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UTROGESTAN 100MG CAPSULES

Active substance: PROGESTERONE

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PATIENT INFORMATION LEAFLET

UTROGESTAN 100mg CAPSULES
Progesterone
Read all of this leaˇet carefully before you start taking this medicine
because it contains important information for you.
ï Keep this leaˇet. You may need to read it again.
ï If you have any further questions, ask your doctor or pharmacist.
ï 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.
ï If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaˇet. See section 4.

What is in this leaˇet:
1. What Utrogestan is and what it is used for
2. What you need to know before you take Utrogestan
3. How to take Utrogestan
4. Possible side effects
5. How to store Utrogestan
6. Content of the pack and other information
1. What Utrogestan is and what it is used for
The name of your medicine is Utrogestan 100mg Capsules (called
Utrogestan in this leaˇet). Utrogestan contains a hormone called
progesterone and is to be used with another medicine called oestrogen.
The combination of Utrogestan and oestrogen belongs to a group of
medicines called hormone replacement therapy (HRT).
What Utrogestan is used for
Utrogestan is used to reduce the symptoms of the menopause (change of
life).
ï It is used only in women who still have a womb (uterus). Utrogestan is
not a contraceptive.
How Utrogestan works
ï As you get near to the menopause, the amount of the female hormones
oestrogen and progesterone in your body goes down.
ï HRT like Utrogestan replaces these hormones and helps reduce the
symptoms of the menopause.
Why Utrogestan is taken with oestrogen
ï If your HRT contains only oestrogen the lining of the womb could
build up. This can cause problems.
ï By taking Utrogestan as well, this makes you shed the womb lining.
This prevents these problems happening.
ï You might get some bleeding at the end of each month, rather like a
period.
2. What you need to know before you take Utrogestan
Do not take Utrogestan if:
ï You are allergic (hypersensitive) to soya.
ï If you are allergic (hypersensitive) to progesterone or any of the other
ingredients of Utrogestan (listed in Section 6).
ï You have severe liver disease.
ï You have ever had breast cancer.
ï You have porphyria (an illness which makes your urine and skin an
unusual colour).
ï You have unexpected and unexplained bleeding from your vagina (and
it is not due to your normal monthly period).
ï You have ever had cancer of your sex organs (ovaries, womb, cervix,
birth canal or external genitals).
ï You have had blood clots, bleeding of the brain, or a stroke.
Do not take Utrogestan if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Utrogestan.
Warnings and precautions
Check with your doctor or pharmacist before taking this medicine if:
ï You have high blood pressure or heart problems.
ï You have kidney or liver problems.
ï You have epilepsy, diabetes, migraine or asthma.
ï You have ever had depression.
ï Your skin is sensitive to light (photo-sensitivity).
If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Utrogestan.
Medical check-ups
Before you start taking HRT, your doctor should ask about your own and
your familyís medical history. Your doctor may decide to examine your
breasts or your tummy, and may do an internal examination. They will
only do this if it is necessary for you or if you have any special concerns.

