Hana

Product Information Hana 75 microgram film coated tablets (desogestrel) Indication: Hana 75 microgram film coated tablets contains desogestrel and is indicated for oral contraception in women of childbearing age to prevent pregnancy. Refer to SmPC for further product information. Dosage and Administration: One tablet taken orally. Must be taken at same time every day, always 24h interval between 2 tablets. First tablet should be taken on day 1 of menstrual bleeding, can be started on days 2-5, but barrier method recommended for first 7 days of tablet-taking. Thereafter one tablet daily (continuously) without taking any notice of possible bleeding. When pack of pills is finished, a new pack should be started directly the day after the previous one. Pre-existing bleeding abnormalities such as oligomenorrhoea and amenorrhoea should be investigated before starting Hana. Refer to SmPC for full directions on how to prevent pregnancy. Contraindications: Known or suspected sex-steroid sensitive malignancies. Women with breast cancer. Active venous thromboembolic disorder. Presence or history of severe hepatic disease (as long as liver function values have not returned to normal). Undiagnosed vaginal bleeding. Hypersensitivity to the active substance or excipients. Special warnings and Precautions: Exclude pregnancy before starting Hana. Before starting Hana, use reliable contraceptive method until first day of next period. Women should be advised if menstrual period does not come when expected, she may be pregnant, to do a pregnancy test or see a physician. Provided pregnancy test is negative she can start Hana on the first day of next period. Before starting a new pack of Hana, a woman should be certain she is not pregnant. Refer to SmPC for full directions. Refer to physician if any of the following conditions/risk factors are present: breast cancer, hepatic disorders and disturbances of liver function, hypertension, thromboembolic disorders, changes in bleeding patterns, diabetes, psychiatric disorders, ectopic pregnancy, effect on bone mineral density, conditions reported during pregnancy or during sex steroid use, chloasma, reduced efficacy in event of missed tablets, does not protect against HIV (AIDS) or other sexually transmitted infections, contains lactose, refer to SmPC for full warning and precaution information. Interactions: refer to SmPC for full interaction information. Undesirable Effects: Always consult the SmPC before prescribing. Only the most common side effects and those which are rare but may be serious are listed below. Most commonly reported adverse reactions: bleeding irregularity headache, acne, mood changes, depressed mood, decreased libido, breast pain, nausea and weight increase, amenorrhoea, irregular menstruation. Rare: rash, urticaria, erythema nodosum. On rare occasions ectopic pregnancies reported, hypersensitivity reactions, breast discharge can occur. Aggravation of angioedema and/or aggravation of hereditary angioedema may occur. In women using combined oral contraceptives a number of (serious) undesirable effects have been reported: venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer), and chloasma, breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with hormonal contraceptives. Consult the SmPC in relation to other adverse reactions. Legal Category: P. Pack size: 28 tablets. Retail Price: £9.48 (1x28) £20.90 (3x28). MA Number: PL 17836/0015. MA Holder: Laboratoire HRA Pharma, 200 avenue de Paris, 92320 Chatillon, France. Marketed by: HRA Pharma UK & Ireland Ltd, Haines House, 21 John Street, Bloomsbury, London, WC1N 2BF. Additional information and full Product Information is available on request from med.info.uk@hra-pharma.com Adverse events should be reported. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to HRA Pharma UK & Ireland Ltd on 0800 917 9548 or email med.info.uk@hra-pharma.com Date of last revision of text: November 2020 Company Reference: UK/HANA/0144