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UTROGESTAN 100MG CAPSULES

Active substance(s): PROGESTERONE

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PATIENT INFORMATION LEAFLET

UTROGESTAN 100mg CAPSULES
Progesterone

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.
•  his medicine has been prescribed for you only. Do
T
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 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 leaflet). 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).

• It is used only in women who still have a womb
(uterus). Utrogestan is not a contraceptive.
How Utrogestan works
•  s you get near to the menopause, the amount of the
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female hormones oestrogen and progesterone in your
body goes down.
• HRT like Utrogestan replaces these hormones and

helps reduce the symptoms of the menopause.
Why Utrogestan is taken with oestrogen
• If your HRT contains only oestrogen the lining of the

womb could build up. This can cause problems.

• By taking Utrogestan as well, this makes you shed
the womb lining. This prevents these problems
happening.
•  ou might get some bleeding at the end of each
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month, rather like a period.
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2.  hat you need to know before you take
Utrogestan
Medical history and regular check-ups
The use of HRT carries risks which need to be
considered when deciding whether to start taking it, or
whether to carry on taking it.
The experience in treating women with a premature
menopause (due to ovarian failure or surgery) is
limited. If you have a premature menopause the risks of
using HRT may be different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask
about your own and your family’s medical history. Your
doctor may decide to perform a physical examination.
This may include an examination of your breasts, your
tummy and/or an internal examination, if necessary.
Once you have started on HRT, see your doctor for
regular check-ups (at least once a year).
At these check-ups, discuss with your doctor the
benefits and risks of continuing to take HRT.
Go for regular breast screening, as recommended by
your doctor.
Do not take Utrogestan
if any of the following applies to you. If you are not
sure about any of the points below, talk to your doctor
or pharmacist before taking Utrogestan.
Do not take Utrogestan:
• If you have ever had breast cancer, or if you are
suspected of having it;
• If you have cancer which is sensitive to oestrogens,


such as cancer of the womb lining (endometrium), or
if you are suspected of having it;
• If you have any unexplained vaginal bleeding;
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•  f you have or have ever had a blood clot in a vein
(thrombosis), such as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism);
•  f you have a blood clotting disorder (such as protein
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C, protein S, or antithrombin deficiency);
•  f you have or recently have had a disease caused by
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blood clots in the arteries, such as a heart attack,
stroke or angina;
•  f you have or have ever had a liver disease and your
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liver function tests have not returned to normal;
•  f you have a rare blood problem called “porphyria”
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which is passed down in families (inherited);
• If you have cerebral haemorrhage;
•  f you are allergic (hypersensitive) to progesterone or
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any of the other ingredients of this medicine (listed in
Section 6).
• If you are allergic (hypersensitive) to soya.

HRT and cancer
Unexpected bleeding
You will have a bleed once a month (so-called
withdrawal bleed) while taking Utrogestan. But, if you
have unexpected bleeding or drops of blood (spotting)
besides your monthly bleeding, which:
• Carries on for more than the first 6 months;
• Starts after you have been taking Utrogestan more
than 6 months;
• Carries on after you have stopped taking Utrogestan;
See your doctor as soon as possible

If any of the above conditions appear for the first time
while taking Utrogestan, stop taking it at once and
consult your doctor immediately.

Compare
Women aged 50 to 79 who are not taking HRT, on
average, 9 to 17 in 1000 will be diagnosed with breast
cancer over a 5-year period. For women aged 50 to
79 who are taking oestrogen-progestogen HRT over 5
years, there will be 13 to 23 cases in 1000 users (i.e. an
extra 4 to 6 cases).

