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Cyclo-Progynova（雌二醇，炔诺孕酮）

Cyclo-Progynova片剂是激素替代疗法（HRT）的制剂。 每个包包含两种类型。 白色药片含有雌二醇，浅棕色药片含有雌二醇和炔诺孕酮。 雌二醇（在英国以前是雌二醇）和炔诺孕酮是主要的女性性激素，雌激素和孕酮的形式。 雌二醇是雌激素的天然存在形式，而炔诺孕酮是孕激素的合成形式。

 

 

 

Cyclo-Progynova有什么用？

激素替代疗法可缓解更年期症状。

绝经后妇女的二线治疗方法是预防骨质疏松症，这些妇女极易发生骨折，不能服用其他许可用于预防骨质疏松症的药物。

 

2003年12月，英国药品和保健产品监管局（MHRA）和药品安全委员会（CSM）对HRT的风险和收益的现有证据进行了审查，得出的结论是，使用HRT的风险长期存在长期预防骨质疏松症对50岁以上女性有好处。因此，该药不应作为预防50岁以上女性绝经后骨质疏松症的一线选择。但是，对于不能接受其他药物治疗的高骨折风险女性，可以将其用作二线选择。已获准用于预防骨质疏松症。

 

被认为在绝经后极有可能发生骨折的女性包括那些更年期较早的女性，具有骨质疏松症家族史的女性，近期接受皮质类固醇激素治疗的女性（如泼尼松龙），细小框架，和吸烟者。

 

您可以在上面链接的有关更年期和骨质疏松的情况说明书中阅读有关HRT和其他药物预防骨质疏松的风险和益处的更多信息。

 

 

Cyclo-Progynova如何工作？

Cyclo-Progynova片剂是激素替代疗法（HRT）的制剂。每个包包含两种类型 。白色药片含有雌二醇，浅棕色药片含有雌二醇和炔诺孕酮。雌二醇（在英国以前是雌二醇）和炔诺孕酮是主要的女性性激素，雌激素和孕激素的形式。雌二醇是雌激素的天然形式，而炔诺孕酮是孕酮的合成形式。

 

在更年期之前，女性卵巢逐渐产生越来越少的雌激素，结果雌激素血液水平下降。雌激素水平下降会引起痛苦的症状，例如不规则时期，潮热，盗汗，情绪波动和阴道干燥或瘙痒。

 

雌激素（在这种情况下为雌二醇形式）可以作为补充品来补充体内的下降水平，并有助于减轻更年期的这些令人困扰的症状。这被称为激素替代疗法（HRT）。通常仅需要HRT才能从绝经期症状中获得短期缓解，并且应至少每年与医生一起检查一次HRT的使用。

 

对于没有进行子宫切除术的女性，HRT需要使用孕激素（在这种情况下为炔诺孕酮形式）。这是因为在子宫完整的女性中，雌激素会刺激子宫内膜（子宫内膜）的生长，如果生长不受影响，则会导致子宫内膜癌。孕激素被用来对抗雌激素对子宫内膜的作用并降低子宫内膜癌的风险，尽管它不能完全消除这种风险。这称为组合HRT。

 

Cyclo-Progynova是组合HRT的顺序形式。这意味着要连续摄取雌激素，并在每月的一部分时间内添加孕激素。在每个Cyclo-Progynova周期的前11天服用的白色药片仅含有雌二醇。在每个周期的后10天服用的棕色片剂含有雌二醇和炔诺孕酮。在这21天之后，您可以在下一个周期开始之前享受为期7天的无片剂休息时间，就像联合避孕药一样。这种类型的HRT更适合仍处于不规则时期的女性，因为它通常会导致无片剂一周内每月流血。

 

HRT有时也用于预防绝经后妇女的骨质疏松症。绝经期雌激素水平下降会影响骨骼，使骨骼变薄，更容易断裂。补充雌激素有助于防止女性更年期后发生的骨质流失和骨折。

 

 

如何服用Cyclo-Progynova片剂？

Cyclo-Progynova平板电脑采用21天日历包装。从第一天开始，您应该每天按照包装上标明的顺序服用一片。然后，您需要在服用后休息7天，然后再开始下一个周期。您是否需要继续进行HRT，应该每年至少与医生进行一次检查。

