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DRETINE 0.03 G/ 3.0 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYL ESTRADIOL

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Dretine 0.03 mg/3 mg Film-coated Tablets

Are you experiencing any of these signs?

What are you
possibly
suffering from?

• 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”)

• swelling of one leg or along a vein 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

Deep vein
thrombosis

Package leaflet: Information for the user

• sudden unexplained breathlessness or rapid breathing
• sudden cough without an obvious cause, which may
bring up blood
• sharp chest pain which may increase with deep
breathing
• severe light headedness or dizziness
• rapid or irregular heartbeat
• severe pain in your stomach
If you are unsure, talk to a doctor as some of these
symptoms such as coughing or being short of breath
may be mistaken for a milder condition such as a
respiratory tract infection (e.g. a ‘common cold’).

Pulmonary
embolism

Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can progress to loss
of vision

Retinal vein
thrombosis
(blood clot in
the eye)

• 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

Heart attack

• 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
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.

Stroke

• swelling and slight blue discolouration of an extremity
• severe pain in your stomach (acute abdomen)

Blood clots
blocking other
blood vessels

ethinylestradiol/drospirenone
Important things to know about combined hormonal contraceptives (CHCs):

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet

1. What Dretine is and what it is used for
2. What you need to know before you take Dretine
3. How to take Dretine
4. Possible side effects
5. How to store Dretine
6. Contents of the pack and other information

1 What Dretine is and what it is used for
• Dretine is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones,
namely drospirenone and ethinylestradiol.
• Contraceptive pills that contain two hormones are called “combination” pills.

2 What you need to know before you take Dretine
General notes
Before you start using Dretine 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 Dretine 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
Dretine, or where the reliability of Dretine may be decreased. In such
situations you should either not have sex or you should take extra
non-hormonal contraceptive precautions, e.g., use a condom or another
barrier method. Do not use rhythm or temperature methods. These methods
can be unreliable because Dretine alters the monthly changes of body
temperature and of the cervical mucus.
Dretine, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.

Blood clots in a vein

Do not take Dretine
You should not use Dretine if you have any of the conditions listed below. If you
do have any of the conditions listed below, you must tell your doctor. Your
doctor will discuss with you what other form of birth control would be more
appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your legs
(deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other
organs
• if you know you have a disorder affecting your blood clotting – for instance,
protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor
V Leiden or antiphospholipid antibodies
• if you need an operation or if you are off your feet for a long time (see
section ‘Blood clots’)
• if you have ever had a heart attack or a stroke
• if you have (or have ever had) angina pectoris (a condition that causes
severe chest pain and may be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke symptoms)
• if you have any of the following diseases that may increase your risk of a
clot in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine with aura’
• if you have (or have ever had) a liver disease and your liver function is still
not normal
• if your kidneys are not working well (renal failure)
• 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 or drospirenone, or any of the other
ingredients of this medicine (listed in section 6). This may cause itching,
rash or swelling.

Warnings and precautions
When to take special care with Dretine
Talk to your doctor or pharmacist before taking Dretine
When should you contact your doctor?
Seek urgent medical attention
• if you notice possible signs of a blood clot that may mean you are
suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood
clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see
‘Blood clot’ (thrombosis) section below.
For a description of the symptoms of these serious side effects please go to
“How to recognise a blood clot”.

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 Dretine 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 Dretine 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 drospirenone, such as Dretine, between about 9 and 12 women will
develop a blood clot in a year.
• The risk of having a blood clot will vary according to your personal medical
history (see “Factors that increase your risk of a blood clot” below).
Risk of developing a
blood clot in a year
Women who are not using a combined hormonal
pill/patch/ring and are not pregnant

About 2 out of
10,000 women

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

About 5-7 out of
10,000 women

Women using Dretine

About 9-12 out of
10,000 women

In some situations you need to take special care while using Dretine or any
other combination pill and your doctor may need to examine you regularly.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Dretine, you
should also tell your doctor if:
• a close relative has or has ever had breast cancer
• you have a disease of the liver or the gallbladder
• you have diabetes
• you have depression
• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel
disease)
• you have systemic lupus erythematosus (SLE –; a disease affecting your
natural defence system)
• you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting
causing failure of the kidneys)
• you have sickle cell anaemia (an inherited disease of the red blood cells)
• 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)
• you need an operation, or you are off your feet for a long time (see in section
2 ‘Blood clots’)
• 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 Dretine
• you have an inflammation in the veins under the skin (superficial
thrombophlebitis)
• you have varicose veins
• you have epilepsy (see "Other medicines and Dretine")
• 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 disease of
the nerves in which sudden movements of the body occur (Sydenham's
chorea))
• you have or have ever had chloasma (a discolouration of the skin especially
of the face or neck known as “pregnancy patches”). If so, avoid direct
sunlight or ultraviolet light.
• 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.

