Medroxyprogesterone 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Medroxyprogesterone acetate

Available from:

Dowelhurst Ltd

ATC code:

L02AB02

INN (International Name):

Medroxyprogesterone acetate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040102

Patient Information leaflet

Package Leaflet: Information for the User
PROVERA
® 5MG TABLETS
(MEDROXYPROGESTERONE ACETATE)
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.
•
The name of your medicine is Provera 5mg Tablets but will be referred
to as Provera Tablets or Provera throughout the remainder of this
leaflet.
•
Provera Tablets are also available in other strengths.
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
•
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)
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
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 ac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Provera 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg 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
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Progestogen. Indicated for dysfunctional (anovulatory) uterine
bleeding,
secondary amenorrhoea and for mild to moderate endometriosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
_Dysfunctional (anovulatory) uterine bleeding:_ 2.5 - 10 mg daily for
5 - 10 days
commencing on the assumed or calculated 16th - 21st 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 in
doses of 5 - 10 mg for 10 days.
_ _
_Secondary amenorrhoea:_ 2.5 - 10 mg daily for 5 - 10 days beginning
on the
assumed or calculated 16th to 21st day of the cycle. Repeat the
treatment for
three consecutive cycles. In amenorrhoea associated with a poorly
developed
proliferative endometrium, conventional oestrogen therapy may be
employed
in conjunction with medroxyprogesterone acetate in doses of 5 - 10 mg
for 10
days.
_ _
_Mild to moderate endometriosis:_ Beginning on the first day of the
menstrual
cycle,
10
mg
three
times
a
day
for
90
consecutive
days.
Breakthrough
bleeding, which is self-limiting, may occur. No additional hormonal
therapy is
recommended for the management of this bleeding.
_Elderly:_ Not applicable
_Paediatric population:_ Not applicable
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Known or suspected pregnancy;
Known, past or suspected breast cancer;
Previous idiopathic or current venous thromboembolism (deep venous
thrombosis, pulmonary
embolism);
Active or recent arterial thromboembolic disease (e.g. angina,
myocardial infarction)