片剂应与饮料一起吞下。他们可以带或不带食物一起服用。

您应每天大约在同一时间服用；这将帮助您记住服用它。

如果您忘记了平时的服药时间，并且记得记得迟到不到12小时，则应该服用错过的剂量。如果迟到了12小时以上，则应将遗忘的剂量遗漏掉，并在通常的时间照常服用下一次剂量。不要服用双倍剂量来弥补错过的剂量。

 

关于Cyclo-Progynova的重要信息

这种药物通常会在无片剂的一周内引起月经出血。在治疗的最初几个月中，您可能还会发现斑点或突破性出血。错过剂量可能会增加这种机会。如果服药数月后或停止治疗后，如果仍有持续的突破性出血或斑点现象，应咨询医生以进行检查。

采取任何形式的HRT的妇女应定期进行医学和妇科检查。您是否需要继续进行HRT，应该每年至少与医生进行一次检查。

重要的是要意识到，与不使用HRT的女性相比，所有使用HRT的女性被诊断出患乳腺癌的风险增加。需要权衡此风险与服用HRT给您带来的个人利益。在上面有关更年期的情况介绍中，有更多与HRT相关的风险和收益的详细信息。开始HRT之前，您应该与您的医生讨论这些问题。使用HRT的妇女应定期进行乳房检查和乳房X线照片，并应定期检查自己的乳房。向您的医生或护士报告乳房的任何变化。

重要的是要意识到，与不使用HRT的女性相比，使用HRT的女性的中风和静脉形成血凝块的风险略有增加（例如，深静脉血栓形成/肺栓塞）。如果您有现存的危险因素（例如，个人或家族有血凝块，吸烟，肥胖，某些血液疾病-请参阅下面的注意事项），并且需要权衡使用HRT对您的个人收益，则该风险会更高。在上面有关更年期的情况介绍中，有更多与HRT相关的风险和收益的详细信息。在开始治疗之前，与您的医生讨论这些问题。

如果您遭受重大创伤，进行手术或长时间不活动（包括旅行超过三个小时），则在接受HRT时可能会暂时增加在静脉中形成血凝块（血栓栓塞）的风险。因此，您的医生可能建议您在进行任何计划的手术之前，尤其是腹部手术或下肢骨科手术之前，或者如果要进行固定手术之前，停止使用HRT一段时间（通常为四到六周）。长时间。通过在旅途中进行适当的锻炼并可能穿弹性袜，可以减少长途旅行中血液凝结的风险。与您的医生讨论。

如果您遇到以下任何症状，请停止服用这种药物并立即通知您的医生：刺痛或一只腿肿胀；呼吸或咳嗽疼痛；咳血；呼吸困难突然的胸痛；突然的麻木影响身体的一侧或一部分；晕倒癫痫病恶化；偏头痛或严重头痛；视觉障碍严重的腹部不适；血压升高；全身瘙痒；皮肤或眼睛发黄（黄疸）；或严重的抑郁症。

如果女性未满50岁，则在其最后一次月经后两年内可生育，如果超过50岁，则一年内可生育。HRT不能为该组女性提供避孕措施。如果可能生育的妇女正在接受HRT治疗，但也需要避孕，则应使用非荷尔蒙方法（例如避孕套或避孕泡沫）。

 

下列情况  应当谨慎使用Cyclo-Progynova

有患雌激素刺激的癌症的妇女，例如母亲或姐姐患有乳腺癌的妇女。

有良性乳房肿块（纤维囊性乳房疾病）史的妇女。

子宫内有肌瘤的妇女。

有子宫内膜异位病史的女性。

有子宫内膜过度生长史（子宫内膜增生）的妇女。

有个人或家族有静脉血栓史的妇女（静脉血栓栓塞，例如深静脉血栓形成或肺栓塞）。

妇女服用预防血凝块（抗凝剂）的药物，例如华法林。

超重或肥胖的女性。

静脉曲张严重的女性。

吸烟者。

高血压妇女。

心力衰竭的妇女。

有肾脏问题的妇女。

糖尿病妇女。

血液中胆固醇，甘油三酸酯等脂肪含量升高的女性。

有胆囊疾病史的女性。

患有长期疾病的女性称为系统性红斑狼疮（SLE）。

患有偏头痛或严重头痛的妇女。

妇女患有癫痫病。

有哮喘病史的女性。

有抑郁史的妇女。

有怀孕或以前使用激素制剂（例如避孕药）的皮肤，通常是面部，有不规则棕色斑块病史的妇女。有这种状况的女性在服用HRT时应尽量减少暴露在阳光或紫外线下。

 

