Levonorgestrel Tablets BP 1.5mg, 0.75mg, 0.03mg Taj pharma

1.Name of the medicinal product

Levonorgestrel Tablets BP 1.5mg, 0.75mg, 0.03mg Taj pharma

2.Qualitative and quantitative composition

a) Levonorgestrel Tablets BP 1.5mg
Each tablet contains
Levonorgestrel                          1.5mg
Excipients                                  q.s.

b) Levonorgestrel Tablets BP 0.75mg
Each tablet contains
Levonorgestrel                          0.75mg
Excipients                                  q.s.

c) Levonorgestrel Tablets BP 0.03mg
Each tablet contains
Levonorgestrel                          0.03mg
Excipients                                 q.s.

Excipient(s) with known effect:

Each tablet contains lactose monohydrate.

For a full list of excipients, see section 6.1.

3.Pharmaceutical form

Tablet.

White to off-white round shaped tablets.

4.Clinical particulars

4.1 Therapeutic indications

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.

4.2 Posology and method of administration

Method of administration

For oral administration.

Posology

One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse (see section 5.1).

If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.

Women who have used enzyme-inducing drugs during the last 4 weeks and need emergency contraception are recommended to use a non-hormonal EC (emergency contraception), 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 (see section 4.5).

Levonorgestrel 1.5mg tablets 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 does not contraindicate the continuation of regular hormonal contraception.

Paediatric population

There is no relevant use of levonorgestrel for children of prepubertal age in the indication emergency contraception.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

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 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, 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).

Levonorgestrel is not recommended in patients with severe hepatic dysfunction.

Severe malabsorption syndromes, such as Crohn’s disease, might impair the efficacy of levonorgestrel.

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

After levonorgestrel 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 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 1.5mg tablets with increasing body weight or body mass index (BMI) (see section 5.1). 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 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.

4.5 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 plasma levels of levonorgestrel include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St.John’s Wort), rifampicin, ritonavir, rifabutin, 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 cyclosporine toxicity due to possible inhibition of cyclosporin metabolism.

4.6 Fertility, pregnancy and lactation

Pregnancy

Levonorgestrel 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 (see section 5.3.).

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 administration.

Fertility

Levonorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in the long term, after treatment with levonorgestrel a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after levonorgestrel EC use.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

The most commonly reported undesirable effect was nausea.

All adverse drug reactions are listed by system, organ class and frequency.

System Organ Class Frequency of adverse reactions
Very common (≥ 1/10) Common (≥ 1/100 to <1/10)
Nervous system disorders Headache Dizziness
Gastrointestinal disorders Nausea

Lower abdominal pain

Diarrhoea

Vomiting

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

Irregular menstruation

Breast tenderness

General disorders and administration site conditions Fatigue

* Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 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.

4.9 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.

5.Pharmacological properties

5.1 Pharmacodynamic properties

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

Mechanism of action

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.

Clinical efficacy and safety

Results from a randomised, double-blind clinical study conducted in 2001 (Lancet 2002; 360: 1803-1810) showed that a 1500 microgram single dose of levonorgestrel (taken within 72 hours of unprotected sex) prevented 84% of expected pregnancies (compared with 79% when the two 750 microgram tablets were taken 12 hours apart).

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.

Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010)

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 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010

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

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).

5.2 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 one tablet of Levonorgestrel 1.5mg maximum drug serum levels of levonorgestrel 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, but65% 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, thelevonorgestrel is hydroxylated by liver enzymes mainly by CYP3A4 and itsmetabolites are excreted after glucuronidation by liver glucuronidase enzymes. (Seesection 4.5).

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.

Pharmacokinetics in obese women

A pharmacokinetic study showed that levonorgestrel concentrations are decreased in obese women (BMI ≥ 30 kg/m²) (approximately 50% decrease in Cmax and AUC0-24), compared to women with normal BMI (< 25 kg/m²) (Praditpan et al., 2017).

Another study also reported a decrease of levonorgestrel Cmax by approximately 50% between obese and normal BMI women, while doubling the dose (3 mg) in obese women appeared to provide plasma concentration levels similar to those observed in normal women who received 1.5 mg of levonorgestrel (Edelman et al., 2016). The clinical relevance of these data is unclear.

5.3 Preclinical safety data

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

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity and carcinogenicity potential, beyond the information included in other sections of the SmPC.

6.Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, Maize starch, Povidone K30, Silica, colloidal anhydrous, Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store below 25°C. Store in the original package in order to protect from light.

6.5 Nature and contents of container

PVC/PVDC/aluminium blister containing one tablet, which is further packed in to a carton.

6.6 Special precautions for disposal and other handling

No specific requirements.

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

7.Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Levonorgestrel Tablets BP 1.5mg, 0.75mg, 0.03mg Taj Pharma

Package leaflet: Information for the user

Read all of this leaflet carefully before you start using 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.

