SLINDA® (DROSPIRENONE 4 mg) TABLETS AUSTRALIAN PRODUCT INFORMATION AUSTRALIAN PRODUCT 4.2 Dose And Method Of INFORMATION Administration SLINDA® (DROSPIRENONE) TABLETS Dose How to take SLINDA 1. NAME OF THE MEDICINE One tablet is to be taken daily for 28 Drospirenone consecutive days; one white active tablet daily during the first 24 days and one green inactive tablet 2. QUALITATIVE daily during the 4 following days. Tablets must be taken every day, at about AND QUANTITATIVE the same time of the day, so that the COMPOSITION interval between two tablets is always 24 hours. Tablets should be taken in White active film-coated tablets: the order shown on the blister. Stickers Each tablet contains 4 mg of marked with the 7 days of the week are drospirenone. provided. The patient should choose the sticker that starts with the day they Green placebo film-coated tablets: begin taking the tablets and stick it on The tablet does not contain active the blister. substances. The first tablet of the treatment should Excipient(s) with known effect: be taken on the first day of menstrual Each white active film-coated tablet bleeding. Thereafter tablet taking contains 17.5 mg of lactose. is continuous. A subsequent pack is started immediately after finishing the Each green placebo film-coated tablet previous pack, without a break in daily contains 55.5 mg of lactose monohydrate. tablet intake. For the full list of excipients, see section How to start SLINDA 6.1 List of Excipients. No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the 3. PHARMACEUTICAL FORM patient’s natural cycle (first day of her menstrual bleeding). When doing so, no Film-coated tablet additional contraceptive measures are necessary. The active tablet is a round, white tablet with the letters “E” and “D” debossed on Starting on days 2-5 is allowed, but opposite sides, with a diameter of 5 mm. during the first pill pack a barrier method should be used until the patient The placebo tablet is a round, green has completed 7 days of uninterrupted tablet with the letter “E” and the number white tablet-taking. “4” debossed on opposite sides, with a diameter of 5 mm. Following first-trimester abortion After first-trimester abortion it is recommended to start SLINDA immediately after abortion took place. 4. CLINICAL PARTICULARS In that case there is no need to use an 4.1 Therapeutic Indications additional contraceptive method. Contraception Following delivery or second-trimester Management of missed tablets abortion The management of missed tablets can Contraceptive treatment with SLINDA is be guided by the following two basic recommended to start between 21 and rules: 28 days after delivery or second trimester 1. Seven days of uninterrupted taking abortion. If contraceptive treatment with SLINDA is initiated later but before the of active tablets is required to menstruations have returned, pregnancy attain adequate suppression of the must be ruled out and an additional hypothalamic-pituitary-ovarian-axis. method of contraception should be used Active tablet-taking must never be for the first week. discontinued for longer than 7 days. For breast-feeding patients, see section 2. The greater the number of white 4.6. Fertility, Pregnancy and Lactation active tablets that are missed, and the closer they are to the green Changing from a combined hormonal placebo tablets, the higher the risk of contraceptive (combined oral a pregnancy. contraceptive (COC), vaginal ring or transdermal patch) The patient should start SLINDA If the patient is less than 24 hours preferably on the day after the last late in taking any white active tablet, active tablet (the last tablet containing contraceptive protection is not reduced. the active substances) of their previous The patient should take the tablet as COC or on the day of removal of their soon as they remember and should take vaginal ring or transdermal patch. In further tablets at the usual time. these cases, the use of an additional If the patient is more than 24 hours contraceptive is not necessary. late in taking any white active tablet, contraceptive protection may be The patient may also start SLINDA at reduced. the latest on the day following the usual The following advice can be given if a tablet-free, ring-free, patch-free or white active tablet is missed during: placebo tablet interval of their previous combined hormonal contraceptive, Day 1-7 but during the first 7 days of tablet taking an additional barrier method is The patient should take the last missed recommended. white active tablet as soon as they remember, even if this means taking Changing from a progestogen-only two tablets at the same time. The patient method (progestogen-only pill should then continue to take tablets at (POP), injection, implant) or from a the usual time. progestogen-releasing intrauterine system (IUS) In addition, a barrier method such as a The patient may switch any day condom should be used until they have from another POP and should start