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BENILEXA 20 MICROGRAMS/24 HOURS INTRAUTERINE DELIVERY SYSTEM

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET

1

Package leaflet: Information for the user
Benilexa 20 micrograms/24 hours Intrauterine Delivery System
Levonorgestrel
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, ask your doctor or pharmacist.
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 Benilexa is and what it is used for
2.
What you need to know before you use Benilexa
3.
How to use Benilexa
4.
Possible side effects
5.
How to store Benilexa
6.
Contents of the pack and other information

1.

What Benilexa is and what it is used for

Benilexa is an intrauterine delivery system (IUS) for insertion in the womb. It is used for:
- contraception (prevention of pregnancy) for up to 3 years
- treating heavy menstrual bleeding (heavy periods) for up to 3 years
Benilexa is an effective, long-term and reversible method of contraception.
Benilexa prevents pregnancy by controlling the monthly development of the womb lining so that it is
not thick enough for you to become pregnant, by making the normal mucus in the opening of the
womb (cervical canal) thicker, so that the sperm cannot get through to fertilise the egg, by preventing
the release of eggs (ovulation) in some women. There are also local effects on the lining of the womb
caused by the presence of the T-shaped frame.
Benilexa is also useful for reducing menstrual blood flow, so it can be used if you suffer from heavy
menstrual bleeding (periods). This is called menorrhagia. This hormone acts by controlling the
monthly development of the womb lining, making it thinner, so that there is less bleeding every
month.
Benilexa is placed inside the uterus (womb) where it slowly releases the hormone levonorgestrel over
a period of 3 years or until it is removed.

2.

What you need to know before you use Benilexa

Do not use Benilexa:
Before you have Benilexa fitted, your doctor or nurse will carry out some tests to make sure that
Benilexa is suitable for you to use. This will include a pelvic examination and may also include other
examinations such as a breast examination, if your doctor or nurse feels this is appropriate.
Genital infections will need to be successully treated before you can have Benilexa fitted
If you have epilepsy, tell the doctor or nurse fitting Benilexa because, although rare, a fit can occur
during insertion. Some women might feel faint after the procedure. This is normal and your doctor or
nurse will tell you to rest for a while.

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Not all women can use Benilexa.
Do not use Benilexa and tell your doctor if you :
-

are pregnant or suspect that you are pregnant
have an unusual vaginal bleeding pattern
have an abnormal womb or fibroids
have an unusual or unpleasant vaginal discharge, or vaginal itching
have or have had pelvic inflammatory disease
have or have had inflammation of the lining of your womb following delivery of your baby
have or have had an infection of the womb after delivery or after abortion during the past 3
months
have or have had inflammation of the cervix (neck of your womb)
have or have had an abnormal smear test (changes in the cervix)
have or have had liver problems
have any condition which makes you susceptible to infections. A doctor will have told you if
you have this
have or have had hormone dependent cancer, such as breast cancer
have cancer affecting your blood (including leukaemia) unless in remission
have or have had trophoblastic disease. A doctor will have told you if you have this
are allergic (hypersensitive) to the levonorgestrel or any of the other ingredients this medicine
(listed in section 6).

Benilexa should not be used as a post-coital contraceptive (after unprotected sexual intercourse).
Warnings and precautions
Benilexa like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any
other sexually transmitted disease (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis
B and syphilis). You will need condoms to protect yourself from these diseases.
Talk to your doctor before using Benilexa if you:
are diabetic (too high blood glucose level), have high blood pressure or abnormal blood lipid
levels
have yellowing of the skin or whites of the eyes (jaundice)
have high blood pressure
have fits (epilepsy)
have a history of blood clots (thrombosis)
have had a stroke, heart attack or any heart problems
are taking any other medicines as some medicines may stop Benilexa from working properly
have or develop migraine, dizziness, blurred vision, unusually bad headaches or if you have
headaches more often than before
have ever had an ectopic pregnancy (development of the foetus outside the womb) or a history
of ovarian cysts
have irregular bleedings
have had cancer affecting your blood (including leukaemia) which is now in remission
are on long-term steroid therapy
have had a stroke or heart attack, or if you have heart problems
have disease of your arteries
Your doctor will decide if you can use Benilexa if you have or have had some of the above conditions.
You must also tell your doctor if any of these conditions occur for the first time whilst you have
Benilexa in place.
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The following signs and symptoms could mean that you may have an extrauterine pregnancy and you
should see your healthcare professional immediately (see also section “Pregnancy, breast-feeding and
fertility”):





