Important safety information including dosage, side effects, and precautions of ProFeme.
Dosage & Administration
Apply to the inner upper arm, upper thigh, abdomen, chest, or neck. Please follow the instructions below according to your individual condition and the symptoms you wish to improve.
・For postmenopausal women: Apply 0.3 ml of cream (30 mg of progesterone) once daily or in divided doses. Use for 25 days per month or 3 weeks, followed by a 1-week drug holiday.
・For perimenopausal women: Apply 0.3 ml of cream (30 mg of progesterone) once daily or in divided doses with a metered applicator on days 12-26 of each menstrual cycle. If menstruation begins before the 26th day, discontinue use of ProFeme® and consider the first day of bleeding as the first day of the new menstrual cycle.
・For premenstrual syndrome (PMS): Apply 0.3 ml of cream (30 mg of progesterone) once daily or in divided doses with a metered applicator on days 12-26 of the menstrual cycle. This dosage can be significantly adjusted 4-5 days prior to menstruation to achieve a crescendo effect.
・For premenstrual dysphoric disorder (PMDD): Apply 0.5-1.0 ml of cream (50-100 mg of progesterone) once daily or in divided doses with a metered applicator on days 12-26 of each menstrual cycle. This dosage can be significantly adjusted to peak 4-5 days prior to menstruation.
・For endometriosis, menstrual pain, and postpartum depression: Apply 1.0-2.0 ml of cream (100-200 mg of progesterone) once daily or in divided doses depending on the severity of symptoms. For women with a reproductive cycle, start treatment on days 12-26, but the frequency can be increased up to 3 times in 4 weeks if symptoms or pain reappear during the drug holiday.
・For infertility/recurrent first-trimester miscarriage: Luteal phase and first trimester pregnancy support. Apply 1 ml of cream (100 mg of progesterone) once daily or in divided doses with a metered applicator on days 12-26 of each cycle until pregnancy is confirmed, and then continue applying 1-2 ml daily until at least the 13th week or until term.
Side Effects
The following side effects may occur. While these side effects usually disappear with dose adjustment, please consult your doctor if you experience any abnormalities.
・Breast pain or tenderness
・Slight vaginal bleeding
・Dizziness, nausea, fatigue, headache, mild headache
Please note that ProFeme contains the same hormone secreted by the human ovary, so side effects are usually minimal.
Precautions
・Consult your doctor if you are taking any other medications.
・Inform other healthcare providers about your use of this product.
・In case of emergency, such as the occurrence of serious side effects, stop taking the medication immediately and consult the nearest medical institution.
・Store below 25°C. (Do not freeze)
Do not use this product if you:
・Have severe liver disease (such as cholestatic jaundice, Rotor syndrome, or Dubin-Johnson syndrome).
・Have unexplained abnormal vaginal bleeding.
・Have a history of herpes during pregnancy.
・Have experienced jaundice during pregnancy.
・Have a known hypersensitivity to ProFeme® cream or any of its ingredients.
Are taking thyroid supplements.
Approval status in Japan
・ProFeme 10 is not approved for treatment in Japan and is not covered by insurance.
*Medicines prescribed in this department are not covered by the Adverse Reactions Relief System.
Availability of approved medicines that have the same active ingredients in Japan
・There are no medicines approved in Japan that have the same active ingredient as ProFeme or are approved for treating symptoms caused by progesterone deficiency.
Means of acquisition
・Our affiliated clinic physicians purchase ProFeme 10 through a domestic pharmaceutical distributor.
Information on safety and approval in other countries
・ProFeme 10 is approved by the Australian Department of Health's Therapeutic Goods Administration (TGA) for the treatment of progesterone deficiency.