Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Levonorgestrel
IMED Healthcare Ltd.
G02BA; G02BA03
Levonorgestrel
Intrauterine delivery system
Intrauterine contraceptives; plastic IUD with progestogen
2022-02-25
PACKAGE LEAFLET: INFORMATION FOR THE USER KYLEENA 19.5 MG INTRAUTERINE DELIVERY SYSTEM levonorgestrel 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 any further questions, ask your doctor or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kyleena is and what it is used for 2. What you need to know before you use Kyleena 3. How to use Kyleena 4. Possible side effects 5. How to store Kyleena 6. Contents of the pack and other information 1. WHAT KYLEENA IS AND WHAT IT IS USED FOR Kyleena is used for the prevention of pregnancy (contraception) for up to five years. Kyleena is a T-shaped intrauterine delivery system (IUS) which after placement inside the womb slowly releases a small amount of the hormone levonorgestrel. Kyleena works by reducing the monthly growth of the lining of the womb and thickening the cervical mucus. These actions prevent the sperm and egg from coming into contact and so prevent fertilization of an egg by sperm. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KYLEENA GENERAL NOTES Before you can begin using Kyleena, your healthcare professional will ask you some questions about your personal health history. In this leaflet, several situations are described where Kyleena should be removed, or where the reliability of Kyleena may be decreased. In such situations you should either not have intercourse or you should use a condom or another barrier method. Kyleena, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease. Kyleena is not suitable for use as an emergency contraceptive (postcoital contraceptive). DO NOT USE KYLEENA IF YOU: • are pregnant (see section “Pregnancy, breast-feedi Read the complete document
Health Products Regulatory Authority 25 February 2022 CRN00CPS0 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kyleena 19.5 mg intrauterine delivery system 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The intrauterine delivery system contains 19.5 mg levonorgestrel. For the full list of excipients, see section 6.1. For details of release rates, see SmPC section 5.2 of PA1410/081/001. 3 PHARMACEUTICAL FORM Intrauterine delivery system (IUS). _Product imported from France:_ The product consists of a whitish or pale yellow drug core covered with a semi-opaque membrane, which is mounted on the vertical stem of a T-body. In addition, the vertical stem contains a silver ring located close to the horizontal arms. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. The blue coloured removal threads are attached to the loop. The vertical stem of the IUS is loaded in the insertion tube at the tip of the inserter. The inserter consists of a handle and slider that are integrated with flange, lock, pre-bent insertion tube and plunger. The removal threads are located within the insertion tube and handle. Dimensions of Kyleena: 28 x 30 x 1.55 mm 4 CLINICAL PARTICULARS As per PA1410/081/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/081/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Polydimethylsiloxane elastomer Silica, colloidal anhydrous Polyethylene Barium sulfate Polypropylene Copper phthalocyanine Silver 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the blister package and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 25 February 2022 CRN00CPS0 Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER The product is individually packed into a thermoformed blister package (PETG) with a peelable lid (PE). Read the complete document