Consumer medicine information

Levonorgestrel-1 GH

Levonorgestrel

BRAND INFORMATION

Brand name

Levonorgestrel-1 GH

Active ingredient

Levonorgestrel

Schedule

What is in this leaflet

This leaflet answers some common questions about Levonorgestrel-1 GH. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist will have discussed and considered the risks of you taking LEVONORGESTREL-1 GH against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist. Your doctor and pharmacist have more information.

Keep this leaflet with the medicine. You may need to read it again.

What Levonorgestrel-1 GH is used for

LEVONORGESTREL-1 GH is an emergency contraceptive only.

LEVONORGESTREL-1 GH is not intended as a regular method of contraception. It is used to prevent pregnancy when taken within 72 hours of unprotected intercourse. It is estimated that LEVONORGESTREL-1 GH will prevent 85% of expected pregnancies. The sooner that you take LEVONORGESTREL-1 GH after unprotected intercourse, the more likely it is that the medication will work.

LEVONORGESTREL-1 GH is most effective if taken within 72 hours of unprotected intercourse. But remember that the sooner you take it, the more likely it will work.

LEVONORGESTREL-1 GH will not prevent you from catching sexually transmitted diseases. Ask your doctor or pharmacist if you have any questions about why you are taking LEVONORGESTREL-1 GH.

Before you take Levonorgestrel-1 GH

Before you start treatment with Levonorgestrel-1 GH, your doctor or pharmacist should

Check you are not already pregnant if he/she suspects you may already have been pregnant before this occurrence of unprotected intercourse
Ask you if you are taking any other medicines (see Taking other medicines)
Ask if you suffer from high blood pressure
Advise you of the need for careful use of a barrier method of contraception until you have your next period
Advise you to see your doctor in three weeks time, especially if you have not had a period by then
Discuss the need for regular contraception.

You should consult your doctor before you take it if:

You have diabetes mellitus (with kidney, eye or nerve damage, or vascular disease) - Diabetes mellitus is a condition in which the body does not produce enough insulin or else the body tissues are not able to use the insulin present. This leads to hyperglycaemia (too much sugar in the blood)
You have ischaemic heart disease (heart disease caused by reduced blood flow in the blood vessels of the heart muscle)
You have suffered a stroke
You have had breast cancer
You have severe liver disease.

If any of these conditions apply to you it may not be suitable for you to take LEVONORGESTREL-1 GH.

You have a disease of your gastro-intestinal tract (such as Crohn’s disease) that interferes with the digestion and absorption of your food;
You are vomiting or have severe diarrhoea.

If these conditions apply to you your doctor may recommend a higher dose.

When you must not take it

Do not take LEVONORGESTREL-1 GH if:

You are pregnant
You have previously had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, as you may already be pregnant
You are experiencing vaginal bleeding for which the reason is not known
You have breast cancer
You are allergic to any of the ingredients of the tablets (See Product Description below)
The tablets do not look quite right.

Do not take LEVONORGESTREL-1 GH after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including those purchased from a supermarket or health food store. Some medicines may prevent LEVONORGESTREL-1 GH from working properly or LEVONORGESTREL-1 GH may affect the way other medicines work. Examples of medicines which may interfere with LEVONORGESTREL-1 GH are:

Medicines used to treat epilepsy (for example, barbiturates, primidone, phenytoin, and carbamazepine).
Medicines used to treat tuberculosis (for example, rifampicin, rifabutin).
A treatment for HIV infection (ritonavir).
A medicine used to treat fungal infections (griseofulvin).
Herbal remedies containing St John’s Wort (Hypericum perforatum).

How to take Levonorgestrel-1 GH

Take the tablet as soon as possible after unprotected intercourse. The sooner that you take the tablet, the more effective the treatment is likely to be. It is best to take it immediately after you receive it. The tablet should be taken no later than 72 hours after intercourse.

LEVONORGESTREL-1 GH is not recommended for children. There is only limited information available on LEVONORGESTREL-1 GH when taken by women aged 14-16 years and no information on its use in younger women or children.

