Climara 50 micrograms/24 hours Transdermal Patch
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
06-03-2024
Summary of Product characteristics
(SPC)
06-03-2024
Active ingredient:
Estradiol
Available from:
Bayer Limited
ATC code:
G03CA; G03CA03
INN (International Name):
Estradiol
Dosage:
50 milligram(s)
Pharmaceutical form:
Transdermal patch
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Natural and semisynthetic estrogens, plain; estradiol
Authorization status:
Not marketed
Authorization date:
1996-07-25
Patient Information leaflet
BP23029_REC31756
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLIMARA
50 micrograms / 24 hour transdermal patch
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 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 CLIMARA IS AND WHAT IT IS USED FOR
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2
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CLIMARA
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2
Medical history and regular check-ups
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2
Do not use Climara
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2
Warnings and precautions
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3
HRT and cancer
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4
Effects of HRT on heart and circulation
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5
Other conditions
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6
Other medicines and Climara
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6
Laboratory tests
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Summary of Product characteristics
Health Products Regulatory Authority
06 March 2024
CRN00DXT7
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Climara 50 micrograms/24 hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 12.5 cm
2
patch contains 3.8 mg estradiol (formed from 3.9 mg estradiol
hemihydrate), releasing a nominal 50 micrograms
of estradiol per 24 hours.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Oval transdermal patch with a translucent homogenous matrix on a
transparent carrier film.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy for estrogen deficiency symptoms in
postmenopausal women more than 1 year
postmenopause.
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
Climara is an estrogen-only patch applied to the skin once weekly.
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. Treatment to control menopausal
symptoms should be initiated with the lowest Climara
patch dose. If considered necessary, a higher dosed patch should be
used. Once treatment is established the lowest effective
dose patch necessary for relief of symptoms should be used.
For prevention of postmenopausal osteoporosis Climara 50 is
recommended. Women receiving Climara 100 for
postmenopausal symptoms can continue at this dose.
In women with an intact uterus, a progestogen should be added to
Climara for at least 12–14 days each month. Unless there is
a previous diagnosis of endometriosis, it is not recommended to add a
progestogen in hysterectomised women.
_For continuous use:_
The patches should be applied once weekly on a continuous basis, each
used patch being removed after 7 days and a fr
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