País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Norethisterone acetate; Ethinylestradiol
Galen Ltd
G03AA05
Norethisterone acetate; Ethinylestradiol
1mg ; 20microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030100; GTIN: 5016298110401
1.3.1 Package Leaflet 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LOESTRIN* 20 TABLETS LOESTRIN* 30 TABLETS (NORETHISTERONE ACETATE AND ETHINYLESTRADIOL) 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, pharmacist 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 Loestrin is and what it is used for 2. What you need to know before you take Loestrin 3. How to take Loestrin 4. Possible side effects 5. How to store Loestrin 6. Contents of the pack and other information 1. WHAT LOESTRIN IS AND WHAT IT IS USED FOR The name of your medicine is Loestrin tablets. Loestrin contains two types of medicine: • Norethisterone acetate – this is a hormone known as a ‘progestogen’ • Ethinylestradiol – this is a hormone known as an ‘estrogen’. These hormones are similar to those produced naturally by your body during pregnancy. WHAT LOESTRIN IS USED FOR Loestrin is a contraceptive pill used to stop you becoming pregnant. • It is called a ‘combined contraceptive pill’ • This is because it contains two types of medicine. HOW LOESTRIN WORKS The hormones in your pill help stop you from getting pregnant in the following ways: • Stopping eggs being released for fertilisation • Thickening the fluid present in the neck of the womb. This makes it more difficult for sperm to enter the womb • The lining of the womb does not thicken enough for a fertilised egg to become embedded in it. 1.3.1 Package Leaflet 2 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOESTRIN DO NOT TAKE LOESTRIN: • if you are allergic to norethisterone acetate, ethin Leia o documento completo
OBJECT 1 LOESTRIN 20 Summary of Product Characteristics Updated 29-Jan-2018 | Galen Limited 1. Name of the medicinal product Loestrin 20 2. Qualitative and quantitative composition Each Loestrin 20 tablet contains: Norethisterone acetate 1mg Ethinylestradiol 0.02mg Excipients with known effect Each tablet contains 22.55mg of lactose and 38.76mg of sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Blue convex film-coated tablet. 4. Clinical particulars 4.1 Therapeutic indications Loestrin 20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives. The efficacy of any contraceptive method, except sterilisation, depends upon the reliability with which it is used. Correct and consistent use of methods can result in lower failure rates. 4.2 Posology and method of administration Posology One Loestrin 20 tablet should be taken daily at approximately the same time of day for three weeks and then an interval of one week allowed before commencing the second course of tablets. Second and subsequent courses should be taken for three weeks with one week without tablets between courses. Thus each new course of tablets is always started on the same day of the week. It is important that the tablets are taken as directed and should be taken without regard to menstrual bleeding except in the initial cycle. _Pill initiation_ Provided that it is reasonably certain that a woman is not pregnant: • COCs can be started at any time within 5 days of the start of menstrual bleeding without additional contraceptive precautions; • COCs can be started at any other time in the cycle, or by women who are not menstruating, with additional contraceptive precautions for the first 7 days; • a switch can be made from other methods of contraception, whether hormonal or not, at any time in the cycle. Additional contraceptive precautions are required for the first 7 days if changing from a non- hormonal method outside the first 5 days of the menstrual cycle. _Post-partum and post- Leia o documento completo