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TRUNELE 75 MICROGRAM FILM-COATED TABLET

Active substance(s): DESOGESTREL

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Package leaflet: Information for the user

Trunele®
75 microgram film-coated tablet
desogestrel
Read all of this leaflet carefully before you start using 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, please ask your doctor, pharmacist or Family Planning
Nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or Family Planning Nurse.
This includes possible side effects not listed in this leaflet.
What is in this leaflet:
1.
What Trunele is and what it is used for
2.
What you need to know before you take Trunele
Do not take…
Take special care…
Pregnancy and breast-feeding
3.
How to take Trunele
Starting your first pack
Changing from other methods
After a baby
If you forget to take Trunele
4.
Possible side effects
5.
How to store Trunele
6.
Contents of the pack and other information
1. What Trunele is and what it is used for
• Trunele is used to prevent pregnancy.
• There are 2 main kinds of hormone contraceptive.
- The combined pill, "The Pill", which contains 2 types of female sex hormone an
oestrogen and a progestogen
- The progestogen-only pill, POP , which doesn't contain an oestrogen.
• Trunele is a progestogen-only-pill (POP).
• Trunele contains a small amount of one type of female sex hormone, the progestogen
desogestrel.
• Most POPs work primarily by preventing the sperm cells from entering the womb but
they do not always prevent the egg cell from ripening, which is the main way that
combined pills work.





Trunele is different from most POPs in having a dose that in most cases prevents the egg
cell from ripening. As a result, Trunele is a highly effective contraceptive.
In contrast to the combined pill, Trunele can be used by women who do not tolerate
oestrogens and by women who are breast feeding.
A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of
Trunele. On the other hand you may not have any bleeding at all.

2. What you need to know before you take Trunele
Trunele, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or
any other sexually transmitted disease.
2.1 Do not take Trunele
• if you are allergic to desogestrel, or any of the other ingredients of Trunele (listed in
section 6).
• if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel
[e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism)].
• if you have or have had jaundice (yellowing of the skin) or severe liver disease and your
liver is still not working normally.
• if you have or if you are suspected of having a cancer that grows under the influence of
sex-steroids, such as certain types of breast cancer.
• if you have any unexplained vaginal bleeding.
If any of these conditions apply to you, tell your doctor before you start to use Trunele. Your
doctor may advise you to use a non-hormonal method of birth control.
If any of these conditions appear for the first time while using Trunele, consult your doctor
immediately.
2.2 Warnings and precautions
Before you start Trunele tell your doctor or Family Planning Nurse, if
• you have ever had breast cancer.
• you have liver cancer, since a possible effect of Trunele cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you suffer from epilepsy (see section ‘Other medicines and Trunele’).
• you have tuberculosis (see section ‘Other medicines and Trunele’).
• you have high blood pressure.
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin,
particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation.
When Trunele is used in the presence of any of these conditions, you may need to be kept under
close observation. Your doctor can explain what to do.
2.3 Breast cancer
• It is important to regularly check your breasts and you should contact your doctor as soon
as possible if you feel any lump in your breasts.
• Breast cancer has been found slightly more often in women who take the Pill than in
women of the same age who do not take the Pill. If women stop taking the Pill, this
reduces the risk, so that 10 years after stopping the Pill, the risk is the same as for women
who have never taken the Pill.

Breast cancer is rare under 40 years of age but the risk increases as the woman gets older.
Therefore, the extra number of breast cancers diagnosed is higher if a woman continues to take
the Pill when she is older. How long she takes the Pill is less important.




In every 10,000 women who take the Pill for up to 5 years but stop taking it by the age of
20, there would be less than 1 extra case of breast cancer found up to 10 years after
stopping, in addition to the 4 cases normally diagnosed in this age group.
In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 30,
there would be 5 extra cases in addition to the 44 cases normally diagnosed.
In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 40,
there would be 20 extra cases in addition to the 160 cases normally diagnosed.

The risk of breast cancer in users of progestogen-only pills like Trunele is believed to be similar
to that in women who use the Pill, but the evidence is less conclusive.
Breast cancers found in women who take the Pill, seem less likely to have spread than breast
cancers found in women who do not take the Pill.
It is not certain whether the Pill causes the increased risk of breast cancer. It may be that the
women were examined more often, so that the breast cancer is noticed earlier.
2.4 Thrombosis
See your doctor immediately if you notice possible signs of a thrombosis (see also ‘Regular
check-ups’).
Thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis
sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot
breaks away from the veins where it is formed, it may reach and block the arteries of the lungs,
causing a so-called “pulmonary embolism”. A pulmonary embolism can cause chest pain,
breathlessness, collapse or even death.


Deep venous thrombosis is a rare occurrence. It can develop whether or not you are
taking the Pill. It can also happen if you become pregnant.