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Dretine 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
Dretine may need to be stopped several weeks before surgery or while you
are less mobile. If you need to stop Dretine 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 Dretine needs to be stopped.
If any of the above conditions change while you are using Dretine, 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
Dretine is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like Dretine
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
Blood clots
young age (less then about 50). In this case you could also have a higher risk
of having a heart attack or stroke;
Using a combined hormonal contraceptive such as Dretine, increases your risk
of developing a blood clot compared with not using one. In rare cases a blood • if you, or someone in your immediate family, have a high level of fat in the
blood (cholesterol or triglycerides);
clot can block blood vessels and cause serious problems.
• if you get migraines, especially migraines with aura;
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or • if you have a problem with your heart (valve disorder, disturbance of the
rhythm called atrial fibrillation)
VTE)
• if you have diabetes.
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
thromboembolism’ or ATE).
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.
Recovery from blood clots is not always complete. Rarely, there may be
If any of the above conditions change while you are using Dretine, for example
serious lasting effects or, very rarely, they may be fatal.
you start smoking, a close family member experiences a thrombosis for no
It is important to remember that the overall risk of a harmful blood clot due to known reason; or you gain a lot of weight, tell your doctor.
Dretine is small.

Dretine and cancer

How to recognise a blood clot
Seek urgent medical attention if you notice any of the following signs or
symptoms.

Breast cancer has been observed slightly more often in women using
combination pills, but it is not known whether this is caused by the treatment.
For example, it may be that more tumours are detected in women on
combination pills because they are examined by their doctor more often. The
occurrence of breast tumours becomes gradually less after stopping the
combination hormonal contraceptives. It is important to regularly check your
breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver
tumours have been reported in pill users. Contact your doctor if you have
unusually severe abdominal pain.

Bleeding between periods
During the first few months that you are taking Dretine, you may have
unexpected bleeding (bleeding outside the gap week). If this bleeding occurs
for more than a few months, or if it begins after some months, your doctor must
find out what is wrong.

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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.

More than 1 tablet
forgotten in 1 strip

Ask your doctor for advice
Yes
In week 1

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.

No
- Take the forgotten tablet
- Use a barrier method (condom)
for the following 7 days and
- Finish the strip

Other medicines and Dretine
Always tell your doctor which medicines or herbal products you are already
using. Also tell any other doctor or dentist who prescribes another medicine
(or the pharmacist) that you use Dretine. They can tell you if you need to take
additional contraceptive precautions (for example condoms) and if so, for
how long.
Some medicines can have an influence on the blood levels of Dretine and can
make it 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 and Hepatitis C virus infections (so-called protease inhibitors and
non-nucleoside reverse transcriptase inhibitors such as ritonavir,
nevirapine, efavirenz) or other infections (griseofulvin)
• high blood pressure in the blood vessels in the lungs (bosentan)
• the herbal remedy St. John’s wort
Dretine may influence the effect of other medicines, e.g.
• medicines containing ciclosporin
• the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures)
Ask your doctor or pharmacist for advice before taking any medicine.

Dretine with food and drink

Had sex in the previous
week before forgetting?

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

In week 2

- Take the forgotten tablet
- Finish the strip
-

In week 3

Take the forgotten tablet and
Finish the strip
Instead of the gap week
Start the next strip
or
- 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 the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours after taking a tablet or you have severe
diarrhoea, there is a risk that the active substances in the pill will not be fully
taken up by 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 that is not possible or 12 hours have passed, you should follow the
advice given under "If you forget to take Dretine".

Dretine may be taken with or without food, if necessary with a small amount of Delaying your period: what you need to know
water.
Even though it is not recommended, you can delay your period by going
straight to a new strip of Dretine instead of the tablet-free period and finishing
Laboratory tests
it. You may experience light or menstruation-like bleeding while using this
If you need a blood test, tell your doctor or the laboratory staff that you are
second strip. After the usual tablet-free period of 7 days, start the next strip.
taking the pill, because hormone contraceptives can affect the results of some You might ask your doctor for advice before deciding to delay your menstrual
tests.
period.