Your menstrual periods have stopped and then you start having persistent bleeding or pain
You have pain in your lower abdomen that is severe or persistent
You have normal signs of pregnancy, but you also have bleeding and feel dizzy.
You have a positive pregnancy test

You must see a doctor or nurse as soon as possible if you develop painful swelling in your leg, sudden
chest pain or difficulty in breathing as these may be a sign of a blood clot. It is important that any
blood clots are treated promptly.
You must also see a doctor without delay if you develop persistent lower abdominal pain, fever, pain
during sexual intercourse or abnormal bleeding. If you get severe pain or fever shortly after Benilexa
has been inserted, you may have a severe infection which must be treated immediately.
You must see a doctor promptly if you no longer feel the threads in your vagina. This may be a sign of
expulsion. You can check by gently putting a finger into your vagina and feeling for the threads at the
end of your vagina near the opening of your womb (cervix). Do not pull the threads because you may
accidentally pull out Benilexa. Avoid intercourse or use a barrier contraceptive (such as condoms)
until your healthcare professional has checked that the IUS is still in position.
Benilexa and smoking
Women are advised to give up smoking. Smoking increases the risk of developing a heart attack,
stroke, or blood clot.
Other medicines and Benilexa
The effect of hormonal contraceptives such as Benilexa may be reduced by medicines that increase the
amounts of enzymes made by the liver. Please tell your doctor if you are taking:
phenobarbital, primidone, phenytoin or carbamazepine (to treat epilepsy)
griseofulvin (an antifungal)
rifampicin or rifabutin (antibiotics)
nevirapine or efavirenz (for HIV).
Tell your doctor if you are taking, have recently taken or might take any other medicines. Benilexa
should not be taken simultaneously to another hormonal contraceptive method.
Pregnancy, breast-feeding and fertility
Can I become pregnant whilst using Benilexa?
It is very rare for women to become pregnant with Benilexa in place.
Missing a period may not mean that you are pregnant. Some women may not have periods whilst
using the system.
If you have not had a period for 6 weeks then consider having a pregnancy test. If this is negative there
is no need to carry out another test, unless you have other signs of pregnancy, e.g. sickness, tiredness
or breast tenderness.
If you become pregnant with the device in place, please contact your doctor as soon as possible so that
ectopic pregnancy can be excluded and Benilexa removed to reduce the risk of spontaneous
miscarriage.
What if I want a baby?
If you want a baby, ask your doctor to remove Benilexa. Your usual level of fertility will return very
quickly after the system is removed.
Can I breast feed while using Benilexa?

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Very small amounts of the hormone in Benilexa are found in breast milk but the levels are lower than
with any other hormonal contraceptive method. No risk for the new-born is to be expected. If you want
to breast feed your baby, you should discuss this with your doctor.
Driving and using machines
There are no known effects on the ability to drive or use machines.
Benilexa contains barium sulphate.
The T-frame of Benilexa contains barium sulphate so that it can be seen on X-rays.

3.

