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CYCLOGEST 200MG

Active substance(s): PROGESTERONE

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Package leaflet: Information for the user

Cyclogest® 200mg pessary
Progesterone
Cyclogest is the registered trademark of
L.D.COLLINS and CO., Limited

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, pharmacist or
nurse.
•  This medicine has been prescribed for you. 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.

What is in this leaflet
1 What Cyclogest is and what it is used for
2 What you need to know before you use Cyclogest
3 How to use Cyclogest
4 Possible side effects
5 How to store Cyclogest
6 Contents of the pack and other information
1 What Cyclogest is and what it is used for

Cyclogest contains progesterone which is a natural, female sex hormone,
produced in the body. Cyclogest works by adjusting the hormonal balance
within the body for the treatment of:
• 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 What you need to know before you use Cyclogest
Do not use Cyclogest if you:

• are allergic to progesterone or any of the other ingredients of this medicine
(listed in section 6),
• have unusual vaginal bleeding that has not been evaluated by the doctor,
• have known or suspected tumour that is hormone sensitive,
• have porphyria disorders (a group of inherited or acquired disorders of certain
enzymes),
• have or have had blood clots in the legs, lungs, eyes or elsewhere in the body,
• currently have or have had severe liver problems.
• h ave a miscarriage and your physician suspects some tissue is still in the
uterus or pregnancy outside of the womb.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Cyclogest.
Take special care and tell your doctor straight away if you experience any of
these symptoms during treatment or even few days after the last dosage:
- pains in the calves or chest, a sudden shortness of breath or coughing blood
indicating possible clots in the legs, heart, or lungs
- severe headache or vomiting, dizziness, faintness, or changes in vision or
speech, weakness or numbness of an arm or leg indicating possible clots in
the brain or eye
- worsening of depression
Check with your doctor or pharmacist before using Cyclogest if you have or
ever have had:
• liver problems such as jaundice (yellowing of the skin and whites of the eyes)
• epilepsy
• migraine
• asthma
• cardiac or renal dysfunction
• diabetes

Children

There is no relevant use of Cyclogest in children.

Other medicines and Cyclogest

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This is especially important in case you
are taking carbamazepine (e.g. to prevent fits, treat certain type of pain or
mood disorders), rifampicin (to treat infections) or phenytoin (e.g. to prevent
fits or treat certain type of pain) as they may decrease the effectiveness of
progesterone.
Using other vaginal products at the same time as Cyclogest is used vaginally is
not recommended as it is not known if it affects the treatment.

Pregnancy and breast-feeding

The risks of congenital (conditions present at birth) anomalies, including
genital abnormalities in male or female infants, from exposure to exogenous
progesterone during pregnancy have not been fully established.
If you are pregnant, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before using this medicine.
This medicine should not be used during breast feeding.

3 How to use Cyclogest

Always use this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is 200 mg once a day or 400 mg twice a day by vaginal
or rectal insertion.
The pessary may be inserted into either the vagina or rectum (back passage)
depending upon the following certain other conditions.

148x210 Leaflet Pre-Folded Profile - Sarong (BST)

Progesterone (Cyclogest) 200mg 15 Pessaries PIL - UK
item no: AAAI7748

dimensions: 148 x 210

print proof no: 1

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origination date: 15.02.16

min pt size: 6.5

revision date:

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originated by: S.Anson
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Cyclogest 200mg x 15’s (UK)
JDE No.:

50888589

Dimensions: 148x210 (Pre-Folded)
Component: Leaflet for Sarong
Pharmacode: 2334
Date Sent:
09/02/16
Technologist: R.Wrey
Technically Approved
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You should insert Cyclogest into the:

• v agina if you have:
- c olitis (inflammation of the colon causing frequent attacks of diarrhoea with
mucous or blood)
- problems controlling your bowel movements (faecal incontinence).
• r ectum (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
- t o 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.
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.

5 How to store Cyclogest

Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place.
Do not use this medicine after the expiry date which is stated on the label/
carton/bottle. The expiry date refers to the last day of that month.
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 protect the environment.

6 Contents of the pack and other information
What Cyclogest contains

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

What Cyclogest looks like and contents of the pack
Cyclogest are off-white pessaries.

Do not swallow Cyclogest.

Pack sizes are 15.

How to insert Cyclogest

Always wash your hands before and after inserting the pessary.
To insert into the:
• V
 agina - 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.
•R
 ectum (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.

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 forget to use 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.

If you stop using Cyclogest

Please consult your doctor or pharmacist for advice if you intend to stop or have
stopped using Cyclogest. Abrupt discontinuation of progesterone dosing may
cause increased anxiety, moodiness, and increased sensibility to seizures.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Stop using Cyclogest and contact your doctor at once if you have an allergic
reaction. Signs may include a skin rash, which may be itchy.
Common (may affect up to 1 in 10 people)
Drowsiness, stomach discomfort or pain, breast pain
Not known (frequency cannot be estimated from the available data)
Diarrhoea, soreness in your rectum (back passage), flatulence (wind), changes
in your menstrual cycle (you may find that your monthly period will start earlier
than usual or it may be delayed), leakage after the pessary has dissolved (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.

Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in: February 2016
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

Further Information:
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 385257.
Actavis, Barnstaple, EX32 8NS, UK

50888589 AAAI7748

148x210 Leaflet Pre-Folded Profile - Sarong (BST)

Progesterone (Cyclogest) 200mg 15 Pessaries PIL - UK
item no: AAAI7748

dimensions: 148 x 210

print proof no: 1

pharmacode:

origination date: 15.02.16

min pt size: 6.5

revision date:

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

Non Printing Colours
1. Print safe area
2.
3.

Cyclogest 200mg x 15’s (UK)
JDE No.:

50888589

Dimensions: 148x210 (Pre-Folded)
Component: Leaflet for Sarong
Pharmacode: 2334
Date Sent:
09/02/16
Technologist: R.Wrey
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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