CLIMEN 28 Tablet

គុណភាពព្យាបាល
- ប្រើសំរាប់ជំនួសអ័រម៉ូនស្ត្រីក្នុងវិបត្តិនៃវដ្ដរដូវ ដូចជាការមិនវិវត្តនៃស្បែក(ភ្នាសស្បូន) ផ្លូវទឹកមូត្រ និងផ្លូវបន្តពូជ។
- ព្យាបាលរោគសញ្ញាខ្វះអ័រម៉ូនស្ត្រីក្រោយការវះកាត់កន្សោមពង ឬអូវែដែលមិនមែនជាជំងឺមហារីក។
- ការពារជំងឺពុកឆ្អឹងចំពោះស្ត្រីដែលអស់ឈាមរដូវ។
ប្រសិនបើការប្រើឱសថនេះពុំមានផលវិបាកអ្វីធ្ងន់ធ្ងរទេនោះ គួរប្រើឱសថនេះជារៀងរហូតក្នុងការកាត់បន្ថយវិបត្តិខាងលើ។
កំរិត និងរបៀបប្រើ
- ប្រសិនបើអ្នកមានវដ្តរដូវនោះ ត្រូវចាប់ផ្ដើមប្រើក្នុងកំឡុងពេល 5 ថ្ងៃ (ថ្ងៃទី1 ដល់ ថ្ងៃទី5) នៃការមកឈាមរដូវ ដោយលេបថ្នាំគ្រាប់ពណ៌ស 1ថ្ងៃ1គ្រាប់ ក្នុងពេលម៉ោងដដែលរហូតដល់អស់ 16 គ្រាប់ បន្ទាប់មកលេបថ្នាំគ្រាប់ពណ៌ផ្កាឈូក 1ថ្ងៃ1គ្រាប់ រហូតអស់ 12 គ្រាប់ (សរុប28គ្រាប់)។ ពេលប្រើអស់បន្ទះទី1 ហើយអាចបន្តបន្ទះទី2ភ្លាមដោយមិនគិតពីវដ្ដរដូវទេ។
- ប្រសិនបើអ្នកគ្មានវដ្ដរដូវ ឬអស់រដូវ ឬយូរៗមកម្ដង នោះអាចចាប់ផ្ដើមប្រើនៅពេលណាក៏បាន តែត្រូវមានការសន្និដ្ឋានច្បាស់លាស់ថាគ្មានផ្ទៃពោះ ទើបអាចប្រើបាន។
- ឱសថនេះលេបទាំងមូលជាមួយទឹកក្នុងពេលម៉ោងដដែល។
- ប្រសិនបើភ្លេចលេបរយៈពេលខ្លី អាចលេបឡើងវិញ តែបើភ្លេចលេបលើសពី24ម៉ោង នោះមិនចាំបាច់លេបថ្នាំដែលភ្លេចនោះទេ។

Indication:

Hormonal replacement therapy (HRT) in climacteric complaints, signs of involution of skin and urogenital tract, deficiency symptoms after ovarietomy for non-carcinomatous disease.

Prevention of postmenopausal osteoporosis.

HRT should only be continued as long as the benefit in alleviation of severe symptoms outweighs the risks of HRT.

Method of administration:

Oral use

Dosage:

How to start Climen 28 Sugar Coated Tablet

If the patient is still menstruating, treatments should begin in the course of the 5 days of menstruation. Patients with amenorrhea or very infrequent periods or who are postmenopausal may start at any time, provided pregnancy has been excluded (see Pregnancy and lactation).

Dosage

One white tablet is taken daily for the first 16 days, followed by one pink tablet daily for 12 days.

Administration

Each pack covers 28 days of treatment. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets are to be swallowed whole with some liquid. The tablets should preferably be taken at the same time ever day.

Missed tablets

In case a table is forgotten, it should be taken as soon as possible. If more than 24 hours have elapsed, no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur. Bleeding usually occurs within the last few days of one pack and/or the first week of the next.

ហាមប្រើចំពោះ
- ស្ត្រីមានផ្ទៃពោះ និងស្ត្រីបំបៅកូន
- អ្នកធ្លាក់ឈាមតាមទ្វារមាសដោយមូលហេតុមិនច្បាស់លាស់
- អ្នកមានជំងឺមហារីកដោះ ឬសង្ស័យថាមានមហារីកដោះ
- អ្នកមានជំងឺមហារីកដែលអាចមានគ្រោះថ្នាក់ដោយសារការប្រើឱសថនេះ (ប្រភេទអ័រម៉ូនភេទ)
- អ្នកមានជំងឺថ្លើមធ្ងន់ធ្ងរ ឬមានមហារីកថ្លើម
- អ្នកមានជំងឺស្ទះសរសៃឈាម (ស្លោកសាច់ដុំបេះដូង ដាច់សរសៃឈាមខួរក្បាល)
- អ្នកមានអត្រា Triglyceride ក្នុងឈាមលើសខ្លាំង
- អ្នកធ្លាប់មានប្រតិកម្មជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ។

Pregnancy and lactation, Undiagnosed vaginal bleeding, Known or suspected cancer of the breast, Known or suspected premalignant conditions or malignancies, if sex steroid-influenced, Presence or history of liver tumors (benign or malignant), Severe hepatic disease, Acute arterial thromboembolism (e.g. myocardial infarction, stroke), Acute deep venous thrombosis, thromboembolic disorders, or a documented history of these conditions, A high risk of venous or arterial thrombosis, Severe hypertriglyceridemia, Known hypersensitivity to any of the components of Climen 28 sugar coated tablet.