How to use Benilexa

Only a doctor or specially trained nurse can fit the system (see special instructions for insertion in the
package).
They will:
give you a pelvic examination to find the position and size of your womb
place a speculum (an instrument to help the doctor see the cervix) into your vagina
clean your vagina and cervix
place a thin flexible tube containing the device into your vagina and then through the cervix into
the womb. At this point you might feel a little discomfort
withdraw the tube leaving the device in place
trim the threads to a suitable length for easy removal.
During insertion procedure, a slight discomfort might be encountered. Inform your doctor about any
pain you feel.
The device should be inserted either during your period or within seven days from the beginning of
your period. If you already have the device and it is time to replace it with a new one, you do not need
to wait until your period.
If you have just had a baby, you should wait at least 6 weeks before having Benilexa fitted. Benilexa
can sometimes be fitted immediately after you have had an abortion, provided that you have no genital
infections.
If you have fits (epilepsy), tell the doctor or nurse fitting the Benilexa because, although rare, a seizure
(fit) can occur during insertion.
Some women might feel faint after the device is fitted. This is normal and your doctor will tell you to
rest for a while.
In very rare cases during fitting, part or all of the device could penetrate the wall of the womb. If this
happens the device is removed.
How quickly should Benilexa work?
Contraception:
You are protected from pregnancy as soon as the system is fitted. The possibility of becoming
pregnant is approximately 2 in 1,000 per year. The failure rate may increase in case of Benilexa
coming out by itself or perforation.
Heavy menstrual bleeding:
Benilexa usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of
treatment.
How often should I have the system checked?
You should have the system checked usually 6 weeks after it is fitted, again at 12 months and then
once a year until it is removed.
What happens if the system comes out by itself?

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If the system comes out either completely or partially, you may not be protected against pregnancy. It
is rare but possible for this to happen without you noticing during your menstrual period. An unusual
increase in the amount of bleeding during your period might be a sign that this has happened. Tell your
doctor or clinic if there are any unexpected changes in your bleeding pattern.
How can I tell whether the system is in place?
After each menstrual period, you can feel for the two thin threads attached to the lower end of the
system. Your doctor will show you how to do this.
Do not pull the threads because you may accidentally pull it out. If you cannot feel the threads, go to
your doctor.
You should also go to your doctor if you can feel the lower end of the device itself or you or your
partner feel pain or discomfort during sexual intercourse.
If you stop using Benilexa
Your doctor can remove the system at any time. The removal is very easy. Unless you plan to have a
new system or an intra-uterine device fitted immediately, it is important to use another form of
contraception in the week leading up to the removal. Intercourse during this week could lead to
pregnancy after /.../ is removed.
How will Benilexa affect my periods?
Benilexa will affect your menstrual cycle. You might experience spotting, shorter or longer periods,
painful periods, lighter periods or no periods at all.
For all users of Benilexa:
Many women have spotting (a small amount of blood loss) for the first 3-6 months after the system is
fitted. Others will have prolonged or heavy bleeding. You may have an increase in bleeding however,
usually in the first 2 to 3 months, before a reduction in blood loss is achieved. Overall you are likely to
have fewer days bleeding in each month and you might eventually have no periods at all. This is due
to the effect of the hormone (levonorgestrel) on the lining of the womb.
If you have had Benilexa fitted for heavy menstrual bleeding:
Benilexa usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of
treatment. You may have an increase in bleeding however, usually in the first 2 to 3 months, before a
reduction in blood loss is achieved. If a significant reduction in blood loss is not achieved after 3 to 6
months, alternative treatments should be considered.
If you have had Benilexa fitted for quite a long time and then start to have bleeding problems, contact
your doctor or clinic for advice.
If you have any further questions on the use of this medicine, ask your doctor.
Moreover, see a doctor as soon as possible if you get:
painful swelling in your leg
sudden chest pain
difficulty breathing
Because these may be signs of a blood clot.
Perforation
In rare cases it is possible that the womb or the neck of the womb is pierced, most commonly during
insertion of Benilexa. This may be associated with severe pain and continued bleeding. If perforation
is suspected the system should be removed as soon as possible. Contact your doctor immediately if
you cannot feel the threads.
The risk of perforation may be increased in insertions following delivery, in lactating women and in
women with a fixed retroverted (bent backwards) uterus.

