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PROGESTERONE 400MG PESSARIES

Active substance(s): PROGESTERONE

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Progesterone 200mg
and 400mg Pessaries
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, ask your doctor
or pharmacist.

Index
1 What Progesterone is and what it is used for
2 Before you use
3 How to use
4 Possible side effects
5 How to store
6 Further information

1 What Progesterone is and what it is used for
Progesterone is a natural, female sex hormone, produced in
the body. This medicine works by adjusting the hormonal
balance within the body.
Progesterone pessaries may be used for treating:
• pre-menstrual syndrome which often affects women during
the 7 to 10 days before their monthly period. The symptoms
of pre-menstrual syndrome include feelings of tension,
irritability, depression, headache, breast tenderness, weight
gain and bloatedness
• post-natal depression which some women get after their
baby has been born.

2 Before you use
Do not use Progesterone pessaries and tell your
doctor if you:

• have ever had any unexpected and unexplained bleeding
from your vagina which was not due to your normal
monthly period.

Check with your doctor or pharmacist before using
Progesterone pessaries if you:

• have ever had liver problems such as jaundice (yellowing of
the skin and whites of the eyes).

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, planning a
family or breast-feeding, ask your doctor or pharmacist for
advice before using this medicines.

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• 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.

3 How to use
Always use Progesterone pessaries exactly as your doctor
has told you. If you are not sure, check with your doctor or
pharmacist.

Do not swallow Progesterone pessaries.
The usual dose is 200mg once a day or 400mg twice a day by
vaginal or rectal insertion.
For premenstrual tension start using Progesterone pessaries
on day 12 or 14 of your menstrual cycle. This can be planned
and marked onto your calendar, day 1 is the first day of your
monthly period, counting forward to day 12 or 14 as advised
by your doctor.
The pessary may be inserted into either the vagina or rectum
(back passage) depending upon the following certain other
conditions. You should insert Progesterone pessaries into the:
• vagina if you have:
- colitis (inflammation of the colon causing frequent attacks
of diarrhoea with mucous or blood)
- problems controlling your bowel movements (faecal
incontinence).
• rectum (back passage) if you have:
- a vaginal infection (discharge from your vagina)
- or often have cystitis (a burning pain on passing water)
- recently given birth
- to use a barrier method of birth control such as a
diaphragm, cap or condom. Such devices may not work
properly in the presence of the vegetable fat from the
pessary.

How to insert Progesterone pessaries

Always wash your hands before and after inserting the
pessary.
To insert into the:
• Vagina - place the pessary between the lips of the vagina
and push the pessary upwards and backwards. You may find
it easier to do this if you are lying down or squatting.
• Rectum (back passage) - gently push the pessary into the
rectum for about one inch.
Your muscles will hold the pessary in place when it is in far
enough. Squeeze your buttocks together for a few seconds.
Continued over page

If you use more Progesterone pessaries than you
should

If you (or someone else) has accidentally swallowed any of the
pessaries or you use too many, contact your nearest hospital
casualty department or your doctor immediately for advice.

If you miss a dose of Progesterone pessaries

If you forget to insert a pessary, do so as soon as you
remember, unless it is nearly time for the next dose. Never use
two doses together. Remember to use the remaining doses at
the correct time.

4 Possible side effects
Like all medicines, Progesterone pessaries can cause side
effects, although not everybody gets them.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
• diarrhoea
• soreness in your rectum (back passage)
• flatulence (wind).
Do not worry if you find changes in your menstrual cycle. You
may find that your monthly period will start earlier than usual
or it may be delayed.
After using Progesterone pressaries you may notice some
leakage after the pessary has dissolved. Do not worry, this is
quite normal when using medicines that are inserted into the
vagina or rectum.
If you notice any side effects, they get worse, or if you notice
any not listed, please tell your doctor or pharmacist.

5 How to store
Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Do not use Progesterone pessaries after the expiry date stated
on the label/carton/bottle. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6 Further information
What Progesterone pessaries contain

• The active substance (the ingredient that makes the tablets
work) is progesterone. Each pessary contains either 200mg
or 400mg of the active ingredient.
• The other ingredients are vegetable fat.

What Progesterone pessaries looks like and
contents of the pack

Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220
Hafnarfjordur, Iceland.
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in May 2010

Premenstrual Syndrome

Many women suffer from a condition called premenstrual
syndrome or PMS. This is commonly known as PMT
(premenstrual tension) because of the anxiety and bad
temper often associated with it. However, there are many
other symptoms that occur with PMS including depression,
bloating and breast tenderness. It is not just your symptoms
that decide whether you have PMS but the time at which they
are at their worst.

PMS is characterised by the symptoms that occur during
the days leading up to your period and are then completely
relieved by menstruation. The cause of PMS is not completely
understood but it is believed to be related to the hormonal
changes that occur during the monthly cycle. Many women
obtain relief from their symptoms when their hormonal
balance is altered with a medicine prescribed by their doctor.
Further information about PMS can be obtained from:
National Association for Premenstrual Syndrome
41 Old Road, East Peckham, Kent, TN12 5AP

Post-Natal Depression

Many mothers experience short-term periods of mild
depression following the birth of their baby. This is a common
condition, usually occurring three or four days after delivery,
affecting at least half of all new mothers who may feel
tearful, overwhelmed and irritable during this time. Support,
reassurance and rest can help these feelings to pass within a
few days.
However, if the anxiety does not improve, the mother may be
developing postnatal depression. Up to 15 per cent of new
mothers develop more severe symptoms within 12 months of
their child’s birth. Postnatal depression (PND) is characterised
by marked low mood for a more prolonged period of time.
Though it may take several weeks or months until a full
recovery is reached, PND is a treatable condition from which
the mother will get better.
Speak to your midwife, health visitor or doctor if you have any
further questions

If you would like a
leaflet with larger
text, please contact
01271 311257.

Progesterone pessaries are off-white pessaries.
Pack sizes are 15.
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MOCK UP
ONLY

Actavis, Barnstaple, EX32 8NS, UK

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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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