While taking Levonorgestrel-1 GH

If you vomit within 2 hours of taking the tablet you should return to your pharmacy, doctor or clinic as the tablet may not be absorbed and you will need to take an additional tablet.

Things you must do

Tell any doctor or pharmacist who are treating you that you have taken Levonorgestrel-1 GH.

Things you must not do

Do not give LEVONORGESTREL-1 GH to anyone else.

Things to be careful of

If LEVONORGESTREL-1 GH makes you drowsy or dizzy, do not drive a car or operate machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after you take Levonorgestrel-1 GH.

All medicines have side effects. Often they are not serious but sometimes they can be. You may need medical treatment if you get some side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Common side effects are tiredness, nausea and vomiting. Some patients have also experienced stomach pain, diarrhoea, dizziness, headache, tender breasts, increased vaginal bleeding and skin reactions.

Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

After taking Levonorgestrel-1 GH

You should see your doctor within 3 weeks of taking Levonorgestrel-1 GH. You may experience spotting or vaginal bleeding earlier than expected.

If you do not get your period within 3 weeks of taking the tablets you must see your doctor, as you may be pregnant. If LEVONORGESTREL-1 GH does not work, you could be pregnant. Your doctor will order a pregnancy test. If stomach pain is severe you should see your doctor immediately as on rare occasions a tubal pregnancy could occur

LEVONORGESTREL-1 GH is only intended as an emergency measure. If you have not already done so you should discuss with your doctor other methods of long term contraception.

You should not breast feed within three days after taking Levonorgestrel-1 GH.

If you take too much (Overdose)

Telephone your doctor, or the Poisons Information Centre (13 11 26) if you take too many LEVONORGESTREL-1 GH tablets, or if a child has taken Levonorgestrel-1 GH.

Product description

LEVONORGESTREL-1 GH contains one blister sheet containing one tablet. Each white tablet contains 1.5 mg of levonorgestrel and the following excipients: lactose, maize starch, povidone, colloidal anhydrous silica, magnesium stearate.

Storage

Keep your tablet in the pack until it is time to take it. If you take the tablet out of the pack it will not keep well.

Keep your tablet in a cool, dry place where the temperature stays below 25°C. Protect from light.

Do not store LEVONORGESTREL-1 GH or any other medicine in the bathroom or near a sink.

Do not leave it in the car on hot days or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least 1 1/2 metres above the ground is a good place to store medicines.

The expiry date is printed on the pack and the foil blister. Do not use LEVONORGESTREL-1 GH after this expiry date.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Supplier

Generic Health Pty Ltd.
Level 1, 1102 Toorak Rd
Camberwell VIC 3124

The AUST R for LEVONORGESTREL-1 GH is 217542.

This leaflet was first prepared in February 2013.

MP/DRUGS/28/6/2010

ID#: 240839

Published by MIMS April 2019

BRAND INFORMATION

Brand name

Levonorgestrel-1 GH

Active ingredient

Levonorgestrel

Schedule

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Levonorgestrel.

2 Qualitative and Quantitative Composition

Levonorgestrel-1 GH tablet contains 1.5 mg of levonorgestrel.

List of excipients with known effect.

Lactose monohydrate (see Section 4.4 Special Warnings and Precautions for Use, Excipients).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Levonorgestrel-1 GH is a white to off-white, round shaped tablet debossed with 'LV1' on one side and plain on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Levonorgestrel is an oral emergency contraceptive indicated for use within 72 hours of unprotected intercourse. It should be used only as an emergency measure.
Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.

4.2 Dose and Method of Administration

Dosage.

One 1.5 mg tablet to be taken as soon as possible (and not later than 72 hours) after unprotected intercourse.
The highest efficacy is achieved if the tablet is taken as early as possible. Therefore, treatment should not be delayed as efficacy declines with time.
If the patient vomits within two hours of taking the tablet, she should return to her pharmacist, doctor or clinic where an additional tablet may be given.
Levonorgestrel can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.

Children.

