Country: Malta
Language: English
Source: Medicines Authority
DIENOGEST, ESTRADIOL VALERATE
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
G03AB08
ESTRADIOL VALERATE DIENOGEST
FILM-COATED TABLET
ESTRADIOL VALERATE DIENOGEST
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2009-01-07
BP22036_REC30610 1 PACKAGE LEAFLET: INFORMATION FOR THE USER QLAIRA FILM-COATED TABLETS Estradiol valerate/Dienogest 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. - 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. IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): - They are one of the most reliable reversible methods of contraception if used correctly - They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks - Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”) _ _ WHAT IS IN THIS LEAFLET: 1. What Qlaira is and what it is used for ............................................................. 2 2. What you need to know before you take Qlaira .............................................. 2 WHEN NOT TO TAKE QLAIRA 2 WARNINGS AND PRECAUTIONS 3 BLOOD CLOTS 4 QLAIRA AND CANCER 9 PSYCHIATRIC DISORDERS 9 BLEEDING BETWEEN PERIODS 9 WHAT TO DO IF NO BLEEDING OCCURS ON DAY 26 OR THE FOLLOWING DAY(S) 9 OTHER MEDICINES AND QLAIRA 9 QLAIRA WITH FOOD AND DRINK 10 LABORATORY TESTS 10 PREGNANCY AND BREAST-FEEDING 10 DRIVING AND USING MACHINES QLAIRA CONTAINS LACTOSE 11 3. How to take Qlaira......................................................................................... 11 PREPARATION OF THE WALLET 11 WHEN CAN YOU START WITH THE FIRST WALLET? 11 BP22036_REC30610 2 IF YOU TAKE MORE QLAIRA THAN YOU SHOULD 12 IF YOU FORGET TO TAKE QLAIRA 12 USE IN CHILDREN 13 WHAT TO DO IF YOU VOMIT OR HAVE SEVERE DIARRHOEA Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Qlaira film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets each containing 3 mg estradiol valerate 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest 2 dark red tablets each containing 1 mg estradiol valerate 2 white tablets do not contain active substances Excipient with known effect: lactose (not more than 50 mg per tablet) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Dark yellow film-coated tablet, round with biconvex faces, one side is marked with the letters “DD” in a regular hexagon Medium red film-coated tablet, round with biconvex faces, one side is marked with the letters “DJ” in a regular hexagon Light yellow film-coated tablet, round with biconvex faces, one side is marked with the letters “DH” in a regular hexagon Dark red film-coated tablet, round with biconvex faces, one side is marked with the letters “DN” in a regular hexagon White film-coated tablet, round with biconvex faces, one side is marked with the letters “DT” in a regular hexagon 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. The decision to prescribe Qlaira should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Qlaira compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Oral use POSOLOGY HOW TO TAKE QLAIRA Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. O Read the complete document