Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Progesterone
L.D. Collins & Co. Ltd
G03DA04
Progesterone
400mg
Pessary
Vaginal; Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040102; GTIN: 5012617014412
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Cyclogest is the registered trademark of L.D. Collins & Co. Ltd. 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 2 WHAT YOU NEED TO KNOW BEFORE YOU USE CYCLOGEST DO NOT USE CYCLOGEST IF YOU: WARNINGS AND PRECAUTIONS 3 HOW TO USE CYCLOGEST _Continued top of next column_ _Continued over page_ 400mg pessary PACKAGE LEAFLET: INFORMATION FOR THE USER • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • 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. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 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: • 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. • women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme. • 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 disorder Lue koko asiakirja
OBJECT 1 CYCLOGEST 400MG PESSARIES Summary of Product Characteristics Updated 29-Nov-2019 | L.D. Collins & Co. Ltd. • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product CYCLOGEST 400mg 2. Qualitative and quantitative composition Each pessary contains 400mg Progesterone PhEur. For the full list of excipients, see section 6.1 3. Pharmaceutical form Off-white pessaries. 4. Clinical particulars 4.1 Therapeutic indications Cyclogest is indicated for the 1) Treatment of premenstrual syndrome, including premenstrual tension and depression. 2) Treatment of puerperal depression. 3) Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women. 4.2 Posology and method of administration _For the treatment of premenstrual syndrome and puerperal depression:_ 200mg daily to 400mg twice a day, by vaginal or rectal insertion. For premenstrual syndrome commence treatment on day 14 of menstrual cycle and continue treatment until onset of menstruation. If symptom Lue koko asiakirja