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 taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Utrogestan Vaginal is and what it is used for
2. Before you take Utrogestan Vaginal
3. How to insert Utrogestan Vaginal
4. Possible side effects
5. How to store Utrogestan Vaginal
6. Further 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. Before you insert Utrogestan Vaginal
Do not insert Utrogestan Vaginal if:
• You are allergic (hypersensitive) to peanuts or soya.
Utrogestan Vaginal contains peanut oil (arachis oil).
• You are allergic (hypersensitive) to progesterone or any of
the other ingredients of Utrogestan Vaginal (listed in
Section 8).
Take special care with Utrogestan Vaginal
Utrogestan Vaginal should be used during the first 3 months of
pregnancy.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before inserting Utrogestan Vaginal.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken 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).

PlL Utrogestan Vaginal 200 mg capsules

Taking 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 4 on how to insert Utrogestan Vaginal.
• Do not insert Utrogestan Vaginal if you are breast-feeding.



Driving and using machines
Utrogestan Vaginal has no effects on driving or using machinery.
Important information about some of the ingredients of
Utrogestan Vaginal
Utrogestan Vaginal contains peanut oil (arachis oil) and soya
lecithin. Do not insert Utrogestan Vaginal if you are allergic
(hypersensitive) to peanuts or soya.

3. How to insert Utrogestan Vaginal to help
pregnancy
Always insert Utrogestan Vaginal exactly as your doctor has told
you. Always read the label. You should 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.
Taking this medicine to help pregnancy
• Take this medicine by inserting it deep into the vagina.
• Do not insert it by mouth, However, if you insert Utrogestan
Vaginal by mouth accidentally it will not harm you, only
reduce your chances of becoming pregnant. .
How much to insert
Your treatment will start the day of embryo transfer.
Every day, insert 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 insert more Utrogestan Vaginal than you should
If you insert 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 insert 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 insert a double dose to make up for a forgotten
dose.

4.

Possible side effects

Like all medicines, Utrogestan Vaginal can cause side effects,
although not everybody gets them. The following side effects
may happen with this medicine:


Local itching, burning, or discharge.

If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. How to store Utrogestan Vaginal



Keep out of the reach and sight of children.

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PACKAGE LEAFLET: INFORMATION FOR THE USER
UTROGESTAN VAGINAL ® 200mg Capsules
Progesterone




Do not use Utrogestan Vaginal after the expiry date stated
on the packaging. The expiry date refers to the last day of
that month.
Store in the original blister pack and in the original outer
carton.
Medicines should not be disposed of via household waste.
Ask your doctor or pharmacist how to dispose of medicines
no longer required. These measures will help to protect the
environment.

6. Further information
What Utrogestan Vaginal 200mg Capsules contain
• The active substance is progesterone. Each capsule
contains 200mg progesterone.
• The other ingredients are arachis (peanut) oil and soybean
lecithin. The other ingredients in the capsule shell are
gelatin, glycerol and titanium dioxide.
What Utrogestan Vaginal 200mg Capsules look like
• Utrogestan Vaginal 200mg Capsules are soft and white.
• They are supplied in cartons containing blister strips of 15 or
21 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Utrogestan Vaginal 200mg
Capsules is held by Marlborough Pharmaceuticals Limited,
35A High Street, Marlborough, Wiltshire SN8 1LW.
Utrogestan Vaginal 200mg Capsules are manufactured by
Laboratoires Besins International, 13, rue Périer 92120,
Montrouge, France , Besins Manufacturing Belgium, Groot
Bijgaardenstraat 128,1620 Drogenbos, Belgium and Cyndea
Pharma, S.L. Poligono Industrial Emiliano Revilla Sanz Avenida
de Agreda, 31, Olvega 42110 (Soria), Spain.
Licence number PL 23138/0020
This leaflet was last revised in April 2013

PlL Utrogestan Vaginal 200 mg capsules

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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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