FEMSEVEN CONTI
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-05-2024
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Active ingredient:
ESTRADIOL HEMIHYDRATE LEVONORGESTREL
Available from:
Merck Serono Limited
Dosage:
50/7 Microgram/day
Pharmaceutical form:
Transdermal Patch
Authorization date:
2004-03-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FemSeven Conti, 50 micrograms/ 7 micrograms/24 hours, transdermal patch.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patch contains 1.5 mg of estradiol hemihydrate and 0.525 mg levonorgestrel in a patch size of 15 cm
2
, releasing
50 micrograms of estradiol and 7 micrograms of levonorgestrel per 24 hours.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Octagonal, transparent, flexible, rounded-edge transdermal matrix patch located on an oversized removable protective
liner.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women more than one
year after menopause.
Experience of treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For transdermal use.
Fem7 Plus has to be applied once a week, i.e. each patch is replaced every 7 days. Fem7 Plus is a continuous combined
hormone replacement therapy (HRT) treatment without a treatment-off phase: as one patch is removed, the next is
applied immediately. Forgetting to change a patch on schedule may increase the likelihood of break-through bleeding
or spotting.
In women with amenorrhoea and not taking HRT or women transferring from another continuous combined HRT
product, treatment with Fem7 Plus may be started on any convenient day.
In women transferring from sequential HRT regimens, treatment should start right after their withdrawal bleeding has
ended.
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.
Method of administration
Fem7 Plus should be applied to clean, dry, healthy skin (which is neither
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