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ALENINI 150/20 MICROGRAMS FILM-COATED TABLETS

Active substance(s): DESOGESTREL / ETHINYLESTRADIOL

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Package leaflet: Information for the user

Alenini 150/20 micrograms Film-coated Tablets
Desogestrel/Ethinylestradiol
Important things to know about combined hormonal contraceptives (CHCs):
• They are one of the most reliable reversible methods of contraception if used
correctly
• 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
• 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.
• 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 Alenini is and what it is used for
2. What you need to know before you take Alenini
3. How to take Alenini
4. Possible side effects
5. How to store Alenini
6. Contents of the pack and other information
1. What Alenini is and what is used for
Alenini are a combined oral contraceptive, also called the pill.
Each of the 21 white tablets 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.

Are you experiencing any of these signs?

What are you possibly suffering
from?
Retinal vein thrombosis (blood
clot in the eye)

Symptoms most commonly occur in one
eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision
• chest pain, discomfort, pressure, heaviness Heart attack
• 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 face, Stroke
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 of
an extremity;
• severe pain in your stomach (acute
abdomen)

Blood clots blocking other
blood vessels

BLOOD CLOTS IN A VEIN
2. What you need to know before you take Alenini
General notes
Before you start using Alenini 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 Alenini, 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
Alenini, or where the reliability of the Alenini 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 the rhythm or temperature methods. These methods can
be unreliable because Alenini alters the monthly changes of body temperature
and of cervical mucus.
Alenini, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.
Do not take Alenini
You should not use Alenini 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.