 

Cyclo-Progynova不应使用:

有已知，疑似或过去乳腺癌史的妇女。

患有已知或疑似癌症的妇女，其中雌激素刺激癌症的生长，例如子宫内膜癌（子宫内膜癌）。

未经治疗的子宫内膜过度增生（子宫内膜增生）的妇女。

阴道出血的女性原因不明。

患有血液疾病的妇女会增加静脉血栓的风险，例如抗磷脂综合征，因子V Leiden，蛋白C缺乏症，蛋白S缺乏症或抗凝血酶缺乏症。

在腿部静脉（深部静脉血栓形成）或肺部（肺栓塞）中有血块的妇女。

患有由血块（血栓性静脉炎）引起的静脉炎症的妇女。

最近因血块引起中风的妇女。

最近心脏病发作的女性。

患有心绞痛的妇女。

患有活动性肝病（例如肝炎，肝癌）或有肝病史且肝功能未恢复正常的女性。

有遗传性血液疾病的女性称为卟啉症。

怀孕或哺乳的妇女。

患有半乳糖不耐症，Lapp乳糖酶缺乏症或葡萄糖-半乳糖吸收不良（Cyclo-Progynova片剂含有乳糖）的罕见遗传病的女性。

 

 

怀孕和母乳喂养

在怀孕或哺乳期间不应该使用某些药物。 但是，在母亲怀孕期间或母乳喂养期间可以安全使用其他药物，因为对母亲的益处要大于对未出生婴儿的危害。 在使用任何药物之前，请务必告知医生您是否怀孕或计划怀孕。

 

孕妇或哺乳期的妇女不应使用这种药物。 如果您认为自己在治疗期间可能怀孕，则应停止服用该药并立即咨询医生。

如果女性未满50岁，则在其最后一次月经后两年内可生育，如果超过50岁，则一年内可生育。HRT不能为该组女性提供避孕措施。 如果您在服用此HRT时可能怀孕，则应使用非激素避孕方法（例如避孕套或避孕泡沫）。 向医生寻求进一步的医疗建议。

 

 

Cyclo-Progynova的可能副作用

药物及其可能产生的副作用可以不同方式影响每个人。以下是已知与该药物有关的一些副作用。另请参见上面的重要信息部分。仅仅因为这里有副作用，并不意味着所有使用这种药物的妇女都会遭受该副作用或任何副作用。

 

肠胃不适，例如恶心和呕吐，腹痛，腹胀，肠胃气胀，消化不良。

月经出血或斑点。请参阅上面的重要信息。

阴道鹅口疮。

子宫肌瘤大小增加。

乳房疼痛，压痛或肿大。

体液retention留，引起肿胀（水肿）。

头痛或偏头痛。

经前样症状。

抑郁，焦虑，烦躁或情绪变化。

性欲改变。

疲劳。

头晕。

体重变化。

腿抽筋。

血压上升。

角膜曲率变陡，可能会使隐形眼镜不适。

皮肤反应，如皮疹和瘙痒。

皮肤，通常是脸部（黄褐斑）的不规则棕色斑块。

肝功能和黄疸紊乱。

胆囊疾病。

胰腺发炎（胰腺炎）。

血管中的血块（例如DVT，肺栓塞，中风，心脏病发作-参见上面的重要信息）。

上面列出的副作用可能不包括药物制造商报告的所有副作用。有关与此药物相关的任何其他可能风险的更多信息，请阅读该药物随附的信息或咨询您的医生或药剂师。

 

如果您认为自己已从药物或疫苗中收到副作用，则应查看患者信息单张。这列出了已知的副作用以及如果您得到了该怎么办。您还可以从医生，护士或药剂师那里获得建议。如果他们认为有必要，他们会为您报告。

 

Cyclo-Progynova如何影响其他药物？

在开始使用这种药物进行治疗之前，务必要告诉您的医生或药剂师您已经服用了哪些药物，包括那些没有处方的药物和草药。同样，在服用任何新药之前，请先咨询您的医生或药剂师，以确保该组合是安全的。

 

以下药物可能会降低该药物的血药浓度和功效，这可能会导致月经不规则出血或您的症状再次出现：

 

