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CYCLOGEST 400MG

Active substance: PROGESTERONE

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Cyclogest® 200mg and 400mg
(progesterone)

Cyclogest is the registered trademark of L.D. COLLINS and CO., Limited
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.

• 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.

Index
1 What Cyclogest 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

3 How to use

Always use Cyclogest exactly as your doctor has told you. If
you are not sure, check with your doctor or pharmacist.
Do not swallow Cyclogest.
The usual dose is 200mg once a day or 400mg twice a day by
vaginal or rectal insertion.

1 What Cyclogest is and what it is used for
Cyclogest contains progesterone which is a natural, female
sex hormone, produced in the body. This medicine works by
adjusting the hormonal balance within the body.



Cyclogest 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 Cyclogest 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
Cyclogest if you:

• 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.

50814475

For premenstrual tension start using Cyclogest 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 Cyclogest 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 Cyclogest

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

AAAH3520

148x210 Leaflet Pre-Folded Profile - Sarong (BST)
colours/plates:
1. Black

Progesterone (Cyclogest) 200mg & 400mg Pessaries PIL - UK
item no:
print proof no:
origination date:

AAAH3520
2
21.10.14

originated by:
approved for print/date

29.10.14

min pt size:

revised by:
supplier:

DR
Actavis UK

JDE No.:

2.
3.

pharmacode:
7pt

4.

50814475

Dimensions: 148x210 (Pre-Folded)
Component: Leaflet for Sarong

technically app. date:

Pharmacode: 2164
Date Sent:
02/07/14
Technologist: R.Wrey

Non Printing Colours

Technical Approval
date sent:

5.
6.

DR

revision date:

dimensions:

148 x 210

Cyclogest Pessaries
200 & 400mg x 15’s (UK)

21.10.14

1. Profile
2.
3.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

If you use more Cyclogest 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 Cyclogest

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, Cyclogest 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 Cyclogest 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: 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

Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Do not use Cyclogest 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.

What Cyclogest looks like and contents of the pack
Cyclogest are off-white pessaries.
Pack sizes are 15.
Marketing Authorisation Holder and manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in October 2014

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.

6 Further information
What Cyclogest contains

• The active substance (the ingredient that makes the
medicine work) is progesterone. Each pessary contains
either 200mg or 400mg of the active ingredient.
• The other ingredients are vegetable fat.
50814475

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

Actavis, Barnstaple, EX32 8NS, UK

AAAH3520

148x210 Leaflet Pre-Folded Profile - Sarong (BST)
colours/plates:
1. Black

Progesterone (Cyclogest) 200mg & 400mg Pessaries PIL - UK
item no:
print proof no:
origination date:

AAAH3520
2
21.10.14

originated by:
approved for print/date

29.10.14

min pt size:

revised by:
supplier:

DR
Actavis UK

JDE No.:

2.
3.

pharmacode:
7pt

4.

50814475

Dimensions: 148x210 (Pre-Folded)
Component: Leaflet for Sarong

technically app. date:

Pharmacode: 2164
Date Sent:
02/07/14
Technologist: R.Wrey

Non Printing Colours

Technical Approval
date sent:

5.
6.

DR

revision date:

dimensions:

148 x 210

Cyclogest Pessaries
200 & 400mg x 15’s (UK)

21.10.14

1. Profile
2.
3.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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