What it is and what it is used for

for

Cyclogest contains micronised 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: x 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 x post-natal depression which some women get after their baby has been born. Cyclogest can also be used for the prevention of: x preterm birth in high-risk pregnant women with a singleton pregnancy who have previously had a premature baby and/or who may have a problem with the lower end part of their womb, known as a short cervix. 2.

What you need to know before you take it

e Cyclogest

Do not use Cyclogest if you: x are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6), x have unusual vaginal bleeding that has not been evaluated by the doctor, x have known or suspected tumour that is hormone sensitive, x have porphyria disorders (a group of inherited or acquired disorders of certain enzymes), x have or have had blood clots in the legs, lungs, eyes or elsewhere in the body, x currently have or have had severe liver problems. x have a miscarriage and your physician suspects some tissue is still in the uterus or pregnancy outside of the womb. x If your "waters break" during pregnancy. 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 If you are taking Cyclogest to prevent preterm birth in a high-risk pregnancy: Your doctor should discuss the benefits, risks and practicalities of all options available with you which have the potential to prevent preterm birth from happening during your pregnancy. You and your doctor should then make a shared decision on which treatment is the most suitable based on your circumstances. If you have a high risk of delivering your baby prematurely before week 37 of pregnancy, Cyclogest may be started between week 16 and 24 of pregnancy and continued until at least week 34 of your pregnancy. If your waters break or have vaginal bleeding while you are using Cyclogest, you must see your doctor or nurse as soon as possible. If these happen during pregnancy, there may be an immediate risk to you and to your baby. 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 pregnancy if your doctor has told you that you are at high risk of having your baby prematurely which is earlier than week 37 of pregnancy. Your doctor or nurse should inform you when to start, when to stop and how to use Cyclogest during pregnancy. For further instructions on how to use Cyclogest see Section 3. 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.

How to take it

Cyclogest Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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. For the prevention of preterm birth in high-risk pregnant women with a singleton pregnancy who have a history of spontaneous preterm birth and/or a short cervix: The recommended dose is 200 mg once a day at bedtime by vaginal insertion, starting between 16 and 24 weeks and continued until at least 34 weeks of pregnancy. 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: x 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). x –

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 hard 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. 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. 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

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 or via the Yellow Card app, which can be downloaded from the Apple App Store, or Google Play Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Cyclogest Keep this medicine out of the sight and reach of children. Do not store above 30°C. 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.

Contents of the pack and other information

What Cyclogest contains • The active substance (the ingredient that makes the medicine work) is micronised progesterone. Each pessary contains 200mg of the active ingredient. • The other ingredients are hard fat. What Cyclogest looks like and contents of the pack Cyclogest are off-white, torpedo-shaped pessaries. Pack sizes are 15.

Marketing Authorisation Holder L.D. Collins & Co. Ltd. 1st Floor, Gallery Court, 28 Arcadia Avenue, London, N3 2FG, UK. Manufacturer Accord-UK Ltd., Barnstaple, EX32 8NS, UK. Fulton Medicinali S.p.A, Via Marconi, 28/9, 20044-Arese (MI) Italy. This leaflet was last revised in April 2025.