LEVONORGESTREL TABLET

NAME OF THE MEDICINAL PRODUCT

LevonorgestrelTablet IP 0.75 mg,

LevonorgestrelTablet IP 1.5 mg,

LevonorgestrelTablet  BP 0.75 mg,

LevonorgestrelTablet  BP 1.5 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 750 microgram levonorgestrel Excipients: each tablet contains 45.45 mg lactose monohydrate.

The tablet contains 1500 microgram of levonorgestrel
Excipient with known effect: each tablet contains 142.5 mg lactose monohydrate.

PHARMACEUTICAL FORM
Tablet White, round and biconvex tablet with no marking.

 CLINICAL PARTICULARS

Therapeutic indications
Emergency contraception within 72 hours after an unprotected sexual intercourse or in case of failure of a contraceptive method.

 Posology and method of administration

Posology
For oral administration: One tablet should be taken as soon as possible, preferably within 12 hours and no later than 72 hours after unprotected intercourse.
If vomiting occurs within three hours of taking the tablet another tablet should be taken immediately. The patient should seek advice from her doctor, nurse, family planning clinic or pharmacist.
Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or take a double dose of levonorgestrel (i.e. 2 tablets taken together) for those women unable or unwilling to use Cu-IUD.
Levonorgestrel One Step can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.
After using emergency contraception it is recommended to use a local barrier method (e.g. condom, diaphragm, spermicide, cervical cap) until the next menstrual period starts. The use of Levonorgestrel One Step does not contraindicate the continuation of regular hormonal contraception.

Paediatric population
There is no relevant use of Levonorgestrel One Step for children of prepubertal age in the indication emergency contraception.

Method of administration
For oral use.

CONTRAINDICATION
Hypersensitivity to the active substance or to any of the excipients

SPECIAL PRECAUTIONS & WARNINGS

Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.
Emergency contraception does not prevent a pregnancy in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with Levonorgestrel One Step following the second act of intercourse may therefore be ineffective in preventing pregnancy. 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. If pregnancy occurs after treatment with Levonorgestrel One Step, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low, as Levonorgestrel One Step prevents ovulation and fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding.
Therefore, Levonorgestrel One Step is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy).
Levonorgestrel One Step is not recommended in patients with severe hepatic dysfunction.
Severe malabsorption syndromes, such as Crohn’s disease, might impair the efficacy of Levonorgestrel One Step.
After Levonorgestrel One Step intake, menstrual periods are usually normal and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. Women should be advised to make a medical appointment to initiate or adopt a method of regular contraception. If no withdrawal bleed occurs in the next pill-free period following the use of Levonorgestrel One Step after regular hormonal contraception, pregnancy should be ruled out.
Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle.
Limited and inconclusive data suggest that there may be reduced efficacy of Levonorgestrel One Step 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.
Levonorgestrel One Step is not as effective as a conventional regular method of contraception and is suitable only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.
Use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases.

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 Interaction with other medicinal products and other forms of interaction

The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%.
Drugs suspected of having similar capacity to reduce the 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 (i.e. a Cu-IUD) should be considered. Taking a double dose of levonorgestrel (i.e. 3000 mcg within 72 hours after the unprotected intercourse) is an option for women who are unable or unwilling to use a Cu-IUD, although this specific combination (a double dose of levonorgestrel during concomitant use of an enzyme inducer) has not been studied.
Medicines containing levonorgestrel may increase the risk of ciclosporin toxicity due to possible inhibition of ciclosporin metabolism.

Fertility, pregnancy and lactation

Pregnancy
Levonorgestrel One Step should not be given to pregnant women. It will not interrupt a pregnancy. In the case of continued pregnancy, limited epidemiological data indicate no adverse effects on the fetus but there are no clinical data on the potential consequences if doses greater than 1.5 mg of levonorgestrel are taken .

Breast-feeding
Levonorgestrel is secreted into breast milk. Potential exposure of an infant to levonorgestrel can be reduced if the breast-feeding woman takes the tablet immediately after feeding and avoids nursing at least 8 hours following Levonorgestrel One Step administration.

Fertility
Levonorgestrel 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 fertility data in the long term.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

System Organ Class

MedDRA 16.0

Frequency of adverse reactions
Very common

(≥10)

Common

(≥1/100 to <1/10)

Nervous system disorders Headache Dizziness
Gastrointestinal disorders Nausea

Abdominal pain lower

Diarrhoea

Vomiting

Reproductive system and breast disorders Bleeding not related to menses* Delay of menses more than 7 days**

Menstruation irregular

Breast tenderness

General disorders and administration site conditions Fatigue

UNDESIRABLE EFFECTS

 

The most commonly reported undesirable effect was nausea.

*Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 5-7 days of the expected time.