气质

 波生坦

巴比妥类

 卡马西平

考比司他

 克唑替尼

 达拉非尼

依法韦仑

 依卡西平

氟哌丁烷

磷苯妥英

莫达非尼

奈韦拉平

奥卡西平

苯巴比妥

 苯妥英

 primidone

利福布汀

 利福平

 利托那韦

芦丁酰胺

特拉普韦

草药圣约翰草（Hypericum perforatum）

 托吡酯

维罗非尼。

一些患有糖尿病的妇女在服用这种药物时可能需要调整胰岛素或抗糖尿病药的剂量。如果开始服用这种药物后血糖控制似乎有所改变，则应监测血糖并寻求医生或药剂师的建议。

 

这种药物可能与降低血压的药物的作用相反。服用HRT时通常会定期检查血压，但是如果您还服用高血压药物，这一点尤其重要。

 

这种药物也可能反对利尿药的流失作用。

 

该药物可减少血液中抗癫痫药拉莫三嗪的量。由于这可能增加癫痫发作复发或恶化的风险，因此可能不建议自行服用拉莫三嗪治疗癫痫的女性服用该药。

 

该药物可能会增加以下药物的血药浓度，并且可能增加其副作用的风险：

 

氨茶碱

罗匹尼罗

司来吉兰

茶碱

替扎尼定。

其他含有相同有效成分的药物

英国目前没有其他药物含有雌二醇和诺孕酮的组合。

 

 

 

 

Cyclo-Progynova (estradiol, norgestrel)

Cyclo-Progynova tablets are a hormone replacement therapy (HRT) preparation. Each pack contains two types of tablets. The white tablets contain estradiol and the pale brown tablets contain estradiol and norgestrel. Estradiol (previously spelt oestradiol in the UK) and norgestrel are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norgestrel is a synthetic form of progesterone

 

 

 

What is Cyclo-Progynova used for?

· Hormone replacement therapy to relieve symptoms of the menopause.

· Second-line option for preventing osteoporosis in postmenopausal women who are at high risk of fractures and cannot take other medicines licensed for preventing osteoporosis.

In December 2003, a review of the available evidence on the risks and benefits of HRT by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) in the UK, concluded that the risks of using HRT long-term to prevent osteoporosis in women aged over 50 years exceed the benefits. As a result, this medicine should not be used as a first-line option for preventing postmenopausal osteoporosis in women over 50. However, it may be used as a second-line option for women at high risk of fractures who cannot take other medicines that are licensed for preventing osteoporosis.

Women considered to be at high risk of developing fractures following the menopause include those who have had an early menopause, those with a family history of osteoporosis, those who have had recent prolonged corticosteroid therapy (eg prednisolone), those with a small thin frame, and smokers.

You can read more about the risks and benefits of HRT and other medicines for preventing osteoporosis in the factsheets about menopause and osteoporosis linked above.

 

How does Cyclo-Progynova work?

Cyclo-Progynova tablets are a hormone replacement therapy (HRT) preparation. Each pack contains two types of tablets. The white tablets contain estradiol and the pale brown tablets contain estradiol and norgestrel. Estradiol (previously spelt oestradiol in the UK) and norgestrel are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and norgestrel is a synthetic form of progesterone.

Womens�' ovaries gradually produce less and less oestrogen in the period up to the menopause, and oestrogen blood levels decline as a result. The declining levels of oestrogen can cause distressing symptoms, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching.

Oestrogen (in this case in the form of estradiol) can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). HRT is usually only required for short-term relief from menopausal symptoms and its use should be reviewed at least once a year with your doctor.

A progestogen (in this case in the form of norgestrel) is needed as part of HRT for women who have not had a hysterectomy. This is because in women with an intact womb, oestrogen stimulates the growth of the womb lining (endometrium), which can lead to endometrial cancer if the growth is unopposed. A progestogen is given to oppose oestrogen's effect on the womb lining and reduce the risk of endometrial cancer, though it does not eliminate this risk entirely. This is known as combined HRT.

Cyclo-Progynova is a sequential form of combined HRT. This means that oestrogen is taken on a continuous basis and a progestogen is added for a portion of each month. The white tablets taken in the first 11 days of each Cyclo-Progynova cycle contain only estradiol. The brown tablets taken in the next 10 days of each cycle contain both estradiol and norgestrel. After these 21 days you then have a seven day tablet-free break before the next cycle is started, rather like the combined contraceptive pill. This type of HRT is more suitable for women who are still having irregular periods, because it usually results in a monthly bleed in the tablet-free week.

