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MAEXENI 150/30 MICROGRAM FILM COATED TABLETS

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

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·
If a close relative has or has 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 Crohn's disease or ulcerative colitis (inflammatory bowel disease)
·
If you have HUS (haemolytic uraemic syndrome; a blood disease that causes kidney damage)
·
If you have epilepsy (see “Other medicines and Maexeni”)
·
If you have SLE (systemic lupus erythematosus; a disease of the immune system)
·
If you have a disease that first appeared during pregnancy or earlier use of sex hormones (for
example, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with
vesicles during pregnancy), Sydenham's chorea (a disease of the nerves in which sudden
movements of the body occur)
·
If you have or have ever had chloasma (golden brown pigment patches, so called “pregnancy
patches”, especially on the face). If this is the case, avoid direct exposure to sunlight or
ultraviolet light
·
If you have hereditary angioedema, products containing estrogens may induce or worsen
symptoms of angioedema. Contact your doctor immediately if you experience symptoms of
angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing or
hives together with difficulty breathing
·
If a pre-existing high blood pressure condition worsens
·
If a pre-existing high level of fat in your blood worsens.
Maexeni and thrombosis
Venous thrombosis
The use of any combination pill, including Maexeni, increases a woman's risk of developing a
venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not
take any (contraceptive) pill.
The risk of venous thrombosis in users of combined pills increases:
·
with age
·
if you are overweight
·
if one of your close relatives has had a blood clot (thrombosis) in the leg, lung, or other organ
at a young age
·
if you must have an operation (surgery), any prolonged period of immobilization, or if you
have had a serious accident. It is important to tell your doctor in advance that you are using
Maexeni as you may have to stop using it. Your doctor will tell you when to start again. This is
usually about two weeks after you are back on your feet.
Arterial thrombosis
The use of combination pills has been connected with an increase of the risk of arterial thrombosis
(obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or the brain
(stroke).
The risk of arterial thrombosis in users of combined pills increases:
·
with age
·
if you smoke; you are strongly advised to stop smoking when you use Maexeni, especially if
you are older than 35 years
·
if you have an increased fat content in your blood (cholesterol or triglycerides)
·
if you have high blood pressure
·
if you have migraine
·
if you have a problem with your heart (valve disorder, a disturbance of the heart rhythm).
Stop taking Maexeni and tell your doctor immediately if you notice possible signs of
thrombosis, such as:
·
any unusual, severe or long-lasting headache or worsening of migraine
·
partial or complete blindness or double vision
·
sudden pain and/or swelling in one of your legs
·
sudden breathlessness
·
sudden cough without an obvious cause
·
sudden severe pain in the chest which may reach the left arm
·
difficulty in speaking or inability to speak
·
weakness, strange feeling, or numbness in any part of the body
·
a feeling of dizziness or spinning
·
collapse with or without focal seizure
·
motor (movement) disturbances
·
sudden severe abdominal pain.
Maexeni and cancer
Breast cancer has been observed slightly more often in women using combined 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 using combined 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 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 unusual severe abdominal pain.

400 mm

252599 INS MAEXENI 150/30MCG TAB UK R1 (FRONT)
Market/Customer :

UK

Location :

Prepared On :

13/06/2017

Version No. :

Product Name :

INS MAEXENI 150/30MCG TAB UK R1

Material Code :

252599

Supersedes Material code :

233609

Open Size :

400 x 265 mm (L X W)

Barcode value :

NA

Folded Size :

50 x 35 mm (L X W)

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

NA

01

GSM : 40 gsm

Component :

Leaflet

Paper : Bible Paper

Font Size :

9 PT

Font Name :

Helvetica Condensed

Gluing :

NA

Perforation :

NA

Pharmacode :

4384

Cover Page
Substrate :

NA

Substrate :

Pantone Colours :
Reason for Change :
.
.

Black

Dieline (Does Not Print)

Change in Textmatter.

