Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
drospirenone, Quantity: 4 mg
Besins Healthcare Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; maize starch; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; triacetin; polysorbate 80; titanium dioxide; indigo carmine aluminium lake; iron oxide yellow
Oral
1 x 28 tablets ( 1 x blister containing 24 white active tablets and 4 green placebo tablets) (starter pack), 4 x 28 tablets ( 4 x blisters each containing 24 white active tablets and 4 green placebo tablets), 1 x 28 tablets ( 1 x blister containing 24 white active tablets and 4 green placebo tablets), 3 x 28 tablets ( 3 x blisters each containing 24 white active tablets and 4 green placebo tablets)
(S4) Prescription Only Medicine
Contraception
Visual Identification: Round, green tablet with 'E' and '4' debossed on opposite sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-07-05
Slinda CMI 1 SLINDA CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING SLINDA? Slinda contains the active ingredient drospirenone. Slinda is a contraceptive pill and is used to prevent pregnancy. For more information, see Section 1. Why am I using Slinda? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE SLINDA? Do not use if you have ever had an allergic reaction to Slinda or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Slinda? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Slinda and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE SLINDA? Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Each blister of Slinda contains 24 white active tablets and 4 green placebo tablets. The two differently coloured tablets are arranged in order. The first tablet of the treatment should be taken on the first day of menstrual bleeding. Thereafter, tablet taking is continuous. More instructions can be found in Section 4. How do I use Slinda? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SLINDA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Slinda. Slinda contains lactose (milk sugar). If you have an intolerance to some sugars, contact your doctor before you start to take Slinda. THINGS YOU SHOULD NOT DO • Do not use Slinda if you are pregnant or think you may be pregnant. • Do not use Slinda if you have a blood clot in a blood vessel of the legs, of the lungs or other organs. • Do not use Slinda if your l Διαβάστε το πλήρες έγγραφο
Besins Healthcare Australia Slinda Product Information Version 03 - 04-2021 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION – SLINDA ® (DROSPIRENONE) TABLETS 1. NAME OF THE MEDICINE Drospirenone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION White active film-coated tablets: Each tablet contains 4 mg of drospirenone. Green placebo film-coated tablets: The tablet does not contain active substances. Excipient(s) with known effect: Each white active film-coated tablet contains 17.5 mg of lactose. Each green placebo film-coated tablet contains 55.5 mg of lactose monohydrate. For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Film-coated tablet The active tablet is a round, white tablet with the letters “E” and “D” debossed on opposite sides, with a diameter of 5 mm. The placebo tablet is a round, green tablet with the letter “E” and the number “4” debossed on opposite sides, with a diameter of 5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE HOW TO TAKE SLINDA One tablet is to be taken daily for 28 consecutive days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. Tablets must be taken every day, at about the same time of the day, so that the interval between two tablets is always 24 hours. Tablets should be taken in the order shown on the blister. Stickers marked with the 7 days of the week are provided. The patient should choose the sticker that starts with the day they begin taking the tablets and stick it on the blister. The first tablet of the treatment should be taken on the first day of menstrual bleeding. Thereafter tablet taking is continuous. A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake. Besins Healthcare Australia Slinda Product Information Version 03 - 04-2021 Page 2 of 16 HOW TO START SLINDA _NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONT Διαβάστε το πλήρες έγγραφο