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Active substance: 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
• 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

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
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

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)

Like all medicines, this medicine can cause side effects, although not
everybody gets them. The following side effects may happen with this
• Local itching, burning, or discharge.

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.

• 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.

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
• 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 breast-feeding.
Driving and using machines
Utrogestan Vaginal has negligible effects on driving or using machinery.
Utrogestan Vaginal contains soya lecithin.

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 By reporting
side effects you can help provide more information on the safety of this

5. How to store Utrogestan Vaginal

6. Contents of the pack and other information
What Utrogestan Vaginal contains
• The active substance is progesterone. Each capsule contains 200mg
• The other ingredients are sunflower oil and soybean lecithin. The other
ingredients in the capsule shell are gelatin, glycerol and titanium dioxide.
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
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. Poligono Industrial Emiliano Revilla Sanz Avenida
de Agreda, 31, Olvega 42110 (Soria), Spain.
This medicine is distributed in the UK by:
Besins Healthcare (UK) Ltd, 35A High Street, Marlborough, SN8 1LW
Tel: 01672516885
Licence number PL 28397/0005
This leaflet was last revised in April 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.