Levonorgestrel is not recommended in children. Only limited data are available in young women of child-bearing potential aged 14-16 years. No data are available about use in young women aged less than 14 years or children.

Method of administration.

For oral administration.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 List of Excipients.
Levonorgestrel should not be given to pregnant women. If menstrual bleeding is overdue, if the last menstrual period was abnormal in timing or character or if pregnancy is suspected for any other reason, pregnancy should be excluded (by pregnancy testing or pelvic examination) before treatment is given.
If a woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle conception may have already occurred. Treatment with levonorgestrel following the second act of intercourse during the same menstrual cycle may therefore be ineffective in preventing pregnancy. While the consensus is that levonorgestrel is not teratogenic, no guarantee can be given that pregnancy will result in a normal baby.
Progestogen-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time and are contraindicated in some conditions. It is not known whether these same conditions apply to the levonorgestrel regimen consisting of the emergency use of one 1.5 mg tablet.
Traditionally many of the contraindications to combined hormonal contraception have been applied to progestogen-only contraception. Since the contraindications largely apply to oestrogen this is inappropriate. In their Medical Eligibility Criteria, the World Health Organisation advises that the only absolute contraindications to high dose progestogen-only contraception are unexplained vaginal bleeding, current breast cancer, pregnancy or hypersensitivity to any of the ingredients of the preparation.

4.4 Special Warnings and Precautions for Use

Conditions which are regarded as relative contraindications include severe hypertension (BP > 180+/110+), diabetes mellitus with nephropathy, retinopathy, neuropathy or vascular disease, ischaemic heart disease, stroke, or a past history of breast cancer. Since exposure to levonorgestrel with Levonorgestrel-1 GH is brief, the risks of pregnancy in all women, including those with pre-existing medical conditions, are almost certainly greater than those associated with levonorgestrel. In individual cases the risk-benefit ratio should be assessed by the practitioner in discussion with the patient.
If pregnancy occurs or there are complaints of severe lower abdominal pain after treatment with levonorgestrel, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low, as levonorgestrel prevents ovulation and fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding. Therefore, levonorgestrel is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy).
Repeated administration within a menstrual cycle is not advisable. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.
Emergency contraception should be taken as soon as possible after unprotected sexual intercourse or failure of a contraceptive method.

Excipients.

Levonorgestrel-1 contains 140.1 mg lactose. This should be taken into account in women with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption.

Regular methods of contraception.

Levonorgestrel is not as effective as conventional regular methods of contraception and is suitable only as an emergency contraceptive measure. Emergency contraception does not protect against sexually transmitted infections. If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded.

Sexually transmitted diseases.

Levonorgestrel does not protect against sexually transmitted diseases (STDs), including HIV/AIDS.

Precautions before use.

Exclude pregnancy if suspected clinically.
Breast or pelvic examinations are not routinely necessary. Perform such examinations only if indicated by the patient's history.
Blood pressure may be measured before prescribing levonorgestrel. An elevated BP is not a contraindication to treatment but indicates the need for further investigation.
No routine laboratory testing is required.
Possibility of an early or late onset of the next menstrual period.
Advise the practice of abstinence or careful use of a barrier method (e.g. condom, diaphragm, spermicide, cervical cap) until the onset of the next period. Follow-up should be offered 3 weeks after administration of therapy to assess the effectiveness of the method, to discuss future management if a period has not occurred, and to counsel the patient about future contraception. The use of levonorgestrel does not affect the continuation or starting of regular hormonal contraception.
Women should be warned that if pregnancy occurs after treatment with levonorgestrel, there is a possibility of an ectopic pregnancy.

Precautions after use.

If pregnancy occurs after treatment with levonorgestrel, the possibility of an ectopic pregnancy should be considered.
Vomiting, severe diarrhoea or other causes of malabsorption, such as Crohn's disease, might impair the efficacy of Levonorgestrel-1 GH. Women suffering from conditions associated with possible malabsorption should be referred for medical consultation as consideration should be given to the taking of another tablet. If the patient vomits within two hours of taking the tablet, she should return to her pharmacist, doctor or clinic where an additional tablet may be given (also see Section 4.2 Dose and Method of Administration).

