Properties
What is it?
CYCLOGEST® 200mg, 400mg Vaginal/Rectal Suppositories CYCLOGEST is a trademark of L.D. Collins & Co. Ltd. registered in Great Britain and other jurisdictions. Package Leaflet: Information for the User Contents of the 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 micronised progesterone, which is a female sex hormone naturally produced by the body. CYCLOGEST regulates hormonal balance in the body: • For the treatment of premenstrual syndrome, which includes premenstrual tension and depression. • For the treatment of postnatal depression. • In women who require additional progesterone during treatment with an assisted reproduction technology (ART) programme. • In women at risk of miscarriage. • In women with recurrent miscarriage. • In women at risk of premature birth. 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), • you have unusual vaginal bleeding that has not been checked by a doctor, • you have or have suspected a hormone-sensitive tumour, • you have porphyria disorders (genetic or acquired disorders of certain enzymes), • you have or have had blood clots in your legs, lungs, eyes or other organs, • you have or have had severe liver disorders. • in case of miscarriage, if your doctor thinks that some tissue has remained in your womb, or in case of ectopic pregnancy. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking CYCLOGEST. Take special care and contact your doctor immediately if you experience any of the following symptoms during treatment or within a few days of your last dose: • Pain in your calves or chest, sudden shortness of breath or coughing up blood, which may indicate possible clots in the legs, heart or lungs. • Severe headache or vomiting, dizziness, paleness or changes in vision or speech, weakness or numbness in your arms and legs, which may indicate possible clots in the brain or eye. • Worsening of depression Before using CYCLOGEST, talk to your doctor or pharmacist if you have or have had: • liver problems, such as jaundice (yellowing of the skin and whites of the eyes) • epilepsy • migraine • asthma • heart or kidney dysfunction • diabetes Children There is no data on the appropriate 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 particularly important if you are taking carbamazepine (e.g. for the prevention of seizures, treatment of certain types of pain or mood disorders), rifampicin (for the treatment of infections) or phenytoin (e.g. for the prevention of seizures or treatment of certain types of pain), as these medicines may reduce the effectiveness of progesterone. As CYCLOGEST is administered vaginally, it is not recommended to use other vaginal preparations at the same time, as it is not known if this will affect the treatment. Pregnancy and breast-feeding CYCLOGEST may be used in the first trimester of pregnancy in women who require additional progesterone during treatment with an assisted reproduction technology (ART) programme. The risk of congenital (existing at birth) abnormalities, including genital abnormalities in male and female infants, from exposure to exogenous progesterone during pregnancy has not been fully studied. For use in other situations, 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 must not be used during breast-feeding. 3. How to use CYCLOGEST Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. In women undergoing treatment with an assisted reproduction technology (ART) programme: The recommended dose is 400 mg twice daily administered vaginally. Start using CYCLOGEST 400 mg on the day of egg collection. If pregnancy is confirmed, CYCLOGEST should be continued for 38 days. Women at risk of miscarriage: 400 mg twice daily for 14 days, then 200 mg twice daily until 10 weeks of pregnancy, administered vaginally or rectally. In women with recurrent miscarriage: 400 mg twice daily until ten weeks of pregnancy, administered vaginally or rectally. In women at risk of premature birth: 200-400 mg once daily between 16-24 weeks of pregnancy and continued for at least 34 weeks, administered vaginally. For the treatment of premenstrual syndrome and postnatal depression: The recommended dose is 200 mg once daily or 400 mg twice daily administered vaginally or rectally. The suppository can be inserted into the vagina or rectum (back passage) depending on certain other conditions. CYCLOGEST can be administered: • vaginally, if you have: - colitis (inflammation of the bowel causing frequent episodes of diarrhoea with mucus or blood) - bowel dysfunction (incontinence of stools). • rectally (back passage), if you have: - vaginal infection (discharge from the vagina) - or frequently have episodes of cystitis (burning and pain when passing urine) - immediately after childbirth - as a method of contraception, such as a diaphragm, cap or condom. Such devices may not function properly if a solid fat is released from the suppository. For the treatment of premenstrual tension, start using CYCLOGEST on day 12 or 14 of your menstrual cycle. You will need to plan or mark these days; Day 1 is the first day of your period, counting from day 12-14 as instructed by your doctor. Do not swallow CYCLOGEST. How to insert CYCLOGEST Always wash your hands before and after inserting the suppository. Insert: • vaginally - place the suppository between the labia and push it upwards with a finger using an up and down motion. It may be easier to do this while lying down or squatting. • rectally (back passage) - carefully insert the suppository into the rectum about one inch. Once inserted sufficiently deep, the suppository will be held in place by the muscles. Hold your buttocks together for a few seconds. If you use more CYCLOGEST than you should If you (or someone else) accidentally swallow any suppositories, or use more than the recommended amount, contact your nearest hospital emergency department or doctor for advice immediately. If you forget to use CYCLOGEST If you forget to insert a suppository, insert it as soon as you remember, unless it is almost time for your next dose. Never use a double dose. Remember to take the remaining doses at the usual times. If you stop using CYCLOGEST If you plan to stop using CYCLOGEST or stop using it, ask your doctor or pharmacist for advice. Suddenly stopping progesterone may cause increased anxiety, mood swings and increased sensitivity to seizures. If you have any questions about 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. If you develop an allergic reaction, stop using CYCLOGEST and contact your doctor immediately. Signs of an allergic reaction may include a skin rash, possibly with itching. Common (may affect up to 1 in 10 people) Drowsiness, discomfort or pain in the stomach, chest pain. Frequency not known (frequency cannot be estimated from the available data) Diarrhoea, pain in the rectum (back passage), flatulence (wind), changes in menstrual cycle (your period may start earlier or later than usual), discharge after the suppository has been absorbed (this is normal when using vaginal or rectal preparations). Side effects in patients undergoing therapy with assisted reproduction technology (ART) are listed below: Common side effects (may affect up to 1 in 10 people) Abdominal bloating (swelling in the abdominal area), abdominal pain, constipation Drowsiness Fatigue Hot flushes Breast pain Uncommon side effects (may affect up to 1 in 100 people) Headache, dizziness, mood swings Change in taste, vomiting, flatulence (wind), diarrhoea, bloating (distension of the stomach), rectal mass Night sweats, skin rash or itching Joint pain Pelvic pain, enlarged ovaries, vaginal bleeding Frequent urination, involuntary urination Weight gain Bleeding Itching at the site of application, feeling cold or changes in body temperature or general discomfort 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. 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 30°C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of 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 substance that makes the medicine work) is micronised progesterone. Each suppository contains 200 mg or 400 mg of the active substance. • The excipient is hard fat. What CYCLOGEST looks like and contents of the pack CYCLOGEST are white torpedo-shaped suppositories. Pack size - 15. Dispensing regime: Pharmaceutical product group - II, dispensed with prescription form №3
