ESTRADOT

e. every three to four days. 5, 50, 75 and 100. 4) should be used. Depending on the clinical response the dose can then be adjusted to the patient’s individual needs. If, after three months, there is insufficient response in the form of alleviated symptoms, the dose can be increased.

g. tender breasts) the dose must be decreased.

Prevention of postmenopausal osteoporosis:

Estradot is available in three strengths: 50, 75 and 100. Treatment must be initiated with an Estradot 50 microgram/24 hours patch. Adjustments can be made by using Estradot 50, 75 and 100 microgram patches. General instructions Estradot is administered as continuous therapy (uninterrupted application twice weekly).

In women with an intact uterus, Estradot should be combined with a progestagen approved for addition to oestrogen treatment in a continuous sequential dosing scheme: the oestrogen is dosed continuously. The progestagen is added for at least 12 to 14 days of every 28-day cycle, in a sequential manner.

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. In women who are not taking HRT or women transferring from a continuous combined HRT product, treatment may be started on any convenient day.

In women transferring from a sequential HRT regimen, treatment should begin the day following completion of the prior regimen. Method of administration The adhesive side of Estradot should be placed on a clean, dry area of the abdomen.

Estradot should not be applied to the breasts. Estradot should be replaced twice weekly. The site of application must be rotated, with an interval of at least 1 week allowed 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 dislodge the patch. The patch should be applied immediately after opening the sachet 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.

In the event that a patch should fall off, the same patch may be reapplied. If necessary, a new patch may be applied. In either case, the original treatment schedule should be continued. The patch may be worn during bathing. If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible.

6%). The erythema was observed after removing the patch by peeling from the skin at the application site. Mild pruritus and rash were also reported around the application site. Adverse drug reactions (Table 1) are ranked under headings of frequency, the most frequent first, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following adverse drug reactions have been reported from clinical trials and from post-marketing experience with either Estradot or oestrogen therapy in general: Table 1 Neoplasms benign, malignant and unspecified (including cysts and polyps) Not known*: Breast cancer.

Immune system disorders Rare:

Hypersensitivity.

Very rare:

Urticaria, anaphylactic reaction.

Not known*:

Anaphylactoid reaction.

Metabolism and nutrition disorders Very rare:

Decreased carbohydrate tolerance.

Psychiatric disorders Common:

Depression, nervousness, affect liability.

Rare:

Libido disorder.

Nervous system disorders Very common:

Headache.

Common:

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

5 are not indicated for osteoporosis. Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.

Medical examination/follow-up Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.

During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below).

g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.

g. g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or (severe) headache - Systemic lupus erythematosus (SLE) - A history of endometrial hyperplasia (see below) - Epilepsy - Asthma - Otosclerosis Reasons for immediate withdrawal of therapy: Therapy should be discontinued in case a contraindication is discovered and in the following situations: - Jaundice or deterioration in liver function - Significant increase in blood pressure - New onset of migraine-type headache - Pregnancy Endometrial hyperplasia and carcinoma In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.

g. g. g. 1; - Porphyria.