Bleeding between periods
During the first few months that you are taking Maexeni, you may have unexpected bleeding
(bleeding outside the gap week). If this bleeding lasts longer than a few months, or if it begins after
some months, talk to your doctor who will investigate the cause.
What to do if no bleeding occurs in the gap week
If you have taken all the tablets correctly, have not vomited or had severe diarrhoea, and you have
not taken any other medicines, it is highly unlikely that you are pregnant.
If your period (withdrawal bleeding) does not happen twice in a row, 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 Maexeni
Tell your doctor if you are using, have recently used or might use any other medicines, including
herbal products. Also tell any other doctor or dentist who prescribes another medicine (or the
dispensing pharmacist) that you are using Maexeni. 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 Maexeni less effective in preventing pregnancy, or can cause
unexpected bleeding. They include medicines used for the treatment of:
·
epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine,
oxcarbamazepine, topiramate, felbamate)
·
tuberculosis (for example, rifampicin),
·
HIV infections (ritonavir, nevirapine)
·
other infectious diseases (griseofulvin, penicillin, tetracycline),
·
medicines that increase the motility of your intestines (metoclopramide),
·
the herbal remedy St. John's wort.
Maexeni may influence the effect of other medicines, for example:
·
medicines containing cyclosporine,
·
or the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures).
Do not use Maexeni 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.
Maexeni can be restarted approximately 2 weeks after completion of this treatment. See section
“Do not take Maexeni”.
Effect on laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because
oral contraceptives can affect the results of some tests.
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 this medicine.
If you become pregnant while taking Maexeni you must stop using the pill immediately and
contact your doctor.
Use of Maexeni is generally not advisable when a woman is breast-feeding. If you want to take the
pill while you are breast-feeding contact your doctor.
Driving and using machines
Maexeni does not have any known effect on your ability to drive or use machines.
Maexeni contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product.
3. How to take Maexeni
Always take this medicine exactly as your doctor, pharmacist or family planning nurse has told
you. Check with your doctor, pharmacist or family planning nurse if you are not sure.
Take Maexeni every day for 21 days
Maexeni comes in strips of 21 tablets, each marked with a day of the week.
·
Take your tablet at the same time every day.
·
Start by taking a tablet marked with the correct day of the week.
·
Follow the direction of the arrows on the strip. Take one tablet each day, until you have
finished all 21 tablets.
·
Swallow each tablet whole, with water if necessary. Do not chew the tablet.
Then have seven tablet-free days
After you have taken all 21 tablets in the strip, you have seven days when you take no tablets (the
so called “gap week”). So if you take the last tablet of one pack on a Friday, you will take the first
tablet of your next pack on the Saturday of the following week.
Within a few days of taking the last tablet from the strip, you should have a withdrawal bleed like a
period. This bleed may not have finished when it is time to start your next strip of tablets.
You do not need to use extra contraception during these seven tablet-free days – as long as you
have taken your tablets correctly and start the next strip of tablets on time.
Then start your next strip
Start taking tablets from your next strip of Maexeni after the seven tablet-free days – even if you
are still bleeding. Always start the new strip on time.

265 mm

Pharmacode 4384_Std

Package leaflet: Information for the user
Maexeni 150/30 microgram film-coated tablets
levonorgestrel / ethinylestradiol
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, pharmacist or family planning nurse.
·
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, pharmacist or family planning nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Maexeni is and what it is used for
2. What you need to know before you take Maexeni
3. How to take Maexeni
4. Possible side effects
5. How to store Maexeni
6. Contents of the pack and other information
1. What Maexeni is and what it is used for
Maexeni is a combined oral contraceptive pill ('the Pill').
Maexeni is a 21-day Pill – you take one tablet each day for 21 days, followed by 7 days when you
take no tablets.
Combined oral contraceptives contain two types of female hormones, an estrogen,
ethinylestradiol and a progestogen, levonorgestrel. When used as instructed it is very unlikely that
you will become pregnant.
Take Maexeni as directed in order to prevent pregnancy.
2. What you need to know before you take Maexeni
It is important that you understand the benefits and risks of taking the Pill before you start taking
it, or when deciding whether to carry on taking it. Although the Pill is suitable for most healthy
women it is not suitable for everyone. Tell your doctor if you have any of the illnesses or risk
factors mentioned in this leaflet.
Before you start taking the Pill
Your doctor will ask about you and your family's medical problems, check your blood pressure
and exclude the likelihood of being pregnant. You may also need other checks, such as a breast
examination, but only if these examinations are necessary for you, or if you have any special
concerns.
Maexeni will not protect you against sexually transmitted infections, such as Chlamydia or HIV.
Only condoms can help to do this.
Do not take Maexeni:
·
if you are allergic to levonorgestrel and ethinylestradiol, or any of the other ingredients of this
medicine (listed in section 6)
·
if you have (or have ever had) a blood clot (thrombosis) in a blood vessel of the leg, lung
(embolus) or other organs
·
if you have (or have ever had) a heart attack or stroke
·
if you have (or have ever had) a disease that can be a predictor of a heart attack (for example,
angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a transient
slight stroke with no residual effects)
·
if you have a disease that may increase the risk of a thrombosis in the arteries, such as:
o Diabetes mellitus with damaged blood vessels
o Very high blood pressure
o A very high level of fat in the blood (cholesterol or triglycerides)
·
if you have a disturbance of blood clotting (for example, protein C deficiency)
·
if you have (or have ever had) a certain form of migraine (with so-called focal neurological
symptoms)
·
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 have absence of menstrual period and the cause is unknown.
Do not use Maexeni if you have hepatitis C and are taking the medicinal products containing
ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section Other medicines and
Maexeni).
Warnings and precautions
In some situations you need to take special care while using Maexeni or any other combined
hormonal contraceptive, and it may be necessary that you are regularly checked by your doctor. If
any of the following conditions applies to you, you must inform your doctor before starting to use
Maexeni. Also if any of the following conditions develops or worsens during the use of Maexeni
you must consult your doctor.