Use in hepatic impairment.

Levonorgestrel is not recommended in patients with severe hepatic dysfunction.

Use in the elderly.

No data available.

Paediatric use.

Levonorgestrel is not indicated for use in children.
Only limited data are available in young women of child-bearing potential aged 14 to 16 years. No data are available about use in young women aged less than 14 years or in children (also see Section 4.2 Dose and Method of Administration).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The metabolism of levonorgestrel can be enhanced by concomitant use of drugs which induce CYP3A4, one of the family of liver enzymes. This may reduce the effectiveness of levonorgestrel in preventing pregnancy. Concomitant use of liver enzyme inducers like efavirenz, rifampin and medicinal products for epilepsy is not recommended.
Drugs suspected of having the capacity to reduce the efficacy of levonorgestrel containing medicines include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St John's Wort), rifampicin, ritonavir, rifabutin, griseofulvin and efavirenz.
Medicines containing levonorgestrel may increase the risk of ciclosporin toxicity due to possible inhibition of cyclosporin metabolism.
Levonorgestrel has the ability to decrease glucose tolerance when it is used in the longer term. However, use of levonorgestrel as an emergency contraceptive is not thought to induce significant modification of carbohydrate metabolism.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Levonorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation dates. These changes can result in modified fertility dates. However, there are no long-term fertility data.
(Category D)
Levonorgestrel is not to be used during an existing or suspected pregnancy. Research has found no significant effects on foetal development associated with the long-term use of contraceptive doses of combined oral steroids before pregnancy or taken inadvertently during early pregnancy. There have been an insufficient number of pregnancies in patients using levonorgestrel-only oral contraceptives to rigorously evaluate the potential for developmental toxicity; however, based on the combined oral contraceptive experience, an increase in abnormalities is not expected. If taken by the mother at or after 8 weeks post conception, progestogens such as levonorgestrel can cause virilisation of the female foetus. This is a dose dependent effect. Prior to 8 weeks post conception, they have no virilising effects. There are no studies of the effect of the high levonorgestrel doses used in Levonorgestrel-1 GH on pregnancy and embryo/foetal development.
Progestogens do not appear to affect the quantity or quality of breast milk. However, levonorgestrel has been identified in the breast milk following oral administration to lactating women. Women should be advised not to breast-feed within 3 days after taking levonorgestrel.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

The adverse reactions reported with an incidence of greater than 1% in the Ho and Kwan and the Pivotal Studies (two 750 microgram tablets taken 12 hours apart) are included in Table 1.

Side effects did not result in any discontinuations in either study. No ectopic pregnancies or congenital abnormalities were reported in either study. However, such a possibility must always be considered, as there have been rare reports of ectopic pregnancies reported during post-marketing surveillance. Cutaneous reactions have also been reported from post-marketing surveillance on rare occasions.
In the additional studies conducted to compare dosing with two 750 microgram tablets taken as a single dose and taking the two tablets 12 hours apart, the adverse events recorded were mostly similar to the above studies, as detailed in Table 2.

One ectopic pregnancy was observed in the pivotal study and none in the supporting (Arowojolu) study.
Overall, there was no indication that taking the full 1.5 mg dose at the one time resulted in an adverse event profile of greater concern than that for the regimen when the two 750 microgram tablets were taken 12 hours apart.
From post-marketing surveillance the following adverse events have been reported:

Skin and subcutaneous tissue disorders.

Very rare (< 1/10,000): rash, urticaria, pruritus.

Reproductive system and breast disorders.

Very rare (< 1/10,000): pelvic pain, dysmenorrhoea.

Gastrointestinal disorders.

Very rare (< 1/10,000): abdominal pain.

General disorders and administration site conditions.

Very rare (< 1/10,000): face oedema.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea and vomiting, and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The precise mode of action of levonorgestrel is not known. Emergency hormonal contraception is thought to work mainly by preventing ovulation and fertilisation by altering tubal transport of sperm and/or ova. Levonorgestrel is not effective once the process of implantation has begun.

