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MUNALEA 150/30 MICROGRAMS FILM-COATED TABLETS

Active substance(s): DESOGESTREL / ETHINYL ESTRADIOL / DESOGESTREL / ETHINYL ESTRADIOL / DESOGESTREL / ETHINYL ESTRADIOL

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57 mm
4419

Package leaflet: Information for the user

Munalea 150/30 micrograms Film-coated Tablets
Desogestrel / Ethinyl estradiol
Important things to know about combined hormonal contraceptives (CHCs):
Ÿ They are one of the most reliable reversible methods of contraception if
used correctly
Ÿ They slightly increase the risk of having a blood clot in the veins and
arteries, especially in the first year or when restarting a combined
hormonal contraceptive following a break of 4 or more weeks
Ÿ Please be alert and see your doctor if you think you may have symptoms of
a blood clot (see section 2 “Blood clots”)
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 Munalea is and what it is used for
2. What you need to know before you Munalea
3. How to Munalea
4. Possible side effects
5. How to store Munalea
6. Contents of the pack and other information

1. What Munalea is and what it is used for
Munalea is a combined oral contraceptive pill, also called the Pill.
Each tablet contains a small amount of two types of female hormones, namely,
a progestogen, desogestrel and an oestrogen, ethinylestradiol.
These help to stop you from getting pregnant, just as your natural hormones
would stop you conceiving again when you are already pregnant.
The combined contraceptive pill protects you against getting pregnant in three
ways. These hormones
1. stop the ovary from releasing an egg each month (ovulation).
2. also thicken the fluid (at the neck of the womb) making it more difficult for
the sperm to reach the egg.
3. alter the lining of the womb to make it less likely to accept a fertilised egg.

1st Fold : 195 mm

40 mm

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2. What you need to know before you take Munalea
Munalea 150/30 microgram
film-coated tablets
252839

4419

General notes
Before you start using Munalea you should read the information on blood clots
in section 2. It is particularly important to read the symptoms of a blood clot –
see Section 2 “Blood clots”). Before you can begin taking Munalea, your
doctor will ask you some questions about your personal health history and that
of your close relatives. The doctor will also measure your blood pressure, and
depending upon your personal situation, may also carry out some other tests.
In this leaflet, several situations are described where you should stop using
Munalea, or where the reliability of the pill may be decreased. In such
situations you should either not have sex, or you should take extra nonhormonal contraceptive precautions (e.g. use a condom or another barrier
method). Do not use rhythm or temperature methods. These methods can be
unreliable because Munalea alters the monthly changes of body temperature
and of cervical mucus.
Munalea, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.
Do not take Munalea
You should not use Munalea if you have any of the conditions listed below. If
you do have any of the conditions listed below, you must tell your doctor. Your
doctor will discuss with you what other form of birth control would be more
appropriate.
·
if you have (or have ever had) a blood clot in a blood vessel of your legs
(deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or
other organs;
·
if you know you have a disorder affecting your blood clotting – for
instance, protein C deficiency, protein S deficiency, antithrombin-III
deficiency, Factor V Leiden or antiphospholipid antibodies;
·
if you need an operation or if you are off your feet for a long time (see
section 'Blood clots');
·
if you have ever had a heart attack or a stroke;
·
if you have (or have ever had) angina pectoris (a condition that causes
severe chest pain and may be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke symptoms);
·
if you have any of the following diseases that may increase your risk of a
clot in the arteries:
– severe diabetes with blood vessel damage
– very high blood pressure
– a very high level of fat in the blood (cholesterol or triglycerides)
– a condition known as hyperhomocysteinaemia
·
if you have (or have ever had) a type of migraine called 'migraine with
aura';
·
if you have (or have ever had) an inflammation of the pancreas
(pancreatitis)
·
if you have (or have ever had) a liver disease and your liver function is still
not normal.
·
if you have (or have ever had) a tumour in the liver.
·
if you have (or have ever had) or if you are suspected to having breast
cancer or cancer of the genital organs.
·
if you have any unexplained bleeding from the vagina.
·
if you are allergic to ethinylestradiol or desogestrel, or any of the other

