FULL CMI

NorLevo-1^®

Active ingredient(s): Levonorgestrel 1.5 mg

Consumer Medicine Information (CMI)

This leaflet provides important information about using NorLevo-1. You should also speak to your doctor, pharmacist, nurse or family planning clinic if you would like further information or if you have any concerns or questions about using NorLevo-1.

Where to find information in this leaflet:

1. Why am I using NorLevo-1?
2. What should I know before I use NorLevo-1?
3. What if I am taking other medicines?
4. How do I use NorLevo-1?
5. What should I know while using NorLevo-1?
6. Are there any side effects?
7. Product details

1. Why am I using NorLevo-1?

NorLevo-1 contains the active ingredient levonorgestrel.
This medicine is an emergency oral contraceptive indicated for use within 72 hours of unprotected sex. It is not intended as a regular method of contraception. It works by:

• stopping your ovaries from releasing an egg
• preventing sperm from fertilizing any eggs you may have already released
• stopping a fertilized egg from attaching itself to your womb lining

NorLevo-1 stops a pregnancy before it is established. It does not work if you are already pregnant. NorLevo-1 does not protect against sexually transmitted diseases.

NorLevo-1 must be taken as soon as possible, preferably within 12 hours and no later than within 72 hours of unprotected intercourse. It has been estimated that NorLevo-1 will prevent 85% of expected pregnancies if taken within 72 hours. The sooner you take NorLevo-1, the more likely it is that it will work.

2. What should I know before I use NorLevo-1?

Warnings

Do not use NorLevo-1 if:

• you know or suspect you are pregnant. NorLevo-1 does not work if you are already pregnant.
• you are allergic to levonorgestrel, or any of the ingredients listed at the end of this leaflet.
• you have previously had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, as you may already be pregnant
• you have unexplained vaginal bleeding
• you have breast cancer

Check with your doctor or pharmacist if you:

• have any severe digestive disease (e.g. Crohn's disease) which impair the absorption of medications
• you suffer from diabetes mellitus
• you suffer from high blood pressure or ischaemic heart disease (a reduced blood flow in the vessels that provide your heart muscle with blood)
• you have ever suffered a stroke
• you have or had breast cancer in the past
• you suffer from severe liver disease
• take any medicines for any other condition

If any of these conditions apply to you, NorLevo-1 may not be suitable for you, or other types of emergency contraception may be better for you.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

You should not take this medicine if you are already pregnant.

If you have had unprotected sex which was more than 72 hours ago in the same menstrual cycle, you may already be pregnant, and the treatment won't work. If your period was more than 5 days late or was unusually light or unusually heavy, you should check with your doctor that you are not already pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed. Small amounts of levonorgestrel may appear in your breast milk. Therefore, you should breastfeed immediately before taking the NorLevo-1 tablet and avoid nursing for at least 8 hours afterwards. During this time, it is recommended you use a breast pump to maintain milk production and that you discard any expressed milk the first 8 hours after dosing.

3. WHAT IF I AM TAKING OTHER MEDICINES?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop, in particular the following:

• medicines used to treat epilepsy: e.g. barbiturates, primidone, phenytoin and carbamazepine,
• medicines used to treat tuberculosis: e.g. rifampicin and rifabutin,
• medicines used to treat HIV infection: e.g. ritonavir, efavirenz,
• griseofulvin, a medicine used to treat fungal infections
• herbal remedies containing St John's wort (Hypericum perforatum)
• medicines used to prevent organ transplant rejection: cyclosporin

These medicines may be affected by NorLevo-1 or may make it less effective. Ask your doctor, pharmacist or nurse if you are taking any of these medicines, including using another non-hormonal emergency contraceptive such as copper-IUD, or doubling the dose of NorLevo-1.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NorLevo-1.

4. How do I use NorLevo-1?

How much to take

• Take 1 tablet as a single dose as soon as possible, preferably within 12 hours, after unprotected sex and not later than 72 hours (3 days) after intercourse.
• Swallow the tablet whole with a full glass of water.
• Follow the instructions provided with the medicine
• Do not exceed the recommended dosage.

When to take NorLevo-1

• The sooner you take the tablet, the more effective the treatment will be and the more likely an unexpected pregnancy will be prevented. It is best to take the tablet immediately after you receive it.

If you take too much NorLevo-1

If you think that you have taken too much NorLevo-1, or if a child has taken this medicine, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick or have vaginal bleeding.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using NorLevo-1?

Things you should know

• You should only take NorLevo-1 in emergencies and not as a regular method of contraception.
• If NorLevo-1 is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle.
• If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular time.
• If you vomit within two hours of taking this medicine, you should return to your doctor, pharmacy, nurse or family planning clinic. You may need another dose, as the first one may not have been absorbed completely.
• NorLevo-1 is not recommended for use in children.
  There is only limited information available on this medicine when taken by women aged 14-16 years and no information on its use in younger women or children.
• NorLevo-1 is for occasional use only and should not be used as a regular method of contraception.

Things you should do after taking NorLevo-1

If you want to have sex, you should use a reliable barrier contraceptive method, such as condoms until your next period. This is because NorLevo-1 will not work if you have unprotected sex again. Your doctor or pharmacist should advise you to use a barrier contraception method until your next period.

You are advised to make an appointment to see your doctor about three weeks after taking NorLevo-1, to make sure the medicine has worked.

Most women have a normal period at the expected time. But some may have their period later or earlier than normal. If your period is more than 5 days late or is unusually light or unusually heavy, or especially painful, you should contact your doctor or pharmacist as soon as possible.

Your doctor can also tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use the contraceptive pill and you do not have a bleed in your pill-free week or while you are taking the non-hormonal tablets, see your doctor to make sure you are not pregnant.

