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UTROGESTAN VAGINAL 200MG CAPSULES

Active substance: PROGESTERONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

UTROGESTAN VAGINAL ® 200mg Capsules
Progesterone
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).
Utrogestan Vaginal is not a contraceptive.

2. Be
2. What you need to know before you use Utrogestan Vaginal
Vaginal
Do not use Utrogestan Vaginal:
• If you are allergic (hypersensitive) to soya.
• If you are allergic (hypersensitive) to progesterone or any of the other ingredients of
Utrogestan Vaginal (listed in Section 6).
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.

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 and breast-feeding
• 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 no 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 3. How to insert Utrogestan Vaginal to help
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.
4. Possible side effects
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.
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.

6.
6. Contents of the pack and other information
Further 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 and titanium dioxide.
What Utrogestan Vaginal looks like and content
• 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. 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 September 2014

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.

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