Package leaflet: Information for the user Levonorgestrel 1.5mg Tablets

Levonorgestrel

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 1.5mg tablets are and what they are used for

A Levonorgestrel 1.5mg 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: o No contraception was used during the sexual intercourse.

o 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 1.5mg 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 1.5mg tablets are thought to work by: stopping your ovaries from releasing an egg;

□    preventing sperm from fertilising any egg you may have already released; or

□    stopping a fertilised egg from attaching itself to your womb lining.

Levonorgestrel 1.5mg 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.

2. What you need to know before you take Levonorgestrel 1.5mg tablets Do not take Levonorgestrel 1.5mg 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 1.5mg tablets as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

o 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: o your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

o 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:

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

o you have severe liver problems o you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb) o 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.

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 1.5mg tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may prevent Levonorgestrel 1.5mg tablets from working properly, these include: 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)

a medicine used to treat fungal infections (griseofulvin)

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

□    a medicine called ciclosporin (suppresses the immune system)

Consult a doctor or pharmacist before using Levonorgestrel 1.5mg tablets if you use any of the above mentioned medicine.

How often can you use Levonorgestrel 1.5mg tablets

You should only use Levonorgestrel 1.5mg tablets in emergencies and not as a regular method of contraception. If Levonorgestrel 1.5mg 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 1.5mg 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.

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

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 avoid nursing following levonorgestrel administration then drain your milk with a breast pump for 6 hours after taking Levonorgestrel 1.5mg tablets 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.

Fertility

Levonorgestrel increases the possibility of menstruation disturbance which can sometimes lead to an earlier or later ovulation date. These changes can result in a modified fertility date; however, there are no fertility data in the long term.

70 mm

SAP Code: 40100005017

238711 Levonorgestrel (POM) UK_ V11.pdf

Issued For Final Production
Issued For Re-Approval :-
Issued For Approval :-		15-OCT-15 17:38:22
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:-info@templepackaging.co.in
Customer :-	Lupin - GERMANY HORMOSAN		SAP Code :-	40100005017
Location :-	Indore		File No. :-	36316
Product Name :-	INS LEVONORGESTRL 1.5MG 1’S		Artwork Sr. No. :-	44/08/14
ProductCode :-	238711		Customer A/W No. :-	NA
Version No. :-	11		OldFileNo. :-	NA
Date :-	15-OCT-15		Old Product Code :-	NA
ArtworkStatus :-	IN PROCESS		Barcode :-	NA
Open Size :-	280 X 230 MM(LXW)		Pharmacode :-	2227
Folding Size :-	70 X 45 MM(WxL)		Perforation :-	NA
Substrate :-	40 GSM BIBLE PAPER		Gluing :-	YES
Cover Page (PAD) :-	NA		Font Name :-	HELVETICA CONDENSED
Cover Pg Substrate :-	NA		Font Size :-	9PT
No.of Pages / PAD :-	NA
Remark :-
PrintingColours

K

Note - This approval will be considered for final printing. Please recheck for corrections indicated earlier, in this proof also.
Prepared by: 15-OCT-15	Checked by:		Q.A. Checked :		Approved by:
shaji
CUSTOMER APPROVAL
Checked By				Approved By
Packaging Development		Production		Regulatory Affairs		Quality Assurance

Driving and using machines

Your Levonorgestrel 1.5mg 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 1.5mg 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 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 1.5mg 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. Do not delay taking the tablet. The tablet works better the sooner you take it after having unprotected sex.

•    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.

Use in children and adolescents

This medicine is not recommended for use in children. Very limited data are available in women under 16 years of age.

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 1.5mg tablets

After you have taken Levonorgestrel 1.5mg 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 1.5mg 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 1.5mg tablets

After the use of Levonorgestrel 1.5mg 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 1.5mg 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 via the Yellow Card Scheme, website: www. mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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 1.5mg tablets contain

-    The active substance is levonorgestrel. Each tablet contains 1.5mg of levonorgestrel.

-    The other ingredients are:

Lactose monohydrate Maize starch Povidone K30

Silica, colloidal anhydrous Magnesium stearate

What Levonorgestrel 1.5mg tablets look like and contents of the pack

White to off-white round shaped tablets, debossed with “LV1” on one side and plain on the other side. PVC/PVDC/aluminium blister containing one tablet, which is further packed in to a carton.

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Limited

Victoria Court

Bexton Road

Knutsford

Cheshire

WA160PF

United Kingdom

This leaflet was last revised in 01/2014

Code No.: MP/DRUGS/28/6/2010

ID#: 238711

SAP Code: 40100005017

238711 Levonorgestrel (POM) UK_ V11.pdf

Issued For Final Production
Issued For Re-Approval :-
Issued For Approval :-		15-OCT-15 17:38:23
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:-info@templepackaging.co.in
Customer :-	Lupin - GERMANY HORMOSAN		SAP Code :-	40100005017
Location :-	Indore		File No. :-	36316
Product Name :-	INS LEVONORGESTRL 1.5MG 1’S		Artwork Sr. No. :-	44/08/14
ProductCode :-	238711		Customer A/W No. :-	NA
Version No. :-	11		OldFileNo. :-	NA
Date :-	15-OCT-15		Old Product Code :-	NA
ArtworkStatus :-	IN PROCESS		Barcode :-	NA
Open Size :-	280 X 230 MM(LXW)		Pharmacode :-	2227
Folding Size :-	70 X 45 MM(WxL)		Perforation :-	NA
Substrate :-	40 GSM BIBLE PAPER		Gluing :-	YES
Cover Page (PAD) :-	NA		Font Name :-	HELVETICA CONDENSED
Cover Pg Substrate :-	NA		Font Size :-	9PT
No.of Pages / PAD :-	NA
Remark :-
PrintingColours

K

Note - This approval will be considered for final printing. Please recheck for corrections indicated earlier, in this proof also.
Prepared by: 15-OCT-15	Checked by:		Q.A. Checked :		Approved by:
shaji
CUSTOMER APPROVAL
Checked By				Approved By
Packaging Development		Production		Regulatory Affairs		Quality Assurance