If you follow either 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 tabletfree period, this may mean that you are pregnant. You must contact your doctor before you go on
to the next strip.
Several tablets
forgotten in 1 strip

Ask your doctor for advice.

yes

In week 1

Had sex in the previous week before forgetting?

no

Ÿ
Take the forgotten tablet.
Ÿ
Use a barrier method (condom) for the following 7 days.
Ÿ
Finish the strip.

Only 1 tablet
forgotten (taken more
than 12 hours late).

In week 2

Ÿ
Take the forgotten tablet.
Ÿ
Finish the strip.

Ÿ
Take the forgotten tablet.
Ÿ
Finish the strip.
Ÿ
Instead of the gap week go straight on the next strip.

or

In week 3

Ÿ
Stop the strip immediately.
Ÿ
Begin the gap week (not longer than 7 days including the

forgotten tablet)
Ÿ
Then go on the next strip.

A lost tablet
If you lose a tablet,
Either take the last tablet of the strip in place of the lost tablet. Then take all the other tablets on
their proper days. Your cycle will be one day shorter than normal, but your contraceptive
protection will not be affected. After your seven tablet-free days you will have a new starting day,
one day earlier than before.
Or if you do not want to change the starting day of your cycle, take a tablet from a spare strip if you
have one. Then take all the other tablets from your current strip as usual. You can then keep the
opened spare strip in case you lose any more tablets.
If you are sick or have 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 pill are not fully adsorbed into your body. The situation is similar what
happens to if you forget a tablet. After vomiting or having diarrhoea, you must 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, follow the advice given under “If you
forget to take Maexeni”.
If you have any further questions on the use of this medicine ask your doctor, pharmacist or family
planning nurses.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects
which you think may be due to Maexeni.
Possible side effects include:
Very common (may affect more than 1 in 10 users):
·
headache
Common (may affect up to 1 in 10 users):
·
mood swings,
·
depression,
·
abdominal pain (stomach ache),
·
breast pain,
·
breast tenderness,
·
weight gain,
·
nausea,
·
rash

400 mm

252599 INS MAEXENI 150/30MCG TAB UK R1 (BACK)
Market/Customer :

UK

Location :

Prepared On :

13/06/2017

Version No. :

Product Name :

INS MAEXENI 150/30MCG TAB UK R1

Material Code :

252599

Supersedes Material code :

233609

Open Size :

400 x 265 mm (L X W)

Barcode value :

NA

Folded Size :

50 x 35 mm (L X W)

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

NA

01

GSM : 40 gsm

Component :

Leaflet

Paper : Bible Paper

Font Size :

9 PT

Font Name :

Helvetica Condensed

Gluing :

NA

Perforation :

NA

Pharmacode :

4384

Cover Page
Substrate :

NA

Substrate :

Pantone Colours :
Reason for Change :
.
.

Black

Dieline (Does Not Print)

Change in Textmatter.

