Consumer medicine information

NorLevo-1

Levonorgestrel

BRAND INFORMATION

Brand name

NorLevo-1 Tablets

Active ingredient

Levonorgestrel

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using NorLevo-1.

What is in this leaflet

This leaflet answers some common questions about NorLevo-1.

It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist, nurse or family planning clinic.

All medicines have risks and benefits. Your doctor, pharmacist, nurse or family planning clinic have weighed the risk of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor, pharmacist, nurse or family planning clinic.

Keep this leaflet with the medicine.

You may want to read it again.

What NorLevo-1 is used for and how it works

NorLevo-1 is an oral emergency contraceptive indicated for use within 72 hours of unprotected intercourse. It is not intended as a regular method of contraception.

It contains the active ingredient levonorgestrel.

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.

NorLevo-1 is thought to work by:

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

Therefore, 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.

Before you take NorLevo-1

When you must not take it

Do not take this medicine if:

  • you are allergic to the active ingredient or any of the other ingredients listed at the end of this leaflet under Product Description
  • you are pregnant or think you may be pregnant
  • 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.

Do not take this medicine after the expiry date printed on the pack 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.

Before you start to take NorLevo-1

Tell your doctor, pharmacist or nurse if you have allergies to any other medicines, foods, preservatives or dyes.

You should consult your doctor, pharmacist or nurse before taking NorLevo-1 if:

  • you have any severe digestive diseases (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 had breast cancer in the past
  • you suffer from severe liver disease.

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.

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.

Tell your doctor, pharmacist or nurse, if you are breastfeeding.

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. The milk should be expressed and discarded the first 8 hours after dosing.

Taking other medicines

Tell your doctor, pharmacist or nurse if you are taking any other medicines, including any that you get 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 affect how well it works. Your doctor, pharmacist or nurse can advise you on what to do if you are taking any of these medicines.

How to take NorLevo-1

Take 1 tablet as a single dose as soon as possible, preferably within 12 hours, after the unprotected intercourse and not later than 72 hours (3 days) after the intercourse.

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.

Swallow the tablet whole with a full glass of water.

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.

Your doctor or pharmacist should advise you to use a barrier contraception method until your next period.

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.

How often can you take NorLevo-1?

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 take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 131 126 or New Zealand 0800 POISON or 0800 764766) or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much NorLevo-1, or if a child has taken this medicine. Do this even if there are no signs of discomfort or poisoning.

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.

While you are taking NorLevo-1

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.

Things you must do

Tell any doctors and pharmacists who treat you that you are taking this medicine.

Things you must not do

Do not give this medicine to anyone else.

Things to be careful of

Be careful driving or operating machinery until you know how NorLevo-1 affects you.

It may cause dizziness or light-headedness in some people.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Tell your doctor, pharmacist or nurse if you notice any of the following and they worry you:

  • nausea and vomiting
  • diarrhoea
  • dizziness, fatigue, headache
  • lower abdominal pain
  • tender breasts
  • increased vaginal bleeding, irregular bleeding or spotting. Most women will 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.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.

These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.

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

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

After taking NorLevo-1

After you have taken this medicine, if you want to have sex, you should use other contraceptive methods, because NorLevo-1 won't stop pregnancy from further unprotected sex. Your doctor or pharmacist should advise you to use a barrier contraception method until your next period.

After you have taken this medicine, you are advised to make an appointment to see your doctor about three weeks later, to make sure that NorLevo-1 has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor 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.

Storage

Keep NorLevo-1 in the original packaging to protect from light until you need to take it.

Keep NorLevo-1 in a cool dry place where the temperature stays below 30°C.

Do not store NorLevo-1 or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

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

The expiry date of your medicine is printed on the pack. Do not use the tablet after this date.

Disposal

Return any unused or out of date medicine to your pharmacist.

Product description

What it looks like

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

Available in blister packs of 1 tablet.

Ingredients

Active ingredient:
Each NorLevo-1 tablet contains 1.5mg levonorgestrel.

Inactive ingredients:

  • lactose monohydrate
  • starch - maize
  • povidone
  • silica - colloidal anhydrous
  • magnesium stearate.

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

Where to go for further information

If you have any questions on the use of NorLevo-1, you should discuss these with your doctor, pharmacist, nurse or family planning clinic.

Supplier

NorLevo-1 is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road,
Macquarie Park, NSW 2113
Tel: 1800 634 500

NorLevo-1 is supplied in New Zealand by:
Novartis New Zealand Limited
Private Bag 65904 Mairangi Bay
Auckland 0754
Tel: 0800 354 335

This leaflet was revised in September 2016

Australian Register Number
NorLevo-1 1.5mg tablet: AUST R 166340 (blister)

BRAND INFORMATION

Brand name

NorLevo-1 Tablets

Active ingredient

Levonorgestrel

Schedule

S3

 

Name of the medicine

Levonorgestrel.

Excipients.

Lactose monohydrate, maize starch, povidone, anhydrous colloidal silica, magnesium stearate.

Description

Chemical name: (-)13β-ethyl-17β-hydroxy, 18,19-dinor-17α-pregn-4-en-20-yn-3-one. Molecular formula: C21H28O2. MW:312. 5. CAS: 797-63-7. 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.
NorLevo-1 contains levonorgestrel 1.5 mg as active ingredient.

Pharmacology

Levonorgestrel is a progestogen.

Pharmacodynamics.

The precise mode of action of Norlevo-1 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. It may also cause endometrial changes that discourage implantation.

Efficacy.

From earlier studies where two levonorgestrel tablets (each 750 micrograms) have been taken 12 hours apart, it has been estimated that levonorgestrel prevents 85% of expected pregnancies. Efficacy appears to decline with time after intercourse (95% within 24 hours, 85% 24 to 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 a single 1.5 mg tablet to two 750 microgram tablets, it has been determined that the efficacy would be similar.

