Ethinylestradiol 50microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ethinylestradiol

Available from:

UCB Pharma Ltd

ATC code:

G03CA01

INN (International Name):

Ethinylestradiol

Dosage:

50microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 5015313012393

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ETHINYLESTRADIOL TABLETS BP
10 MICROGRAMS, 50 MICROGRAMS, 1 MG
TABLETS
ETHINYLESTRADIOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
ETHINYLESTRADIOL.
•
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 symptoms are the same as yours.
•
In this leaflet, Ethinylestradiol Tablets BP 10 micrograms, 50
micrograms and 1 mg
will be called Ethinylestradiol.
IN THIS LEAFLET:
1. What Ethinylestradiol is for
2. Before you take Ethinylestradiol
3. How to take Ethinylestradiol
4. Possible side effects
5. How to store Ethinylestradiol
6. Further information
1. WHAT ETHINYLESTRADIOL IS 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 occurring
oestrogen if not enough is
being produced. This can be in older women going through, or after the
menopause or in
younger women whose ovaries have not developed properly.
•
PERIOD PROBLEMS
– You may be prescribed Ethinylestradiol if you are suffering from
problems associated with your periods. If you still have your womb and
are prescribed
an oestrogen, such as Ethinylestradiol, then your doctor should
no

Summary of Product characteristics

OBJECT 1
ETHINYLESTRADIOL TABLETS BP 50 MCG
Summary of Product Characteristics Updated 12-Jul-2016 | UCB Pharma
Limited
1. Name of the medicinal product
Ethinylestradiol Tablets BP 50 mcg
2. Qualitative and quantitative composition
Ethinylestradiol 52.5 mcg
For excipients see 6.1.
3. Pharmaceutical form
White flat bevel edged uncoated tablets. Breakline on one side and
engraved EVANS 50-137 on the other
side. For oral administration
4. Clinical particulars
4.1 Therapeutic indications
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
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 endometrial hyperplasia an