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MELKINE 1.5 MG TABLET

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Material Leaflet Drawing #: P030
Scale: 100%
type:
LICONSA
LEON FARMA

Dimensions: 222 x 340 mm
Launch:

X

Customer change:

X

Internal change:

Material #/ 532849-01 PR LEV 1,5MG X 1COM CRESCENT UK
Product :

Substitutes
Laetus #: 18070 Date: 28.10.16 mat. #: ********

C

Version:

Folded:

Pantones:

YES
NO

170 x 37

(*) Customer:

Signature:
5HYLHZHGE\3KDUVROXWLRQIRU
&UHVFHQW
Date:

Quality Assurance:
Signature:

Por cezquerro fecha 10:48 , 28/10/2016
Date:

Drawed by:

black

112

358

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
o
o
o
o

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. What Melkine 1.5 mg is and what it is used for
2. What you need to know before you take Melkine 1.5 mg
3. How to take Melkine 1.5 mg
4. Possible side effects
5. How to store Melkine 1.5 mg
6. 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:
o No contraception was used during the sexual intercourse
o 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).
o 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:
o stopping your ovaries from releasing an egg;
o preventing sperm from fertilising any egg that may have already
released; or
o 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 Melkine 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 Melkine 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

Material Leaflet Drawing #: P030
Scale: 100%
type:
LICONSA
LEON FARMA

Dimensions: 222 x 340 mm
Launch:

X

Customer change:

X

Internal change:

Material #/ 532849-01 PR LEV 1,5MG X 1COM CRESCENT UK
Product :

Substitutes
Laetus #: 18070 Date: 28.10.16 mat. #: ********

C

Version:

Folded:

Pantones:

YES
NO

black

170 x 37

(*) Customer:

Signature:
5HYLHZHGE\3KDUVROXWLRQIRU
&UHVFHQW
Date:

Quality Assurance:

112

358

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.
o 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.
o 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.

o 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):
o 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.

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

Signature:

What to do if you are sick (vomit)

Por cezquerro fecha 10:48 , 28/10/2016
Date:

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

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.

Drawed by:

After you have taken Melkine 1.5 mg

What Melkine 1.5 mg looks like and contents of the pack

Signature:

Por nmoreno fecha 10:15 , 28/10/2016

Date:

After you have taken Melkine1.5 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.

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.

Your next period after you took Melkine
1.5 mg

This leaflet was last approved in February 2016

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):
o
o
o
o
o

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):
o Being sick (vomiting). If you are sick, read the section ‘‘What to do if
you are sick (vomit).
o 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.

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

Expand Transcript

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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