DRETINE 28 0.03 MG/ 3.0 MG FILM-COATED TABLETS

Active substance: ETHINYL ESTRADIOL

View full screen / Print PDF » Download PDF ⇩

Transcript
DRETINE 28 0.03 mg/3 mg FILM-COATED TABLETS
Ethinylestradiol/Drospirenone
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:

1. What Dretine 28 is and what it is used for
2. Before you take Dretine 28
• When you should not use Dretine 28
• When to take special care with Dretine 28
• Dretine 28 and venous and arterial blood clots
• Dretine 28 and cancer
• Bleeding between periods
• What to do if no bleeding occurs during the placebo days
• Dretine 28 and using other medicines
• Taking Dretine 28 with food and drink
• Laboratory tests
• Pregnancy
• Breast-feeding
• Driving and using machines
• Important information about some of the ingredients of Dretine 28.
3. How to take Dretine 28
• When can you start with the first strip?
• If you take more Dretine 28 than you should
• If you forget to take Dretine 28
• What to do in the case of vomiting or severe diarrhoea
• Delaying your period: what you need to know
• Changing the first day of your period: what you need to know
• If you want to stop taking Dretine 28.
4. Possible side effects
5. How to store Dretine 28
6. Further information

1

WHAT DRETINE 28 IS AND WHAT IT IS USED FOR

The risk of a venous blood clot in users of combination pills increases:
• with increasing age
• if you are overweight
• if one of your close relatives has ever had a blood clot in the leg, lung
(pulmonary embolism), or other organ at a young age
• if you have to have surgery, if you have had a serious accident or if you are
immobilized for a long time. It is important to tell your doctor that you are using
Dretine as you may have to stop taking it. Your doctor will tell you when to
start again. This is usually about two weeks after you are back on your feet.
Your chances of having a blood clot are increased by taking the Pill.
- Of 100,000 women who are not on the Pill and not pregnant, about 5-10 may
have a blood clot in a year.
- Of 100,000 women taking a Pill like Dretine, 30-40 may have a blood clot in a
year, the exact number is unknown.
- Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.
A blood clot in the veins may travel to the lungs and may block blood vessels
(called a lung embolus). Formation of blood clots in the veins may be fatal in
1-2 % of cases.
The level of risk may vary according to the type of pill you take. Discuss with
your doctor the available options.
The use of combination pills has been connected with an increase of the risk of
an arterial blood clot (arterial thrombosis), for example, in the blood vessels of
the heart (heart attack) or the brain (stroke).
The risk of an arterial blood clot in users of combination pills increases:
• if you smoke. You are strongly advised to stop smoking when you use
Dretine 28, especially if you are older than 35 years
• if the fat content of your blood is increased (cholesterol or triglycerides)
• if you are overweight
• if one of your close relatives ever had a heart attack or stroke at a young age
• if you have high blood pressure
• if you suffer from migraine
• if you have a problem with your heart (valve disorder, a disturbance of the
cardiac rhythm).
Stop taking Dretine 28 and contact your doctor immediately if you notice
possible signs of a blood clot, such as:
• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting headache or worsening of migraine
• partial or complete blindness or double vision
• difficulty in speaking or inability to speak
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of the body.