The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills like
Trunele is believed to be lower than in users of Pills that also contain oestrogens (combined
Pills).
Childen and adolescents
No clinical data on efficacy and safety are available in adolescents below 18 years.
2.5 Other medicines and Trunele
Please tell your doctor, pharmacist, or Family Planning Nurse if you are taking, have recently
taken or might take any other medicines or herbal products, including medicines obtained without
a prescription.
Some medicines may stop Trunele from working properly. These include medicines used for the
treatment of
• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and
phenobarbital)






tuberculosis (e.g. rifampicin)
HIV infections (e.g. ritonavir), or other infectious diseases (e.g. griseofulvin)
stomach upset (medical charcoal)
depressive moods (the herbal remedy St. John’s Wort).

Your doctor can tell you if you need to take additional contraceptive precautions and if so, for
how long.
Trunele may also interfere with how certain medicines work, causing either an increase in effect
(e.g. medicines containing cyclosporine) or a decrease in effect.
2.6 Pregnancy and breast-feeding
Pregnancy
Do not use Trunele if you are pregnant, or think you may be pregnant.
Breast-feeding
Trunele may be used while you are breast-feeding. Trunele does not influence the production or
the quality of breast milk. However, a small amount of the active substance of Trunele passes
over into the milk.
The health of children who were breast-fed for 7 months while their mothers were using Trunele
has been studied up until they were 2½ years of age. No effects on the growth and development
of the children were observed.
If you are breast feeding and want to use Trunele, please contact your doctor.
2.7 Driving and using machines
Trunele has no known effect on the ability to drive or use machines
2.8 Trunele contains lactose
Trunele contains lactose (milk sugar). Please contact your doctor before taking Trunele if you
have been told by your doctor that you are intolerant to some sugars.
2.9 Regular check-ups
When you are using Trunele, your doctor will tell you to return for regular check-ups. In general,
the frequency and nature of these check-ups will depend on your personal situation.
Contact your doctor as soon as possible if:
• you notice possible signs of a blood clot e.g. severe pain or swelling in either of your
legs; unexplained pains in the chest, breathlessness, an unusual cough, especially when
you cough up blood;
• you have a sudden, severe stomach ache or jaundice (you may notice yellowing of the
skin, the whites of the eyes, or dark urine, possibly a sign of liver problems);
• you feel a lump in your breast;
• you have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign
of an ectopic pregnancy - a pregnancy outside the womb);
• you are to be immobilised or are to have surgery (consult your doctor at least four weeks
in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect that you are pregnant.

3. How to take Trunele
3.1 When and how to take the tablets?
Each strip of Trunele contains 28 tablets – 4 weeks supply.
• Take your tablet each day at about the same time. Swallow the tablet whole, with
water.
• Arrows are printed on the front of the strip, between the tablets. The days of the week are
printed on the back of the strip. Each day corresponds with one tablet.
• Every time you start a new strip of Trunele, take a tablet from the top row. Don’t start
with just any tablet. For example if you start on a Wednesday, you must take the tablet
from the top row marked (on the back) with WED.
• Continue to take one tablet every day until the pack is empty, always following the
direction indicated by the arrows. By looking at the back of your pack you can easily
check if you have already taken your tablet on a particular day.
• You may have some vaginal bleeding during the use of Trunele, (See Section 4 Side
Effects) but you must continue to take your tablets as normal.
• When a strip is empty, you must start with a new strip of Trunele on the next day without interruption and without waiting for a bleed.
3.2 Starting your first pack of Trunele
• If you are not using hormonal contraception at present (or in the past month)
Wait for your period to begin. On the first day of your period take the first Trunele tablet.
Additional contraceptive precautions are not necessary. If you take your first tablet on days 2-5
of your period use an additional barrier method of contraception for the first 7 days of tablettaking.
• When you change from a combined pill (COC), vaginal ring, or transdermal patch
If you have a tablet-, ring- or patch-free break
- You can also start at the latest the day following the tablet-, ring- or patch-free
break, or placebo tablet interval, of your present contraceptive.
- If you follow these instructions, make sure you use an additional barrier
method of contraception for the first 7 days of tablet-taking.
If you don’t have a tablet-, ring- or patch-free break
- Start taking Trunele on the day after you take the last tablet from the present Pill
pack, or on the day of removal of your vaginal ring or patch (this means no
tablet-, ring- or patch-free break).
- If your present Pill pack also contains inactive tablets you can start Trunele on
the day after taking the last active tablet (if you are not sure which this is, ask
your doctor or pharmacist).
- If you follow these instructions, additional contraceptive precautions are not
necessary.
• When changing from another progestogen-only pill:
Switch on any day from another mini pill. Additional contraceptive precautions are not necessary.