Pharmacokinetics.

Absorption.

After oral administration of 1.5 mg levonorgestrel (two 750 microgram tablets as a single dose), the plasma terminal half-life of the product is estimated to 43 hours. The maximal plasma concentration of levonorgestrel (approximately 40 nanomol/L) is reached within 3 hours.
Another study on pharmacokinetics following administration of a 1.5 mg levonorgestrel tablet found maximum plasma drug levels of 15.4 nanogram/mL at two hours. Thereafter, levonorgestrel plasma levels decreased with a half-life of approximately 29 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 in 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 breastfed infant.

Clinical Trials

Two recent studies compare the efficacy of two 0.75 mg doses of levonorgestrel when given 12 hours apart with a single dose of 1.5 mg levonorgestrel.
The pivotal study was a randomised, double blind multicentre trial conducted in ten countries by the WHO (Lancet 2002, 360:1803-10). Of 4,071 women with known outcome, groups of 1,356 women each took either two doses of 0.75 mg levonorgestrel 12 hours apart or 2 x 0.75 mg levonorgestrel at once. There was no significant difference in efficacy between the two levonorgestrel treatment groups. When levonorgestrel was administered within 72 hours after unprotected intercourse 84% (95% CI: 73.0-90.5) of expected pregnancies were prevented with the single dose regimen compared to 79% (95% CI: 66.2-86.8) in the two dose group.
In a second double blind, randomised study (Contraception 2002, 66, 269-273), the efficacy and safety of levonorgestrel given in two doses of 0.75 mg 12 hours apart (group A) or 1.5 mg given at once (group B) was studied in 1,160 Nigerian women seeking emergency contraception up to 72 hours after unprotected intercourse. Of the 1,118 women analysed for efficacy, 545 were in group A and 573 in group B. Eleven intrauterine pregnancies (7 in group A and 4 in group B) were recorded. Results for the two regimens using the conception probabilities for all conceptions and recognized conceptions calculated from pooled British and North Carolina data indicate that both regimens were effective with the single 1.5 mg dose treatment being significantly more effective (p < 0.05).
For interval between intercourse and initiation of treatment, shorter intervals were associated with lower pregnancy rates in both levonorgestrel treatment groups of both studies.

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.

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.

Precautions

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 (see Use in children and Dosage and 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.

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 recommending NorLevo-1. An elevated blood pressure is not a contraindication to treatment but indicates the need for further investigation.
No routine laboratory testing is required.
Explain the importance of follow up and the possibility of an early or late onset of the next menstrual period to the patient. Advise the practice of abstinence or careful use of a barrier method until the onset of the next period. Follow up with a doctor three weeks after administration of therapy should be advised 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. Women should be warned that if pregnancy occurs after treatment with NorLevo-1, there is a possibility of an ectopic pregnancy.

Precautions after use.

If pregnancy occurs after treatment with NorLevo-1, 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 NorLevo-1. Women suffering from conditions associated with possible malabsorption should be referred for medical consultation as consideration should be given to the taking of more tablets. Patients should be given another tablet if they vomit within two hours of taking NorLevo-1 (see Dosage and Administration).

Impaired hepatic function.

NorLevo-1 is not recommended in patients with severe hepatic dysfunction.

Use in pregnancy.

(Category D)
NorLevo-1 is not to be used during an existing or suspected pregnancy. Research has found no significant effects on fetal 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 eight weeks postconception, progestogens such as levonorgestrel can cause virilisation of the female fetus. This is a dose dependent effect. Prior to eight weeks postconception, they have no virilising effects. There are no studies of the effect of the high levonorgestrel doses used in levonorgestrel 1.5 mg tablets on pregnancy and embryo/ fetal development.

Use in lactation.

Progestogens do not appear to affect the quantity or quality of breast milk. However, levonorgestrel is secreted into breast milk. Therefore, it is suggested to breastfeed immediately before taking the NorLevo-1 tablet and to skip nursing following NorLevo-1 administration for at least 8 hours. The milk should be expressed and discarded during the first 8 hours after dosing.

Effect on fertility.

Levornorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date; however there are no long term fertility data.

Use in children.

NorLevo-1 is not indicated for the use in children.

Carcinogenesis and mutagenesis.

No studies of the carcinogenic or mutagenic potential of levonorgestrel 1.5 mg 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.

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 NorLevo-1 in preventing pregnancy. Drugs suspected of having the capacity to reduce the efficacy of levonorgestrel containing medications include barbiturates (including primodone), 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 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.

Adverse 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 post-marketing 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: Very rare (< 1/10,000): rash, urticarial, 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.

Dosage and Administration

Adults.

One tablet should be taken. The efficacy of the method is higher the sooner after the unprotected intercourse the treatment is initiated. Therefore, the tablet must be taken as soon as possible, preferably within 12 hours, after the unprotected intercourse and no longer than 72 hours (3 days) after the intercourse.
If the patient vomits within two hours of taking the tablet, she should return to her pharmacist, doctor or clinic where another tablet may be given.
NorLevo-1 can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.

Children.

NorLevo-1 is not recommended in children. Only limited data are available 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.

Overdosage

Contact the Poisons Information Centre on 131 126 for advice on management of overdose.

Symptoms.

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea and withdrawal bleeding may occur.

Treatment.

In case of overdose treatment should be supportive and symptomatic. There are no specific antidotes.

Presentation

Tablet, 1.5 mg (white, round, biconvex, marked NL 1.5 on one side): 1's (blister pack).

Storage

Store below 30°C. Store in the original package to protect from light.
Shelf life: 36 months.

Poison Schedule

S3.