• Dretine 28 is a contraceptive pill and is used to prevent pregnancy.
• Each of the 21 yellow tablets contains a small amount of two different female
hormones, namely drospirenone and ethinylestradiol.
• The 7 white tablets contain no active substances and are also called placebo
Dretine 28 and cancer
tablets.
Breast cancer has been observed slightly more often in women using combination
• Contraceptive pills that contain two hormones are called “combination” pills.
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
BEFORE YOU TAKE DRETINE 28
2
they are examined by their doctor more often. The occurrence of breast tumours
becomes gradually less after stopping the combination hormonal contraceptives.
General notes
It is important to regularly check your breasts and you should contact your
Before you can begin taking Dretine 28 your doctor will ask you some
doctor if you feel any lump.
questions about your personal health history and that of your close
In rare cases, benign liver tumours, and in even fewer cases malignant liver
relatives. The doctor will also measure your blood pressure, and depending
tumours have been reported in pill users. Contact your doctor if you have
upon your personal situation, may also carry out some other tests.
unusually severe abdominal pain.
In this leaflet, several situations are described where you should stop using
Bleeding between periods
Dretine 28, or where the reliability of Dretine 28 may be decreased. In such
During the first few months that you are taking Dretine 28, you may have
situations you should either not have sex or you should take extra non
unexpected bleeding (bleeding outside the week when you are taking the
hormonal contraceptive precautions, e.g., use a condom or another barrier
white tablets). If this bleeding occurs for more than a few months, or if it
method. Do not use rhythm or temperature methods. These methods can
begins after some months, your doctor must find out what is wrong.
be unreliable because Dretine 28 alters the monthly changes of body
What to do if no bleeding occurs during the placebo days
temperature and of the cervical mucus.
If you have taken all the yellow active tablets correctly, have not had vomiting
Dretine 28, like other hormonal contraceptives, does not protect against
or severe diarrhoea and you have not taken any other medicines, it is highly
HIV infection (AIDS) or any other sexually transmitted disease.
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
When you should not use Dretine 28
start the next strip until you are sure that you are not pregnant.
Do not take Dretine 28:
Dretine 28 and using other medicines
• if you have (or have ever had) a blood clot in a blood vessel of the leg
(thrombosis), lung (pulmonary embolism) or other organs
Always tell your doctor which medicines or herbal products you are already
• if you have (or have ever had) a heart attack or stroke
using. Also tell any other doctor or dentist who prescribes another medicine
• if you have (or have ever had) a disease that can be an indicator of a heart attack (or the pharmacist) that you use Dretine 28. They can tell you if you need to
in the future (for example, angina pectoris, which causes severe pain in the
take additional contraceptive precautions (for example condoms) and if so,
chest) or of a stroke (for example, a passing slight stroke with no residual effects) for how long.
• if you have a disease that may increase the risk of a blood clot in the arteries.
Some medicines can make Dretine less effective in preventing pregnancy, or
This applies to the following diseases:
can cause unexpected bleeding. These include:
• diabetes with damaged blood vessels
• medicines used for the treatment of:
• very high blood pressure
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
• a very high level of fat in the blood (cholesterol or triglycerides)
oxcarbazepine)
• if you have a disturbance of blood clotting (for example, protein C deficiency)
• tuberculosis (e.g. rifampicin)
• if you have (or have ever had) a certain form of migraine (with so-called focal
• HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as
neurological symptoms)
griseofulvin, penicillin, tetracycline)
• if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
• high blood pressure in the blood vessels in the lungs (bosentan)
• if you have (or have ever had) a liver disease and your liver function is still
• the herbal remedy St. John’s wort.
not normal
Dretine 28 may influence the effect of other medicines, e.g.
• if your kidneys are not working well (renal failure)
• medicines containing ciclosporin
• 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 • the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures).
or cancer of the genital organs
Ask your doctor or pharmacist for advice before taking any medicine.
• if you have any unexplained bleeding from the vagina
• if you are allergic to ethinylestradiol or drospirenone, or any of the other
Taking Dretine 28 with food and drink
ingredients of Dretine 28. This may cause itching, rash or swelling.
Dretine 28 may be taken with or without food, if necessary with a small
amount of water.
When to take special care with Dretine 28
In some situations you need to take special care while using Dretine 28 or any Laboratory tests
other combination pill, and your doctor may need to examine you regularly. If If you need a blood test, tell your doctor or the laboratory staff that you are taking
any of the following conditions applies to you, tell your doctor before starting to the pill, because hormone contraceptives can affect the results of some tests.
use Dretine 28. Also, if any of the following applies or if any of the conditions
Pregnancy
develops or worsens while you are using Dretine 28 consult your doctor if:
If you are pregnant, do not take Dretine 28. If you become pregnant while
• a close relative has or has ever had breast cancer
taking Dretine 28 stop immediately and contact your doctor. If you want to
• you have a disease of the liver or the gallbladder
become pregnant, you can stop taking Dretine 28 at any time (see also “If you
• you have diabetes
want to stop taking Dretine 28”).
• you have depression
Ask your doctor or pharmacist for advice before taking any medicine.
• you have Crohn’s disease or inflammatory bowel disease (ulcerative colitis)
• you have a blood disease called HUS (haemolytic uraemic syndrome) which Breast-feeding
Use of Dretine 28 is generally not advisable when a woman is breast-feeding. If you
causes kidney damage
want to take the pill while you are breast-feeding you should contact your doctor.
• you have a blood disease called sickle cell anaemia
Ask your doctor or pharmacist for advice before taking any medicine.
• you have epilepsy (see “Dretine 28 and using other medicines”)
• you have a disease of the immune system, called SLE (systemic lupus
Driving and using machines
erythematosus)
There is no information suggesting that use of Dretine 28 affects driving or use
• you have a disease that first appeared during pregnancy or earlier use of sex of machines.
hormones (for example, hearing loss, a blood disease called porphyria, skin Important information about some of the ingredients of Dretine 28
rash with blisters during pregnancy (gestational herpes), a disease of the
Dretine 28 contains lactose.
nerves in which sudden movements of the body occur (Sydenham’s chorea)) If you have been told by your doctor that you have an intolerance to some
• you have or have ever had chloasma (a discolouration of the skin especially
sugars, contact your doctor before taking this medicinal product.
of the face or neck known as “pregnancy patches”). If so, avoid direct
sunlight or ultraviolet light
3 HOW TO TAKE DRETINE 28
• you have hereditary angioedema, products containing oestrogens may cause or
Each blister contains 21 active yellow tablets and 7 white placebo tablets. The 7
worsen the symptoms. You should see your doctor immediately if you
white placebo tablets are enclosed by a box printed on the blister.
experience symptoms of angioedema such as swollen face, tongue and/or
throat and/or difficulty swallowing, or hives together with difficulty breathing. The two differently coloured tablets of Dretine 28 are arranged in order. A strip
contains 28 tablets.
Dretine 28 and venous and arterial blood clots
The use of any combination pill, including Dretine, increases a woman’s risk of Take one tablet of Dretine 28 every day, if necessary with a small amount of
water. You may take the tablets with or without food, but you should take the
developing a venous blood clot (venous thrombosis) compared with women
tablets every day around the same time.
who do not take any contraceptive pill.