អន្តរកម្មឱសថ
- នៅពេលប្រើឱសថ ត្រូវឈប់ប្រើថ្នាំពន្យារកំណើត បើចង់ពន្យារកំណើតនោះ ត្រូវអនុវត្តវិធីការពារដោយមិនប្រើឱសថ(ពាក់ស្រោមអនាម័យ)
- គួរជៀសវាងប្រើឱសថចំរុះជាមួយឱសថ: Anticonvulsant, Hydantoin, Barbiturate, Primidone, Carbamazepine, Rifampicines, Penicillines, Tetracycline, Paracetamol
- ហាមពិសាស្រាក្នុងពេលព្យាបាល
- ឱសថនេះអាចធ្វើអោយលទ្ធភាពនៃការវិភាគថ្លើម តំរងនោម ឈាម....មានការប្រែប្រួល។

Long-term treatment with hepatic enzyme-including drugs (e.g. several anticonvulsants and antimicrobials) can increase the clearance of sex hormones and may reduce clinical efficacy. Such hepatic enzyme-inducing properties have been established for hydantoins, barbiturates, primidone, carbamazepine and rifampicin and are also suspected for oxcarbazepine, topiramate, felbamate and griseofulvin. Maximal enzyme induction is generally not seen before 2-3 weeks but may then be sustained for at least 4 weeks after the cessation of drug therapy.

In rare cases reduced estradiol levels have been observed under the simultaneous use of certain antibiotics (e.g. penicillins and tetracycline).

In individual cases the requirement for oral antidiabetics or insulin can change as a result of the effect on glucose tolerance.

Acute alcohol ingestion during use of HRT may lead to elevations in circulating estradiol levels.

ហាមប្រើចំពោះស្ត្រីមានផ្ទៃពោះ និងស្ត្រីបំបៅកូន។

HRT is not indicated for use during pregnancy or lactation. If pregnancy occurs during medication with this tablet, treatment should be discontinued immediately.

Extensive epidemiological studies with steroid hormones used for contraception and hormone replacement therapy have revealed neither an increased risk of birth defects in children born to women who used such hormones prior to pregnancy, not a teratogenic effect when they were taken inadvertently during early pregnancy.

Small amounts of sex hormones may be excreted in human milk.

ការប្រុងប្រយ័ត្ន
- ឱសថនេះមិនអាចប្រើជំនួសថ្នាំពន្យារកំណើតបានទេ បើចង់ពន្យារកំណើតនោះ ត្រូវអនុវត្តវិធីការពារដោយមិនប្រើឱសថ(Non-hormonal method) ដូចជា ពាក់ស្រោមអនាម័យ
- ប្រសិនបើពេលប្រើឱសថនេះស្រាប់តែមានរោគសញ្ញាមានផ្ទៃពោះនោះ ត្រូវឈប់ប្រើឱសថនេះភ្លាមរហូតដល់មានការសន្និដ្ឋានច្បាស់លាស់
- ត្រូវឈប់ប្រើឱសថនេះជាបន្ទាន់ ប្រសិនបើមានអាការៈ ឬរោគសញ្ញាដូចខាងក្រោម:
・ឈឺក្បាលខ្លាំងមួយចំហៀង ឬញឹកញាប់ដែលអាចជារោគសញ្ញានៃការស្ទះសរសៃឈាមខួរក្បាល
・ខាន់លឿង និងរមាស់ ដោយការស្ទះទឹកប្រមាត់
・ក្រិន ឬស្ទះសរសៃឈាមខ្មៅ (Venous thromboembolism)
・ក្រិន ឬស្ទះសរសៃឈាមក្រហម (Arterial thromboembolism)
・ជំងឺ Gallbladder, Dementia
・ជំងឺមហារីក

This tablet cannot be used as a contraceptive.

During HRT, therapy should be discontinued immediately in case a contraindication is discovered, as well as in the following situations:

 Migrainous of frequent and unusually severe headaches that occur for the first time or other symptoms that are possible prodromal of cerebrovascular occlusion.

 Recurrence of cholestatic jaundice or cholestatic pruritus which occurred first during pregnancy or previous use of sex steroids.

 Symptoms of a thrombotic event or suspicion thereof.

In the event of new onset or deterioration of the following conditions or risk factors, the individual benefit/risk analysis should be re-done, taking into consideration the possible necessity of discontinuing therapy.

 Venous thromboembolism

 Arterial thromboembolism

 Gallbladder disease

 Dementia

 Tumors (breast cancer, endometrial cancer, liver tumor)

 Other conditions (hypertension, liver function, women with moderately elevated levels of triglycerides, peripheral insulin resistance and glucose tolerance, certain patients may develop undesirable manifestations of estrogenic stimulation under HRT such as abnormal uterine bleeding, uterine fibroids (myomas), endometriosis, prolactinoma, chloasma, epilepsy, benign breast disease, asthma, migraine, porphyria, otosclerosis, systemic lupus erythematosus, chorea minor, in women with hereditary angioedema exogenous estrogens.

This tablet contains the estrogen estradiol valerate, a prodrug of the natural human 17 beta-estradiol. The constituent cyproterone acetate is synthetic hydroxyprogesterone derivative with progestogenic, antigonadotropic and antiandrogenic properties.

With the composition and the sequential regimen of this tablet, including an estrogen monophase of 16 days, an estrogen-progestogen combination phase of 12 days, menstrual cycle is established in women with an intact uterus, provided the preparation is taken regularly.

Ovulation is not inhibited during the use of this tablet, and the endogenous production of hormones is hardly affected. Due to its sequential composition, the preparation can be employed in younger women to develop and regulate the cycle as well as in perimenopausal women to treat irregular uterine bleeding.