Once you have started on HRT, see your doctor for regular check-ups
(at least once a year). At these check-ups, your doctor may discuss the
beneˇts and risks of continuing to take HRT.
Make sure that you:
ï Go for regular breast screening and cervical smear tests.
ï Regularly check your breasts for any changes such as dimpling of the
skin, changes in the nipple, or any lumps you can see or feel.
Other medicines and Utrogestan
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. This is because Utrogestan can
affect the way some other medicines work. Also some other medicines
can affect the way Utrogestan works.
In particular tell your doctor or pharmacist if you are taking any of the
following medicines:
ï Bromocriptine used for problems with the pituitary gland or
Parkinsonís Disease.
ï Cyclosporin (used to suppress the immune system).
ï Rifamycin medicines such as rifampicin.
ï Ketoconazole (used for fungal infections).
If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Utrogestan.
Operations or tests
Tell your doctor if you are going to have surgery. You may need to stop
taking HRT for 4 to 6 weeks before an operation to reduce the risk of
a blood clot. Your doctor will tell you when you can start taking HRT
again.
Utrogestan with food and drink
Do not take Utrogestan with food. See Section 3 ëHow to take
Utrogestaní for more information on when to take this medicine.
Pregnancy and breast-feeding
ï Do not take Utrogestan if you are pregnant or might become pregnant.
ï If you get pregnant while taking this medicine, stop taking it straight
away and tell your doctor.
ï Talk to your doctor before taking this medicine if you are breastfeeding.
Driving and using machines
You may feel sleepy or dizzy while taking Utrogestan. If this happens,
do not drive or use any tools or machines. Taking Utrogestan at bedtime
can reduce these effects.
Utrogestan contains soya lecithin
Do not take Utrogestan if you are allergic (hypersensitive) to soya.
3. How to take Utrogestan
Always take this medicine exactly as your doctor has told you. Always
read the label. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
ï Take this medicine by mouth.
ï Swallow the capsule whole with a glass of water.
ï Take this medicine at bedtime.
ï Take your oestrogen HRT at the same time as Utrogestan.
How much to take
ï Take two capsules at bedtime on days 15 to 26 of your 28- day cycle.
ï You will usually have a few days withdrawal bleeding (like a period)
after this time.
ï Continue to take your oestrogen HRT every day.
ï If you have any problems with the withdrawal bleed, your doctor may
change the way that you take Utrogestan. This will help to reduce the
amount of withdrawal bleeding.
If you take more Utrogestan than you should
If you take more Utrogestan than you should, talk to your doctor or go to
a hospital. Take the medicine pack with you.
The following effects may happen: feeling dizzy, feeling tired or having
a painful period.
If you forget to take Utrogestan
ï If you forget a dose, take it as soon as you remember it. However, if it
is nearly time for the next dose, skip the missed dose.
ï Do not take a double dose to make up for a forgotten dose.
If you stop taking Utrogestan
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them. The following side effects may happen with this
medicine
Stop taking Utrogestan and tell your doctor straight away if you
notice any of the following:
ï Headaches.
ï Problems with your eyes.
ï Yellowing of the skin or the whites of your eyes (jaundice).
See a doctor as soon as possible if you notice any of the following:
ï Blood clots in the veins of your legs or pelvis (see ëSafety of HRTí
below).
ï You have any of the problems listed in ëSafety of HRTí below.
Other side effects include:
ï Feeling tired or dizzy.
ï Difˇculty sleeping
ï High temperature.
ï Depression.
ï Feeling sick or having an upset or bloated stomach.
ï Changes to your menstrual ˇow or bleeding at times other than the
withdrawal bleed. If this happens, your doctor may change the way you
take your medicine.
ï Pre-menstrual symptoms such as irritability, backache or lower stomach
pain.
ï Changes to your breasts. They may become tender.
ï Changes in secretions from your genitals.
ï Changes in your libido (interest in sex).
ï Changes to your weight or swollen ankles.
ï Loss of hair or an increase in hair growth.
ï Rash (which may be itchy) or other changes in your skin such as acne.
Safety of HRT
As well as beneˇts, HRT has some risks which you need to consider
when youíre deciding whether to take it, or whether to carry on taking it.
Risk of developing cancer
Breast cancer
Women who have breast cancer, or have had breast cancer in the past,
should not take HRT.
Taking HRT for 5 years or more slightly increases the risk of breast
cancer. The risk is also slightly increased if you have a later menopause.
The risk for a post-menopausal woman taking HRT for 5 years is about
the same as for a woman of the same age who is still having periods
over that time and not taking HRT. The risk for a woman who is taking
oestrogen plus progestogen HRT is higher than for oestrogen-only HRT.
However, oestrogen plus progestogen HRT is beneˇcial for the lining of
the womb.
For all kinds of HRT, the extra risk of breast cancer goes up the longer
you take it. However, it returns to normal about 5 years after stopping
HRT.
Your risk of breast cancer is also higher if:
ï You have a close relative (mother, sister or grandmother) who has had
breast cancer.
ï You are seriously overweight.
How likely is breast cancer?
Looking at women aged 50, on average, by the time they reach 70:
ï Women not taking HRT: 45 in 1000 would be expected to get breast
cancer.
ï Women taking HRT for 5 years: 47 in 1000 would be expected to get
breast cancer. This means an extra 2 cases.
ï Women taking HRT for 10 years: 51 in 1000 would be expected get
breast cancer. This means an extra 6 cases.
ï Women taking HRT for 15 years: 57 in 1000 would be expected to get
breast cancer. This means an extra 12 cases.
If you notice any changes in your breast, such as:
ï Dimpling of the skin.
ï Changes in the nipple.
ï Any lumps you can see or feel.
Make an appointment to see your doctor as soon as possible.