Clinical trials.

Two large controlled studies of levonorgestrel using 750 microgram tablets (two tablets taken 12 hours apart), for emergency contraception have been undertaken. The first of these is referred to as the Ho and Kwan study and the second, which included larger numbers, as the Pivotal study. Both studies compared this treatment regime to the Yuzpe regimen (ethinylestradiol 100 micrograms plus levonorgestrel 500 micrograms, repeated 12 hours later).
The Ho and Kwan study was a single-centre and open-label (age range 18-45 years) while the Pivotal study was multi-centre, randomised and double-blind (age range 14-47 years), with both including women requiring emergency contraception resulting from no contraception used during intercourse or contraception method failure. The regimens were similar with two exceptions:
The Ho and Kwan study allowed treatment to be initiated up to 48 hours post intercourse whereas the Pivotal study allowed a 72-hour gap between treatment initiation and intercourse.
The treatment regimen in both studies used two tablets, the second taken 12 hours after the first. In the Pivotal study only, women in each of the two groups were provided with replacement medication to take should vomiting occur within four hours of either dose.
The efficacy results from the efficacy population analysis from the two studies are summarised in Table 3.

The relative risk of pregnancy in the Pivotal study for the Yuzpe versus levonorgestrel regimens was 2.8 with a lower one-sided 95% confidence bound of 1.53.
Stratified analyses of the data showed no significant effect for age or ethnicity. For interval between intercourse and initiation of treatment, shorter intervals were associated with lower pregnancy rates.
Two further studies have been conducted in order to determine whether taking two 750 microgram tablets at the same time (as a single dose) was as efficacious as taking the two tablets 12 hours apart.
The pivotal study for this comparison was a double blind, randomised, double dummy multicentre study, conducted by the WHO/HRP across 10 countries. This study included women ranging in age from 14 to 52 years and allowed for enrolment up to 120 hours after intercourse.
A supporting study (Arowojolu et al, 2002) for this comparison was conducted in Nigeria at a single-centre. A total of 1,118 women were assessed for efficacy in this study.
The efficacy results from the data analysis for the two treatment regimens from both studies are summarised in Table 4.

There was no significant difference in efficacy between the two levonorgestrel treatment groups in the pivotal study. Shorter intervals between intercourse and treatment were associated with lower pregnancy rates in both groups.
The authors of the supporting study (Arowojolu et al, 2002) concluded that both treatment regimens were effective - the single two tablet dose appeared to be more effective than when the two tablets were taken 12 hours apart and that the earlier the medication is taken after unprotected intercourse, the better the efficacy.
Adverse events reported in these two studies were similar for both treatment groups (see Section 4.8 Adverse Effects (Undesirable Effects)).
No specific clinical trials investigating pregnancy outcome have been conducted on the single 1.5 mg tablet. Evidence for its efficacy is based on the 1.5 mg tablet and two 750 microgram tablets taken at the same time having the same pharmacokinetic profile.

Efficacy.

From earlier studies where two levonorgestrel tablets (each 750 micrograms) have been taken 12 hours apart, it has been estimated that this regimen prevents 85% of expected pregnancies. Efficacy appears to decline with time after intercourse (95% within 24 hours, 85% 24-48 hours, 58% if used between 48 and 72 hours).
In an additional study to compare taking the two tablets 12 hours apart versus taking a total dose of 1.5 mg after unprotected intercourse, similar rates of prevention of pregnancy were observed when taken within 72 hours. In this study, it was also observed that efficacy declined with increasing time of taking the medication after intercourse.
In further studies to compare the bioavailability of the single 1.5 mg tablet to two 750 microgram tablets, it has been determined that the efficacy would be similar.

5.2 Pharmacokinetic Properties

Absorption.