Pregnancy

Changing the first day of your period: what you need to know

If you are pregnant, do not take Dretine. If you become pregnant while taking
Dretine stop immediately and contact your doctor. If you want to become
pregnant, you can stop taking Dretine at any time (see also "If you want to stop
taking Dretine").

If you take the tablets according to the instructions, then your period will
begin during the tablet-free week. If you have to change this day, reduce the
number of tablet-free days (but never increase them – 7 is the maximum!). For
example, if your tablet-free days normally begin on a Friday, and you want to
change this to a Tuesday (3 days earlier) start a new strip 3 days earlier than
usual. If you make the tablet-free interval very short (for example, 3 days or
less) you may not have any bleeding during these days. You may then
experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
Use of Dretine 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 Dretine affects driving or use of
machines.

If you want to stop taking Dretine
You can stop taking Dretine 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 Dretine 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 product, ask your doctor
or pharmacist.

Dretine 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 Dretine
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them. If you get any side effect, particularly if severe and
persistent, or have any change to your health that you think may be due to
Dretine, please talk to your doctor.

An increased risk of blood clots in your veins (venous thromboembolism (VTE))
or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all
women taking combined hormonal contraceptives. For more detailed
information on the different risks from taking combined hormonal
The strip contains 21 tablets. Next to each tablet is printed the day of the week contraceptives please see section 2 “What you need to know before you use
that it should be taken. If, for example, you start on a Wednesday, take a tablet Dretine”.
with "WED" next to it. Follow the direction of the arrow on the strip until all 21
If you experience any of the following, stop taking this medicine
tablets have been taken.
Take one tablet of Dretine every day, if necessary with a small amount of
water. You may take the tablets with or without food, but you should take the
tablets every day around the same time.

immediately and seek urgent medical advice.

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.

Common side effects (may affect up to 1 in 10 people):
• bleeding between periods
• migraine (severe headache)
• vaginal yeast infection (itching, irritation and swelling of the vagina and
surrounding area) with thick, whitish vaginal discharge.

On the 8th day after the last Dretine 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 Uncommon side effects (may affect up to 1 in 100 people):
• high blood pressure
and that the withdrawal bleed should occur on the same days each month.
• infection of the vagina (abnormal, unpleasant smelling vaginal discharge,
If you use Dretine in this manner, you are also protected against pregnancy
itching in the vagina and discomfort during sex).
during the 7 days when you are not taking a tablet.
Rare side effects (may affect up to 1 in 1,000 people):
When can you start with the first strip?
• allergic reactions (hypersensitivity) including swelling of the face, lips,
mouth, tongue or throat
• If you have not used a contraceptive with hormones in the previous month
• asthma (difficulty in breathing)
Begin with Dretine on the first day of the cycle (that is, the first day of your
• the skin conditions erythema nodosum (characterised by painful reddish
period). If you start Dretine on the first day of your period you are
skin nodules) or erythema multiforme (characterised by rash with
immediately protected against pregnancy. You may also begin on day 2-5 of
target-shaped reddening or sores).
the cycle, but then you must use extra protective measures (for example, a
• harmful blood clots in a vein or artery for example:
condom) for the first 7 days.
• in a leg or foot (i.e. DVT)
• Changing from a combination hormonal contraceptive, or combination
• in a lung (i.e. PE)
contraceptive vaginal ring or patch
• heart attack
You can start Dretine preferably on the day after the last active tablet (the
• stroke
last tablet containing the active substances) of your previous pill, but at the
• mini-stroke or temporary stroke-like symptoms, known as a transient
latest on the day after the tablet-free days of your previous pill (or after the
ischaemic attack (TIA)
last inactive tablet of your previous pill). When changing from a combination
• blood clots in the liver, stomach/intestine, kidneys or eye.
contraceptive vaginal ring or patch, follow the advice of your doctor.
The chance of having a blood clot may be higher if you have any other
• Changing from a progestogen-only-method (progestogen-only pill,
conditions that increase this risk (See section 2 for more information on the
injection, implant or a progestogen-releasing IUD)
conditions that increase risk for blood clots and the symptoms of a blood clot).
You may switch any day from the progestogen-only pill (from an implant or
an IUD on the day of its removal, from an injectable when the next injection
The following is a list of the side effects that have been linked with the
would be due) but in all of these cases use extra protective measures (for
use of Dretine:
example, a condom) for the first 7 days of tablet-taking.
Common side effects (may affect up to 1 in 10 people):
• After a miscarriage
• menstrual disorders, breast pain, breast tenderness
Follow the advice of your doctor.
• headache, depressive mood
• After having a baby
• nausea.
You can start Dretine 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 Dretine use.
If, after having a baby you have had sex before starting Dretine (again), be
sure that you are not pregnant or wait until your next period.
• If you are breast-feeding and want to start Dretine (again) after having a baby.
Read the section "Breast-feeding".