**If the next menstrual period is more than 5 days overdue, pregnancy should be excluded.

From Post-marketing surveillance additionally, the following adverse events have been reported:

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

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

General disorders and administration site conditions
Very rare (<1/10,000): face oedema

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose
Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic.

Pharmacological particulars

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives, ATC code: G03AD01
The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. Levonorgestrel is not effective once the process of implantation has begun.

BMI (kg/m2) Underweight

0-18.5

Normal

18.5-25

Overweight

25-30

Obese

≥ 30

N total 64 933 339 212
N pregnancies 1 9 8 11
Pregnancy rate 1.56% 0.96% 2.36% 5.19%
Confidence Interval 0.04-8.40 0.44-1.82 1.02-4.60 2.62-9.09

Efficacy:
It was estimated from the results of an earlier clinical study (Lancet 1998: 352: 428-33), that 750 micrograms of levonorgestrel (taken as two 750 microgram doses with a 12 hour interval) prevents 85% of expected pregnancies. Efficacy appears to decline with time of start of treatment after intercourse (95% within 24 hours, 85% 24-48 hours, 58% if started between 48 and 72 hours).
Results from a recent clinical study (Lancet 2002: 360: 1803-1810) showed that two 750 microgram tablets of levonorgestrel taken at the same time (and within 72 hours of unprotected sex) prevented 84% of expected pregnancies. There was no difference between pregnancy rates in case of women who were treated on the third or the fourth day after the unprotected act of intercourse (p>0.2).

There is limited and inconclusive data on the effect of high body weight/high BMI on the contraceptive efficacy. In three WHO studies no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1), whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 2). Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of levonorgestrel) and women who had further acts of unprotected intercourse.

BMI (kg/m2) Underweight

0-18.5

Normal

18.5-25

Overweight

25-30

Obese

≥ 30

N total 600 3952 1051 256
N pregnancies 11 39 6 3
Pregnancy rate 1.83% 0.99% 0.57% 1.17%
Confidence Interval 0.92 3.26 0.70-1.35 0.21-1.24 0.24-3.39

Table 1: Meta-analysis on three WHO studies (VonHertzen et al.,1998 and 2002; Dada et al.,2010)
Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010

At the recommended regimen, levonorgestrel is not expected to induce significant modification of blood clotting factors, and lipid and carbohydrate metabolism.

Paediatric population
A prospective observational study showed that out of 305 treatments with levonorgestrel emergency contraceptive tablets, seven women became pregnant resulting in an overall failure rate of 2.3%. The failure rate in women under 18 years (2.6% or 4/153) was comparable to the failure rate in women 18 years and over (2.0% or 3/152).

Pharmacokinetic properties

Absorption
Orally administered levonorgestrel is rapidly and almost completely absorbed.

The absolute bioavailability of levonorgestrel was determined to be almost 100% of the dose administered.

The results of a pharmacokinetic study carried out with 16 healthy women showed that following ingestion of single dose of 1.5 mg levonorgestrel maximum drug serum levels of 18.5 ng/ml were found at 2 hours.

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.

About 0.1% of the maternal dose can be transferred via milk to the nursed infant.

Biotransformation
The biotransformation follows the known pathways of steroid metabolism, the levonorgestrel is hydroxylated in the liver and the metabolites are excreted as glucuronide conjugates.

No pharmacologically active metabolites are known.

Elimination
After reaching maximum serum levels, the concentration of levonorgestrel decreased with a mean elimination half-life of about 26 hours.
Levonorgestrel is not excreted in unchanged form but as metabolites.
Levonorgestrel metabolites are excreted in about equal proportions with urine and faeces.

Preclinical safety data

Animal experiments with levonorgestrel have shown virilisation of female fetuses at high doses.

Pharmaceutical particulars

List of excipients
Potato starch
Maize starch,
Colloidal silica anhydrous,
Magnesium stearate
Talc
Lactose monohydrate.

 Incompatibilities

Not applicable.

 Shelf life

5 years.

Special precautions for storage
Store in original packaging in order to protect from light.

Nature and contents of container

PVC/Aluminium-blister containing one tablet. The blister is packaged in a folded carton.

Special precautions for disposal and other handling
No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER

TAJ PHARMA CIS LTD.
Marksistsky lane 6, office 221, Moscow, 109147, Russia

MANUFACTURER:

Manufactured in India by:
TAJ PHARMACEUTICALS LTD,
220, Mahagujarat Ind. Estate,  Moraiya,

Tal. Sanand , Dist. Ahmedabad,

Gujarat, INDIA.