A study compared the pharmacokinetics of a 1.5 mg levonorgestrel tablet taken as a single dose with that of two 750 microgram tablets taken 12 hours apart. Following ingestion of one 1.5 mg tablet, maximum plasma drug levels of 18.5 nanogram/mL were found at 2 hours. Thereafter, levonorgestrel plasma levels decreased with a half-life of approximately 26 hours. In this study, the C_max was higher for the single 1.5 mg tablet, but plasma levels over a 24-hour period were similar, as were the T_max and half-life.
In another study, a comparison of the pharmacokinetics with two 750 microgram tablets taken together (as a single dose) or 12 hours apart showed similar levels of serum levonorgestrel over a 24-hour period, and similar terminal half-lives (43.7 versus 43.3 hours). The C_max was about 50% higher when the two tablets were taken together than when they were taken 12 hours apart (12.3 versus 7.9 nanogram/mL, p = 0.03), and this occurred at 2.5 and 1.8 hours, respectively, after the (first) dose.
When the bioavailability of a single 1.5 mg levonorgestrel tablet was compared to two 750 microgram tablets taken at the same time, AUC and C_max were found to be the same with both treatments. In this study, maximum plasma drug levels of 19.1 nanogram/mL were found at 1.7 hours following the ingestion of one 1.5 mg tablet. Thereafter, levonorgestrel plasma levels decreased with a half-life of approximately 27 hours.
In general, it is recognised that the pharmacokinetics of levonorgestrel can be quite variable.

Distribution.

Levonorgestrel is bound to serum albumin and sex hormone binding globulin (SHBG). Only about 1.5% of the total serum levels are present as free steroid, but 65% are specifically bound to SHBG.

Metabolism and excretion.

Levonorgestrel is not excreted in unchanged form but as metabolites. Levonorgestrel metabolites are excreted in about equal proportions with urine and faeces. The biotransformation follows the known pathways of steroid metabolism with levonorgestrel being hydroxylated in the liver and the metabolites then excreted as glucuronide conjugates. No pharmacologically active metabolites are known.
The absolute bioavailability of levonorgestrel was determined to be almost 100% of the dose administered.
About 0.1% of the maternal dose can be transferred via milk to the nursed infant.

5.3 Preclinical Safety Data

Genotoxicity.

No studies of the mutagenic potential of levonorgestrel have been performed.

Carcinogenicity.

No studies of the carcinogenic potential of levonorgestrel have been performed.
Numerous epidemiological studies have been performed to determine the incidence of breast, endometrial, ovarian and cervical cancer in women using combination oral contraceptives. Some studies suggest that combination oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women but 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 human papilloma virus (HPV). Evidence in the literature suggests that use of combination oral contraceptives is not associated with an increased risk of developing breast cancer in the overall population of users. However, some of these same studies have shown an increased relative risk of breast cancer in certain subgroups of combination-oral-contraceptive users, although no consistent pattern of findings has been identified. Benign hepatic adenomas have been found to be associated with the use of oral contraceptives containing levonorgestrel. Although benign, hepatic adenomas may rupture and cause death through intra-abdominal haemorrhage. The contribution of the progestin component of oral contraceptives to the development of hepatic adenomas is not known.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each white tablet contains the following excipients: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C in original container. Do not remove from primary pack except for immediate use. Protect from light.

6.5 Nature and Contents of Container

Levonorgestrel-1 GH contains one blister sheet (PVC/PVDC/Aluminium).

Australian registration numbers.

Levonorgestrel-1 GH: AUST R 217542.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Levonorgestrel is a white or almost white, odourless or almost odourless, crystalline powder. Practically insoluble in water; slightly soluble in alcohol, acetone, and ether; soluble in chloroform; sparingly soluble in methylene chloride.

Chemical structure.

Levonorgestrel-1 GH is an emergency oral contraceptive tablet containing the synthetic progestogen, levonorgestrel. Levonorgestrel is a progestogen.

Chemical Name: 13- Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one.
Molecular Formula: C₂₁H₂₈O₂.
Molecular Weight: 312.45.
Melting Point: 232-239°C.

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Levonorgestrel-1 GH

Levonorgestrel

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BRAND INFORMATION

Levonorgestrel-1 GH 1.5 mg Tablets