Uncommon side effects (may affect up to 1 in 100 people):
• changes in interest in sex
• low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• breast enlargement
• fluid retention and body weight changes.

Ask your doctor what to do if you are not sure when to start.
Rare side effects (may affect up to 1 in 1,000 people):
• breast secretion
There are no reports of serious harmful results of taking too many Dretine tablets. • hearing impairment.

If you take more Dretine than you should

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 Dretine tablets, or you discover that a child has
taken some, ask your doctor or pharmacist for advice.

If you forget to take Dretine

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.

• 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
5 How to store Dretine
then take the following tablets again at the usual time.
Keep this medicine out of the sight and reach of children.
• If you are more than 12 hours late taking a tablet, the protection against
pregnancy may be reduced. The greater the number of tablets that you have This medicine does not require any special storage conditions.
forgotten, the greater is the risk of becoming pregnant.
Expiry date
The risk of incomplete protection against pregnancy is greatest if you forget a
Do not use this medicine after the expiry date which is stated on the blister
tablet at the beginning or at the end of the strip. Therefore, you should keep to
and package after "Do not use after:" or "EXP:"
the following rules (see the diagram below):
Do not throw away any medicines via wastewater or household waste. Ask
• More than one tablet forgotten in this strip
your pharmacist how to throw away medicines you no longer use. These
Contact your doctor.
measures will help protect the environment.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Continue taking the tablets at
the usual time and use extra precautions for the next 7 days, for example, a
condom. If you have had sex in the week before forgetting the tablet you
may be pregnant. In that case, contact your doctor.

6 Contents of the pack and other information

What Dretine contains
The active ingredients are ethinylestradiol and drospirenone.
Each tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
The other ingredients are:
• One tablet forgotten in week 2
Tablet core: lactose monohydrate, maize starch, pregelatinised starch (maize),
Take the forgotten tablet as soon as you remember, even if that means that
crospovidone, povidone, polysorbate 80, magnesium stearate.
you have to take two tablets at the same time. Continue taking the tablets at
Coating: Polyvinyl alcohol partial hydrolized, titanium dioxide (E171), macrogol
the usual time. The protection against pregnancy is not reduced, and you do
3350, talc, yellow iron oxide (E172).
not need to take extra precautions.
What Dretine looks like and contents of the pack
• One tablet forgotten in week 3
Yellow, round film-coated tablets.
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that Dretine is available in boxes of 1, 2, 3, 6 and 13 blisters, each one containing
you have to take two tablets at the same time. Continue taking the tablets at 21 tablets.
the usual time. Instead of taking the tablet-free period start the next strip.
Most likely, you will have a period at the end of the second strip or you may Not all pack sizes may be marketed
also have light or menstruation-like bleeding during the second strip.
Marketing Authorisation Holder
2. You can also stop the strip and go directly to the tablet-free period of 7 days Teva UK Limited, Eastbourne, BN22 9AG, UK
(record the day on which you forgot your tablet). If you want to start a new
Manufacturer
strip on the day you always start, make the tablet-free period less than 7
Laboratorios León Farma, S.A., Pol. Ind. Navatejera., C/ La Vallina s/n,
days.
24008 - Villaquilambre, León., Spain
If you follow one of these two recommendations, you will remain protected
This leaflet was last revised in 12/2015.
against pregnancy.
• If you have forgotten any of the tablets in a strip, and you do not have a
bleeding during the first tablet-free period, you may be pregnant. Contact
your doctor before you start the next strip.

PL 00289/1456

88328-F

REG0083510

Version 2.5

Approved

Page 2 of 3

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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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