Warnings and precautions
When to take special care with HRT
Check with your doctor or pharmacist before taking this
medicine if:
• You have high blood pressure or heart problems.
• You have kidney or liver problems.
• You have epilepsy, diabetes, migraine or asthma.
• You have ever had depression.
• 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.
Tell your doctor if you have or ever had any of the
following problems, before you start the treatment, as
these may return or become worse during treatment
with HRT. If so, you should see your doctor for more
often check-ups:
• Fibroids inside your womb;
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•  rowth of womb lining outside your womb
(endometriosis) or a history of excessive growth of
the womb lining (endometrial hyperplasia);
•  ncreased risk of developing blood clots (see “Blood
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clots in a vein (thrombosis)”);
•  ncreased risk of getting a oestrogen-sensitive cancer
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(such as having a mother, sister or grandmother who
has had breast cancer);
• Gallstones;
• Severe headaches;
•  disease of the immune system that affects many organs
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of the body (systemic lupus erythematosus, SLE);
• A disease affecting the eardrum and hearing
(otosclerosis);
• A very high level of fat in your blood (triglycerides);
• Fluid retention due to cardiac or kidney problems.
Stop taking Utrogestan and see a doctor
immediately
If you notice any of the following when taking HRT:
•  ny of the conditions mentioned in the ‘DO NOT take
A
Utrogestan’ section;
•  ellowing of your skin or the whites of your eyes
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(jaundice). These may be signs of a liver disease;
•  large rise in your blood pressure (symptoms may be
A
headache, tiredness, dizziness);
•  igraine-like headaches which happen for the first
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time;
• If you become pregnant;
• Sudden or gradual, partial or complete loss of vision;
•  roptosis (forward displacement of the eye) or
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diplopia (double vision);
• Papilloedema (swelling of the optic nerve);
• Retinal vascular lesions (eye diseases);
• If you notice signs of a blood clot, such as:
- painful swelling and redness of the legs;
- sudden chest pain;
- difficulty in breathing;
For more information, see ‘Blood clots in a vein
(thrombosis)’
Note: Utrogestan is not a contraceptive. If it is less than
12 months since your last menstrual period or you are
under 50 years old, you may still need to use additional
contraception to prevent pregnancy. Speak to your
doctor for advice.

Breast cancer
Evidence suggests that taking combined oestrogenprogestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. The extra risk
depends on how long you take HRT. The additional risk
becomes clear within a few years. However, it returns
to normal within a few years (at most 5) after stopping
treatment.


• Regularly check your breasts. See your doctor if
you notice any changes such as:
• Dimpling of the skin;
• Changes in the nipple;
• Any lumps you can see or feel.
Additionally, you are advised to join mammography
screening programs when offered to you. For
mammogram screening, it is important that you inform
the nurse/healthcare professional who is actually taking
the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect
the outcome of the mammogram. Where the density of
the breast is increased, mammography may not detect
all lumps.
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of
ovarian cancer has been reported in women taking HRT
for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on
average about 2 women in 1000 will be diagnosed
with ovarian cancer over a 5-year period. For women
who have been taking HRT for 5 years, there will be
between 2 and 3 cases per 1000 users (i.e. up to 1 extra
case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3times higher in HRT users than in non-users, especially
during the first year of taking it.
Blood clots can be serious, and if one travels to the
lungs, it can cause chest pain, breathlessness, fainting
or even death.
You are more likely to get a blood clot in your veins as
you get older and if any of the following applies to you.
Inform your doctor if any of these situations applies
to you:
•  ou are unable to walk for a long time because of
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major surgery, injury or illness (see also section 3, If
you need to have surgery);
• You are seriously overweight (BMI >30 kg/m2);
•  ou have any blood clotting problem that needs
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long-term treatment with a medicine used to prevent
blood clots;

• If any of your close relatives has ever had a blood clot
in the leg, lung or another organ;
• You have systemic lupus erythematosus (SLE);
• You have cancer;
For signs of a blood clot, see “Stop taking Utrogestan
and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT,
on average, over a 5-year period, 4 to 7 in 1000 would
be expected to get a blood clot in a vein.
For women in their 50s who have been taking
oestrogen-progestogen HRT for over 5 years, there will
be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
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Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
attack.

twelve days in the last half of each therapeutic cycle
(beginning on Day 15 of the cycle and ending on Day
26).

Women over the age of 60 years who use oestrogenprogestogen HRT are slightly more likely to develop
heart disease than those not taking any HRT.

Taking this medicine
• Take this medicine by mouth.
• Swallow the capsule whole with a glass of water.
• Take this medicine at bedtime.
•  ake your oestrogen HRT at the same time as
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Utrogestan.

