Skip to Content

UK Edition. Click here for US version.

CYCLOGEST 400MG

Active substance(s): PROGESTERONE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Cyclogest® 400mg pessary
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.
•K
 eep this leaflet. You may need to read it again.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• I f you have any further questions, ask your doctor, pharmacist or
This includes any possible side effects not listed in this leaflet. See
nurse.
section 4.
• 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.

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:
•p
 re-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
•p
 ost-natal depression which some women get after their baby has been
born.
•w
 omen who need extra progesterone while undergoing treatment in an
Assisted Reproductive Technology (ART) programme.

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.
• have 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
Continued top of next column

• 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

Cyclogest can be used during the first trimester of pregnancy for women
who need extra progesterone while undergoing treatment in an Assisted
Reproductive Technology (ART) programme.
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.
For other use, 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.
For women undergoing Assisted Reproductive Technology (ART)
programme:
The recommended dose is 400 mg twice a day by vaginal insertion. Start
using Cyclogest 400 mg on the day of egg retrieval. The administration
of Cyclogest should be continued for 38 days if pregnancy has been
confirmed.
For the treatment of premenstrual syndrome and post-natal depression:
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.
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.
Continued over page

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

Progesterone (Cyclogest) 400mg 15 Pessaries PIL - UK
item no: AAAI7749

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 16.02.16

min pt size: 6

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

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 19.02.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

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

Cyclogest 400mg x 15’s (UK)
JDE No.:

50888597

Dimensions: 148x210 (Pre-Folded)
Component: Leaflet for Sarong
Pharmacode: 5650
Date Sent:
09/02/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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.
Do not swallow Cyclogest.
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.
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.

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 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

• The active substance (the ingredient that makes the medicine work) is
progesterone. Each pessary contains 400 mg of the active ingredient.
• The other ingredients are vegetable fat.
What Cyclogest looks like ad 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 February 2016

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Further Information:

Common (may affect up to 1 in 10 people)
Drowsiness, stomach discomfort or pain, breast pain

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.

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)

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.

Adverse reactions in patients undergoing ART treatment is presented
below:

Further information about PMS can be obtained from:
National Association for Premenstrual Syndrome
41 Old Road
East Peckham
Kent
TN12 5AP

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 side effects (may affect up to 1 in 10 people):
• Abdominal distension (swelling in the abdomen), abdominal pain,
constipation
• Sleepiness
• Tiredness
• Hot flush
• Breast pain
Uncommon side effects (may affect up to 1 in 100 people):
• Headache, dizziness, mood changes
• Change in taste, vomiting, flatulence (wind), diarrhoea, bloat (gastric
dilatation), rectal tumour
• Night sweats, skin rash or itching
• Joint pain
• Pelvic pain, ovarian enlargement, vaginal bleeding
• Frequent urination, involuntary excretion of urine
• Weight increase
• Bleeding
• Itching at the application site, feeling cold or body temperature change
or general discomfort

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.
Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

50888597 AAAI7749

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

Progesterone (Cyclogest) 400mg 15 Pessaries PIL - UK
item no: AAAI7749

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 16.02.16

min pt size: 6

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

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 19.02.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

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

Cyclogest 400mg x 15’s (UK)
JDE No.:

50888597

Dimensions: 148x210 (Pre-Folded)
Component: Leaflet for Sarong
Pharmacode: 5650
Date Sent:
09/02/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Expand view ⇕

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.

Hide