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 1.5mg tablets are and what they are used for
  2. What you need to know before you take Levonorgestrel 1.5mg tablets
  3. How to take Levonorgestrel 1.5mg tablets
  4. Possible side effects
  5. How to store Levonorgestrel 1.5mg tablets
  6. Contents of the pack and other information

1.What Levonorgestrel  tablets are and what they are used for

A Levonorgestrel tablet is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

It is about the following cases:

No contraception was used during the sexual intercourse.

The contraception measure was used incorrectly, for example if a condom was penetrated, slipped away or used in the wrong way, if vaginal pessary or diaphragm changed position, burst, was broken or taken out ahead of time, in the case of a failed interruption during coitus interruptus (e.g. sperm ejaculated in vagina or on external genitalia).

Levonorgestrel  tablets contain a synthetic hormone like active 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 tablets are thought to work by:

stopping your ovaries from releasing an egg; preventing sperm from fertilising any egg you may have already released.

Levonorgestrel  tablets 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 another unprotected intercourse takes place after the use of Levonorgestrel 1.5mg tablets (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.

Levonorgestrel tablets are not indicated for use before the first menstrual bleeding (menarche).

2.What you need to know before you take Levonorgestrel  tablets

Do not use Levonorgestrel tablets

If you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonorgestrel  tablets as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Levonorgestrel 1.5mg tablets cannot terminate pregnancy, so Levonorgestrel 1.5mg tablets are not an “abortion pill”

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

The use of Levonorgestrel 1.5mg tablets are not advised if:

you have a disease of your small bowel (such as Crohn’s disease) that inhibits the absorption of the drug.

you have severe liver problems

you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

you have a history of salpingitis (inflamation of the fallopian tubes)

A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel 1.5mg tablets may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonorgestrel 1.5mg tablets 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.

Children and adolescents

Levonorgestrel  tablets are not indicated for use before the first menstrual bleeding (menarche).

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

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.

Other medicines and Levonorgestrel  tablets

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  tablets from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonorgestrel 1.5mg tablets may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) 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  tablets:

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 (ritonavir, efavirenz)

a medicine used to treat fungal infections (griseofulvin)

herbal remedies containing St John’s wort (Hypericum perforatum)

Talk to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult a doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy (See section also 3 “How to take Levonorgestrel  tablets” for further advice).

Levonorgestrel tablets may also affect how well other medicines work a medicine called cyclosporin (suppresses the immune system).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 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 1.5mg tablets will harm a baby that develops in your uterus/womb if you use Levonorgestrel 1.5mg tablets as described. 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 1.5mg tablets or if you have previously had an ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

The active ingredient of this medicine is excreted into your breast milk. Therefore, it is suggested that you take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following levonorgestrel administration then drain your milk with a breast pump for 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Fertility

Levonorgestrel tablet increases the possibility of menstruation disturbance which can sometimes lead to an earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in the long term, after treatment with Levonorgestrel 1.5mg tablets a rapid return  to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after Levonorgestrel  tablets use.

Driving and using machines

Your Levonorgestrel  tablets are 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 1.5mg tablets contain lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonorgestrel  tablet also contains 140.1mg lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

 3.How to take Levonorgestrel 1.5mg tablets 

Always use this medicine exactly as described in the leaflet or as your 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. Do not delay taking the tablet. The tablet works best the sooner you take it after having unprotected sex. It can only prevent you becoming pregnant, if you take it within 72 hours of unprotected sex.

Levonorgestrel tablets 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 but swallow the tablet whole with water.

If you are using one of the medicines that may prevent Levonorgestrel tablets from working properly (see section above “Other medicines and Levonorgestrel  tablets”) or if you have used one of these medicines in the past 4 weeks, Levonorgestrel  tablets may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) 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 tablets (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 1.5mg tablets (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.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

How often can you use Levonorgestrel tablets

You should only use Levonorgestrel  tablets in emergencies and not as a regular method of contraception. If Levonorgestrel  tablets are used more than once in a menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period).

Levonorgestrel tablets do 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.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should immediately take another tablet.

After you have taken Levonorgestrel  tablets

After you have taken Levonorgestrel tablets, 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 Levonorgestrel 1.5mg tablets will not work if you have unprotected sex again, before your next period is due.

After you have taken Levonorgestrel tablets, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonorgestrel 1.5mg tablets have 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 tablets

After the use of Levonorgestrel tablets, your period is usually normal and will start on 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  tablets 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 medicine, ask your doctor or pharmacist.

4.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). If you are sick, read the section ‘What to do if you are sick’ (vomit).

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.

5.How to store Levonorgestrel 1.5mg tablets

Keep this medicine out of the sight and reach of children.

Do not use Levonorgestrel 1.5mg 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.

6.Contents of the pack and other information What Levonorgestrel tablets contain

The active substance is levonorgestrel. Each tablet contains  1.5mg, 0.75mg, 0.03mg levonorgestrel. The other ingredients are:

Lactose monohydrate Maize starch Povidone K30, Silica, colloidal anhydrous Magnesium stearate

What Levonorgestrel  tablets look like and contents of the pack

 White to off-white round shaped tablets. PVC/PVDC/aluminium blister containing one tablet, which is further packed in to a carton.

7.Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com