Progynova 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol valerate

Available from:

Bayer Plc

ATC code:

G03CA03

INN (International Name):

Estradiol valerate

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 5016703004004

Patient Information leaflet

027_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 2 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)...…………………………�

Summary of Product characteristics

OBJECT 1
PROGYNOVA 2 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® 2 mg Tablets
2. Qualitative and quantitative composition
Each memo pack contains 28 tablets each containing estradiol valerate
2.0 mg.
Excipients with known effect
Lactose monohydrate and sucrose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White 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.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant of, or
contraindicated for, other medicinal products approved for the
prevention of osteoporosis.
See also Section 4.4.
4.2 Posology and method of administration
• POSOLOGY
Progynova is an oestrogen-only product.
One tablet of Progynova 2 mg to b