprogesterone acetate

Dostępny od:

Pfizer Healthcare Ireland

Kod ATC:

G03DA; G03DA02

INN (International Nazwa):

Medroxyprogesterone acetate

Dawkowanie:

5 milligram(s)

Forma farmaceutyczna:

Tablet

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Pregnen (4) derivatives; medroxyprogesterone

Status autoryzacji:

Not marketed

Data autoryzacji:

1979-04-01

Ulotka dla pacjenta

Page 1 of 7
Pfleet no: 2015-0011402 & 2015-0013777
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROVERA
®
2.5MG, 5MG AND 10MG TABLETS
Medroxyprogesterone acetate
_PFIZER_
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT PROVERA IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROVERA
3.
HOW TO TAKE PROVERA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PROVERA
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PROVERA IS AND WHAT IT IS USED FOR

Provera contains the active substance medroxyprogesterone acetate
which is one of a
group of medicines called ‘progestogens’. Progestogens are similar
to the natural
female hormone, progesterone.

Provera has several uses. You can take Provera to treat or manage:
o
heavy periods
o
painful periods
o
irregular periods or periods that are more frequent than normal
o
absence of periods
o
mild to moderate endometriosis (where tissue from your womb is found
outside your womb)
o
to protect the womb lining during treatment with oestrogens in women
after
the menopause.
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
PROVERA MAY NOT BE SUITABLE FOR ALL WOMEN. PLEASE READ THE FOLLOWING
LIST CAREFULLY TO SEE
IF ANY OF THESE APPLY TO YOU. CONSULT YOUR DOCTOR IF YOU ARE NOT SURE.
DO NOT TAKE PROVERA IF YOU:
o
are allergic to medroxyprogesterone acetate or other similar hormone
medicines,
or to any of the other ingredients of this medicine (listed in

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Provera 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg medroxyprogesterone acetate
Excipients with known effect:
Lactose monohydrate 84.2 mg, sucrose 1.465 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Pale blue, round tablets. One surface is engraved with the logo
“286” on both sides of a break score. The other surface
is engraved with the logo “U”.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Progestogen.
Indicated for dysfunctional (anovulatory) uterine bleeding where
progesterone deficiency exists, secondary
amenorrhoea, and mild to moderate endometriosis.
Also indicated for use in the menopause to oppose the endometrial
effects of oestrogen in post-menopausal women being treated with
oestrogen.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use of combined oestrogen/progestin therapy in post-menopausal women
should be limited to the shortest duration
consistent with treatment goals and risks for the individual woman,
and should be periodically evaluated (see section 4.4).
_Adults:_
_Dysfunctional (anovulatory) uterine bleeding:_ 2.5 - 10 mg daily for
5 - 10 days commencing on the assumed or
calculated 16
th
- 21
st
day of the cycle. Treatment should be given for two consecutive
cycles. When bleeding occurs
from a poorly developed proliferative endometrium, conventional
oestrogen therapy may be employed in conjunction
with medroxyprogesterone acetate (MPA) in doses of 5 - 10 mg for 10
days.
_Secondary amenorrhoea:_ 2.5 to 10 mg daily for 5 to 10 days
commencing on the assumed or calculated 16
th
- 21
st
day of
the cycle. Treatment should be given for three consecutive cycles. In
amenorrhoea associated with a poorly developed
proliferative endometrium, conventional oestrogen therapy may be used
in conjunction with medroxyprogesterone acetate,
the latter