it can cause chest pain, breathlessness, collapse or even death. This is
called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
You are more likely to get a blood clot if:
ï You are seriously overweight.
ï You have had a blood clot before.
ï Any of your close family have had blood clots.
ï You have any blood clotting problems that need treatment with a
medicine such as warfarin.
ï You are off your feet for a long time because of major surgery, injury
or illness.
If any of these apply to you, talk to your doctor to see if you should take
HRT.
How likely is a blood clot?
Looking at women in their 50s, on average, over 5 years:
ï Women not taking HRT: 3 in 1000 would be expected to get a blood
clot.
ï Women taking HRT: 7 in 1000 would be expected to get a blood clot.
Looking at women in their 60s, on average, over 5 years:
ï Women not taking HRT: 8 in 1000 would be expected to get a blood
clot.
ï Women taking HRT: 17 in 1000 would be expected to get a blood clot.
If you get painfull swelling in your leg, sudden chest pain or difˇculty
breathing see a doctor as soon as possible. Do not use any more HRT
until a doctor says you can. These may be signs of a blood clot.
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 leaˇet. You can also
report side effects directly via the 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 Utrogestan
ï Keep this medicine out of the sight and reach of children.
ï Do not use Utrogestan after the expiry date stated on the packaging
after ëExpí. The expiry date refers to the last day of that month.
ï Store in the original blister pack and in the original outer carton.
ï Do not throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help protect the environment.
6. Content of the pack and other information
What Utrogestan 100mg Capsules contain
ï The active substance is progesterone. Each capsule contains 100mg
progesterone.
ï The other ingredients are sunˇower oil and soya lecithin. The other
ingredients in the capsule shell are gelatin, glycerol and titanium
dioxide.
What Utrogestan 100mg Capsules look like and content of the pack
ï Utrogestan 100mg Capsules are soft and white.
ï They are supplied in cartons containing blister strips of 30 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Utrogestan 100mg Capsules is held by
Besins Healthcare - Avenue Louise, 287-1050 Brussels - Belgium
Utrogestan 100mg Capsules are manufactured by
Besins Manufacturing Belgium, Groot Bijgaardenstraat 128,1620
Drogenbos, Belgium
Cyndea Pharma, S.L. Poligono Industrial Emiliano Revilla Sanz Avenida
de Agreda, 31, Olvega 42110 (Soria), Spain.
Distributed in the UK by
Besins Healthcare (UK) Ltd
35A High Street ñ Marlborough - SN8 1LW ñ United Kingdom
Tel 01672516885
Licence number PL 28397/0003
This leaˇet was last revised in July 2014.
For information in large print, tape, CD or Braille, telephone 01672
516885.

Heart or circulation
Blood clots
HRT may increase the risk of blood clots in the veins (also called deep
vein thrombosis or DVT), especially during the ˇrst year of taking it.
These blood clots are not always serious, but if one travels to the lungs,
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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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