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.    • This medicine has been prescribed for you. Do not pass

•    If you have any further questions, ask your doctor    it on to others. It may harm them, even if their symptoms

or pharmacist.    are the same as yours.

Index

T| What Cyclogest is and what it is used for Before you use _3 How to use

Possible side effects T| How to store a Further information

^ 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.

^ 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.

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.

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.

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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.

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.

|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.

0 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.

0 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.

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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.

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

Actavis

Actavis, Barnstaple, EX32 8NS, UK

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