Package leaflet:

Information for the patient

Levonorgestrel 0.75mg and 1.5mg tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Levonorgestrel is and what is it used for
    2. What do you need to know Before you take Levonorgestrel
    3. How to take Levonorgestrel
    4. Possible side effects
    5. How to store Levonorgestrel
    6. Contents of the pack and other information

1.What  Levonorgestrel is and what is it used for

Levonorgestrel is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.
When should emergency contraception be used?
Levonorgestrel contains a synthetic hormone-like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.
Levonorgestrel is thought to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you may have already released.
Levonorgestrel can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking this medicine, it will not stop you from becoming pregnant.
Levonorgestrel is not indicated for use before the first menstrual bleeding (menarche).

  1. What do you need to know Before you take Cyproterone Acetate/Ethinylestradiol40mg

Do not take Levonorgestrel:
• if you are allergic to levonorgestrel or any of the other ingredients of this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levonorgestrel.
If any of the following points apply to you, tell your doctor before you take Levonorgestrel as emergency contraception may not be suitable for you.
• you are pregnant or think that you may already be pregnant; as this medicine will not work if you are already pregnant.
You may already be pregnant if:
• your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due
• you have had unprotected sex more than 72 hours ago, and since your last period
You should also tell your doctor if:
• you have a disease of your small bowel (such as Crohn’s disease) that interferes with the way you digest your food
• you have severe liver problems
• you have ever had an ectopic pregnancy (where the baby develops somewhere outside the womb)
• you have ever had inflamed fallopian tubes (salpingitis)
A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy.
Your doctor may decide that this medicine is not suitable for you, or that another type of emergency contraception would be better for you.

Other medicines and Levonorgestrel
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines.
Some medicines may prevent Levonorgestrel from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonorgestrel may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (CuIUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel:
• barbiturates and other medicines used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)
• medicines used to treat tuberculosis (for example, rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal remedies containing St John’s wort (Hypericum perforatum)
Speak to your pharmacist or doctor if you need further advice on the correct dose for you. Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy.
Levonorgestrel may also affect how well other medicines work
• a medicine called cyclosporin (suppresses the immune system).

If you are worried about sexually transmitted diseases
This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

How often can you use Levonorgestrel
You should only use Levonorgestrel in emergencies and not as a regular method of contraception. If this medicine is used more than once in a menstrual cycle (period), it is less reliable and it is more likely to upset your menstrual cycle.
Levonorgestrel does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy
You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonorgestrel will harm a baby that develops in your uterus/womb. Nevertheless, 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 Levonorgestrel or if you have previously had an ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding
Women who breast-feed can use Levonorgestrel but should take the following measures.
Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby. However if you are worried you can take your tablet immediately after a breast-feed and then drain your milk with a breast pump for 6 hours after taking Levonorgestrel and throw away the milk. In this way you can reduce the amount of active ingredient your baby may take in with the breast milk.

Driving and using machines
Your Levonorgestrel tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.


Levonorgestrel contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

  1. How to take Levonorgestrel

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

Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Levonorgestrel can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew the tablet, swallow it whole with water. Do not delay taking the tablet. The tablet works best the sooner you take it after having unprotected sex.
If you are using one of the medicines that may prevent Levonorgestrel from working properly or if you have used one of these medicines in the past 4 weeks, Levonorgestrel may work less effectively for you. Your doctor may prescribe another type of (nonhormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel (i.e. 2 tablets taken together at the same time).
If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.
If another unprotected intercourse takes place after the use of Levonorgestrel (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy.
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that levonorgestrel may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, levonorgestrel is still recommended for all women regardless of their weight or BMI.
You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet. After you have taken Levonorgestrel

 After you have taken Levonorgestrel,
if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because this medicine won’t work if you have unprotected sex again, before your next period is due.
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 Levonorgestrel 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. If you do become pregnant even after taking this medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.
If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonorgestrel After the use of Levonorgestrel, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal’ bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonorgestrel than you should
Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

Very common (may affect more than 1 in 10 people):
· Feeling sick (nausea)
·You might have some irregular bleeding until your next period
·You might have lower abdominal pain
·Tiredness
·Headache

Common (may affect up to 1 in 10 people):
·Being sick (vomiting).
·Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. 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.
·You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10,000 people):
·Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine

  1. How to store Levonorgestrel
    Do not use Levonorgestrel tablets after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of the month
    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment
    Store below 25°C. Store in the original package in order to protect from light.
  2. Contents of the pack and other information


What  Levonorgestrelcontain

The active substance is levonorgestrel. Each tablet contains 1.5mg and 0.75mg of levonorgestrel. The other ingredients are: Lactose monohydrate, Maize starch, Povidone K30, Silica, colloidal anhydrous, Magnesium stearate

What  Levonorgestrel looks like and contents of the pack
Your medicine comes as a round, white to off-white, uncoated flat tablet marked ‘145’ on one side and plain on the other side. Levonorgestrel is available in blister packs containing 1 tablet.

Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar

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