Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand 1685, South Africa
Hormone replacement therapy (HRT) for the relief of menopausal symptoms (vasomotor symptoms such as hot flushes and atrophic vaginitis/vulvitis) for women with an intact uterus.
EVOREL CONTI should be applied twice weekly, without interruption to the trunk below the waist.
EVOREL CONTI should not be continued for longer than 5 years.
Should a patch fall off, it should be replaced immediately with a new patch. However, the usual day of changing patches should be maintained.
Insufficient data are available to guide dose adjustments for patients with severe liver or kidney function impairment.
Data are insufficient in regard to the use of EVOREL CONTI in the elderly (>65 years old).
Transdermal use.
The EVOREL CONTI should be placed on a clean, dry, healthy, intact area of skin, on the trunk of the body below the waist. Creams, lotions or powders may interfere with the adhesive properties of the patch.
The patch should not be applied on or near the breasts.
The area of application should be changed, with an interval of at least one week allowed between applications to a particular site.
The skin area selected should not be damaged or irritated.
The waistline should not be used because excessive rubbing of the patch may occur.
The patch should be used immediately after opening the sachet.
Remove one part of the protecting foil. Apply the exposed part of adhesive to the application site from the edge to the middle; avoid wrinkling of the patch.
The second part of the protective foil should now be removed and the freshly exposed adhesive applied. Wrinkling should again be avoided and the palm of the hand used to press the patch onto the skin and to bring the patch to skin temperature at which the adhesive effect is optimised.
The patient should avoid contact between fingers and the adhesive part of the patch during application.
Should a patch fall off, a new patch should be applied immediately. However, the usual day of changing patches should be maintained.
It is not necessary to remove the patch during bathing or showering. It is recommended, however, that the patch be removed prior to a sauna bath, and that a new patch is applied immediately thereafter.
If a patch change is missed, the missed patch should be applied as soon as remembered. However, the usual day of changing patches should be maintained.
Forgetting a dose may increase the likelihood of break through bleeding and spotting.
To remove the EVOREL CONTI patch, peel away an edge of the patch and pull smoothly away from the skin. The patches should be disposed of in household waste (do not flush down the toilet).
Any adhesive that remains on the skin after removal of EVOREL CONTI patch may be removed washing with soap and water or by rubbing it off with the fingers.
Symptoms of overdose of EVOREL CONTI therapy may include nausea, break-through bleeding, breast tenderness, abdominal cramps and/or bloating. These symptoms can be reversed by removing the EVOREL CONTI.
24 months.
Store at or below 25°C.
Do not freeze.
Cartons containing eight EVOREL CONTI patches in foil lined pouches.
The pouch comprises a 4 layer laminate including an aluminium barrier and paper exterior surface.
Once removed, the patches should be disposed of in household waste (do not flush down the toilet).
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