CATHATE Tablets 0.625 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ESTROGENS CONJUGATED
Available from:
John Wyeth & Brother Limited
Dosage:
0.625 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1995-09-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cathate* 0.625mg Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cathate tablet contains 0.625 mg Conjugated Estrogens.
_For excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Coated Tablet.
A white, oval, coated tablet printed “0.625” in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cathate is indicated for hormone replacement therapy (HRT) for estrogen deficiency symptoms in menopausal and
postmenopausal women.
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
Cathate Tablets are an estrogen only HRT for oral use.
POSOLOGY:
ADULTS
Cathate 0.625–1.25mg daily is the usual starting dose for women without a uterus. Cyclic administration is
recommended (three weeks on followed by one week off).
For treatment of postmenopausal symptoms, the lowest effective dose should be administered. Patients should be re-
evaluated periodically to determine if treatment for symptoms is still necessary.
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.
VASOMOTOR SYMPTOMS:
0.625–1.25 mg daily depending on the response of the individual.
ATROPHIC VAGINITIS, KRAUROSIS VULVAE, ATROPHIC URETHRITIS:
0.625–1.25mg daily depending on the response of the individual.
PROPHYLAXIS OF OSTEOPOROSIS:
The minimum effective dose is 0.625mg for most patients.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/10/2010_
_CR
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