Vagifem 10microgram vaginal tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol

Available from:

Novo Nordisk Ltd

ATC code:

G03CA03

INN (International Name):

Estradiol

Dosage:

10microgram

Pharmaceutical form:

Pessary

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020100; GTIN: 5017954001729

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VAGIFEM
® 10 MICROGRAMS VAGINAL TABLETS
Estradiol
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 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 Vagifem
®
is and what it is used for
2.
What you need to know before you use Vagifem
®
3.
How to use Vagifem
®
4.
Possible side effects
5.
How to store
Vagifem
®
6.
Contents of the pack and other information
1.
WHAT VAGIFEM
® IS AND WHAT IT IS USED FOR
Vagifem
®
contains estradiol
•
Estradiol is a female sex hormone.
•
It belongs to a group of hormones called oestrogens.
•
It is exactly the same as the estradiol produced by the ovaries of
women.
Vagifem
®
belongs to a group of medicines called local Hormone Replacement
Therapy (HRT).
IT IS USED_ _TO
relieve menopausal symptoms in the vagina such as dryness or
irritation. In medical terms
this is known as ‘vaginal atrophy’. It is caused by a drop in the
levels of oestrogen in your body. This
happens naturally after the menopause.
VAGIFEM
® WORKS BY
replacing the oestrogen which is normally produced in the ovaries of
women. It is
inserted into your vagina, so the hormone is released where it is
needed. This may relieve discomfort
in the vagina.
The experience of treating women older than 65 years is limited.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VAGIFEM
®
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, or
whether to carry on taking it.
Before you start (or restart) HRT, your doctor will ask about you

Summary of Product characteristics

OBJECT 1
VAGIFEM 10 MICROGRAMS VAGINAL TABLETS
Summary of Product Characteristics Updated 07-Jun-2017 | Novo Nordisk
Limited
1. Name of the medicinal product
Vagifem 10 micrograms vaginal tablets.
2. Qualitative and quantitative composition
Each vaginal tablet contains:
Estradiol hemihydrate equivalent to estradiol 10 micrograms.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Vaginal tablet.
White, film-coated, biconvex tablet, engraved with NOVO 278 on one
side. Diameter 6 mm.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of vaginal atrophy due to oestrogen deficiency in
postmenopausal women (see section 5.1).
The experience treating women older than 65 years is limited.
4.2 Posology and method of administration
Vagifem is administered intravaginally as a local oestrogen therapy by
use of an applicator.
Initial dose: One vaginal tablet daily for two weeks.
Maintenance dose: One vaginal tablet twice a week.
Treatment may be started on any convenient day.
If a dose is forgotten, it should be taken as soon as the patient
remembers. A double dose should be
avoided.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for
the shortest duration (see also section 4.4) should be used.
Vagifem is a local vaginal therapy and in women with an intact uterus,
progestagen treatment is not
necessary (however see section 4.4, 'Special warnings and precautions
for use', 'Endometrial hyperplasia
and carcinoma').
Vagifem may be used in women with or without an intact uterus.
Vaginal infections should be treated before start of the Vagifem
therapy.
Administration:
1. Open the blister pack at the plunger end.
2. Insert the applicator in the vagina until resistance is met (8-10
cm).
3. Release the tablet by pressing the plunger.
4. Withdraw the applicator and discard.
4.3 Contraindications
• Known, past or suspected breast cancer
• Known, past or suspected oestrogen-dependent malignant tumours
(e.g. endometrial cancer)
• Undiagnosed genital ble