One strip contains 28 tablets, each marked with a day of the week. Start by taking
a yellow active tablet from the 1st row marked with the correct day of the week.
If, for example, you start on Wednesday, you should take a yellow tablet from
the first row, labelled “WED” Continue by taking one yellow tablet marked with
.
the correct day of the week each day until you have taken all 21 yellow tablets.
Then move on to the boxed area of the blister and take one white placebo
tablet each day for the last 7 days, following the correct days of the week. Do
not confuse the tablets: take a yellow tablet once per day for the first 21 days,
and then one white tablet per day for the last 7 days. When you have taken all
28 tablets you should start a new strip (21 yellow tablets and 7 white tablets).
Consequently there is no drug-free interval between strips.
During the 7 days when you are taking the white placebo tablets (the placebo
days), bleeding should begin (so-called withdrawal bleeding). This usually
starts on the 2nd or 3rd day after the last yellow active tablet of Dretine 28. Once
you have taken the last white tablet, you should start with the following strip,
whether your bleeding has stopped or not. This means that you should start
every strip on the same day of the week, and that the withdrawal bleed should
occur on the same days each month.
If you use Dretine 28 in this manner, you are protected against pregnancy also
during the 7 days when you are taking a placebo tablet.
When can you start with the first strip?
• If you have not used a contraceptive with hormones in the previous month
Begin with Dretine 28 on the first day of the cycle (that is, the first day of your
period). If you start Dretine 28 on the first day of your period you are immediately
protected against pregnancy. You may also begin on day 2-5 of the cycle, but then
you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from a combination hormonal contraceptive, or combination
contraceptive vaginal ring or patch
You can start Dretine 28 preferably on the day after the last active tablet (the
last tablet containing the active substances) of your previous pill, but at the
latest on the day after the tablet-free days of your previous pill (or after the
last inactive tablet of your previous pill). When changing from a combination
contraceptive vaginal ring or patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen-only pill, injection,
implant or a progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from an implant or
an IUD on the day of its removal, from an injectable when the next injection
would be due) but in all of these cases use extra protective measures (for
example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage
Follow the advice of your doctor.
• After having a baby
You can start Dretine 28 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 28 use.
If, after having a baby you have had sex before starting Dretine 28 (again), be
sure that you are not pregnant or wait until your next period.
• If you are breast-feeding and want to start Dretine 28 (again) after having a baby
Read the section on “Breast-feeding”
.
Ask your doctor what to do if you are not sure when to start.
If you take more Dretine 28 than you should
There are no reports of serious harmful results of taking too many Dretine 28 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 Dretine 28 tablets, or you discover that a child has
taken some, ask your doctor or pharmacist for advice.
If you forget to take Dretine 28
The white tablets in the 4th row of the strip are the placebo tablets. These are enclosed
by a box which is printed on the blister. If you forget one of these tablets, this has
no effect on the reliability of Dretine 28. Throw away the forgotten placebo tablet.
If you miss a yellow, active tablet from the 1st, 2nd or 3rd row, do as follows:
• 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 that you have forgotten, the greater is the
risk of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget a
tablet at the beginning or at the end of the strip. Therefore, you should keep to
the following rules (see the diagram below):
• More than one tablet forgotten in this strip.
Contact your doctor.
• One tablet forgotten in week 1.
Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Continue taking the tablets at
the usual time and use extra precautions for the next 7 days, for example, a
condom. If you have had sex in the week before forgetting the tablet you
may be pregnant. In that case, contact your doctor.
• One tablet forgotten in week 2.
Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Continue taking the tablets at
the usual time. The protection against pregnancy is not reduced, and you do
not need to take extra precautions.
• One tablet forgotten in week 3.
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that
you have to take two tablets at the same time. Continue taking the tablets at
the usual time. Instead of taking the white placebo tablets on this strip, throw
them away, and start the next strip.
Most likely, you will have a period at the end of the second strip - while
taking the white placebo tablets - but you may have light or
menstruation-like bleeding during the second strip.
2. You can also stop the active yellow tablets and go directly to the 7 white
placebo tablets (before taking the placebo tablets, record the day on which
you forgot your tablet). If you want to start a new strip on the day you always
start, take the placebo tablets for less than 7 days.
If you follow one of these two recommendations, you will remain protected
against pregnancy.
• If you have forgotten any of the tablets in a strip, and you do not have a
bleeding during the normal placebo days, you may be pregnant. Contact
your doctor before you start the next strip.
Ask your doctor for advice

