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UTROGESTAN VAGINAL 200MG CAPSULES

Active substance(s): PROGESTERONE / PROGESTERONE / PROGESTERONE

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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.
• 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 includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Utrogestan Vaginal is and what it is used for
2. What you need to know before you use Utrogestan
Vaginal
3. How to use Utrogestan Vaginal
4. Possible side effects
5. How to store Utrogestan Vaginal
6. Contents of the pack and other information

1. What Utrogestan Vaginal is and what it is
used for
The name of your medicine is Utrogestan Vaginal
200mg Capsules (called Utrogestan Vaginal in this
leaflet).
Utrogestan Vaginal contains a hormone called
progesterone.
What Utrogestan Vaginal is used for
Utrogestan Vaginal can be used to help pregnancy.
To help pregnancy
Utrogestan Vaginal is used to assist fertility treatment
techniques using your own eggs, such as IVF, gamete
intra-Fallopian transfer (GIFT) or zygote intra-Fallopian
transfer (ZIFT).

2. What you need to know before you use
Utrogestan Vaginal
Do not use Utrogestan Vaginal:
• If you are allergic (hypersensitive) to soya
• If you are allergic to progesterone or any of the other
ingredients of this medicine (listed in Section 6)
• If you have severe liver disease
• If you have unexplained vaginal bleeding
• If you have mammary or genital tract carcinoma
• If you have thrombophlebitis
• If you have or have had blood clots in a vein
(thrombosis), such as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism)
• If you have cerebral haemorrhage

• If you have a rare blood problem called “porphyria”
which is passed down in families (inherited)
Warning and precautions
Utrogestan Vaginal should be used during the first 3
months of pregnancy.
Talk to your doctor or pharmacist before using
Utrogestan Vaginal.
Utrogestan Vaginal is not a contraceptive.
If you think you may have miscarried, you should speak
for your doctor as you will need to stop using Utrogestan
Vaginal.
Children
Utrogestan vaginal is not for use in children.
Other medicines and Utrogestan Vaginal
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes medicines obtained without a prescription,
including herbal medicines. This is because Utrogestan
Vaginal can affect the way some other medicines work.
Also some other medicines can affect the way
Utrogestan Vaginal works.
In particular tell your doctor or pharmacist if you are
taking any of the following medicines:
• Bromocriptine used for problems with the pituitary
gland or Parkinson’s Disease.
• Cyclosporin (used to suppress the immune system).
• Rifamycin medicines such as rifampicin.
• Ketoconazole (used for fungal infections).
Utrogestan Vaginal with food and drink
Utrogestan Vaginal is to be administered intravaginally.
Food and drink have no effect on the treatment.
Pregnancy breast-feeding and fertility
• Utrogestan Vaginal will help you become pregnant.
See Section 3 on how to use Utrogestan Vaginal.
• Do not use Utrogestan Vaginal if you are breastfeeding.
Driving and using machines
Utrogestan Vaginal has negligible effects on driving or
using machinery.
Utrogestan Vaginal contains soya lecithin
Do not use Utrogestan Vaginal if you are allergic
(hypersensitive) to soya.

3. How to use Utrogestan Vaginal
Always use this medicine exactly as your doctor has told
you. Always read the label. Check with your doctor or
pharmacist if you are not sure.

Please contact the pharmacy if you require an
applicator. The applicator supplied by your pharmacy
contains a leaflet. This leaflet includes pictures and
describes how to use the applicator.
Using this medicine to help pregnancy
• Use this medicine by inserting it deep into the vagina.
• Do not take it by mouth, However, if you take
Utrogestan Vaginal by mouth accidentally it will not
harm you, only reduce your chances of becoming
pregnant.
How much to use
• Your treatment will start the day of embryo transfer.
• Every day, use 200mg of Utrogestan Vaginal in the
morning, at lunchtime and at bedtime, or 200mg in the
morning and the evening, as instructed by your doctor.
• If there is laboratory evidence of pregnancy, continue
with the same dose regime until the 7th to 12th week
of pregnancy, as instructed by your doctor.
If you use more Utrogestan Vaginal than you should
If you use more Utrogestan Vaginal 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 or
feeling tired.
If you forget to use Utrogestan Vaginal
• If you forget a dose, insert it as soon as you remember
it. However, if it is nearly time for the next dose, skip
the missed dose.
• Do not use a double dose to make up for a forgotten
dose.

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:
• Local itching, burning, or discharge.

6. Contents of the pack and other
information
What Utrogestan Vaginal contains
• The active substance is progesterone. Each capsule
contains 200mg progesterone.
• The other ingredients are sunflower oil and soybean
lecithin. The other ingredients in the capsule shell are
gelatin, glycerol, titanium dioxide and purified water.
What Utrogestan Vaginal looks like and contents of
the pack
• Utrogestan Vaginal 200mg Capsules are soft and
white.
• They are supplied in cartons containing blister strips of
15, 21 or 90 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Utrogestan Vaginal is
held by Besins Healthcare, Avenue Louise 287, 1050
Brussels, Belgium.
Utrogestan Vaginal is manufactured by:
• Besins Manufacturing Belgium,
Groot Bijgaardenstraat 128
1620 Drogenbos,
Belgium.
• Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz,
Avenida de Ágreda, 31,
Ólvega 42110 (Soria),
Spain.
This medicine is distributed in the UK by:
Besins Healthcare (UK) Ltd, 1st Floor, 28 Poland Street,
London, W1F 8QN, United Kingdom.
Tel: +44(0)203862 0920.
Licence number PL 28397/0005
This leaflet was last revised in May 2017

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 Vaginal
• 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 or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

For information in large print, tape, CD or Braille,
telephone +44(0)203862 0920.

Expand Transcript

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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