ingredients of this medicine (listed in section 6).
·
if you have hepatitis C and are taking the medicinal products containing
ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section Other
medicines and Munalea).
Warnings and precautions
In some situations you need to take special care while using Munalea or any
other combination pill, and your doctor may need to examine you regularly.
Tell your doctor if any of the following conditions apply to you, if a condition
develops, or gets worse while you are using Munalea.
·
if you have Crohn's disease or ulcerative colitis (chronic inflammatory
bowel disease);
·
if you have systemic lupus erythematosus (SLE –; a disease affecting your
natural defence system);
·
if you have haemolytic uraemic syndrome (HUS - a disorder of blood
clotting causing failure of the kidneys);
·
if you have sickle cell anaemia (an inherited disease of the red blood cells);
·
if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a
positive family history for this condition. Hypertriglyceridaemia has been
associated with an increased risk of developing pancreatitis (inflammation
of the pancreas);
·
if you need an operation, or you are off your feet for a long time (see in
section 2 'Blood clots').
·
if you have just given birth you are at an increased risk of blood clots. You
should ask your doctor how soon after delivery you can start taking
Munalea.
·
If you have an inflammation in the veins under the skin (superficial
thrombophlebitis).
·
If you have varicose veins.
·
if a close relative has or has ever had breast cancer
·
if you have a disease of the liver or the gallbladder
·
if you have diabetes
·
if you have depression
·
if you have epilepsy (see “The pill and using other medicines”)
·
if you have a disease that first appeared during pregnancy or earlier use of
sex hormones (for example, hearing loss, a blood disease called
porphyria, skin rash with blisters during pregnancy (gestational herpes) a
nerve disease causing sudden movements of the body (Sydenham's
chorea)
·
if you have or have ever had chloasma (a discoloration of the skin
especially of the face or neck known as “pregnancy patches”). If so, avoid
direct sunlight or ultraviolet light.
·
If you have hereditary angioedema, products containing oestrogens may
cause or worsen symptoms. You should see your doctor immediately if
you experience symptoms of angioedema such as swollen face, tongue
and/or throat and/or difficulty swallowing or hives together with difficulty
breathing.
When should you contact your doctor?
Seek urgent medical attention
- if you notice possible signs of a blood clot that may mean you are suffering
from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the
lung (i.e. pulmonary embolism), a heart attack or a stroke (see 'Blood clot'
(thrombosis) section below.
For a description of the symptoms of these serious side effects please go to
“How to recognise a blood clot”.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Munalea increases your
risk of developing a blood clot compared with not using one. In rare cases a
blood clot can block blood vessels and cause serious problems.
Blood clots can develop
Ÿ in veins (referred to as a 'venous thrombosis', 'venous
thromboembolism' or VTE)
Ÿ in the arteries (referred to as an 'arterial thrombosis', 'arterial
thromboembolism' or ATE).
Recovery from blood clots is not always complete. Rarely, there may be
serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due
to Munalea is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or
symptoms.
Are you experiencing any of these signs?

What are you possibly
suffering from?

·
swelling of one leg or along a vein in the Deep vein thrombosis
leg or foot especially when accompanied
by:
·
pain or tenderness in the leg which
may be felt only when standing or
walking
·
increased warmth in the affected leg
·
change in colour of the skin on the
leg e.g. turning pale, red or blue
·
sudden unexplained breathlessness or Pulmonary embolism
rapid breathing;
·
sudden cough without an obvious cause,
which may bring up blood;
·
sharp chest pain which may increase
with deep breathing;
·
severe light headedness or dizziness;
·
rapid or irregular heartbeat
·
severe pain in your stomach;