What can happen if a blood clot forms in a vein?
• 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.
• If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis
(DVT).
• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary
embolism.
• 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 Alenini 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 Alenini 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.
• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein • Out of 10,000 women who are using a combined hormonal contraceptive that
thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a
• if you know you have a disorder affecting your blood clotting – for instance, protein blood clot in a year.
C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or
• Out of 10,000 women who are using a combined hormonal contraceptive that
antiphospholipid antibodies;
contains desogestrel, such as Alenini, between about 9 and 12 women will develop
• if you need an operation or if you are off your feet for a long time (see section
a blood clot in a year.
‘Blood clots’);
• The risk of having a blood clot will vary according to your personal medical history
• if you have ever had a heart attack or a stroke;
(see “Factors that increase your risk of a blood clot” below)
• if you have (or have ever had) angina pectoris (a condition that causes severe chest
Risk of developing a blood clot in a year
pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA –
temporary stroke symptoms);
Women who are not using a
About 2 out of 10,000 women
• if you have any of the following diseases that may increase your risk of a clot in the
combined hormonal pill/patch/
arteries:
ring and are not pregnant
• severe diabetes with blood vessel damage
Women using a combined
About 5-7 out of 10,000 women
• very high blood pressure
hormonal contraceptive pill
• a very high level of fat in the blood (cholesterol or triglycerides)
containing levonorgestrel,
• a condition known as hyperhomocysteinaemia
norethisterone or norgestimate
• 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)
Women using Alenini
About 9-12 out of 10,000 women
• if you have (or have ever had) a liver disease and your liver function is still not
normal.
Factors that increase your risk of a blood clot in a vein
• if you have (of have ever had) a tumour in the liver.
The risk of a blood clot with Alenini is small but some conditions will increase the
• if you have (or have ever had) or if you are suspected to having breast cancer or
risk. Your risk is higher:
cancer of the genital organs.
• if you are very overweight (body mass index or BMI over 30kg/m2);
• if you have any unexplained bleeding from the vagina.
• if one of your immediate family has had a blood clot in the leg, lung or other organ
• if you are allergic to ethinylestradiol, desogestrel or any of the other ingredients
at a young age (e.g. below the age of about 50). In this case you could have a
of this medicine (listed in section 6). This can be recognised by itching, rash or
hereditary blood clotting disorder;
swelling
• if you need to have an operation, or if you are off your feet for a long time because
• if you are allergic to peanut or soya.
of an injury or illness, or you have your leg in a cast. The use of Alenini may need to
be stopped several weeks before surgery or while you are less mobile. If you need
If any of these circumstances appear for the first time while you are taking the pill,
to stop Alenini ask your doctor when you can start using it again.
stop taking it and consult your doctor immediately. Meanwhile, use non-hormonal • as you get older (particularly above about 35 years);
contraceptives.
• if you gave birth less than a few weeks ago
The risk of developing a blood clot increases the more conditions you have.
When to take special care with Alenini
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if
you have some of the other factors listed.
When should you contact your doctor?
It is important to tell your doctor if any of these conditions apply to you, even if you
Seek urgent medical attention
are unsure. Your doctor may decide that Alenini needs to be stopped.
• if you notice possible signs of a blood clot that may mean you are suffering
If any of the above conditions change while you are using Alenini, for example a
from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the
close family member experiences a thrombosis for no known reason; or you gain a
lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clot’
lot of weight, tell your doctor.
(thrombosis) section below.
For a description of the symptoms of these serious side effects please go to
BLOOD CLOTS IN AN ARTERY
“How to recognise a blood clot”.
What can happen if a blood clot forms in an artery?
In some situations you need to take special care while using Alenini or any other
Like a blood clot in a vein, a clot in an artery can cause serious problems. For
combination pill, and your doctor may need to examine you regularly. If any of the
following conditions applies to you, inform your doctor before start to take Alenini. example, it can cause a heart attack or a stroke.
Also if any of the following applies or if any of the conditions develops or gets worse
Factors that increase your risk of a blood clot in an artery
while you are using Alenini, you should also tell your doctor:
It is important to note that the risk of a heart attack or stroke from using Alenini is
• if a close relative has or has ever had breast cancer
very small but can increase:
• if you have a disease of the liver or the gallbladder
• with increasing age (beyond about 35 years);
• if you have diabetes
• if you smoke. When using a combined hormonal contraceptive like Alenini you are
• if you have depression
advised to stop smoking. If you are unable to stop smoking and are older than 35
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel
your doctor may advise you to use a different type of contraceptive;
disease);
• if you are overweight;
• if you have systemic lupus erythematosus (SLE –; a disease affecting your natural
• if you have high blood pressure;
defence system);
• if a member of your immediate family has had a heart attack or stroke at a young
• if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting
age (less then about 50). In this case you could also have a higher risk of having a
causing failure of the kidneys);
heart attack or stroke;
• 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 • if you, or someone in your immediate family, have a high level of fat in the blood
(cholesterol or triglycerides);
family history for this condition. Hypertriglyceridaemia has been associated with
• if you get migraines, especially migraines with aura;
an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you have a problem with your heart (valve disorder, disturbance of the rhythm
• if you need an operation, or you are off your feet for a long time (see in section 2
called atrial fibrillation)
‘Blood clots’).
• if you have diabetes.
• 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 Alenini.
If you have more than one of these conditions or if any of them are particularly
• if you have an inflammation in the veins under the skin (superficial
severe the risk of developing a blood clot may be increased even more.
thrombophlebitis).
• if you have varicose veins.
If any of the above conditions change while you are using Alenini, for example
• if you have epilepsy (see “Other medicines and Alenini”)
you start smoking, a close family member experiences a thrombosis for no known
• if you have a disease that first appeared during pregnancy or earlier use of sex
reason; or you gain a lot of weight, tell your doctor.
hormones (for example, hearing loss, a blood disease called porphyria, skin rash
with blisters during pregnancy (gestational herpes), a nerve disease causing
The pill and cancer
sudden movements of the body (Sydenham’s Chorea)
• if you have or have ever had chloasma (a discoloration of the skin especially of the Breast cancer has been observed slightly more often in women using combination
face or neck known as “pregnancy patches”. If so, avoid direct sunlight or ultraviolet 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
light.
they are examined by their doctor more often. The occurrence of breast tumours
• if you have hereditary angioedema, products containing estrogens may cause
becomes gradually less after stopping the combination hormonal contraceptives. It
or worsen symptoms. You should see your doctor immediately if you experience
is important to regularly check your breasts and you should contact your doctor if
symptoms of angioedema such as swollen face, tongue and/or throat and/or
you feel any lump.
difficulty swallowing or hives together with difficulty breathing.
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.

Talk to your doctor or pharmacist before taking Alenini.
The pill and venous arterial blood clots (thrombosis)

Bleeding between periods
During the first few months that you are taking Alenini, you may have unexpected
bleeding (bleeding outside the gap week). If this bleeding occurs for more than a
Using a combined hormonal contraceptive such as Alenini increases your risk of
developing a blood clot compared with not using one. In rare cases a blood clot can few months, or if it begins after some months, your doctor find out what is wrong.
block blood vessels and cause serious problems.
What to do if no bleeding occurs during the gap week
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea
Blood clots can develop
and you have not taken any other medicines, it is highly unlikely that you are
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or 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
ATE).
are sure that you are not pregnant.
Recovery from blood clots is not always complete. Rarely, there may be serious
lasting effects or, very rarely, they may be fatal.
Children and adolescents
No clinical data on efficacy and safety are available in adolescents below 18 years.
It is important to remember that the overall risk of a harmful blood clot due to
Alenini is small.
Other medicines and Alenini
Always tell your doctor which medicines or herbal products you are already using,
HOW TO RECOGNISE A BLOOD CLOT
have recently used or might use. Also tell any other doctor or dentist who prescribes
Seek urgent medical attention if you notice any of the following signs or symptoms. another medicine (or the pharmacist) that you use Alenini. They can tell you if you
need to take additional contraceptive precautions (for example condoms) and if so,
Are you experiencing any of these signs?
What are you possibly suffering for how long.
from?
• Some medicines can make Alenini less effective in preventing pregnancy, or can
• swelling of one leg or along a vein in the
Deep vein thrombosis
cause unexpected bleeding.
leg or foot especially when accompanied
by:
These include:
• pain or tenderness in the leg which may
• medicines used for the treatment of
be felt only when standing or walking
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• increased warmth in the affected leg
• tuberculosis (e.g. rifampicin)
• change in colour of the skin on the leg
• HIV infections (ritonavir, nevirapin) or other infections (antibiotics such as
e.g. turning pale, red or blue
griseofulvin, penicillin, tetracycline)
• sudden unexplained breathlessness or
Pulmonary embolism
• the herbal remedy St., John’s wort.
rapid breathing;
• sudden cough without an obvious cause,
• Alenini may influence the effect of other medicines, e.g.
which may bring up blood;
• medicines containing cyclosporin
• sharp chest pain which may increase with
• the anti-epileptic lamotrigine (this could lead to an increased frequency of
deep breathing;
seizures).
• severe light headedness or dizziness;
• rapid or irregular heartbeat
Ask your doctor or pharmacist for advice before taking any medicine.
• severe pain in your stomach;
Alenini with food and drink
If you are unsure, talk to a doctor as some
Alenini may be taken with or without food, if necessary with a small amount of
of these symptoms such as coughing or
water.
being short of breath may be mistaken for a
milder condition such as a respiratory tract
infection (e.g. a ‘common cold’).
BLOOD CLOTS

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Desogestrel/Ethinylestradiol 150mcg / 20mg, PIL, United Kingdom
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AAAG7462

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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 affect the results of some tests.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant, do not take Alenini. If you become pregnant while taking
Alenini stop immediately and contact your doctor. If you want to become pregnant,
you can stop taking the pill at any time (see also “If you want to stop taking Alenini”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Alenini 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Alenini affects driving or use of
machines.
Alenini contains lactose and soybean oil
If you have been told by your doctor that can not tolerate certain sugars, contact
your doctor before taking this product.
If you are allergic to peanut or soya, do not use this medicinal product.
3. How to take Alenini

You might ask your doctor for advice before deciding to delay your menstrual
period.
Change 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, you do this by making
the tablet-free period shorter (but never longer!). For example, if your tablet-free
period begins on a Friday, and you want to change this to a Tuesday (3 days earlier)
you must start a new strip 3 days earlier than usual. If you make the tablet-free
period very short (for example, 3 days or less) then it may be that you do not have
any bleeding during this tablet-free period. You may light or menstruation-like
bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking Alenini
You can stop taking Alenini 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 Alenini 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

Take one tablet of Alenini every day, if necessary with a small amount of water. You
Like all medicines, Alenini can cause side effects, although not everybody gets them.
may take the tablets with or without food, but you should take the tablets every day If you get any side effect, particularly if severe and persistent, or have any change to
around the same time.
your health that you think may be due to Alenini please talk to your doctor.
The strip contains 21 tablets. Next to each tablet is printed the day of the week that
it should be taken. Start by taking a tablet from the first row marked with the correct
day of the week. 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.

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 Alenini”.

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 so-called “withdrawal
bleeding”, usually starts on the 2nd or 3rd day of the gap week.

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.

On the 8th day after the last Alenini tablet (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
The following side effects have been reported in women using the pill: Crohn’s
withdrawal bleed should occur on the same days each month.
disease or ulcerative colitis (chronic inflammatory bowel diseases), systemic lupus
erythematosus (SLE, a disease of the connective tissue), epilepsy, the rash known as
If you use Alenini in this manner, you are also protected against pregnancy during
herpes gestationis, chorea (a movement disease), a blood disorder called haemolytic
the 7 days when you are not taking a tablet.
uraemic syndrome – HUS (a disorder where blood clots cause the kidneys to
fail), brown patches on the face and body (chloasma), movement disorder called
When can you start with the first strip?
Sydenham’s chorea, yellowing of the skin, gynaecological disorders (endometriosis,
• If you have not used a contraceptive with hormones in the previous month
uterine myoma).
Begin Alenini on the first day of the cycle (that is the first day of your period). If you
start Alenini on the first day of your period you are immediately protected against Other possible side effects
pregnancy. You may also start on days 2-5 of your cycle, but in that case make sure The following side effects have been reported in women using the pill, which can
you also use an additional contraceptive method (barrier method) for the first 7
occur in the first few months after starting Alenini, but they usually stop once your
days of tablet-taking in the first cycle.
body has adjusted to the pill. The most commonly reported side effects (more than
1 in every 10 users may be affected) are irregular bleeding and weight gain.
• Changing from another combination hormonal contraceptive, or combination
contraceptive vaginal ring or patch
Common or uncommon (between 1 and 100 in every 1,000 users may be
You can start Alenini preferably on the day after taking the last active tablet (the last affected): none or reduced bleeding, tender breasts, breast enlargement, breast
tablet containing active substances) of your previous pill, but at the latest on the
pain, decreased sexual desire, depression, headache, nervousness, migraine,
day after the tablet-free days of your previous pill (or after the last inactive tablet of dizziness, nausea, vomiting, acne, rash, nettle-rash (urticaria), fluid retention, high
your previous pill). When changing from a combination contraceptive vaginal ring blood pressure.
or patch, follow the advice of your doctor.
Rare (between 1 and 10 in every 10,000 users may be affected): vaginal
• Changing from a progestogens-only-method (progestogen-only-pill, injection, candidiasis (fungal infection), impaired hearing (otosclerosis), thromboembolism,
implant or a progestogen-releasing IUD)
hypersensitivity, increased sexual desire, eye irritation due to contact lens, loss
You may switch any day from the progestogen-only pill (from an implant or an IUD of hair (alopecia), itching, skin disorders (erythema nodosum – a skin disease
on the day of its removal, from an injectable when the next injection would be due) associated with joint pain, fever, hypersensitivity, or infection, and characterised
but in all of these cases you must use extra protective measures (for example, a
by small, painful, pink to blue nodules under the skin and on the shins that tend to
condom) for the first 7 days of tablet-taking.
recur, erythema multiforme - a skin disease characterized by solid raised spots on
the skin on fluid-filled blisters lesions and reddening or discoloration of the skin
• After a miscarriage
often in concentric zones about the lesions, vaginal discharge, breast discharge,
Follow the advice of your doctor.
harmful blood clots in a vein or artery, for example: in a leg or foot (i.e. DVT), in a
lung (i.e. PE), heart attack, stroke, mini-stroke or temporary stroke-like symptoms,
• After having a baby
known as a transient ischaemic attack (TIA), blood clots in the liver, stomach/
You can start Alenini between 21 and 28 days after having a baby. If you start later intestine, kidneys or eye.
than day 28, use a so-called barrier method (for example, a condom) during the first
seven days of Alenini use. If after having a baby, you have had sex before starting
The chance of having a blood clot may be higher if you have any other conditions
Alenini (again), be sure that you are not pregnant or wait until your next period.
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)
• If you are breastfeeding and want to start Alenini (again) after having a baby.
Read the section “Breast-feeding”.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
Ask your doctor what to do if you are not sure when to start.
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.
If you take more Alenini than you should
By reporting side effects you can help provide more information on the safety of this
There are no reports of serious harmful results of taking to many Alenini tablets.
medicine.
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 Alenini tablets, or you discover that a child has taken some, ask your doctor or 5. How to store Alenini
pharmacist for advice.
Keep this medicine out of the sight and reach of children.
What to do if you forget to take Alenini
• If you are less than 12 hours late taking a tablet, the protection against pregnancy Do not store this medicine above 30ºC. Store in the original package in order to
is not reduced. Take the tablet as soon as you remember and then take the
protect from light.
following tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection against
Expiry Date
pregnancy may be reduced. The greater the number of tablets you have forgotten, Do not use this medicine after the expiry date which is stated on the package, after
the greater is the risk of becoming pregnant.
‘EXP.’. The expiry date refers to the last day of that month.
Do not use Alenini if you notice a change of colour, broken tablets or any other
The risk of incomplete protection against pregnancy is greatest if you forget a
visible signs of deterioration.
tablet at the beginning or the end of the strip. Therefore, you should adhere to the
following rules (see also the diagram below):
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
• More than one tablet forgotten in this strip
help protect the environment.
Contact your doctor.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if this means that you
have to take two tablets at the same time. Continue taking the tablets at the usual
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 or you have forgotten to start a
new strip after the tablet-free period, 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 the tablet-free period go straight on to the next strip.
Most likely, you will have a period at the end of the second strip buy 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 your fixed start day, make the tablet-free period less than 7 days.

6. Contents of the pack and other information
What Alenini contains
• The active substances are desogestrel and ethinylestradiol. Each white tablet
contains 150 micrograms desogestrel and 20 micrograms ethinylestradiol.
• The other ingredients are: lactose monohydrate, maize starch, povidone K-30
(1201), rrr-alpha-tocopherol (E307), soybean oil, silica colloidal hydrated (E551),
silica colloidal anhydrous (E551), stearic acid (E570), hypromellose 2910 (E464),
macrogol 400, titanium dioxide (E171).
What Alenini looks like and contents of the pack
• Each film-coated tablet is white and rounded. Each tablet is coded on one side “C”
and on the reverse side “5”.
• Alenini is available in blisters of 21 tablets.
Pack sizes are 3 strips, each strip with 21 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

If you follow one of these two recommendations, you will remain protected against
pregnancy.

Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Pol. Ind. Navatejera.
24008 - Navatejera, León.
Spain

• 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.

This leaflet was last revised in April 2014.

More than 1 tablet
forgotten in 1 strip

Ask your doctor for advice

Yes

in week 1

If you would like a leaflet with larger text,
please contact 01271 385257.

Had sex in the previous
week before forgetting?

No

• Take the forgotten tablet
• Use a barrier method
(condom) for the
following 7 days
• And finish strip
only 1 tablet
forgotten
(taken more than 12
hours late)

in week 2

• Take the forgotten tablet
and
• Finish the strip
• Take the forgotten tablet
and
• Finish the strip
• Instead of the gap week
• Start the next strip

Or

in week 3

• Stop the strip
immediately
• Begin the gap week
not longer than 7 days,
(including the forgotten
tablet)
• Then start 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 Alenini”.
Delay of menstrual period: what you need to know
Even though is not recommended, you can delay your menstrual period by going
straight to a new strip of Alenini 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.

continued top of next column

AAAG7462

Actavis, Barnstaple, EX32 8NS UK

Desogestrel/Ethinylestradiol 150mcg / 20mg, PIL, United Kingdom
item no:

AAAG7462

dimensions: 222 x 680

print proof no:

1

pharmacode:

origination date: 2.4.14
approved for print/date

originated by:

min pt size:

db

2.
3.
5.
6.

Technical Approval

revised by:

date sent:

León Farma

1. black

4.

8.5 pt

revision date:

supplier:

colours/plates:

approved:

2.4.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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