When changing from an injection or implant or a hormonal IUS:

Start using Trunele when your next injection is due or on the day that your implant or your IUS is
removed. Additional contraceptive precautions are not necessary.
• After you have a baby
You can start Trunele between 21 to 28 days after the birth of your baby.
If you start later, make sure that you use an additional barrier method of contraception until you
have completed the first 7 days of tablet-taking. However, if you have already had sex, check that
you are not pregnant before starting Trunele. Information for breast-feeding women can be found
in section 2 'Before you take Trunele' in the paragraph 'Pregnancy and breast-feeding'. Your
doctor can also advise you.
• After a miscarriage or an abortion:
Your doctor will advise you.
3.3 If you forget to take Trunele



If you are less than 12 hours late:
- Take the missed tablet as soon as you remember and take the next one at the
usual time. Trunele will still protect you from pregnancy.
If you are more than 12 hours late:
- If you are more than 12 hours late in taking any tablet, you may not be
completely protected against pregnancy. The more consecutive tablets you
have missed, the higher the risk that you might fall pregnant.
- Take a tablet as soon as you remember and take the next one at the usual time.
This may mean taking two in one day. This is not harmful. (If you have forgotten
more than one tablet you don’t need to take the earlier missed ones). Continue to
take your tablets as usual but you must also use an extra method, such as a
condom, for the next 7 days.
- If you are more than 12 hours late taking your tablet and have had sex it is safe to
use emergency contraception; please consult your pharmacist or doctor.
- If you missed one or more tablets in the very first week of tablet-intake and had
intercourse in the week before missing the tablets, you may fall pregnant. Ask
your doctor for advice.

3.4 If you vomit or use medical charcoal
If you vomit, or use medical charcoal within 3 - 4 hours after taking your Trunele tablet or have
severe diarrhoea, the active ingredient may not have been completely absorbed. Follow the
advice for forgotten tablets in the section above.
3.5 If too many Trunele tablets are taken (overdose)
There have been no reports of serious harmful effects from taking too many Trunele tablets at one
time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding.
For more information ask your doctor for advice.
3.6 If you stop taking Trunele
You can stop taking Trunele whenever you want. From the day you stop you are no longer
protected against pregnancy.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Trunele can cause side effects, although not everybody gets them.
Tell your doctor if you notice any unwanted effect, especially if severe or persistent.
Serious side effects associated with the use of Trunele are described in section 2 'What you need
to know before you take Trunele'. Please read this section for additional information on ‘Breast
cancer’ and ‘Thrombosis’ and consult your doctor at once where appropriate.
Vaginal bleeding may occur at irregular intervals while using Trunele. This may be just slight
staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty
period. You may need to use tampons or sanitary towels. You may also not have any bleeding at
all. Irregular bleeding is not a sign that Trunele is not working. In general, you need not take any
action; just continue to take Trunele. If bleeding is heavy or prolonged you should consult
your doctor.
How often are other possible side effects seen?
Common (affecting less than 1 in 10 women): mood changes, depressed mood, decreased sexual
drive (libido), headache, nausea, acne, breast pain, irregular or no periods, weight increase.
Uncommon (affecting less than 1 in 100 women) infection of the vagina, difficulties in wearing
contact lenses, vomiting, hair loss, painful periods, ovarian cysts, tiredness.
Rare (affecting less than 1 in 1000 women) skin conditions such as: rash, hives, painful blue-red
skin lumps (erythema nodosum)
Apart from these side effects, breast secretion or leakage may occur.
You should see your doctor immediately if you experience symptoms of angioedema, such as (i)
swollen face, tongue or pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties to
breathe.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or Family Planning Nurse. This
includes any possible side effects not listed in this leaflet. You can also report side effects via the
national 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 TRUNELE
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the package. The expiry date is the last day of
the month stated.
This medicine does not require any special temperature storage conditions. Store the blister pack
in the original sachet in order to protect from light and moisture. Use within 1 month from the
date of first opening of the sachet.
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 to protect the environment.

6. Contents of the pack and other information
What Trunele contains
The active substance is: desogestrel (75 microgram)
The other ingredients are: colloidal anhydrous silica; all-rac-α-tocopherol; maize starch;
povidone; stearic acid; hypromellose; macrogol 400; talc; titanium dioxide (E171);
lactose monohydrate (see also ‘Trunele contains lactose’ in section 2).
What Trunele looks like and contents of the pack
Each strip of Trunele contains 28 white round tablets. The tablets are marked KV above 2 on one
side and ORGANON* on the other. Trunele comes in a pack of 3 strips. Each strip is sealed in a
foil sachet.
Marketing Authorisation Holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
Manufacturer:
N.V. Organon, P.O. Box 20, 5340 BH Oss, The Netherlands, or
Organon (Ireland) Ltd., Drynam Road, P.O. Box 2857, Swords, Co. Dublin, Ireland
This medicinal product is authorised in the Member States of the EEA under the following
names:
Belgium, Denmark, Finland, Germany, Luxembourg, Norway, Portugal, Spain, Sweden:Lueva
Austria, Italy: Jubrele
United Kingdom: Trunele
This leaflet was updated in October 2013
In correspondence please quote packing number.
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name: Trunele Reference Number: PL 00025/0614
This is a service provided by the Royal National Institute of Blind people.

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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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