If you do become pregnant even after taking this medicine, it is important to see your doctor. There is no evidence that NorLevo-1 will harm a baby that develops in your uterus/womb, but your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking NorLevo-1 or if you previously had an ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.

You should tell your doctor if you have had any unusual pain or vaginal bleeding. If abdominal pain is severe, you should see your doctor immediately.

Some women using hormonal contraceptives have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. Although there is limited evidence with emergency contraceptive use specifically, if you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible. Remind any doctor or pharmacist you visit that you are using NorLevo-1.

Things you should not do

• Do not take NorLevo-1 if you are or think that you are pregnant.
• Do not give this medicine to anyone else.
• Do not use NorLevo-1 as a regular method of contraception.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how NorLevo-1 affects you.

After taking NorLevo-1 some women experience dizziness or light-headedness. If this happens, do not drive or operate machinery.

Looking after your medicine

• Store below 30°C.
• Store in the original packaging in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
  - in the bathroom or near a sink, or
  - in the car or on windowsills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

Do not use this medicine after the expiry date or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may also occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over the counter without a doctor's prescription.

What NorLevo-1 contains

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What NorLevo-1 looks like

NorLevo-1 is a white, round, biconvex tablet engraved with code NL 1.5 on one face. Available in blister packs of 1 tablet (Aust R 166340).

Who distributes NorLevo-1

Perrigo Australia,
25 – 29 Delawney Street
Balcatta WA 6021 Australia
Tel: 1800 805 546
E-mail: [email protected]

NorLevo-1^® is a registered trademark and product of:

Laboratoire HRA Pharma,
200 avenue de Paris
92320 CHATILLON
France

This leaflet was prepared in January 2025.

Published by MIMS April 2025

1 Name of Medicine

Levonorgestrel.

2 Qualitative and Quantitative Composition

NorLevo-1 contains 1.5 mg of levonorgestrel as active ingredient.

List of excipients with known effect.

3 Pharmaceutical Form

NorLevo-1 is a white, round, biconvex tablet engraved with code 'NL 1.5' on one face.

4 Clinical Particulars

4.1 Therapeutic Indications

NorLevo-1 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

Adults.

Children.

4.3 Contraindications

NorLevo-1 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 NorLevo-1 following the second act of intercourse 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 NorLevo-1 regimen consisting of the emergency use of one 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 Organization 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.
Isolated cases of thromboembolic events have been reported after levonorgestrel intake. No causal relationship with levonorgestrel has been formally demonstrated, but the possibility of occurrence of a thromboembolic event should be considered in women with other pre-existing thromboembolic risk factor(s), especially personal or family history suggesting thrombophilia.
Since exposure to levonorgestrel with NorLevo-1 is brief, the risks of pregnancy in all women, including those with pre-existing medical conditions, are almost certainly greater than those associated with NorLevo-1. In individual cases the risk benefit ratio should be assessed by the practitioner in discussion with the patient. Only limited data are available about use in young women of childbearing 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 Paediatric use; Section 4.2 Dose and Method of Administration).
NorLevo-1 is not as effective as conventional regular methods of contraception and is suitable only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider a long-term method of contraception.
Emergency contraception does not protect against sexually transmitted infections.
Limited and inconclusive data suggest that there may be reduced efficacy of levonorgestrel with increasing body weight or body mass index (BMI). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
Depressed mood and depression have been reported as undesirable effects of hormonal contraceptives. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Although there is limited evidence with emergency contraceptive use specifically, women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after NorLevo-1 intake.

Precautions before use.

Precautions after use.

Use in hepatic impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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. Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%. This may reduce the effectiveness of NorLevo-1 in preventing pregnancy. Drugs suspected of having similar capacity to reduce plasma levels of levonorgestrel include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John's wort), rifampicin, ritonavir, rifabutin, and griseofulvin.
For women who have used enzyme-inducing drugs in the past 4 weeks and need emergency contraception, the use of non-hormonal emergency contraception (e.g. Cu-IUD) should be considered. Taking a double dose of levonorgestrel (i.e. 3000 micrograms within 72 hours after the unprotected intercourse) is an option for women who are unable or unwilling to use the non-hormonal emergency contraception. The concomitant use of the double dose of levonorgestrel with an enzyme inducer has not been studied.
Medicines containing levonorgestrel may increase the risk of cyclosporin 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.

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)

Table 1 gives the frequency of undesirable effects reported in clinical trials.
One ectopic pregnancy was observed in trial 2 and none in trial 1.
There have been rare reports of ectopic pregnancies reported during postmarketing surveillance.
Breast tenderness, spotting and irregular bleeding are reported in up to 30 percent of patients and can last until the next menstrual period which can be delayed.
Cutaneous hypersensitivity reactions have been reported following administration of levonorgestrel.
Isolated cases of thromboembolic events have been reported during the postmarketing period, but no causal relationship with levonorgestrel has been formally demonstrated.

From postmarketing surveillance additionally, the following adverse events have been reported.

Skin and subcutaneous tissue disorders.

Reproductive system and breast disorders.

Gastrointestinal disorders.

General disorders and administration site conditions.

Psychiatric disorders.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives. ATC code: G03AD01.

Mechanism of action.

Efficacy.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

NorLevo-1 also contains the following inactive ingredients: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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 30°C. Store in the original package to protect from light.

6.5 Nature and Contents of Container

NorLevo-1 is available in PVC/PE/PVDC-Aluminium blister packs of 1 tablet.

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, crystalline powder. Practically insoluble in water, sparingly soluble in methylene chloride, slightly soluble in alcohol, acetone and ether and soluble in chloroform.
Chemical name: (-)13β-ethyl-17β-hydroxy, 18,19-dinor-17α-pregn-4-en-20-yn-3-one.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes