国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Conjugated estrogens; Norgestrel
Pfizer Healthcare Ireland
G03FB; G03FB01
Conjugated estrogens; Norgestrel
0.625 milligram(s)
Coated tablet
Product subject to prescription which may not be renewed (A)
Progestogens and estrogens, sequential preparations; norgestrel and estrogen
Not marketed
1988-11-16
PC 6_0 Page 1 of 11 2016-0014995 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PREMPAK ® -C 0.625MG COATED TABLETS PREMPAK ® -C 1.25MG COATED TABLETS (conjugated estrogens and norgestrel) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Prempak-C is and what it is used for 2. What you need to know before you take Prempak-C 3. How to take Prempak-C 4. Possible side effects 5. How to store Prempak-C 6. Contents of the pack and other information 1. WHAT PREMPAK-C IS AND WHAT IT IS USED FOR Prempak-C is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen and a progestogen. Prempak-C is used to treat some of the symptoms and conditions associated with the menopause. Prempak-C is a sequential HRT (an HRT product where you have a monthly bleed). Prempak-C is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the estrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Prempak-C alleviates these symptoms after menopause. You will only be prescribed Prempak-C if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Prempak-C to prevent osteoporosis after menopause. You must talk to a doc 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prempak-C 0.625mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Conjugated estrogens tablet: 28 maroon tablets each containing 0.625mg of conjugated estrogens. Norgestrel tablet: 12 light brown tablets each containing 0.15mg of norgesterel. Excipients with known effect: 0.625mg conjugated estrogens tablet Each tablet contains lactose monohydrate 91.8 mg, sucrose 126.0 mg and sunset yellow (E110). 0.15mg norgestrel tablet Each tablet contains lactose monohydrate 33 mg, sucrose 21.4 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet. Conjugated estrogen tablets: Oval maroon sugar coated tablets marked with “0.625” in white ink. Norgesterel tablets: Round light brown sugar coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis, (see also section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ Prempak-C is taken orally in a continuous sequential 28-day regimen of conjugated estrogen tablets, with 12 days of Norgestrel tablets taken with the estrogen tablets on days 17 to 28 of the woman’s cycle with no breaks between packs. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see section 4.4) should be used. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 完全なドキュメントを読む