Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OESTROGENS,CONJUGATED
PFIZER (MALAYSIA) SDN. BHD.
OESTROGENS,CONJUGATED
28 Tablet Tablets
PFIZER IRELAND PHARMACEUTICALS
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PREMARIN ® TABLET Conjugated oestrogens (0.3 mg, 0.625 mg) 2 WHAT IS IN THIS LEAFLET 1. What PREMARIN is used for 2. How PREMARIN works 3. Before you use PREMARIN 4. How to use PREMARIN 5. While you are using it 6. Side effects 7. Storage and Disposal of PREMARIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PREMARIN IS USED FOR PREMARIN helps to relieve symptoms associated with deficiency of female hormone oestrogen or female hypoestrogenism. Symptoms such as: -hot flushes and night sweats -vaginal burning, itching, irritation, and dryness -discomfort/pain during intercourse -painful urination and an increased incidence of urinary tract infections -urinary incontinence After the menopause some women may be at risk of developing fragile bones (osteoporosis). PREMARIN helps to prevent and manage thinning of the bones which can cause fractures. HOW PREMARIN WORKS PREMARIN is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. It is like the hormones produced by the ovaries before menopause. When given during or after menopause, they can help control the symptoms. BEFORE YOU USE PREMARIN - _When you must not use it _ Do not take PREMARIN: - if you have or have had breast cancer, or if you are suspected of having it; - if you have cancer which is sensitive to oestrogens, such as cancer of the lining of the womb (endometrium) or if you are suspected of having it; - if you have excessive thickening of the womb lining (endometrial hyperplasia); - if you are pregnant or think you are pregnant; - if you have uterine bleeding of unknown cause; - if you have or have had a blood clot in a vein, such as in the legs or the lungs; - if you have or recently have had a disease caused by blood clots in the arteries, such as heart attack or stroke ; - if you are allergic to oestrogen or any of the ingredients of PREMARIN; - if you have liver disease; - if you have a disorder affecting Прочетете целия документ
Pfizer Conf iden tial LPD Title: Premarin Tablets (Con jug ated Estrog ens) LPD Date: 27 May 2016 Cou ntry: Malay sia Reference : CDS Version 29.0 (Dated 15 April 20 15), USPI (Rev ised: 12 /20 14 ) Reason for chan ge: The CDS is being revised to update section 5.1. A 12 week, prospective, randomized double blind placebo - controlled study data is being reworded so that the data is more correctly presented. The ADR tables were updated to appear in correct SOC sequence as p er MedDRA a nd no ADR was added or deleted. Opportunity has been taken to make some minor editorial corrections throughout the CDS. 1. NAME OF THE ME DICIN AL PRODUCT Premarin ® 2. QU ALITATIVE AND QUANT ITATIVE COM POSITION Premarin ® (con juga ted estrog ens tablets, USP) for o ral admi nistration cont ains a mix ture of conjugated estrogens obtained exclusi vely from natural sources, occurr ing as the sodium salts of water-soluble estrogen sulfates blende d to r ep resent the ave rage co mposition of material deri ved from pregnant ma res’ urine. It is a mixture of sod ium estrone sulfate and sod ium equilin sulfate. It contains as co ncomitant com pon ents, as sodium sulfate conjugates, 1 7α-dihydroequilin, 1 7α-estradiol, and 17β- dihydroequilin. 3. PHARM ACEUTICAL FORM Tab lets in 0.3 mg and 0.625 mg str engths of conjugated estr ogens. 4. CLINIC AL PARTIC ULARS 4.1 Thera peutic Indic ation 1. Mo derate to severe vasomotor sym ptoms associ ated with estrogen deficiency. 2. Pre vent ion and ma nag ement of osteopo rosis associated with estrog en deficiency. W hen prescribi ng solely for the preve ntion of post -men opau sal osteoporosis, therapy sho uld only be conside red for wo men at significant risk of osteo porosis and for whom no n-estrogen med icat ions are not c onside red ap propriat e. W hen prescribing solely for the man ageme nt of post-menopausal os teo porosis, no n-est roge n me dications shou ld be first co nsidered. 3. Atro phic vaginitis and atrophic urethritis. W hen prescr ibing solely for the treatment of sym pt Прочетете целия документ