描述
Cyclogest 400mg (progesterone 黄体酮栓插入)其中含有黄体酮,黄体酮是准备子宫植入和维持妊娠所必需的激素之一。 将片剂插入阴道或肛门后,它会迅速溶解,可被吸收到循环系统中,体内吸收。
Cyclogest 400mg (progesterone 黄体酮栓插入) 400毫克
一盒15粒 一个月可买两盒。
作用机理
孕酮是一种天然存在的类固醇,由卵巢,胎盘和肾上腺分泌。在存在足够的雌激素的情况下,孕酮将增生的子宫内膜转化为分泌的子宫内膜。孕酮对于增加子宫内膜的接受胚胎植入所必需的。 一旦胚胎被植入,孕激素就可以维持妊娠。
适应症和用途
是一种孕激素,可通过补充黄体功能来支持不孕女性的胚胎着床和早孕,这是辅助生殖技术(ART)治疗计划的一部分。
剂量和给药
剂量为取卵后第二天开始每天经阴道两次或三次100mg给药,并持续长达10周。尚未明确确定35岁及35岁以上妇女的疗效。尚未确定该年龄组中适当剂量的ENDOMETRIN。
剂量形式和强度
400mg阴道或者肛门插入物。
使用方法:临睡前塞进阴道或肛门(建议放在冰箱冰冻后使用,以免融化)
高强含量的孕激素,通过皮下肛门或阴道吸收,适合不想通过口服或者针剂接受孕激素的人
禁忌症
以前对孕酮或ENDOMETRIN阴道插剂的任何成分的过敏反应。
未诊断的阴道出血。
已知错过流产或异位妊娠。
肝病。
乳房或生殖器官的已知或怀疑的恶性肿瘤。
活动性动脉或静脉血栓栓塞或严重的血栓性静脉炎,或有这些事件的病史。
警告和注意事项
在激素治疗期间(包括使用ENDOMETRIN进行治疗),可能会发生危及生命的动脉或静脉血栓栓塞性疾病。如果怀疑其中任何一种,请中止内啡肽。
密切观察有抑郁史的患者。如果症状恶化,请考虑停药。
不建议将ENDOMETRIN与其他阴道产品(例如抗真菌产品)一起使用,因为这可能会改变孕激素从阴道插入物中的释放和吸收。
不良反应
报告的最常见的不良反应(大于2%)是卵母细胞检索后疼痛,腹痛,恶心和卵巢过度刺激综合征。
Package leaflet: Information for the user
400mg pessary
Cyclogest is the registered trademark of
L.D. Collins & Co. Ltd.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• Keep this leaflet. You may need to read it again.
This includes any possible side effects not listed in this leaflet. See
• If you have any further questions, ask your doctor, pharmacist or nurse.
section 4.
• 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.
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
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.
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),
• have unusual vaginal bleeding that has not been evaluated by the doctor,
• have known or suspected tumour that is hormone sensitive,
• have porphyria disorders (a group of inherited or acquired disorders of certain
enzymes),
• have or have had blood clots in the legs, lungs, eyes or elsewhere in the body,
• currently have or have had severe liver problems.
• have a miscarriage and your physician suspects some tissue is still in the
uterus or pregnancy outside of the womb.
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
Continued top of next column
• migraine
• asthma
• cardiac or renal dysfunction
• diabetes
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 the first trimester of pregnancy for women who
need extra progesterone while undergoing treatment in an Assisted Reproductive
Technology (ART) programme.
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.
3 How to use Cyclogest
Always use this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
For women undergoing Assisted Reproductive Technology (ART) programme:
The recommended dose is 400 mg twice a day by vaginal insertion. Start
using Cyclogest 400 mg on the day of egg retrieval. The administration of
Cyclogest should be continued for 38 days if pregnancy has been confirmed.
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.
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.
Continued over page
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)
Adverse reactions in patients undergoing ART treatment is presented below:
Common side effects (may affect up to 1 in 10 people):
• Abdominal distension (swelling in the abdomen), abdominal pain, constipation
• Sleepiness
• Tiredness
• Hot flush
• Breast pain
Uncommon side effects (may affect up to 1 in 100 people):
• Headache, dizziness, mood changes
• Change in taste, vomiting, flatulence (wind), diarrhoea, bloat (gastric dilatation),
rectal tumour
• Night sweats, skin rash or itching
• Joint pain
• Pelvic pain, ovarian enlargement, vaginal bleeding
• Frequent urination, involuntary excretion of urine
• Weight increase
• Bleeding
• Itching at the application site, feeling cold or body temperature change 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. You can also report
side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard.
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.
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.
6 Contents of the pack and other information
What Cyclogest contains
• The active substance (the ingredient that makes the medicine work) is
progesterone. Each pessary contains 400 mg of the active Ingredient.
• The other ingredients are vegetable fat.
What Cyclogest looks like ad contents of the pack
Cyclogest are off-white 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.
This leaflet was last revised in August 2019.
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.
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.
Continued top of next column
评价
目前还没有评价