If you are unsure, talk to a doctor as some of
these symptoms such as coughing or being
short of breath may be mistaken for a milder
condition such as a respiratory tract infection
(eg a 'common cold').
Symptoms most commonly occur in one eye: Retinal vein thrombosis
(blood clot in the eye)
·
immediate loss of vision or
·
painless blurring of vision which can
progress to loss of vision
·
chest pain, discomfort, pressure, Heart attack
heaviness
·
sensation of squeezing or fullness in the
chest, arm or below the breastbone;
·
fullness, indigestion or choking feeling;
·
upper body discomfort radiating to the
back, jaw, throat, arm and stomach;
·
sweating, nausea, vomiting or dizziness;
·
extreme weakness, anxiety, or shortness
of breath;
·
rapid or irregular heartbeats
·
sudden weakness or numbness of the Stroke
face, arm or leg, especially on one side of
the body;
·
sudden confusion, trouble speaking or
understanding;
·
sudden trouble seeing in one or both
eyes;
·
sudden trouble walking, dizziness, loss
of balance or coordination;
·
sudden, severe or prolonged headache
with no known cause;
·
loss of consciousness or fainting with or
without seizure.
Sometimes the symptoms of stroke can be
brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be at risk of
another stroke.
·
swelling and slight blue discolouration Blood clots blocking other
blood vessels
of an extremity;
·
severe pain in your stomach (acute
abdomen)
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
Ÿ The use of combined hormonal contraceptives has been connected with
an increase in the risk of blood clots in the vein (venous thrombosis).
However, these side effects are rare. Most frequently, they occur in the
first year of use of a combined hormonal contraceptive.
Ÿ If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
Ÿ If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.
Ÿ Very rarely a clot may form in a vein in another organ such as the eye
(retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of
taking a combined hormonal contraceptive for the first time. The risk may also
be higher if you restart taking a combined hormonal contraceptive (the same
product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you
were not using a combined hormonal contraceptive.
When you stop Munalea your risk of a blood clot returns to normal within a few
weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined
hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Munalea is
small.
-Out of 10,000 women who are not using any combined hormonal
contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive that
contains levonorgestrel, norethisterone, or norgestimate about 5-7 will
develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive that
contains desogestrel, such as Munalea, between about 9 and 12 women will
develop a blood clot in a year.
- The risk of having a blood clot will vary according to your personal medical
history (see “Factors that increase your risk of a blood clot” below).
Risk of developing a
blood clot in a year
Women who are not using a combined
hormonal pill/patch/ring and are not pregnant

About 2 out of 10,000 women

Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone
or norgestimate

About 5-7 out of 10,000 women

Women using Munalea

About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Munalea is small but some conditions will increase