Stroke
The risk of getting stroke is about 1.5 times higher in
HRT users than in non-users. The number of extra cases
of stroke due to use of HRT will increase with age.
Compare
Looking at women in their 50s who are not taking
HRT, on average, 8 in 1000 would be expected to have
a stroke over a 5-year period. For women in their 50s
who are taking HRT, there will be 11 cases in 1000
users, over 5 years (i.e. an extra 3 cases).
Other conditions
HRT will not prevent memory loss. There is some
evidence of a higher risk of memory loss in women
who start using HRT after the age of 65. Speak to your
doctor for advice.
Children
Utrogestan is not for use in children.
Other medicines and Utrogestan
Utrogestan can affect the way some other medicines
work. Also some medicines may interfere with the
effect of Utrogestan or HRT. This applies to the
following medicines:
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•  edicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepin);
• Medicines for tuberculosis (such as rifampicin,
rifabutin);
•  edicines for HIV infection (such as nevirapine,
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efavirenz, ritonavir and nelfinavir);
• Herbal remedies containing St John’s Wort
(Hypericum perforatum);
•  romocriptine used for problems with the pituitary
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gland or Parkinson’s Disease.
• Cyclosporin (used to suppress the immune system).
• Ketoconazole (used for fungal infections).
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines including
medicines obtained without a prescription, herbal
medicines or other natural products.
Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are taking HRT, because HRT
can affect the results of some tests.
Utrogestan with food and drink
Do not take Utrogestan with food. See Section 3 ‘How
to take Utrogestan’ for more information on when to
take this medicine.
Pregnancy and breast-feeding
• Do not take Utrogestan if you are pregnant or might
become pregnant.
•  trogestan is for use in postmenopausal women only.
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If you become pregnant, stop taking Utrogestan and
contact your doctor.
•  alk to your doctor before taking this medicine if you
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are breast-feeding.
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.
Your doctor will aim to prescribe the lowest dose to
treat your symptom for as short as necessary. Speak to
your doctor if you think this dose is too strong or not
strong enough.
The recommended dose is 200 mg daily at bedtime, for

How much to take
•  ake two capsules at bedtime on days 15 to 26 of your
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28- day cycle.
•  ou will usually have a few days withdrawal bleeding
Y
(like a period) after this time.
• Continue to take your oestrogen HRT every day.
•  f you have any problems with the withdrawal bleed,
I
your doctor may change the way that you take
Utrogestan. This will help to reduce the amount of
withdrawal bleeding.
If you need to have surgery
If you are going to have surgery, tell the surgeon that
you are taking HRT. You may need to stop taking HRT
about 4 to 6 weeks before the operation to reduce the
risk of a blood clot (see section 2, Blood clot in a vein).
Ask your doctor when you can start taking HRT again.
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
•  f you forget a dose, take it as soon as you remember
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it. However, if it is nearly time for the next dose, skip
the missed dose.
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•  o 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.
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
The following diseases are reported more often in
women using HRT compared to women not using HRT:
• Breast cancer;
A
•  bnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer);
• Ovarian cancer;
•  lood clots in the veins of the legs or lungs (venous
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thromboembolism);
• Heart disease;
• Stroke;
•  robable memory loss if HRT is started over the age
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of 65;
For more information about these side effects, see
Section 2.
The following side effects may happen with Utrogestan
taken orally:
Common side effects (more than 1 patient of 100 and
less than 1 of 10)
• Altered periods;
• Amenorrhoea;
• Intercurrent bleading;
• Headaches.
Uncommon side effects (more than 1 patient of 1 000
and less than 1 of 100)
• Mastodynia;
• Drowsiness;
• Dizziness;
• Vomiting;
• Diarrhoea;
• Constipation;
• Cholestatic jaundice (yellowing of the skin and eyes);
• Pruritus (intense itching);
• Acne.

• Nausea (sickness in the stomach).
Very rare (less than 1 patient of 10 000)
• Depression;
• Urticaria (itchy eruption of the skin);
• Chloasma (patchy brown or dark brown skin

discoloration)
The following side effects have been reported with
other HRTs:
Rashes (group of spots or red, inflamed skin), weight
changes, change in libido (increase or decrease in
sexual desire), pyrexia (fever), insomnia (inability to
obtain an adequate amount or quality of sleep), alopecia
(hair loss), hirsutism (excessive growth of facial or
body hair), gall bladder disease, various skin disorders
as erythema nodosum (painful reddish skin nodules)
and erythema multiform (rash with target-shaped
reddening or sores).
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 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

• Keep this medicine out of the sight and reach of
children.

• Do not use this medicine after the expiry date stated
on the packaging after ‘Exp’. The expiry date refers
to the last day of that month.
• Store in the original blister pack and in the original

outer carton.

• 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
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•  he active substance is progesterone. Each capsule
contains 100mg progesterone.
•  he other ingredients are sunflower oil and soya
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lecithin. The other ingredients in the capsule shell are
gelatin, glycerol and titanium dioxide.
What Utrogestan 100mg Capsules look like and
contents of the pack
• Utrogestan 100mg Capsules are soft and white.
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•  hey 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 – Marlborough - SN8 1LW – United
Kingdom
Tel 01672516885
Licence number PL 28397/0003
This leaflet was last revised in August 2015.
For information in large print, tape, CD or Braille,
telephone 01672 516885.

Rare (more than 1 patient of 10 000 and less than 1 of
1 000)
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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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