Uncommon (may affect up to 1 in 100 users):
·
vomiting,
·
diarrhoea,
·
fluid retention,
·
migraine,
·
decreased libido (interest in sex),
·
breast enlargement,
·
itchy red rash of the skin (urticaria)
Rare (may affect up to 1 in 1,000 users):
·
contact lens intolerance,
·
allergic reactions,
·
weight loss,
·
increased libido (interest in sex),
·
breast discharge,
·
vaginal discharge,
·
allergic reactions which can sometimes be severe with swelling of the skin and/or mucous
membranes (erythema nodosum and eruthema multiforme)
Other serious side effects you should be aware off are also mentioned in section 2 of this leaflet
(“Do not take Maexeni” and “Warnings and precautions”). These include:
- Blood clotting disorders
- High blood pressure
- Liver tumours
- Swelling of the skin (angioedema)
- Occurrence or deterioration of conditions such as: Crohn's disease, epilepsy, migraine etc.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or family planning nurse. 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 Maexeni
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 below 25°C.
Do not throw away any medicines via waste water 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 Maexeni contains
·
The active substances are levonorgestrel and ethinyl estradiol. One (1) film-coated tablet
contains 150 micrograms of levonorgestrel and 30 micrograms of ethinyl estradiol.
·
The other ingredients are:
Tablet core: lactose anhydrous, microcrystalline cellulose, povidone K30, croscarmellose
sodium, magnesium stearate (E470b).
Film-coating: hypromellose (HPMC, E464), titanium dioxide (E171), macrogol 400 (PEG 400,
E1521), iron oxide yellow (E172).
What Maexeni looks like and contents of the pack
Maexeni film-coated tablets are yellow, round biconvex, debossed with 'LE4' on one side and
plain on other side. Maexeni film-coated tablets are packed in blister strips. Each blister contains
21 tablets.
Maexeni 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 medicinal product is authorised in the Member States of the EEA under the following names:
Germany:
Maexeni 30 0,03mg/0,15mg Filmtabletten
United Kingdom: Maexeni 150/30 microgram film-coated tablets
This leaflet was revised in 04/2017
Code No. MP/DRUGS/28/6/2010
ID#: 252599

265 mm

As long as you take Maexeni correctly, you will always start each new strip on the same day of the
week.
Starting Maexeni
As a new user or starting the Pill again after a break
·
If you have not used a contraceptive with hormones in the previous month
Start taking Maexeni on the first day of the cycle (that is the first day of your menstruation). If you
start Maexeni on the first day of your menstruation 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 another combined hormonal contraceptive, or combined contraceptive,
vaginal ring or patch
You can start taking Maexeni preferably on the day after the last active tablet (the last tablet
containing the active substance) of your previous pill, but at the latest on the day after the tabletfree days of your previous pill finish (or after the last inactive tablet of your previous pill). When
changing from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.
·
Changing from a progestogen-only-method (progestogen-only pill “POP” or “mini pill”,
injection, implant or a progestogen-releasing intrauterine device - IUD)
You may switch any day from the progestogen-only pill (from an implant or the IUD on the day of
its removal, from an injectable when the next injection would be due) but in all of these cases you
must 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
After having a baby, you can start Maexeni between 21 and 28 days later. If you start later than day
28, you must use a so-called barrier method (for example, a condom) during the first seven days
of Maexeni use.
If, after having a baby, you have had intercourse before starting Maexeni (again), you must first be
sure that you are not pregnant or you must wait until the next menstrual bleed.
Your doctor will advise you in case you are not sure when to start.
·
If you are breast-feeding and want to start Maexeni after having a baby
Read the section on “Pregnancy and breast-feeding”.
If you take more Maexeni than you should
There are no reports of serious harmful results of taking too many Maexeni tablets.
If you take several tablets at once, you may have symptoms of nausea or vomiting. Young girls
may have bleeding from the vagina.
If you have taken too many Maexeni tablets, or you discover that a child has taken some, ask your
doctor or pharmacist for advice.
If you forget to take Maexeni
If you are less than 12 hours late in taking your tablet, the protection from pregnancy is not
reduced. Take the tablet as soon as you remember, and then continue to take the following tablets
at the usual time.
If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced.
The greater the number of tablets that you have forgotten, the greater is the risk that the protection
from pregnancy is reduced.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the
beginning or the end of the strip. Therefore, follow the instructions below (also see the diagram
below):
·
If you forgot more than one tablet in this strip
Contact your doctor.
·
If you forgot one tablet in week 1
Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the
same time. Take the following tablets at the usual time and use extra precautions for the next 7
days, for example, a condom. If you have had intercourse in the week before the oversight or you
have forgotten to start a new strip after the tablet-free period, you must realize that there is a risk of
pregnancy. In that case, contact your doctor.
·
If you forgot one tablet in week 2
Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the
same time. Take the following tablets at the usual time. If you have taken the tablets correctly for
the last seven days, your protection from pregnancy is not reduced. If you did not use the tablets
correctly, use extra precaution for the next 7 days.
·
If you forgot one tablet in week 3
You can choose between two options:
1. Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the
same time. Take the following tablets at the usual time. Instead of the tablet-free period go straight
on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of the second strip but you may
also have spotting or breakthrough bleeding during the second strip.
2. You can also stop taking tablets from 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 your fixed start
day, make the tablet-free period less than 7 days.

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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