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MELKINE 1.5 MG TABLET

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Melkine 1.5 mgMelkine 1.5 mg tablet
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 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.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Melkine 1.5 mg is and what it is used for
What you need to know before you take Melkine 1.5 mg
How to take Melkine 1.5 mg
Possible side effects
How to store Melkine 1.5 mg
Content of the pack and other information

1.

What Melkine 1.5 mg is and what it is used for

Melkine 1.5 mg is an emergency contraceptive that can be used within 72 hours (3
days) of unprotected sex or if your usual method of contraception has failed.
It is about the following cases:
• No contraception was used during the sexual intercourse
• The contraception measure was used incorrectly, for example as if a condom was
penetrated, slipped away or used in a 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).



Melkine 1.5 mg contains a synthetic hormone-like substance called
levonorgestrel. It prevents about 85% 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.

Melkine 1.5 mg is thought to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg that may have already released; or
• stopping a fertilised egg from attaching itself to your womb lining .

Melkine 1.5 mg can only prevent you from becoming pregnant if you take it within 72
hours of having unprotected sex. It does not work if you are already pregnant. If
another unprotected intercourse takes place after the use of Melkine 1.5 mg (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.
This tablet is only for emergency contraception, not for a regular contraception as it is
less effective than the regular contraceptive tablet.
2.

What you need to know before you take Melkine 1.5 mg

Do not take Melkine 1.5 mg
-

if you are allergic (hypersensitive) 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 Melkine 1.5 mg
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, Melkine 1.5
mg cannot terminate pregnancy, so Melkine 1.5 mg is not an “abortion tablet”.
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 Melkine 1.5 mg is 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 (inflammation 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 Melkine 1.5 mg may be less
effective with increasing body weight or body mass index (BMI), but these data were
limited and inconclusive. Therefore, Melkine 1.5 mg 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.
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 the
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 Melkine 1.5 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines may prevent Melkine 1.5 mg 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 and rifabutin).
− Some medicines used to treat HIV infection (ritonavir).
− A medicine used to treat fungal infections (griseofulvin).
− Herbal medicines containing St. John's Wort (Hypericum perforatum).
− A medicine called ciclosporin (used to suppress the immune system).
Consult a doctor or pharmacist before using Melkine 1.5 mg if you use any of the
above mentioned medicine.

How often can Melkine 1.5 mg be used
You should only use Melkine 1.5 mg in emergencies, and not as a regular method of
contraception. If you use Melkine 1.5 mg more than once in a menstrual cycle, it is
less reliable and it is more likely to upset your menstrual cycle (period).
Melkine 1.5 mg 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
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 Melkine 1.5 mg will harm a baby that develops in your
uterus/womb if you use Melkine 1.5 mg 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 Melkine 1.5 mg 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 the 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 Melkine 1.5 mg and throw away this 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
Melkine 1.5 mg 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 machines.

Melkine 1.5 mg contains lactose
In case of milk sugar (lactose) intolerance it should be considered that each Melkine
1.5 mg tablet contains 43.3 mg of lactose. If your doctor has told you that you have
intolerance to certain sugars, contact your doctor before taking this medicine.

3.

How to take Melkine 1.5 mg

Always use this medicine exactly as described in the leaflet or 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 having unprotected sex. You can take Melkine 1.5 mg at
any time during 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 tablet, you can continue to take this at your regular times.

If another unprotected intercourse takes place after the use of Melkine 1.5 mg (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 and only intended for use in women
who had a first menstrual bleeding. 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 Melkine 1.5 mg
After you have taken Melkine 1.5 mg, if you want to have sex, , and are not using the
contraceptive tablet, you should use condoms or a cap plus spermicide until your next
menstrual period. This is because Melkine 1.5 mg will not work if you have
unprotected sex again, before your next period is due.
After taking Melkine 1.5 mg, you are advised to make an appointment to see your
doctor about three weeks later to make sure that Melkine 1.5 mg has worked. If your
period is more than 5 days late or is unusually light or 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 long-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 tablet
and you do not have a bleed in your tablet-free period, see your doctor to make sure
you are not pregnant.
Your next period after you took Melkine 1.5 mg
After the use of Melkine 1.5 mg, your period is usually normal and will start at the
usual day; however sometimes, it will start a few days earlier or later. If your period
starts more than 5 days later than expected, an "abnormal" bleeding occurs at that time
or if you think you might be pregnant, you should check whether you are pregnant by
pregnancy test.
If you take more Melkine 1.5 mg than you should
Although there have been no reports of serious harmful effects after taking too many
tablets at once, you may feel sick, actually be sick (vomit) or have vaginal bleeding.
You should ask your doctor, pharmacist, 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, Melkine 1.5 mg can cause side effects, although not everybody
gets them.
Possible side effects are listed below according to how common they are:
Very common side effects (may affect more than 1 in every 10 users):
• Feeling sick (Nausea)






You might have some irregular bleeding until your next period
You might have lower abdominal pain
Tiredness
Headache

Common side effects (may affect up to 1 in 10 users):
• Being sick (vomiting). If you are sick, read the section "What to do if you are
sick (vomit).
• Your period may 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
may also have irregular bleeding or spotting until your next period. If your period
is more than 5 days late or is unusually light or heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea or feel dizzy after taking this medicine.
Very rare side effects (may affect up to 1 in 10,000 users):
• Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

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.

5.

How to store Melkine 1.5 mg

Keep this medicine out of the sight and reach of children.
Do not use Melkine 1.5 mg after the expiry date which is stated on the pack and
blister. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage condition.
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 protect the environment.

6.

Contents of the pack and other information

What Melkine 1.5 mg contains

The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
The other ingredients are cellulose microcrystalline, lactose monohydrate, poloxamer
188, croscarmellose sodium and magnesium stearate.
What Melkine 1.5 mg looks like and contents of the pack
Each pack contains one complete treatment of one round, white tablet, of approximate
6 mm of diameter and marked “C” on one side and “1” on the other.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
C/ La Vallina s/n, 24008- Navatejera, León
Spain
Manufacturer:
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
C/ La Vallina s/n, 24008- Navatejera, León
Spain
This medicinal product is authorised in the Member States of the EEA under the
following names:
The Netherlands
Austria
Czech Republic
Estonia
France
Germany
Italy
Lithuania
Latvia
Slovakia
Spain

Tansy 1500 microgram tabletten
Velafam 1,5 mg Tabletten
Levonorgestrel Ladee Pharma 1.5mg tablety
Levonorgestrel Ladee Pharma
Levunique 1,5 mg comprimé
Navela 1,5 mg Tabletten
Afterel
Levonorgestrel Ladee Pharma 1.5mg tabletė
Levonorgestrel Ladee Pharma 1.5mg tabletes
Isabelle 1,5mg tablety
Levonorgestrel Exeltis 1,5mg comprimido EFG

This leaflet was last approved in March 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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