Progynova 1mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Estradiol valerate

Tillgänglig från:

Bayer Plc

ATC-kod:

G03CA03

INN (International namn):

Estradiol valerate

Dos:

1mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 06040101; GTIN: 5016703003984

Bipacksedel

025_0
Page 1 of 10
Due to regulatory changes, the content of the following Patient
Information
Leaflet may vary from the one found in your medicine pack. Please
compare the
'Leaflet prepared/revised date' towards the end of the leaflet to
establish if there
have been any changes.
If you have any doubts or queries about your medication, please
contact your
doctor or pharmacist.
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROGYNOVA 1 MG TABLETS
Estradiol valerate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, ask your doctor or pharmacist.
•
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 PROGYNOVA IS AND WHAT IT IS USED
FOR…………………………………………......1
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROGYNOVA
.……………………………2
MEDICAL HISTORY AND REGULAR
CHECK-UPS…………………………………………………………………………..2
DO NOT TAKE PROGYNOVA
……………………………………………………………………………………………..2
WARNINGS AND
PRECAUTIONS……………………………….….………………………………………………...…...3
HRT AND
CANCER……………………………….……………………………………………………………………...3
EFFECTS OF HRT ON HEART OR CIRCULATION
…………………………………………………………………………..4 BLOOD CLOTS IN A VEIN
(THROMBOSIS)…………………………………………………………………………4 HEART DISEASE (HEART
ATTACK)...……………

Produktens egenskaper

OBJECT 1
PROGYNOVA 1 MG TABLETS
Summary of Product Characteristics Updated 15-Jun-2022 | Bayer plc
•
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
Progynova® 1mg Tablets
2. Qualitative and quantitative composition
Each memo pack contains 28 tablets each containing estradiol valerate
1.0 mg.
Excipients with known effect
Lactose monohydrate and sucrose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pale yellow sugar coated tablet for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
peri- and postmenopausal
women.
See also Section 4.4.
4.2 Posology and method of administration
Posology
Progynova is an oestrogen-only product.
One tablet of Progynova 1 mg to be taken daily. It does not matter at
what time of day the woman takes her
tablet, but once she has selected a particular time she should keep to
it every day. Treatment is continuous,
which means that