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4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Benilexa, side effects are most common during the first months after the system is fitted and
decrease as time goes on.
Very common (affects more than 1 in 10 women) side effects can include:
menstrual changes. You might experience spotting, shorter or longer periods, painful periods.
Though Benilexa usually achieves a significant reduction in menstrual blood loss in 3 to 6
months of treatment, you may have an increase in bleeding, usually in the first 2 to 3 months,
before a reduction in blood loss is achieved. Periods can totally disappear. If a significant
reduction in blood loss is not achieved after 3 to 6 months, alternative treatments should be
considered.
ovarian cysts. They are fluid-filled sacs in the ovary.
Common (may affect up to 1 in 10 women) side effects can include:
weight gain;
depression, nervousness or other mood changes;
headache;
abdominal, pelvic or back pain;
feeling sick (nausea);
spots (acne);
reduced sex drive;
painful periods;
increased vaginal discharge;
tender, painful breasts; or
Benilexa coming out by itself.
Uncommon (may affect up to 1 in 100 women) side effects can include:
genital infections that may cause: vaginal itching; pain on passing urine; or lower abdominal
(tummy) pain from inflammation of the womb, ovaries or Fallopian tubes;
migraine;
bloated abdomen;
eczema;
inflammation of the neck of the womb (cervicitis);
bloating or swelling of your legs or ankles;
increased growth of hair on the face and body;
hair loss;
itchy skin (pruritus); or
skin discolouration or increased skin pigment, especially on the face (chloasma).
Rare (may affect up to 1 in 1,000 women) side effects can include:
rashes, itching, or
the wall of the womb torn when the Benilexa is fitted.
Severe pain or fever developing shortly after insertion may mean that you have a severe infection
which must be treated immediately. In rare cases very severe infection (sepsis) can occur.
Ovarian cysts and pelvic inflammatory disease have been reported. So tell your doctor if you have
lower abdominal pain or if you experience painful or difficult sex. This is important as pelvic
infections can reduce your chances of having a baby and can increase the risk of ectopic pregnancy
(development of a foetus outside the womb). Ectopic pregnancy is possible with Benilexa but highly
unlikely. The risk of this happening is lower than for women using no contraception or a copper
intrauterine device.
You should tell your doctor if you have lower abdominal (tummy) pain especially if you also have a
fever or have missed a period or have unexpected bleeding. This might be a sign of ectopic pregnancy.
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If you think you are reacting badly to Benilexa or are having any other problems, please tell your
doctor or clinic.
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 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 Benilexa

Store in the original package. Keep the pouch in the outer carton in order to protect from light. Do not
open the Benilexa pack. Only your doctor or clinic should do this.
This medicinal product does not require any special temperature storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use the device after the expiry date which is stated on the label and the outer pack after EXP.
The expiry date refers to the last day of that month.
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 Benilexa contains
-

-

Benilexa consists of a small T-shaped frame made from a plastic called polyethylene. This
carries 52 mg of levonorgestrel, the active substance. The hormone is contained within a
substance called polydimethylsiloxane. This is surrounded by a membrane (skin) also made of
polydimethylsiloxane.
The T-shaped frame also contains barium sulphate so that it can be seen on X-rays.
This structure provides a device for releasing the hormone gradually into the uterus (womb).
There are two fine threads, made of polyethylene and copper phtalocyanine blue, attached to the
bottom of the frame. These allow easy removal and allow you or your doctor to check that the
device is in place.

What Benilexa looks like and contents of the pack
Each pack contains one Benilexa.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Allergan Pharmaceuticals International Limited.
Clonshaugh Industrial Estate
Coolock
Dublin 17
Ireland
Manufacturer
Odyssea Pharma SA
Rue du Travail 16
4460 Grâce Hollogne
Belgium
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This medicinal product is authorised in the Member States of the EEA under the following
names:
Benilexa, Levosert

This leaflet was last revised in March 2016
_________________________________________________________________________________

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Instructions for use and handling
Benilexa 20 micrograms/24 hours Intrauterine Delivery System
Levonorgestrel