completed 7 days of uninterrupted SLINDA the day after, within 24 hours white active table-taking. of discontinuing the previous POP. A patient may switch from an implant If intercourse took place in the or following IUS removal on the same preceding 7 days, the possibility of a day that the implant or IUS is removed. pregnancy should be considered. A patient may switch from using an injectable contraceptive and should start SLINDA on the day the next injection Days 8-17 was due to occur. In all of these cases, the use of an additional contraceptive is The patient should take the last missed not necessary. tablet as soon as they remember, even if this means taking two tablets at the same Provided that in the 7 days preceding time. The patient should then continue to the first missed tablet the patient has take tablets at the usual time. taken all tablets correctly, there is no need to use extra contraceptive Provided that the patient has taken the precautions. active tablets correctly in the 7 days preceding the first missed tablet, there If the patient has missed a tablet is no need to use extra contraceptive during the preceding 7 days, then the precautions. However, if they have patient should use extra contraceptive missed more than 1 tablet, they should precautions for the next 7 days and be advised to use extra precautions follow option a) above. until they have completed 7 days of uninterrupted white active tablet-taking. If the patient missed tablets and subsequently has no withdrawal bleed Days 18-24 in the placebo tablet interval, the possibility of a pregnancy should be Contraceptive reliability is reduced. considered. Contraceptive protection can still be provided, by adhering to either of the Please note: If the patient is not sure following two options: about the number or colour of tablets missed and what advice to follow, a barrier method should be used a. The patient should take the last until they have completed 7 days of missed tablet as soon as they uninterrupted white active tablet-taking. remember, even if this means taking two tablets at the same time. They Green placebo tablets missed then continue to take tablets at the Contraceptive protection is not reduced. Green tablets from the last (4th) row usual time until the white active tablets of the blister can be disregarded. are used up. The 4 green placebo However, the missed tablets should tablets from the last row should be be discarded to avoid unintentionally discarded, and the next blister pack prolonging the placebo tablet phase. started straight away. The patient is unlikely to have a withdrawal bleed Advice in case of gastrointestinal until the end of the active tablets disturbances In case of severe gastrointestinal section of the second pack, but disturbances (e.g., vomiting or they may experience spotting or diarrhoea), absorption may not be breakthrough bleeding on active complete and additional contraceptive tablet-taking days. measures should be taken. b. Alternatively, the patient may be If vomiting or diarrhoea occurs within advised to discontinue active tablet- 3-4 hours after tablet-taking, a new taking from the current blister pack. (replacement) tablet should be taken They should immediately commence as soon as possible. The new tablet taking the green placebo tablets for should be taken within 12 hours of the a maximum of 3 days, such that the usual time of tablet-taking if possible. If more than 12 hours elapse, the advice total number of green placebo tablets concerning missed tablets, as given plus missed active white tablets is in Section 4.2 Dose and Method of not more than 4. The patient should Administration, “Management of missed subsequently commence taking active tablets”, is applicable. If the patient does white tablets from a new blister pack. not want to change their normal tablet- taking schedule, they have to take the extra tablet(s) from another blister pack. Paediatric population exacerbation or first appearance of any Safety and efficacy of SLINDA have been of these conditions, the patient should established in patients of reproductive contact their physician. The physician age. Safety and efficacy are expected should then decide whether SLINDA use to be the same for post pubertal should be discontinued. adolescents under the age of 18 and patients 18 years and older. Use of Hyperkalaemia this product before menarche is not Drospirenone is an aldosterone indicated. antagonist with potassium sparing properties. In most cases, no increase Method of administration of potassium levels is to be expected. For oral use. However, it’s recommended to check serum potassium levels during the first 4.3 Contraindications treatment cycle in patients presenting with renal insufficiency and pre- Progestogen-only contraceptives (POCs) treatment serum potassium in the like SLINDA should not be used in the upper reference range, and during presence of any of the conditions listed concomitant use of potassium sparing below.