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Composition |
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Each soft gelatin capsule of Each 2 ml ampoule of REMENS contains:
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REMENS 100 / 200 contains: Progesterone . . . ....100 mg |
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Micronised progesterone . . |
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. 100 / 200 mg Benzyl alcohol . . . 200 mg |
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Ethyl oleate . . . q.s. |
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Therapeutic Indications & Usage |
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REMENS is indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized post-menopausal women who are receiving conjugated estrogens tablets. It is also indicated for use in secondary amenorrhea, as menopausal hormone therapy as an adjunct, prevention of recurrent miscarriage or treatment of threatened abortion.
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Contraindications |
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REMENS is contraindicated in known hypersensitivity to its ingredients, known / suspected pregnancy, thrombophlebitis, thromboembolic disorders, cerebral apoplexy, severe liver disease or dysfunction, known / suspected malignancy of breast or genital organs, undiagnosed vaginal bleeding, missed abortion and as a diagnostic test for pregnancy.
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Precautions |
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REMENS must be advocated with due precaution in epilepsy, migraine, asthma, cardiac or renal dysfunction, and along with estrogens especially in diabetics.
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Warnings |
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Before instituting therapy with REMENS, physical examination including especially of breast and genital organs, as well as Papanicolaou smear are advisable. In case of any vaginal bleeding whilst on progesterone (REMENS) adequate diagnostic measures are indicated. REMENS must be promptly discontinued if any manifestations of thrombotic disorders occur. Sudden partial or complete vision loss, onset of proptosis, diplopia, or migraine necessitates withdrawal of REMENS if examination reveals papilledema or retinal vascular lesions. |
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Since transient dizziness can occur, caution is advisable whilst driving a motorvehicle, or operating machinery during REMENS treatment. REMENS must be advocated during lactation only if strictly required. In pregnancy, it must be advised only if indicated. The safety and efficacy of natural progesterone (REMENS) in pediatric patients have not been established. |
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Adverse Reactions |
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The most common side effects with progesterone (REMENS) include dizziness, breast pain, headache, abdominal pain, fatigue, viral infection, abdominal distention, musculoskeletal pain, emotional lability, irritability, and upper respiratory tract infections. However, these adverse reactions are lesser with REMENS as it provides natural progesterone (REMENS) as compared to other already available traditional estrogen brands.
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Other uncommon reactions include dry mouth, accidental injury, chest pain, fever, anorexia / increased appetite, increased sweating, asthenia, tooth disorder, hypertension, confusion, somnolence, speech disorder, gastrointestinal disturbances, ear ache, palpitations, edema, musculoskeletal complaints, psychiatric manifestations, female genital system abnormalities, respiratory inflammations, acne verruca, wound debridement, urinary tract infection, abnormal vision and lymphadenopathy. |
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Drug Interaction: |
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REMENS should be administered shift here with caution along estrogens. |
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Recommended Dosage & Administration |
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REMENS Soft Gelatin Capsule |
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PREVENTION OF ENDOMETRIAL HYPERPLASIA: 2 REMENS 100 / 1 REMENS 200 Soft Gelatin Capsule/s as single daily evening dose for 12 days sequentially per 28 day cycle in postmenopausal women who are receiving daily conjugated estrogen tablets. |
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PREVENTION OF ENDOMETRIAL HYPERPLASIA: 2 REMENS 100 / 1 REMENS 200 Soft Gelatin Capsule/s as single daily evening dose for 12 days sequentially per 28 day cycle in postmenopausal women who are receiving daily conjugated estrogen tablets.
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SECONDARY AMENORRHEA: 2 REMENS 200 Soft gelatin Capsules as a single daily evening dose for 10 days. |
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REMENS Injection |
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DYSFUNCTIONAL UTERINE BLEEDING / AMENORRHEA: 5-10 mg intramuscular (IM) injection of progesterone daily for about 5-10 days until 2 days before the anticipated onset of menstruation. |
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PREVENTION OF RECURRENT MISCARRIAGE: 25-100 mg IM progesterone from about day 15 of the pregnancy until 8 to 16 weeks. |
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Presentation |
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REMENS 100 Soft Gelatin Capsules: Blister of 10s.
REMENS 200 Soft Gelatin Capsules: Blister of 10s.
REMENS Injections: 2 ml ampoules. |
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