국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clomifene citrate
Waymade Healthcare Plc
G03GB02
Clomifene citrate
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050100
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text • Removed pre-printed neutral code from pg1/2 • Reduced the title blocks to run to the margin edge PACKAGE LEAFLET: INFORMATION FOR THE USER CLOMIFENE 50MG TABLETS CLOMIFENE CITRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Clomifene Tablets is and what it is used for 2. What you need to know before you take Clomifene Tablets 3. How to take Clomifene Tablets 4. Possible side effects 5. How to store Clomifene Tablets 6. Contents of the pack and other information 1. WHAT CLOMIFENE TABLETS IS AND WHAT IT IS USED FOR Clomifene Tablets contain a medicine called clomifene citrate. This belongs to a group of medicines called ovulation stimulants. It works by stimulating the release of eggs from the ovary (ovulation). Clomifene Tablets are used for some types of infertility, in women who are not ovulating properly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOMIFENE TABLETS BEFORE TAKING THIS MEDICINE TALK TO YOUR DOCTOR ABOUT THE RISKS OF: • Becoming pregnant with more than one child at the same time (multiple pregnancies) • Pregnancies where the baby grows outside of the womb (ectopic) • A possible increased risk of ovarian cancer Any pregnancy could lead to birth defects or miscarriage. This can happen even if you are not taking Clomifene Tablets. You should talk to your doctor about the possible risks before you take Clomifene Tablets. DO NOT TAKE CLOMIFENE 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clomifene 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contain 50mg of Clomifene Citrate Excipient with known effect Lactose 0.220 g For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White, round tablets with HG C50 on one side and a breakline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clomifene 50mg Tablets are indicated for the treatment of ovulatory failure in women desiring pregnancy. Clomifene 50mg Tablets is indicated only for patients in whom ovulatory dysfunction is demonstrated. Other causes of infertility must be excluded or adequately treated before giving Clomifene 50mg Tablets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults Only: The recommended dose for the first course of Clomifene 50mg Tablets is 50mg (one tablet) daily for five days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of 50mg daily for 5 days should be started on or about the fifth day of the cycle. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment. If ovulation appears not to have occurred after the first course of therapy, a second course of 100mg daily (two 50mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one. Increase of the dosage or duration of therapy beyond 100mg/day for 5 days should not be undertaken. The majority of patients who are going to respond will respond to the first course of therapy, and three courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re- evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation. _Long-term cyclic therapy: _ 전체 문서 읽기