Consumer medicine information

1. Why am I using Rosie?

Rosie contains the active ingredients drospirenone and ethinylestradiol. Rosie is a contraceptive pill and is used to prevent pregnancy, treat moderate acne and treat symptoms of premenstrual dysphoric disorder (PMDD) in women seeking oral contraception.
For more information, see Section 1. Why am I using Rosie? in the full CMI.

2. What should I know before I use Rosie?

Do not use if you have ever had an allergic reaction to Rosie 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 Rosie? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Rosie 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 use Rosie?

• Take one tablet daily at about the same time each day. You must take Rosie every day regardless of how often you have sex. This will also help you remember when to take it.

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Rosie has 24 active tablets and 4 inactive tablets per blister, rather than the traditional 21 active tablets and 7 inactive tablets. This means that with Rosie, you take the active (hormone) tablets for three more days. This helps your hormone levels to stay even.

5. What should I know while using Rosie?

6. Are there any side effects?

Serious side effects that need to be noted are: pain in the chest, arm or below the breastbone; pain or discomfort that goes to your back; breathlessness and/or difficulty breathing; swelling, pain or tenderness of one leg; sudden weakness, numbness or bad ‘pins and needles’ of the face, arm or leg, especially on one side of the body; sudden trouble walking, dizziness, loss of balance or coordination; severe, sudden stomach pains; a fainting attack or you collapse; unusual headaches or migraines that are worse than usual; sudden problems with speaking, seeing or understanding what people are saying to you.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Sandoz Pty Ltd

1 Name of Medicine

Drospirenone and ethinylestradiol.

2 Qualitative and Quantitative Composition

Rosie is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol.
Each pink active tablet contains 20 microgram ethinylestradiol and 3 mg drospirenone.
List of excipients with known effects. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Active tablets. Pink, round, biconvex film-coated tablets, plain on one side and with "DR1" on the other side.
Placebo tablets. White to off-white, round, biconvex film-coated tablets, plain on both sides.

4 Clinical Particulars

4.9 Overdose

There has not yet been any clinical experience of overdose with ethinylestradiol/drospirenone 20 microgram/3 mg. On the basis of general experience with COCs, symptoms that may occur in case of overdose of active tablets are: nausea, vomiting and withdrawal bleeding. The last may even occur in girls before their menarche, if they have accidentally taken the medicinal product. There are no antidotes and further treatment should be symptomatic.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There is limited evidence available in the literature suggesting that estrogens may be weakly genotoxic at high doses. Ethinylestradiol was negative in studies for DNA-adduct formation in cultured human liver slices and in assays for gene mutations (bacterial or mammalian cells in vitro) and gave equivocal results in assays for chromosomal damage in vitro (clastogenic effects were not consistently seen and occurred at high concentrations). In vivo studies did not confirm these results.
Drospirenone was found to induce chromosome aberrations in human peripheral lymphocytes. However, drospirenone was not mutagenic in bacterial and mammalian cell gene mutation assays in vitro, and was not clastogenic in mouse micronucleus assays in vivo. Interactions between drospirenone and the DNA of liver cells which indicate a genotoxic potential were found in in vitro and in vivo studies in rats. No such finding was observed in human liver cells in vitro.
Carcinogenicity. Long-term carcinogenicity studies were performed in mice and rats with drospirenone, ethinylestradiol and with a combination of both products. After 2 years oral treatment of mice and rats with drospirenone alone there were no increases in the incidence of neoplastic lesions. Exposure to drospirenone (based on AUC) was up to 3-fold (mice) and 8-fold (rats) than that anticipated in humans at the recommended clinical dose. In contrast, treatment with the combination of drospirenone and ethinylestradiol resulted in an increased rate of neoplastic lesions in the mammary glands and uteri of mice and rats and in the pituitary glands of mice. The tumour pattern was similar but the incidence increased even further in animals receiving ethinylestradiol alone, indicating that ethinylestradiol was responsible for the increase in neoplastic lesions. Co-administration of drospirenone decreased the carcinogenic potential of ethinylestradiol in the mouse pituitary and in the mouse and rat uterus and mammary gland.
The ethinylestradiol-induced tumours in rodents have previously been seen with other ethinylestradiolcontaining products, and are considered attributable to species-specific effects of estrogens on prolactin secretion in rodents.
Although, long-term animal studies did not definitively indicate a tumourigenic potential for the clinical use of either drospirenone or ethinylestradiol, it should be borne in mind that sex steroids can promote the growth of certain hormone-dependent tissues and tumours.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ethinylestradiol is an estrogen. Ethinylestradiol is a white or slightly yellowish-white, crystalline powder. It is practically insoluble in water, freely soluble in ethanol (96%). It dissolves in dilute alkaline solutions.
Drospirenone is a progestogen. Drospirenone is white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in ethanol (96%).
Chemical structure. Ethinylestradiol.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSETHEST.gif Chemical name: 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol.
Molecular formula: C₂₀H₂₄O₂.
Molecular weight: 296.41.
Drospirenone.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDROSPI.gif Chemical name: 3-Oxo-6α,7α,15α,16α-tetrahydro-3'H,3''H-dicyclopropa[6,7:15,16]-17α-pregn4-en-21,17-carbolactone.
Molecular formula: C₂₄H₃₀O₃.
Molecular weight: 366.50.
CAS number. Ethinylestradiol. 57-63-6.
Drospirenone. 67392-87-4.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ROSIEDST.gif