SLINDA drospirenone 4 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

drospirenone, Quantity: 4 mg

Available from:

Besins Healthcare Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

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)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Contraception

Product summary:

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

Authorization status:

Registered

Authorization date:

2021-07-05

Patient Information leaflet

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

Summary of Product characteristics

Besins Healthcare Australia
Slinda Product Information
Version 03 - 04-2021
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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
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HOW TO START SLINDA
_NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONT