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ALENVONA 150/30MICROGRAMS FILM-COATED TABLETS

Active substance(s): DESOGESTREL MICRONISED / ETHINYLESTRADIOL MICRONISED

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Package leaflet: Information for the user

Alenvona 150/30micrograms 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 Alenvona is and what it is used for
2. What you need to know before you take Alenvona
3. How to take Alenvona
4. Possible side effects
5. How to store Alenvona
6. Contents of the pack and other information
1. What Alenvona is and what it is used for
Alenvona 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.
2. What you need to know before you take Alenvona
General notes
Before you start using Alenvona 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”. 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 taking
Alenvona, or where the reliability of the Alenvona 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 Alenvona alters the monthly changes of body
temperature and of cervical mucus.
Alenvona, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or any other sexually transmitted disease.
When you should not use Alenvona
You should not use Alenvona 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 have ever had a heart attack or 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 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 have (or have ever had) a type of migraine called ‘migraine with aura’.
• if you need an operation or if you are off your feet for a long time (see section
‘Blood clots’).
• 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 of having breast cancer or
cancer of the genital organs
• if you have any unexplained bleeding from the vagina
• if you are allergic to ethinylestradiol, desogestrel or any of the other
ingredients of this medicine (listed in section 6). This can be recognised by
itching, rash or swelling
• if you are allergic to peanut or soya.
When to take special care with Alenvona
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’
section below).
For a description of the symptoms of these serious side effects please go to
“How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you
In some situations you need to take special care while using Alenvona or any
other 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 Alenvona. If the condition develops, or gets worse while you are using
Alenvona, you should also tell your doctor.
• 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 Crohn’s disease or ulcerative colitis (chronic inflammatory bowel
disease)
• if you have a 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 epilepsy (see “Other medicines and Alenvona”)
• if you have systemic lupus erythematosus (SLE – a disease affecting your
natural defence system)
• 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 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 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 Alenvona
• 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 need an operation, or you are off your feet for a long time (see in section
2 ‘Blood clots’)
• if you have an inflammation in the veins under the skin (superficial
thrombophlebitis)
• if you have varicose veins
• if you have hereditary angioedema, products containing estrogens 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.
Talk to your doctor or pharmacist before taking Alenvona.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Alenvona 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
• in veins (referred as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
• 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.

• 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
(e.g. a ‘common cold’).
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
• 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, 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.

Retinal vein thrombosis (blood clot in
the eye)

Heart attack

Stroke

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
Blood clots blocking other blood
discolouration of an extremity;
vessels
• severe pain in your stomach (acute
abdomen)
BLOOD CLOTS IN A VEIN
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 Alenvona 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 Alenvona 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 Alenvona, 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
About 2 out of 10,000 women
combined hormonal pill/patch/
ring and are not pregnant
Women using a combined
About 5-7 out of 10,000 women
hormonal contraceptive pill
containing levonorgestrel,
norethisterone or norgestimate
Women using Alenvona
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 Alenvona 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 (e.g. 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
Alenvona may need to be stopped several weeks before surgery or while you
are less mobile. If you need to stop Alenvona 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 (>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 Alenvona needs to be stopped.
If any of the above conditions change while you are using Alenvona, 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
Alenvona is very small but can increase:
• with increasing age (beyond about 35 years);
• i f you smoke. When using a combined hormonal contraceptive like Alenvona
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 than 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 Alenvona, 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
It is important to remember that the overall risk of a harmful blood clot due combination pills because they are examined by their doctor more often.
to Alenvona is small.
The occurrence of breast tumours becomes gradually less after stopping the
combination hormonal contraceptives. It is important to regularly check your
HOW TO RECOGNISE A BLOOD CLOT
breasts and you should contact your doctor if you feel any lump.
Seek urgent medical attention if you notice any of the following signs or
symptoms.
Are you experiencing any of these
What are you possibly suffering from?
signs?
• swelling of one leg or along a vein
Deep vein thrombosis
in the 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 Pulmonary embolism
or rapid breathing;
• sudden cough without an obvious
cause, which may bring up blood;

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.
Bleeding between periods
During the first few months that you are taking Alenvona, 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 will
find out what is wrong.
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 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
Children and adolescents
No clinical data on efficacy and safety are available in adolescents below 18
years.
Other medicines and Alenvona
Always tell your doctor which medicines or herbal products you are already
using, have recently used or might use. Also tell any other doctor or dentist
who prescribes another medicine (or the pharmacist) that you use Alenvona.
They can tell you if you need to take additional contraceptive precautions (for
example condoms) and if so, for how long.

AAAG6963

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Desogestrel/Ethinylestradiol 150mcg / 30mcg, PIL, United Kingdom
item no:

AAAG6963

dimensions: 222 x 680

print proof no:

7

pharmacode:

origination date: 24.1.14
approved for print/date

min pt size:

colours/plates:
1. black
2.
3.
4.

8.5 pt

originated by:

db

revision date:

31.7.14

Technical Approval

revised by:

db

date sent:

20.3.14

supplier:

León Farma

approved:

28.5.14

5.
6.
Non Printing Colours
1.
2.
3.

• Some medicines can make Alenvona 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,
oxcarbazepine)
- tuberculosis (e.g. rifampicin)
- HIV infections (ritonavir, nevirapin) or other infections (antibiotics such as
griseofulvin, penicillin, tetracycline)
• the herbal remedy St. John’s wort.
•A
 lenvona may influence the effect of other medicines, e.g.
- medicines containing cyclosporin
- the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures).
Ask your doctor or pharmacist for advice before taking any medicine.
Alenvona with food and drink
Alenvona 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 affect the results of some
test.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant, do not take Alenvona. If you become pregnant while taking
Alenvona 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 Alenvona”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Alenvona 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.

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 Alenvona”.
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 Alenvona 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.
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 then
experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking Alenvona
You can stop taking Alenvona 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 Alenvona 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.

Driving and using machines
There is no information suggesting that use of Alenvona affects driving or use of 4. Possible side effects
machines.
Like all medicines, Alenvona can cause side effects, although not everybody
Alenvona contains lactose and soybean oil
gets them. If you get any side effect, particularly if severe and persistent, or have
If have been told by your doctor that can not tolerate certain sugars, contact
any change to your health that you think may be due to Alenvona, please talk to
your doctor before taking this medicine.
your doctor.
If you are allergic to peanut or soya, do not use this medicinal product.
An increased risk of blood clots in your veins (venous thromboembolism
(VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is
3. How to take Alenvona
present for all women taking combined hormonal contraceptives. For more
detailed information on the different risks from taking combined hormonal
Take one tablet of Alenvona every day, if necessary with a small amount of
contraceptives please see section 2 “What you need to know before you take
water. You may take the tablets with or without food, but you should take the
Alenvona”.
tablets every day around the same time.
Serious reactions
The strip contains 21 tablets. Next to each tablet is printed the day of the week
More serious reactions associated with combined hormonal contraceptive pills
that it should be taken. Start by taking a tablet from the first row marked with
are detailed above in section 2 under “The pill and venous and arterial blood
the correct day of the week. If, for example you start on a Wednesday, take a
clots (thrombosis)”· and “The pill and cancer”. Please read these subsections
tablet with “WED” next to it. Follow the direction of the arrow on the strip until
carefully, and if you have any questions, ask your doctor.
all 21 tablets have been taken.
The following serious side effects have been reported in women using the
Then take no tablets for 7 days. In the course of these 7 tablet-free days
pill: Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases),
(otherwise called a stop or gap week) bleeding should begin. This so-called
systemic lupus erythematosus (SLE, a disease of the connective tissue),
“withdrawal bleeding”, usually starts on the 2nd or 3rd day of the gap week.
epilepsy, the rash known as herpes gestationis, chorea (a movement disease),
a blood disorder called haemolytic uraemic syndrome – HUS (a disorder where
On the 8th day after the last Alenvona tablet (that is, after the 7-day gap week), blood clots cause the kidneys to fail), brown patches on the face and body
you should start with the following strip, whether your bleeding has stopped or (chloasma), movement disorder called Sydenham’s chorea, yellowing of the skin,
not. This means that you should start every strip on the same day of the week
gynaecological disorders (endometriosis, uterine myoma).
and that the withdrawal bleed should occur on the same days each month.
Other possible side effects
If you use Alenvona in this manner, you are also protected against pregnancy
The following side effects have been reported in women using the pill, which
during the 7 days when you are not taking a tablet.
can occur in the first few months after starting Alenvona, but they usually stop
once your body has adjusted to the pill. The most commonly reported side
When can you start with the first strip
effects (more than 1 in every 10 users may be affected) are irregular bleeding
• I f you have not used a contraceptive with hormones in the previous month and weight gain.
Begin Alenvona on the first day of the cycle (that is the first day of your period).
If you start Alenvona on the first day of your period you are immediately
Common or uncommon (between 1 and 100 in every 1,000 users may be
protected against pregnancy. You may also start on days 2-5 of your cycle, but affected): none or reduced bleeding, tender breast, breast enlargement, breast
in that case make sure you also use an extra additional contraceptive method
pain, decreased sexual desire, depression, headache, nervousness, migraine,
(barrier method) for the first 7 days of tablet-taking in the first cycle.
dizziness, nausea, vomiting, acne, rash, nettle-rash (urticaria), fluid retention,
high blood pressure.
•C
 hanging from a combination hormonal contraceptive, or combination
contraceptive vaginal ring or patch
Rare (between 1 and 10 in every 10,000 users may be affected):
You can start Alenvona preferably on the day after the last active tablet (the
vaginal candidiasis (fungal infection), impaired hearing (otosclerosis),
last tablet containing active substances) of your previous pill, but at the
thromboembolism, hypersensitivity, increased sexual desire, eye irritation due to
latest on the day after the tablet-free days of your previous pill (or after the
contact lens, loss of hair (alopecia), itching, skin disorders (erythema nodosum
last inactive tablet of your previous pill). When changing from a combination
– a skin disease associated with joint pain, fever, hypersensitivity, or infection,
contraceptive vaginal ring or patch, follow the advice of your doctor.
and characterised by small, painful, pink to blue nodules under the skin and on
the shins that tend to recur, erythema multiforme – a skin disease characterised
•C
 hanging from a progestogen-only-method (progestogen-only–pill,
by solid raised spots on the skin on fluid-filled blisters lesions and reddening or
injection, implant or a progestogen-releasing IUD)
discolouration of the skin often in concentric zones about the lesions), vaginal
You may switch any day from the progestogen-only pill (from an implant or
discharge, breast discharge. Harmful blood clots in a vein or artery for example:
an IUD on the day of its removal, from an injectable when the next injection
in a leg or foot (i.e. DVT); in a lung (i.e. PE); heart attack; stroke; mini-stroke or
would be due) but in all of these cases you must use extra protective measures temporary stroke-like symptoms, known as transient ischaemic attack (TIA) and
(for example, a condom) for the first 7 days of tablet-taking.
blood clots in the liver, stomach/intestine, kidneys or eye.
•A
 fter a miscarriage
Follow the advice of your doctor.
•A
 fter having a baby
You can start Alenvona 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 Alenvona use. If after having a baby, you have
had sex before starting Alenvona (again), be sure that you are not pregnant or
wait until your next period.
• I f you are breastfeeding and want to start Alenvona (again) after having a
baby.
Read the section “Breast-feeding”.
Ask your doctor what to do if you are not sure when to start
If you take more Alenvona than you should
There are no reports of serious harmful results of taking too many Alenvona
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 Alenvona tablets, or you discover that a child has taken some,
ask your doctor or pharmacist for advice.
What to do if you forget to take Alenvona
• 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.
• If you are more than 12 hours late taking a tablet, the protection against
pregnancy may be reduced. The greater the number of tablets 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 adhere to
the following rules (see also 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 or you
have forgotten to start a new strip after the tablet-free period, you may be
pregnant. In that case, contact your doctor.

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).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or 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 Alenvona
Keep this medicine out of the sight and reach of children.
Do not store this medicine above 30ºC. Store in the original package in order to
protect from light.
Expiry Date
Do not use this medicine after the expiry date which is stated on the package,
after ‘EXP.’. The expiry date refers to the last day of that month.
Do not use Alenvona if you notice a change of colour, broken tablets or any
other visible signs of deterioration.
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 Alenvona contains
• The active substances are desogestrel and ethinylestradiol. Each white tablet
contains 150 micrograms desogestrel and 30 micrograms ethinylestradiol.
• The other ingredients are: lactose monohydrate, maize starch, povidone K-30
(E1201), rrr-alpha-tocopherol (E307), soybean oil, silica colloidal hydrated
(E551), silica colloidal anhydrous (E551), stearic acid (E570), hypromellose 2910
(E464), triacetin (E1518), polysorbate, titanium dioxide (E171).
What Alenvona looks like and contents of the pack
• Each film-coated tablet is white and rounded. Each tablet is marked “C” on one
side and “7” on the reverse side.
• Alenvona is available in blisters of 21 tablets.
Pack sizes are of 3 strips, each strip with 21 tablets.

• 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.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

• 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.

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

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 your fixed start day, make the tablet-free period less than 7 days.

This leaflet was last revised in July 2014

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

If you follow one 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.
Several tablets
forgotten in 1 strip

Ask your doctor for advice

Yes

In week 1

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
• 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 to the next
strip
continued top of next column

AAAG6963

Actavis, Barnstaple, EX32 8NS UK

Desogestrel/Ethinylestradiol 150mcg / 30mcg, PIL, United Kingdom
item no:

AAAG6963

dimensions: 222 x 680

print proof no:

7

pharmacode:

origination date: 24.1.14
approved for print/date

min pt size:

colours/plates:
1. black
2.
3.
4.

8.5 pt

originated by:

db

revision date:

31.7.14

Technical Approval

revised by:

db

date sent:

20.3.14

supplier:

León Farma

approved:

28.5.14

5.
6.
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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