Ethinylestradiol 1mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Ethinylestradiol

Disponível em:

UCB Pharma Ltd

Código ATC:

G03CA01

DCI (Denominação Comum Internacional):

Ethinylestradiol

Dosagem:

1mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06040101; GTIN: 5015313012409

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ETHINYLESTRADIOL TABLETS BP
10 MICROGRAMS, 50 MICROGRAMS, 1 MG
TABLETS
ETHINYLESTRADIOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
ETHINYLESTRADIOL BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
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. 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.
-
In this leaflet, Ethinylestradiol Tablets BP 10 micrograms, 50
micrograms and 1 mg will be
called Ethinylestradiol.
WHAT IS IN THIS LEAFLET
1. What Ethinylestradiol is and what it is used for
2. What you need to know before you take Ethinylestradiol
3. How to take Ethinylestradiol
4. Possible side effects
5. How to store Ethinylestradiol
6. Contents of the pack and other information
1. WHAT ETHINYLESTRADIOL IS AND WHAT IT IS USED FOR
Ethinylestradiol belongs to a group of medicines called oestrogens
(female sex hormones).
Ethinylestradiol is a synthetic (man-made) oestrogen.
Oestrogens are a group of naturally occurring hormones which have a
wide range of actions in the
body. These include effects on the development of the body and
maintaining the menstrual cycle
(periods) in women.
During the menopause (sometimes called “the change of life”) a
woman’s body slowly produces less
oestrogen. This may cause hot flushes, night sweats, mood swings and
dryness in the vagina. Over a
long time it may also cause a thinning of the bones, which may be more
likely to then break
(osteoporosis).
Ethinylestradiol is used for:
•
HORMONE REPLACEMENT THERAPY (HRT)
- This is the most common use of Ethinylestradiol.
The tablets replace the naturally occur

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ethinylestradiol Tablets BP 1 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ethinylestradiol 1.048 mg
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White flat bevel edged uncoated tablets. Breakline on one side and
engraved Evans 1-
138 on the other side.
4.1
THERAPEUTIC INDICATIONS
Ethinylestradiol Tablets are indicated in adults for:
•
post menopausal symptoms due to estrogen deficiency.
•
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.
•
palliative treatment of prostatic cancer.
•
hormone replacement therapy for failure of ovarian development e.g. in
patients with gonadal dysgenesis where initial estrogen therapy is
later
followed by combined estrogen/progestogen therapy.
•
disorders of menstruation, given in conjunction with a progestogen.
(See also Section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Ethinylestradiol Tablets is an estrogen-only preparation of hormone
replacement
therapy (HRT) for oral administration.
_Post menopausal symptoms due to estrogen deficiency including
prevention of _
_postmenopausal osteoporosis: _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. The usual dose range is 10 to 50
micrograms daily,
usually on a cyclical basis (e.g., 3 weeks on and 1 week off).
For women without a uterus, who did not have endometriosis diagnosed,
it is not
recommended to add a progestogen.
In women with an intact uterus (or in endometriosis when endometrial
foci may be
present despite hysterectomy), where a progestogen is necessary, it
should be added
for at least 12-14 days every month/28 day cycle to reduce the risk to
the
endometrium.
The benefits of the lower risk of endom