Cyclogest

CYCLOGEST®
PROGESTERONE
Manufacturers Information Sheet for Patients

This leaflet Contains important information. Please read it carefully before you start to use Cyclogest.
This leaflet only provides a summary of the Information that is available about your medicine, If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

What is Cyclogest?
Cyclogest is a pessary which is white in colour. There are two strengths of pessaries which contain either 200mg or 400mg of progesterone as the active ingredient. Progesterone is a natural, female sex hormone which is produced in the body. Cyclogest Pessaries also contain vegetable fat.
Cyclogest is available in packs of 15 pessaries.

Marketing authorisation holder and manufacturer
Cyclogest is made by Cox Pharmaceuticals, Barnstaple, EX32 8NS, England who are also the Marketing Authorisation holder.

Why use Cyclogest?
Cyclogest is used to treat 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.
Cyclogest is also used to treat post-natal depression which some women get after their baby has been born.

Before taking Cyclogest
Tell your doctor if you are taking any other medicines. Make sure that you have told your doctor everything about your condition.
Medicines are not always suitable for everyone. If the answer to any of the following questions is Yes’, do not use any pessaries before asking your doctor or pharmacist if they are suitable for you:

Have you ever had any unexpected and unexplained bleeding from your vagina which is not due to your normal monthly period?
Have you ever had any problems with your liver, for example, jaundice (yellowing of the skin or eyes)?
Are you pregnant or are you trying to become pregnant? If you become pregnant whilst using Cyclogest, contact your doctor for advice.
Are you breastfeeding your baby?
Have you had any problems taking the hormone progesterone in the past?
Are you allergic to any of the ingredients in Cyclogest?

Your doctor will give you advice on how to use Cyclogest. Cyclogest is a pessary which is inserted into either the vagina or the rectum (back passage). It is important to tell your doctor if you have any of the following conditions, you will still be able to use Cyclogest, but your doctor will give you advice on the best method of insertion.

Do you have a vaginal infection (discharge from your vagina)?
Do you have recurrent cystitis (a burning pain on passing water)?
Have you recently had a baby?
Do you use a barrier method of contraception (for example, a condom, diaphragm or cap)?

Your contraceptive device may not work properly if it gets into contact with the vegetable fat which is an ingredient of Cyclogest.

If you have any of the above, you should use Cyclogest by inserting it into the rectum (back passage).

Do you have colitis (an inflammation of the colon which causes frequent attacks of diarrhoea with mucus or blood)?
Do you have problems controlling your bowel movements (faecal incontinence)?

It you have either of the above problems, you should use Cyclogest by inserting it into the vagina.

How should I use Cyclogest?
Follow your doctor’s advice about when and how use Cyclogest. Always read the label and the leaflet.
You can also ask your pharmacist for help if you are not sure about anything.
Your doctor will tell you to use one pessary either once or twice a day. The pessary should be inserted into the vagina or rectum.
You should start using Cyclogest on day 12 or 14 of your menstrual cycle. You can work out the correct day to start using it as follows:
Day 1 of your menstrual cycle is the first day of your monthly period. It is useful to mark this date on your calendar and then count either to day 12 or day 14 (as advised by your doctor). You can then mark the correct date on your calendar when you should start using Cyclogest.
A wash your hands before and after inserting the pessary.
If you are inserting the pessary into your vagina, you should 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.
If you are inserting the pessary into your 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 s few seconds.
Cyclogest should not be swallowed.

If you miss a dose
If you forget to use Cyclogest at the usual time, do not worry. You should insert a pessary as soon as you remember unless it is almost time for your next dose. If your next dose is due, do not use the missed pessary. Never double-up on the next dose to make up for the one you missed.

If you use too many Cyclogest Pessaries
If you (or someone else) accidentally swallows a pessary, or if you use too many, contact your doctor for advice as soon as possible.

What side effects may Cyclogest cause?
Like all medicines, Cyclogest may cause unwanted effects in some people. If you get any of the following, tell your doctor:-

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 if may be delayed.
If you think that this medicine is causing you any other problem or you are worried, talk to your doctor. 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.

How should I store Cyclogest?
Keep the pessaries stored below 25°C in a dry place and in their original packaging. Keep this medicine in a safe place where children cannot reach it. Your medicine could harm them. Do not use Cyclogest after the ‘Use by’ date which is printed on the pack.
If your doctor decides to atop your treatment, return any unused medicine to your pharmacist (chemist) so that it can be disposed of properly.
Do not throw unused medicines in the bin or flush them down the toilet.
Remember, that this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them, even if they have the same symptoms as you.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Date of Preparation: August 2000

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. This is the likely reason why your doctor has prescribed this product.
Further information about PMS can be obtained from:
National Association for Premenstrual Syndrome, National Headquarters, P.O. Box 72, Sevenoaks,
Kent. TN13 1XQ.
or
PMS Help, P.O Box 83, Hereford, HR4 8YQ.