the risk. Your risk is higher:
·
if you are very overweight (body mass index or BMI over 30kg/m2);
·
if one of your immediate family has had a blood clot in the leg, lung or other
organ at a young age (eg. below the age of about 50). In this case you
could have a hereditary blood clotting disorder;
·
if you need to have an operation, or if you are off your feet for a long time
because of an injury or illness, or you have your leg in a cast. The use of
Munalea may need to be stopped several weeks before surgery or while
you are less mobile. If you need to stop Munalea ask your doctor when you
can start using it again.
·
as you get older (particularly above about 35 years);
·
if you gave birth less than a few weeks ago
The risk of developing a blood clot increases the more conditions you have.
Air travel (longer than 4 hours) may temporarily increase your risk of a blood
clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if
you are unsure. Your doctor may decide that Munalea needs to be stopped.
If any of the above conditions change while you are using Munalea, for
example a close family member experiences a thrombosis for no known
reason; or you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For
example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using
Munalea is very small but can increase:
·
with increasing age (beyond about 35 years);
·
if you smoke. When using a combined hormonal contraceptive like
Munalea you are advised to stop smoking. If you are unable to stop
smoking and are older than 35 your doctor may advise you to use a
different type of contraceptive;
·
if you are overweight;
·
if you have high blood pressure
·
if a member of your immediate family has had a heart attack or stroke at a
young age (less then about 50). In this case you could also have a higher
risk of having a heart attack or stroke;
·
if you, or someone in your immediate family, have a high level of fat in the
blood (cholesterol or triglycerides);
·
if you get migraines, especially migraines with aura;
·
if you have a problem with your heart (valve disorder, disturbance of the
rhythm called atrial fibrillation)
·
if you have diabetes.
If you have more than one of these conditions or if any of them are particularly
severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Munalea, for
example you start smoking, a close family member experiences a thrombosis
for no known reason; or you gain a lot of weight, tell your doctor.
The pill and cancer
Breast cancer has been observed slightly more often in women using
combination pills, but it is not known whether this is caused by the treatment.
For example it may be that more tumours are detected in women on
combination pills because they are examined by their doctor more often. The
occurrence of breast tumours becomes gradually less after stopping the
combination hormonal contraceptives. It is important to regularly check your
breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver
tumours have been reported in pill users. Contact your doctor if you have
unusually severe abdominal pain.
Bleeding between periods
During the first few months that you are taking Munalea, you may have
unexpected bleeding (bleeding outside the gap week). If this bleeding occurs
for more than a few months, or if it begins after some months, your doctor
must find out what is wrong.
What you must do if no bleeding occurs in the gap week
If you have taken all the tablets correctly, have not had vomiting or severe
diarrhoea and you have not taken any other medicines, it is highly unlikely that
you are pregnant.
If the expected bleeding does not happen twice in succession, you may be
pregnant. Contact your doctor immediately. Do not start the next strip until
you are sure that you are not pregnant.
Other medicines and Munalea
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes herbal products. Also tell any other
doctor or dentist who prescribes another medicine (or the pharmacist) that
you use Munalea. They can tell you if you need to take additional contraceptive
precautions (for example condoms) and if so, for how long.
Some medicines can make Munalea less effective in preventing pregnancy,
or can cause unexpected bleeding. These include:
Medicines used for the treatment of
·
epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbamazepine)
·
tuberculosis (e.g. rifampicin),
·
HIV infections (ritonavir, nevirapin) or other infections (antibiotics such as
griseofulvin, penicillin, tetracycline)
·
The herbal remedy St. John's wort.
Munalea may influence the effect of other medicines, e.g.
Ÿ medicines containing cyclosporin,
Ÿ the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures).

252839 INS MUNALEA 150/30MCG TABS UK R3 (FRONT)
Market/Customer :

UK

Location :

Pithampur

Prepared On :

24/07/2017

Version No. :

03

Product Name :

INS MUNALEA 150/30MCG TABS UK R3

Material Code :

252839

Supersedes Material code :

251723

Open Size :

450 x 350 mm (L x W)

Barcode value :

NA

Folded Size :

57 x 40 mm (L x W)

Barcode Type (Ex. NDC, PZN, EAN-13)

NA

Substrate :

GSM : 40 gsm

Component :

Leaflet

Paper : Bible Paper

Font Size :

9 PT

Font Name :

Helvetica Condensed

Gluing :

YES

Perforation :

NA

Pharmacode :

4419

Cover Page
Substrate :

NA

Pantone Colours :
Reason for Change :

Black
Change in Textmatter.

Unicorn Creation
D/Lupin/Regulatory/UK/Munalea/

Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Munalea if you have Hepatitis C and are taking the medicinal
products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this
may cause increases in liver function blood test results (increase in ALT liver
enzyme).
Your doctor will prescribe another type of contraceptive prior to start of the
treatment with these medicinal products.
Munalea can be restarted approximately 2 weeks after completion of this
treatment. See section “Do not take Munalea”.
Munalea with food and drink
Munalea may be taken with or without food, if necessary with a small amount
of water.
Laboratory tests:
If you need a blood test, tell your doctor or the laboratory staff that you are
taking the pill, because hormone contraceptives can effect the results of some
tests.
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
this medicine.
Pregnancy
If you are pregnant, do not take Munalea. If you become pregnant while taking
Munalea stop immediately and contact your doctor. If you want to become
pregnant, you can stop taking the pill at any time.
Breast-feeding
Use of Munalea is generally not advisable when a woman is breast-feeding. If
you want to take the pill while you are breast feeding you should contact your
doctor.
Fertility
There is no evidence to suggest any short or long term infertility effects
following the use of this medicine. However, in patients receiving similar oral
contraceptive products, temporary infertility after discontinuance of treatment
has been seen occasionally.
Driving and using machines
There is no information suggesting that use of Munalea affects driving or use
of machines
Munalea contains lactose
This product contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before you take this
product.

