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Active substance: PROGESTERONE

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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.
• 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.
• If you get any side effects, talk to your doctor
or pharmacist. This include 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.  hat you need to know before you take UtroW
3. How to take Utrogestan
4. Possible side effects
5. How to store Utrogestan
6. Content of the pack and other information
1.  hat Utrogestan is and what it is used for
The name of your medicine is Utrogestan 200mg
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 female hormones oestrogen and progesterone
in your body goes down.
•  RT like Utrogestan replaces these hormones
and helps reduce the symptoms of the menopause.
Why Utrogestan is taken with oestrogen
•  f your HRT contains only oestrogen the lining
of the womb could build up. This can cause
•  y 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
month, rather like a period.
2.  hat you need to know before you take
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:
•  f you have ever had breast cancer, or if you are

suspected of having it;
• If you have cancer which is sensitive to oestro
gens, such as cancer of the womb lining (endometrium), or if you are suspected of having it;
•  f you have any unexplained vaginal bleeding;
•  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
•  f you have a blood clotting disorder (such as
protein C, protein S, or antithrombin deficiency);
•  f you have or recently have had a disease caused
by 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 liver function tests have not returned to
•  f you have a rare blood problem called “porI
phyria” which is passed down in families (inherited);
•  f you have cerebral haemorrhage;
•  ou are allergic (hypersensitive) to progesterone
or any of the other ingredients of this medicine
(listed in Section 6).
•  f you are allergic (hypersensitive) to soya.
If any of the above conditions appear for the first
time while taking Utrogestan, stop taking it at once
and consult your doctor immediately.
Warnings and precautions
When to take special care with HRT
Check with your doctor or pharmacist before
taking this medicine if:
•  ou have high blood pressure or heart problems;
• You have kidney or liver problems;
•  ou have epilepsy, diabetes, migraine or asthma;
• You have ever had depression;
•  our skin is sensitive to light (photo-sensitive).
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;

• Growth of womb lining outside your womb
(endometriosis) or a history of excessive growth
of the womb lining (endometrial hyperplasia);
• Increased risk of developing blood clots (see

“Blood clots in a vein (thrombosis)”);
• Increased risk of getting a oestrogen-sensitive

cancer (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 of the body (systemic lupus erythematosus, SLE);
•  disease affecting the eardrum and hearing
•  very high level of fat in your blood (triglycA
• Fluid retention due to cardiac or kidney prob
Stop taking Utrogestan and see a doctor immediately
If you notice any of the following when taking
•  ny of the conditions mentioned in the ‘DO NOT
take Utrogestan’ section;
•  ellowing of your skin or the whites of your eyes
(jaundice). These may be signs of a liver disease;
•  large rise in your blood pressure (symptoms
may be headache, tiredness, dizziness);
• Migraine-like headaches which happen for the

first time;
• Sudden or gradual, partial or complete loss of

• Proptosis (forward displacement of the eye) or

diplopia (double vision);
• Papilloedema (swelling of the optic nerve);
• Retinal vascular lesions (eye diseases);
• If you become pregnant;
• 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
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.
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
Breast cancer
Evidence suggests that taking combined oestrogen-progestogen 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.
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).
• 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 3- times 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
major surgery, injury or illness (see also section
3, If you need to have surgery);
•  ou are seriously overweight (BMI >30 kg/m2);
•  ou have any blood clotting problem that needs
long-term treatment with a medicine used to
prevent blood clots;
•  f any of your close relatives has ever had a blood
clot in the leg, lung or another organ;
•  ou have systemic lupus erythematosus (SLE);
•  ou have cancer;
For signs of a blood clot, see “Stop taking Utrogestan and see a doctor immediately”.
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
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 ( extra 5
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to
develop heart disease than those not taking any
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.
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
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.
Utrogestan is not for use in children.
Other medicines and Utrogestan
Utrogestan can affect the way some other medicines work. Also other medicines may interfere
with the effect of Utrogestan or HRT. This applies
to the following medicines:
•  edicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepin);
•  edicines for tuberculosis (such as rifampicin,
•  edicines for HIV infection (such as nevirapine,
efavirenz, ritonavir and nelfinavir);
•  erbal remedies containing St John’s Wort (HyH
pericum perforatum);
•  romocriptine used for problems with the pituiB
tary gland or Parkinson’s Disease.
•  yclosporin (used to suppress the immune sysC
•  etoconazole (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
•  o not take Utrogestan if you are pregnant or
might become pregnant.
•  trogestan is for use in postmenopausal women
only. If you become pregnant, stop taking Utrogestan and contact your doctor.
•  alk to your doctor before taking this medicine if
you 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
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 twelve days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and
ending on Day 26).
Taking this medicine
•  ake this medicine by mouth.
• Swallow the capsule whole with a glass of water.

• Take this medicine at bedtime.
• Take your oestrogen HRT at the same time as
How much to take
•  ake one capsule at bedtime on days 15 to 26 of
your 28- day cycle.
•  ou will usually have a few days withdrawal
bleeding (like a period) after this time.
• Continue to take your oestrogen HRT every day.

• 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 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
• If you forget a dose, take it as soon as you re
member it. However, if it is nearly time for the
next dose, skip the missed dose.
•  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
• Breast cancer;
•  bnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer);
• Ovarian cancer;
• Blood clots in the veins of the legs or lungs

(venous thromboembolism);
• Heart disease;

• Stroke;
• Probable memory loss if HRT is started over the

age 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

• Pruritus (intense itching);
• Acne.
Rare (more than 1 patient of 10 000 and less than
1 of 1 000)
• 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

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), 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
uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this
5. How to store Utrogestan
•  eep this medicine out of the sight and reach of
•  o 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.
•  tore in the original blister pack and in the origiS
nal outer carton.
•  o not throw away any medicines via wasteD
water. Ask your pharmacist how to throw away
medicines you no longer use. These measures
will help protect the environment
6.  ontent of the pack and other information
What Utrogestan 200mg Capsules contain
•  he active substance is progesterone. Each
capsule contains 200mg progesterone.
•  he other ingredients are sunflower oil and soybean lecithin. The other ingredients in the capsule
shell are gelatin, glycerol and titanium dioxide.
What Utrogestan 200mg Capsules look like
• Utrogestan 200mg Capsules are soft and white.

•  hey are supplied in cartons containing blister
strips of 15 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Utrogestan
200mg Capsules is held by Besins Healthcare Avenue Louise, 287-1050 Brussels - Belgium
Utrogestan 200mg 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),
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.

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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.