For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory Gestodene and Ethinylestradiol Tablets MINESSE Tablets PHYSICIAN LABELING PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. 1. NAME OF THE MEDICINAL PRODUCT MINESSE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each cycle pack contains: 24 pink active tablets: Each uncoated tablet contains: Gestodene B.P. 60 mcg, Ethinylestradiol I.P. 15 mcg 4 white inactive tablets: Each uncoated tablet contains: Lactose I.P. 45 mg. For the full list of excipients, refer section 6.1. 3. PHARMACEUTICAL FORM Uncoated Tablets 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Minesse is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. 4.2 Posology and Method of Administration How to take Minesse 1 Trademark Proprietor: Wyeth LLC, USA. Licensed User: Pfizer Limited, India. Minesse Tablet Page 1 of 19 LPDMNS052019 PfLEET Number 2018-0045587 The blister of Minesse contains 28 tablets. Minesse pink tablet are to be started on the first day of menstrual bleeding. The Minesse-pill pack has 24 pink pills to be taken for 24 days, followed by 4 white pills to be taken for four days. Start the next pack on the next day of the last white pill taken. After 2–3 days of the ingestion of the last tablet of Minesse the bleeding usually starts due to the withdrawal of the drug and may have not finished until the start of the next pack. Tablets must be taken orally in the order directed on the package every day at about the same time. How to start Minesse No hormonal contraceptive use within the preceding month: the first tablet of Minesse should be taken on the 1st day of the natural menstrual cycle (it means, on the first day of menstrual bleeding). The treatment with Minesse can begin between the 2nd and 7th day of the menstrual cycle, but the use of a non-hormonal contraceptive method is recommended (like condom, spermicidal agent) on the first 7 days after the begin of Minesse. When Minesse is started switching from other oral contraceptive: preferentially, the ingestion of Minesse should begin on the following day after the ingestion of the last active tablet of the former combined oral contraceptive but not later than on the following day after the interval without tablets or after the ingestion of the last inactive tablet of the combined former oral contraceptive. Starting the use of Minesse instead of other contraceptive method with progestogen only (mini-pills), implant, intrauterine device ([IUD], injections): the use of mini- pills can be interrupted at any day and the ingestion of Minesse should begin on the following day. The use of Minesse should begin on the same day when the progestogen implant is removed or of the intrauterine device removal. The use of Minesse should begin on the next date when the injection is scheduled. In each of these situations, the user should be advised to use other non-hormonal contraceptive method during the first 7 days of the Minesse administration. After the abortion in the first quarter: the use of Minesse can begin immediately. Other contraceptive methods are not necessary. Post-partum: because the immediate postpartum period is associated with an increased risk of thromboembolism, the use of Minesse should begin no sooner than the 28th postpartum day following either delivery in a non-lactating woman or on the second quarter after the abortion. The patient should be advised to use a non-hormonal back-up method of birth control during the first 7 days of the administration of Minesse. However, if intercourse has already occurred, the possibility of pregnancy must be ruled out before the use of Minesse is started; otherwise, the woman must wait until her Minesse Tablet Page 2 of 19 LPDMNS052019 PfLEET Number 2018-0045587 spontaneous first menstrual period (see Section 4.4 Special Warnings and Special Precautions for Use). Management of missed tablets of Minesse The contraceptive protection can be reduced if the patient forgets to take a tablet of Minesse and particularly, if the missing of tablets exceeds the interval without taking tablets. It is recommended to ask your doctor about how to proceed. If the patient misses to take a tablet of Minesse but is remembered within 12 hours of the usual dose, it should be taken as soon as it is remembered. Subsequent tablets should be taken at the usual time. If the patient misses to take a tablet of Minesse and it is remembered in more than 12 hours after the usual dose or if two or more active tablets are missed, contraceptive protection may be reduced. The last missed tablet should be taken as soon as it is remembered, which may result in the user taking two tablets on the same day. Subsequent tablets should be taken at the usual time. A non-hormonal back-up method of birth control must be used for the next 7 days. If the patient takes the last active tablet before the end of the 7-day interval during which use of a non-hormonal back-up method of birth control is not required, she must begin a new pack immediately; there should be no tablet-free interval between packs. This prevents an extended break in the tablet-taking interval, thereby reducing the risk of escape ovulation. The user is unlikely to have a withdrawal bleed until all tablets of the new pack are taken, although she may experience spotting or breakthrough bleeding on tablet-taking days. If the patient does not have a withdrawal bleed after all tablets in the new pack are taken, pregnancy must be ruled out before tablet taking is resumed. Guidelines in case of vomits and/or diarrhea If vomiting or diarrhea occurs within 3 to 4 hours after tablet taking, tablet absorption may be incomplete. In this case, the information contained in the section Management of missed tablets of Minesse is applicable. The patient should take an additional active tablet obtained from a new pack. Additional Contraceptive Protection: Use barrier contraceptive methods if it is necessary to use an additional contraceptive protection (for instance, diaphragm or male condom). Do not use table or temperature methods as an additional contraceptive protection because oral contraceptives modify the cyclic menstrual changes, such as the cervical temperature and mucus. Do not interrupt the treatment without the knowledge of your doctor. Inform your doctor if undesirable reactions occur, such as: headache, swelling, nausea, vomits, abdominal pain, weight changes (increase or decrease), depression, nervousness, faintness, sexual interest changes, virginities, intolerance to contact lenses, menstrual flow changes, sensitivity, increase of breasts and breasts secretion. Minesse Tablet Page 3 of 19 LPDMNS052019 PfLEET Number 2018-0045587 The patient should visit her doctor if reactions remain or if they become very uncomfortable. Gastrointestinal upsets If you have severe gastrointestinal upset (such as vomiting or diarrhoea) it is possible that the tablet will not be completely absorbed. Extra contraceptive measures must therefore be taken. If you vomit within 3 to 4 hours after taking a tablet, you must take another tablet as soon as possible. The new tablet must be taken within 12 hours after the time you usually take it. This situation is similar to forgetting to take a tablet and the same advice applies (see Section 4.2 Management of missed tablets of Minesse). If you do not wish to change your normal tablet use calendar, you must start taking the additional tablets by starting another pack. Paediatric population Safety and efficacy was evaluated in subjects aged 18 years and above. Limited data available for use in adolescents below 18 years. Elderly patients Minesse is not indicated after menopause. Patients with hepatic impairment Minesse is contraindicated in women with severe hepatic diseases. See also section ‘Contraindications’. Patients with renal impairment Minesse has not been specifically studied in renally impaired patients. Method of administration Oral use. 4.3 Contraindications Combined hormonal contraceptives (CHCs) should not be used in the following conditions. If one of these disorders occurs during the use of Minesse, Minesse must be discontinued immediately. - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 - Presence or risk of venous thromboembolism (VTE) Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]) Minesse Tablet Page 4 of 19 LPDMNS052019 PfLEET Number 2018-0045587 Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency Major surgery with prolonged immobilisation (see section 4.4) A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4) - Presence or risk of arterial thromboembolism (ATE) Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris) Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA) Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant). History of migraine