3. How to take Munalea
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 one tablet of Munalea every day, if necessary with a small amount of
water. You may take the tablets with or without food, but you should take the
tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet is printed the day of the week
that it should be taken. If, for example you start on a Wednesday, take a tablet
with “WED” next to it. Follow the direction of the arrow on the strip until all 21
tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days
(otherwise called a stop or gap week) bleeding should begin. This is socalled “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap
week.
On the 8th day after the last tablet of Munalea (that is, after the 7-day gap week),
you should start with the following strip, whether your bleeding has stopped or
not. This means that you should start every strip on the same day of the week
and that the withdrawal bleed should occur on the same days each month.
If you use Munalea in this manner, you are also protected against pregnancy
during the 7 days when you are not taking a tablet.
When can you start with the first strip?
·
If you have not used a contraceptive with hormones in the previous month
Begin with Munalea on the first day of the cycle (that is the first day of your
period). If you start Munalea on the first day of your period you are
immediately protected against pregnancy. You may also begin on day 2-5
of the cycle, but then you must use extra protective measures (for
example, a condom) for the first 7 days.
·
Changing from a combination hormonal contraceptive, or combination
contraceptive vaginal ring or patch
You can start Munalea preferably on the day after the last active tablet (the
last tablet containing active substances) of your previous pill, but at the
latest on the day after the tablet-free days of your previous pill (or after the
last inactive tablet of your previous pill). When changing from a
combination contraceptive vaginal ring or patch, follow the advice of your
doctor.
·
Changing from a progestogen-only-method (progestogen-only pill,
injection, implant or a progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from an implant
or an IUD on the day of its removal, from an injectable when the next
injection would be due) but in all of these cases use extra protective
measures (for example, a condom) for the first 7 days of tablet-taking.
·
After a miscarriage
Follow the advice of your doctor.
·
After having a baby
You can start Munalea between 21 and 28 days after having a baby. If you
start later than day 28, use a so-called barrier method (for example, a

condom) during the first seven days of Munalea use. If, after having a
baby, you have had sex before starting Munalea (again), be sure that you
are not pregnant or wait until your next period.
·
If you are breastfeeding and want to start Munalea (again) after having a
baby.
Read the section on “Pregnancy, breast feeding and fertility”.
Ask your doctor what to do if you are not sure when to start.
If you take more Munalea than you should
There are no reports of serious harmful results of taking too many Munalea
tablets. If you take several tablets at once then you may have symptoms of
nausea or vomiting. Young girls may have bleeding from the vagina. If you
have taken too many Munalea tablets, or you discover that a child has taken
some, ask your doctor or pharmacist for advice.
If you forget to take Munalea
Ÿ If you are less than 12 hours late taking a tablet, the protection against
pregnancy is not reduced. Take the tablet as soon as you remember and
then take the following tablets again at the usual time.
Ÿ If you are more than 12 hours late taking a tablet, the protection against
pregnancy may be reduced. The greater the number of tablets that you
have forgotten, the greater is the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget a
tablet at the beginning or the end of the strip. Therefore, you should keep to
the following rules (see the diagram below):
·
More than one tablet forgotten in this strip
Contact your doctor.
·
One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Continue taking the tablets
at the usual time and use extra precautions for the next 7 days, for
example, a condom. If you have had sex in the week before forgetting the
tablet you may be pregnant. In that case, contact your doctor.
·
One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Continue taking the tablets
at the usual time. The protection against pregnancy is not reduced, and
you do not need to take extra precautions.
·
One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means
that you have to take two tablets at the same time. Continue taking the
tablets at the usual time. Instead of taking the tablet-free period start
next strip.
Most likely, you will have a period at the end of the second strip but you
may also have light or menstruation–like bleeding during the second
strip.
2. You can also stop the strip and go directly to the tablet-free period of 7
days (record the day on which you forgot your tablet). If you want to
start a new strip on the day you always start, make the tablet-free
period less than 7 days.
If you follow one of these two recommendations, you will remain protected
against pregnancy.
·
If you have forgotten any of the tablets in a strip, and you do not have
bleeding in the first tablet-free period, you may be pregnant. Contact your
doctor before you start the next strip.

