Expiration date: 12/2026
Structure and Composition:
Plaster-TDTS 12.5 cm2, released 50 mg of substance per day 1 patch
Estradiol 3.9 mg
in a multilayer pouch 1 pc. bag in box 4.
Excipients: ethyl oleate, isopropyl glycerol monolaurate acrylate copolymer
Description pharmaceutical form:
Oval patch (about 4.5 cm by 3.3 cm, which corresponds to 12.5 cm2) consisting of a transparent carrier film with a clear, homogeneous matrix comprising the active substance.
Pharmachologic effect:
It compensates for a lack of endogenous estrogen, reduces the level of LDL cholesterol in the blood. It relieves somatic, psychic and other menopausal symptoms during periods of pre- and post-menopause or after ovariectomy to prevent a decrease in bone mass and osteoporosis.
Pharmacokinetics:
Estradiol released from the patch (50 mg daily) and enters the bloodstream transdermally at a constant speed, maintaining a predetermined level of the hormone in plasma.
Testimony:
Hormone replacement therapy for disorders caused by natural or surgical menopause (only in case of non-cancer diseases): vasomotor symptoms (hot flushes, sweating), sleep disturbances, atrophic processes.
Prevention of postmenopausal osteoporosis.
Contraindications:
Hypersensitivity, breast cancer, endometriosis, liver tumors, depending on the sex steroid hormones, vaginal bleeding of unknown etiology, thromboembolic processes (thrombophlebitis, thrombosis), pregnancy, breast-feeding.
Application of pregnancy and breastfeeding:
Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.
Side effect:
In rare cases:
With the genitourinary system: the changing nature of uterine bleeding, increase in uterine leiomyoma size, a change in vaginal secretions, swelling.
From the digestive tract: nausea, stomach pain, bloating, cholestatic jaundice.
For the skin: the emergence of chloasma or melasma, in some cases - allergic contact dermatitis, itching, generalized rash.
From the nervous system and sensory organs: headache, migraine, dizziness.
Other: a change in body weight, increase in size and power of the mammary glands, worsening of porphyria flow, libido change.
Dosage and administration:
Cutaneous.
Control of menopausal symptoms. Treatment starts with the lowest dose patch CLIMAR. If necessary, you can use a patch vysokodozirovanny. After the selection of a dose to relieve symptoms should use the lowest effective dose patch.
Prevention of osteoporosis. The treatment for the prevention of postmenopausal bone loss should be initiated immediately after menopause. Recommended long-term treatment based on an individual approach. Treatment should be carried out either continuously or in cyclic operation.
Treatment with estrogen only used if a woman has had a hysterectomy. In all other cases appointed by the respective doses of progestogen therapy for 10-14 days each month.
The patch should be affixed on a weekly basis in a constant mode, each used patch should be removed after 7 days, after which a fresh patch is attached to another place.
Patches may also be recommended for treatment in a cyclic mode. In this case, the patch is attached weekly for 3 consecutive weeks, followed by a 7-day intervals without attaching the patch to the next treatment. Menstrualnopodobnoe bleeding normally develops 2-3 days after discontinuation of the progestogen.
Method of attachment patch
After removing the protective film patch CLIMAR attached adhesive side on a clean, dry area of ??the skin along the spine or on the buttocks. CLIMAR should not be attached in the breast or adjacent to them. The site chosen for fixing the patch should not be fat, damaged or irritated, you must also avoid the waist, as the friction tight clothing patch may come off.
The patch should be attached immediately after opening the package and removing the protective film. The patch must be pressed firmly to the place of fixing the palm for about 10 seconds. It must be ensured that there is good contact with the skin, especially around the edges. Place applications should vary at an interval of at least one week in between applications.
If the patch is attached correctly, the patient can wash in the bath or shower as usual. However, the patch may come off from the skin under the influence of very hot water or in the sauna.
If the patch come off, to be a new patch attached to the remaining days of the 7-day interval.
Precautionary measures:
Before the start of the application necessary to carry out a full general medical and gynecological examination (including breast examination, cytology, cervical smear), with the exception of pregnancy. Do not place the patch on the breast or waist. If the patch is applied correctly, it is possible to take a bath or shower, but be aware that the patch may come off in hot water. You must inform the doctor about the presence of diabetes mellitus, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, small chorea, heart failure, disorders of the liver or kidney disease, migraines, as well as the simultaneous administration of barbiturates, phenylbutazone, hydantoin , rifampicin, the appearance of irregular bleeding or unusually heavy bleeding during the period between the application of the drug, discomfort in the epigastric region.
In the course of treatment should be borne in mind that long-term use only estrogen in menopause may lead to endometrial hyperplasia and increase the risk of endometrial cancer. To reduce the risk of endometrial cancer requires supplementation progestogen (normally within 10-12 days per month), which leads to transition to the endometrium in the secretory phase and its subsequent menstrualnopodobnoe rejection after cessation of bleeding progestogen.
