PROGYNOVA Transdermal patch Ref.[27704] Active ingredients: Estradiol

Posology

Progynova TS 50 is an oestrogen-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 Progynova TS 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 Progynova TS 50 is recommended. Women receiving Progynova TS 100 for postmenopausal symptoms can continue at this dose.

In women with an intact uterus, a progestogen should be added to Progynova TS 50 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 fresh patch applied to a different site.

For cyclical use:

The patches may also be prescribed on a cyclical basis. Where this is the preferred option, the patches should be applied weekly for 3 consecutive weeks followed by a 7 day interval, without a patch being applied, before the next course.

How to start Progynova TS 50

Women who do not take oestrogens or women who change from a continuous combined HRT product may start treatment at any time.

Patients changing from a continuous sequential HRT regimen should begin the day following completion of the prior regimen.

Patients changing from a cyclic HRT regimen should begin the day after the treatment-free period.

Missed or lost patch

In the event that a patch falls off before 7 days are up, it may be reapplied. If necessary, a new patch should be applied for the remainder of the 7-day dosing interval.

If the patient forgets to replace a patch, this should be done as soon as possible after she remembers it. The next patch has to be used after the normal 7-day interval.

After several days without replacement of a new patch there is an increased likelihood of breakthrough bleeding and spotting.

Method of administration

Following removal of the protective liner the adhesive side of Progynova TS patches should be placed on a clean, dry area of the skin of the trunk or buttocks. Progynova TS patches should not be applied to the breasts. The sites of application should be rotated, with an interval of at least one week between applications to a particular site. The area selected should not be oily, damaged or irritated. The waistline should be avoided since tight clothing may rub the patch off. The patch should be applied immediately after opening the pouch and removing the protective liner. The patch should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. The patch should be changed once weekly. If the patch is applied correctly, the patient can bath or shower as usual. The patch might, however, become detached from the skin in very hot bath water or in the sauna.

Paediatric population

Progynova TS is not indicated for use in children and adolescents.

Geriatric patients

There are no data suggesting a need for dosage adjustment in elderly patients. In women aged 65 years or older see section 4.4.

Patients with hepatic impairment

Progynova TS has not been specifically studied in hepatic impaired patients. In women with impaired liver function, see section 4.4.

Overdosage is unlikely with this type of application. Nausea, vomiting and withdrawal bleeding may occur in some women. There is no specific antidote and treatment should be symptomatic. The patch(es) should be removed.

3 years.

Store below 30°C.

Store in the original package in order to protect from moisture.

Each patch is sealed in a multilaminate pouch containing a desiccant. The desiccant consists of sodium alumino silicate;

Pack of 4 or 12 patches.

(Not all pack sizes may be marketed).

After use the patch still contains substantial quantities of estradiol, which may have harmful effects if reaching the aquatic environment. Therefore, the used patch should be discarded carefully. Any used or unused patches should be folded in half, adhesive side together, and disposed off in the solid waste disposal system. Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.