Ask your doctor for advice

Several tablets
forgotten in
1 strip

yes

in week 1

only 1 tablet
forgotten (taken
more than
12 hours late)

Had sex in the previous week
before forgetting?

Take the forgotten tablet
Use a barrier method (condom)
for the following 7 days
And finish strip
in week 2

Take the forgotten tablet and
Finish the strip
Take the forgotten tablet and
Finish the strip
Instead of the gap week
Go straight on to the next strip

in week 3

or
Stop the strip immediately
Begin the gap week (not longer
than 7 days, including the
forgotten tablet)
Then go on the next strip

What to do in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea,
there is a risk that the active substances in the tablet are not fully absorbed into

your body. The situation is almost the same as forgetting a tablet. After
vomiting or diarrhoea, take another tablet from a reserve strip as soon as
possible. If possible take it within 12 hours of when you normally take your
pill. If this is not possible or 12 hours have passed, you should follow the
advice given under “If you forget to take Munalea.”
Delay of menstrual period: what you need to know
Even though it is not recommended, you can delay your menstrual period by
going straight to a new strip of Munalea instead of the tablet-free period, and
finishing it. You may experience light or menstruation-like bleeding while
using this second strip. After the usual tablet-free period of 7 days, start the
next strip.You might ask your doctor for advice before deciding to delay your
menstrual period.
Changing of the first day of your menstrual period: what you must know
If you take the tablets according to the instructions, then your period will begin
during the tablet-free week. If you have to change this day, reduce the number
of the tablet-free days (but never increase them – 7 is the maximum). For
example, if your tablet-free days normally begin on a Friday, and you want to
change this to a Tuesday (3 days earlier) start a new strip 3 days earlier than
usual. If you make the tablet-free interval very short (for example, 3 days or
less) you may not have any bleeding during these days. You may then
experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking Munalea
You can stop taking Munalea whenever you want. If you do not want to
become pregnant, ask your doctor for advice about other reliable methods of
birth control. If you want to become pregnant, stop taking Munalea and wait
for a period before trying to become pregnant. You will be able to calculate the
expected delivery date more easily.
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. If you get any side effect, particularly if severe and
persistent, or have any change to your health that you think may be due to
Munalea, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism
(VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is
present for all women taking combined hormonal contraceptives. For more
detailed information on the different risks from taking combined hormonal
contraceptives please see section 2 “What you need to know before you use
Munalea”.
Serious reactions
More serious reactions associated with combined hormonal contraceptive
pills are detailed above in section 2 under “The pill and venous and arterial
blood clots (thrombosis)” and “The pill and cancer”. Please read these
subsections carefully, and if you have any questions, ask your doctor.
The following serious side effects have been reported in women using the pill:
Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
systemic lupus erythematosus (SLE, a disease of the connective tissue),
epilepsy, the rash known as herpes gestationis, chorea (a movement disease),
a blood disorder called haemolytic uraemic syndrome - HUS (a disorder where
blood clots cause the kidneys to fail), brown patches on the face and body
(chloasma), movement disorder called Sydenham's chorea, yellowing of the
skin, gynaecological disorders (endometriosis, uterine myoma).
Other possible side effects
The following side effects have been reported in women using the pill, which
can occur in the first few months after starting Munalea, but they usually stop
once your body has adjusted to the pill.
Very common (more than 1 in every 10 users may be affected)
·
irregular bleeding
·
weight gain
Common or uncommon (between 1 and 100 in every 1,000 users may be
affected
·
none or reduced bleeding
·
tender breasts
·
breast enlargement
·
breast pain
·
decreased sexual desire
·
depression
·
headache
·
nervousness
·
migraine
·
dizziness
·
nausea
·
vomiting
·
acne
·
rash
·
nettle-rash (urticaria)
·
fluid retention
·
high blood pressure.
Rare (between 1 and 10 in every 10,000 users may be affected)
·
vaginal candidiasis (fungal infection)
·
impaired hearing (otosclerosis)
·
thromboembolism
·
hypersensitivity
·
increased sexual desire
·
eye irritation due to contact lens
·
loss of hair (alopecia)
·
itching
·
skin disorders (erythema nodosum – a skin disease associated with joint

