Consumer medicine information

1. Why am I using ELEANOR 150/30 ED?

ELEANOR 150/30 ED contains the active ingredients ethinylestradiol and levonorgestrel. ELEANOR 150/30 ED is used to prevent pregnancy. For more information, see Section 1. Why am I using ELEONOR 150/30 ED? in the full CMI.

2. What should I know before I use ELEANOR 150/30 ED?

Do not use if you have ever had an allergic reaction to ELEANOR 150/30 ED 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 ELEANOR 150/30 ED? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ELEANOR 150/30 ED 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 ELEANOR 150/30 ED?

• Take one tablet daily at about the same time every day.

• You must take ELEANOR 150/30 ED every day regardless of how often you have sex.

• Swallow the tablet whole with a full glass of water. It does not mater if you take it before or after food.

5. What should I know while using ELEANOR 150/30 ED?

6. Are there any side effects?

Common side effects: acne; nausea; stomach pain; changes in weight; headache, including migraines; mood changes, including depression; breast tenderness or pain; hair loss or hair growth.
Serious side effects: Blood clots, jaundice (yellowing skin or yellowing eyes), you cough up blood, unexplained vaginal bleeding and breast lumps.
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 Arrotex Pharmaceuticals

1 Name of Medicine

Levonorgestrel and ethinylestradiol.

2 Qualitative and Quantitative Composition

Eleanor 150/30 ED is a combined oral contraceptive (COC) tablet containing the synthetic progestogen levonorgestrel and the synthetic estrogen ethinylestradiol.
Each yellow film-coated active tablet contains 30 microgram ethinylestradiol and 150 microgram levonorgestrel.
List of excipients with known effects: Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Active tablet. Yellow, round biconvex film-coated tablets debossed with LE4 on one side and plain on other side.
Placebo tablet. White to off-white, round shaped, biconvex film-coated tablets, plain on both sides.

4 Clinical Particulars

4.9 Overdose

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case 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 (clastogenic effects were not consistently seen and occurred at high doses).
The genotoxic potential of levonorgestrel has not been fully investigated, although limited data available to date suggest that it does not appear to be genotoxic.
Carcinogenicity. Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis and liver. A long-term study with levonorgestrel in dogs showed an increased incidence of mammary tumours, although a similar effect was not apparent in studies in mice, rats or monkeys. The occurrence of these mammary tumours in dogs may be due in part to a hormonal feedback mechanism. The clinical relevance of these findings is uncertain.
Numerous epidemiological studies have been conducted to determine the incidence of breast, endometrial, ovarian and cervical cancer in women taking COCs. Some of these studies have shown an increased relative risk of breast cancer in certain subgroups of COC users. Women with a strong family history of breast cancer or who have breast nodules, fibrocystic disease or abnormal mammograms should be monitored with particular care. Benign hepatic adenomas have been found to be associated with the use of oral contraceptives. Although benign, hepatic adenomas may rupture and cause death through intra-abdominal haemorrhage. Some epidemiological studies also suggest that COC use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women, although there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as HPV. It must also be borne in mind that sexual steroids can promote the growth of certain hormone dependent tissues and tumours (see Section 4.4 Special Warnings and Precautions for Use).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Levonorgestrel is a white or almost white, crystalline powder. Practically insoluble in water; sparingly soluble in methylene chloride and slightly soluble in ethanol (96%).
Ethinylestradiol is a white or slightly yellowish-white crystalline powder. It is practically insoluble in water, soluble in chloroform and in ether, freely soluble in alcohol.
Chemical structure. Levonorgestrel.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLEVONO.gif Chemical name: 13β-ethyl-17β-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one.
Molecular formula: C₂₁H₂₈O₂.
Molecular weight: 312.45.
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, 17β-diol.
Molecular formula: C₂₀H₂₄O₂.
Molecular weight: 296.41.
CAS number. Levonorgestrel. 797-63-7.
Ethinylestradiol. 57-63-6.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes

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

References

1. Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance study on Oral Contraceptives based on 142,475 women-years of observation. Contracept 2007; 75:344-54.
2. Long-term Active Surveillance Study for Oral contraceptives (LASS), 2nd update report based on study status. May 2009.