The following information is intended for medical or healthcare professionals only
Prescriber Check List
Ask yourself the following questions before prescribing/inserting Benilexa:
I have checked that the patient’s needs meet the indications of contraception or heavy menstrual
bleeding and for duration of use of up to three years?
I have completed the patient card included in the pack and given this to the patient as a reminder (any
insertions of more than three years in duration should be reported as off label use)?
Please read the following instructions for use carefully as there may be some difference in the type of
inserter device compared with other IUDs you have used previously:

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Conditions for use
1.
In women of fertile age, Benilexa is inserted within seven days of the onset of menstruation. It
can be replaced by a new system at any time of the cycle.
2.
It is strongly recommended that Benilexa should only be inserted by physicians/health care
professionals who have undergone sufficient training and have read carefully these instructions
before Benilexa insertion.
3.
Benilexa is supplied in a sterile pack which should not be opened until required for insertion.
The exposed product should be handled with aseptic precautions. Do not use if the inner
package is damaged or open.
4.
Determine the position (anteversion, retroversion) and size of the uterus by a gynaecological
examination. Exclude pregnancy and contraindications.
5.
Place a speculum, use appropriate antiseptic solution to clean the vagina and cervix.
6.
Use cervical dilators if cervical stenosis is diagnosed. Do not force to overcome resistance.
7.
Grasp the cervix with a Tenaculum forceps and apply a gentle traction in order to straighten
alignment of the cervical canal and uterine cavity.
8.
Determine the uterine depth by hysterometry. If uterine depth is < 5.5 cm discontinue the
procedure.

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Description

12

Preparation for insertion

Introduce the plunger and the IUD in the
insertion tube
Partly open the blister (about 1/3 from the
bottom) and introduce the plunger in the
insertion tube. Extricate the threads from
the flange. Pull the thread to introduce the
IUD into the tube. The arms of the IUD
must stay in a horizontal plan, parallel to
the flat side of the flange.

Position the lower edge of the flange at the
sounded value
Position the blue flange so as the lower
edge of the flange indicates the value found
by hysterometry. The flat sides of the
flange must always remain parallel to the
arms. This will allow the arms to open
correctly in the uterine cavity.

13

Adjust the position of the IUD in the
insertion tube
Hold the plunger firmly while pulling the
thread and moving the tube to adjust the
IUD´s position.
The knobs of the lateral arms must be
closely opposed to each other, slightly
above the upper extremity of the insertion
tube (see zoom 1) and the distal edge of the
tube must be aligned with the first indent of
the plunger (see zoom 2). If the tube is not
aligned with the first indent of the plunger
you must pull the thread more firmly.

Insertion

Introduce the device in the cervical canal
until the blue flange is in contact with the
cervix
Take the whole device out of the blister, by
holding firmly the plunger and tube
together in the correctly adjusted position.
Introduce the assembly into the cervical
canal until the blue flange is in contact with
the cervix.

14

Release the arms of the
intrauterine device
Hold the plunger, release the thread and
pull the insertion tube down until its lower
extremity reaches the second indent of the
plunger.

Push the IUD against
the fundus
To position the IUD in the uterine cavity,
push the insertion tube simultaneously with
the plunger, until the blue flange is again in
contact with the cervix.
Benilexa is then correctly placed in the
uterine cavity.

15

Release the IUD from the tube into the
uterine cavity
Without moving the plunger, pull the
insertion tube down to the ring of the
plunger.
A slight resistance marks the passage of the
bulge of the plunger. Nevertheless pull
down the tube to the ring of the plunger.
Benilexa is then released completely from
the insertion tube.

Remove sequentially the inserter
components and cut the threads
Remove sequentially, first the plunger, then
the insertion tube.
Cut the threads at around 3 cm from the
cervix.

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IMPORTANT!
In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, physical
examination and ultrasound should be performed immediately to exclude perforation of the uterine
body or cervix. If necessary remove the system and insert a new, sterile system.
Please report to our pharmacovigilance department any case of uterine perforation or insertion
difficulties:
Allergan Ltd, 1st Floor, Marlow International, Parkway, Marlow, Buckinghamshire SL7 1YL, United
Kingdom
Tel: +44 (0)1628 494026
Email: uk_medinfo@allergan.com

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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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