pain, fever, hypersensitivity, or infection, and characterized by small,
painful, pink to blue nodules under the skin and on the shins that tend to
recur
·
erythema multiforme – a skin disease characterized by solid raised spots
on the skin or fluid-filled blisters lesions and reddening or discoloration of
the skin often in concentric zones about the lesions)
·
vaginal discharge
·
breast discharge.
·
harmful blood clots in a vein or artery for example:
o in a leg or foot (i.e. DVT)
o in a lung (i.e. PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known as a transient
ischaemic attack (TIA)
o blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other
conditions that increase this risk (See section 2 for more information on the
conditions that increase risk for blood clots and the symptoms of a blood clot)
Before you have any blood tests
Tell your doctor or the laboratory staff that you are taking the pill, because oral
contraceptives can affect the results of some tests.
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 Munalea
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the carton
and blister. The expiry date refers to the last day of that month.
Store blisters in the original pouches. This medicinal product does not require
any special storage conditions.
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 Munalea contains
The active substance(s) are desogestrel and ethinyl estradiol.
One (1) film-coated tablet contains 150mcg of desogestrel and 30
micrograms of ethinyl estradiol.
The other ingredients are:
Tablet core: lactose monohydrate, All rac α Tocopherol (E307), povidone K30,
silica colloidal anhydrous, talc (E553b), maize starch, Stearic acid,
magnesium stearate (E470b)
Film-coating:
hypromellose (HPMC2910, E464), titanium dioxide (E171), macrogol 400
(PEG 400)
What Munalea looks like and contents of the pack
Munalea film-coated tablets are white, round, biconvex, debossed with “L” on
one side and “7” on the other side. Munalea film-coated tablets are packed in
blister strips. Each blister contains 21 tablets.
Munalea is available in packs of 21 (1x21), 63 (3x21), 126 (6x21) and 273
(13x21) tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
WA16 0PF
United Kingdom
This leaflet was last revised in (05/2017).
Code No. MP/DRUGS/28/6/2010
ID#: 252839

252839 INS MUNALEA 150/30MCG TABS UK R3 (BACK)
Market/Customer :

UK

Location :

Pithampur

Prepared On :

24/07/2017

Version No. :

03

Product Name :

INS MUNALEA 150/30MCG TABS UK R3

Material Code :

252839

Supersedes Material code :

251723

Open Size :

450 x 350 mm (L x W)

Barcode value :

NA

Folded Size :

57 x 40 mm (L x W)

Barcode Type (Ex. NDC, PZN, EAN-13)

NA

Substrate :

GSM : 40 gsm

Component :

Leaflet

Paper : Bible Paper

Font Size :

9 PT

Font Name :

Helvetica Condensed

Gluing :

YES

Perforation :

NA

Pharmacode :

4419

Cover Page
Substrate :

NA

Pantone Colours :
Reason for Change :

Black
Change in Textmatter.

Unicorn Creation
D/Lupin/Regulatory/UK/Munalea/

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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