Provera 10mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Medroxyprogesterone acetate

Tersedia dari:

Pfizer Ltd

Kode ATC:

L02AB02

INN (Nama Internasional):

Medroxyprogesterone acetate

Dosis:

10mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 06040102; GTIN: 5012882002237 5012882001971 5012882002244

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROVERA
®
10MG 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 10mg
tablets but it will be referred to as Provera
throughout in this leaflet.
Please note that this leaflet also contains
information about other strengths Provera 2.5mg
and 5mg tablets.
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)
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, o

Karakteristik produk

OBJECT 1
PROVERA 10 MG TABLETS
Summary of Product Characteristics Updated 26-Feb-2020 | Pfizer
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Provera 10 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 10 mg medroxyprogesterone acetate.
Excipients with known effect:
Lactose monohydrate 110 mg, sucrose 2 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets
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