More than 1 yellow
tablet forgotten in
1 strip

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 the strip

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

In week 2

In week 3

Delaying your period: what you need to know
Even though it is not recommended, you can delay your period by not taking the
white placebo tablets from the 4th row and going straight to a new strip of
Dretine 28 and finishing it. You may experience light or menstruation-like
bleeding while using this second strip. Finish this second strip by taking the 7
white tablets from the 4th row. Then start your next strip.
You might ask your doctor for advice before deciding to delay your menstrual period.
Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, then your period will begin
during the placebo week. If you have to change this day, reduce the number of
placebo days (but never increase them – 7 is the maximum!). For example, if you
normally start taking the placebo tablets 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 placebo interval very short (for example, 3 days or less) you may
not have any bleeding during these days. You may then experience light or
menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking Dretine 28
You can stop taking Dretine 28 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 28 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.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Dretine 28 can cause side effects, although not everybody
gets them.
The following is a list of the side effects that have been linked with the use of
Dretine 28:
Common side effects (between 1 and 10 in every 100 users may be affected):
• menstrual disorders, bleeding between periods, breast pain, breast tenderness
• headache, depressive mood
• migraine
• nausea
• thick, whitish vaginal discharge and vaginal yeast infection.
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
• changes in interest in sex
• high blood pressure, low blood pressure
• vomiting
• acne, skin rash, severe itching
• infection of the vagina
• fluid retention and body weight changes.
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
• allergic reactions (hypersensitivity), asthma
• breast secretion
• hearing impairment
• blockage of a blood vessel by a clot formed elsewhere in the body
• the skin conditions erythema nodosum (characterized by painful reddish skin
nodules) or erythema multiforme (characterized by rash with target-shaped
reddening or sores).
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet or if you think that this may be the case, please tell your doctor
or pharmacist.

5

HOW TO STORE DRETINE 28

Keep Dretine 28 out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Expiry date
Do not use Dretine 28 after the expiry date which is stated on the blister and
package after the phrase "Do not use after:" or "EXP:"
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help protect the environment.

6

FURTHER INFORMATION

What Dretine 28 contains
A strip of Dretine 28 contains 21 yellow active tablets in the 1st, 2nd and 3rd
rows of the strip and 7 white placebo tablets in row 4. The 7 white placebo
tablets in row 4 are enclosed by a box printed on the blister.
Active tablets
The active ingredients are ethinylestradiol 0.03 mg and drospirenone 3 mg.
The other ingredients are:
Tablet core: lactose monohydrate, maize starch, pregelatinised starch (maize),
crospovidone, povidone, polysorbate 80, magnesium stearate.
Coating: Polyvinyl alcohol partial hydrolyzed, titanium dioxide (E171),
macrogol 3350, talc, yellow iron oxide (E172).
Placebo tablets
Tablet core: lactose anhydrous, povidone, magnesium stearate.
Coating: Polyvinyl alcohol partial hydrolized, titanium dioxide (E171), macrogol
3350, talc.
What Dretine 28 look like and contents of the pack
Active tablets are yellow, round film-coated tablets.
Placebo tablets are white, round film-coated tablets.
Dretine 28 is available in boxes of 1, 2, 3, 6 and 13 blisters, each one containing
28 tablets (21 active plus 7 placebo tablets).
Not all package sizes may be marketed§
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer
Laboratorios León Farma, S.A., Pol. Ind. Navatejera., C/ La Vallina s/n, 24008 Villaquilambre, León., Spain
This leaflet was last approved in: January 2012
PL 00289/1457

- Take the forgotten tablet
- Finish the strip
- Take the forgotten tablet and
- Finish taking the yellow tablets
- Throw away the 7 white tablets
- Start the next strip
or
- Stop the yellow tablets immediately
- Go on directly to the 7 white tablets
- 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 an active yellow 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 yellow 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 28”
.

88898-A

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.

Hide
(web4)