HRT is also sometimes used to prevent osteoporosis in postmenopausal women. The declining level of oestrogen at menopause can affect the bones, causing them to become thinner and more prone to breaking. Oestrogen supplements help prevent bone loss and fractures that may occur in women in the years after menopause.

 

 

 

 

How do I take Cyclo-Progynova tablets?

· Cyclo-Progynova tablets come in a 21 day calendar pack. You should take one tablet every day in the order marked on the pack, starting with day one. You then have a seven day break from tablet taking before you start the next pack. Your need for continued HRT should be reviewed with your doctor at least once a year.

· The tablets should be swallowed whole with a drink. They can be taken either with or without food.

· Your tablet should be taken at around the same time each day; this will help you remember to take it.

· If you forget to take a dose at your usual time and it is less than 12 hours late when you remember, you should take the missed dose. If it is more than 12 hours late you should just leave out the forgotten dose and take your next dose as usual at your usual time. Don't take a double dose to make up for a missed dose.

Important information about Cyclo-Progynova

· This medicine will usually cause a menstrual bleed in the tablet-free week. You may also experience spotting or breakthrough bleeding during the first few months of treatment. Missing a dose may increase the chance of this. If any breakthrough bleeding or spotting continues after a few months of taking the medicine, or after stopping treatment, you should consult your doctor so that it can be investigated.

· Women taking any form of HRT should have regular medical and gynaecological check-ups. Your need for continued HRT should be reviewed with your doctor at least once a year.

· It is important to be aware that all women using HRT have an increased risk of being diagnosed with breast cancer compared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. You should discuss these with your doctor before starting HRT. Women on HRT should have regular breast examinations and mammograms and should examine their own breasts regularly. Report any changes in your breasts to your doctor or nurse.

· It is important to be aware that women using HRT have a slightly increased risk of stroke and of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism) compared with women who don't use HRT. The risk is higher if you have existing risk factors (eg personal or family history of blood clots, smoking, obesity, certain blood disorders - see cautions below) and needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. Discuss these with your doctor before starting treatment.

· The risk of blood clots forming in the veins (thromboembolism) while taking HRT may be temporarily increased if you experience major trauma, have surgery, or are immobile for prolonged periods of time (this includes travelling for over three hours). For this reason, your doctor may recommend that you stop taking HRT for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.

· Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms: stabbing pains or swelling in one leg; pain on breathing or coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness affecting one side or part of the body; fainting; worsening of epilepsy; migraine or severe headaches; visual disturbances; severe abdominal complaints; increased blood pressure; itching of the whole body; yellowing of the skin or eyes (jaundice); or severe depression.

· A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If a potentially fertile women is taking HRT but also requires contraception, a non-hormonal method (eg condoms or contraceptive foam) should be used.

 

 

Cyclo-Progynova should be used with caution by

· Women with a risk of developing cancers that are stimulated by oestrogen, for example women whose mother or sister has had breast cancer.

· Women with a history of benign breast lumps (fibrocystic breast disease).

· Women with fibroids in the womb.

· Women with a history of endometriosis.

· Women with a history of overgrowth of the lining of the womb (endometrial hyperplasia).

· Women with a personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).

· Women taking medicines to prevent blood clots (anticoagulants), eg warfarin.

· Women who are very overweight or obese.

· Women with severe varicose veins.

· Smokers.

· Women with high blood pressure.

· Women with heart failure.

· Women with kidney problems.

· Women with diabetes.

· Women with raised levels of fats such as cholesterol or triglycerides in their blood.

· Women with a history of gallbladder disease.

· Women with a long-term condition called systemic lupus erythematosus (SLE).

· Women who suffer from migraines or severe headaches.

· Women with epilepsy.

· Women with a history of asthma.

· Women with a history of depression.

· Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking HRT.

 

Cyclo-Progynova should not be used by

· Women with known, suspected, or a past history of breast cancer.

· Women with known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer).

· Women with untreated overgrowth of the lining of the womb (endometrial hyperplasia).

· Women with vaginal bleeding where the cause is not known.

· Women with blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden, protein C deficiency, protein S deficiency or antithrombin deficiency.

· Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).

· Women with inflammation of a vein caused by a blood clot (thrombophlebitis).

· Women who have recently had a stroke caused by a blood clot.

· Women who have recently had a heart attack.

· Women with angina pectoris.

· Women with active liver disease, eg hepatitis, liver cancer, or a history of liver disease when liver function has not returned to normal.

· Women with inherited blood disorders called porphyrias.

· Women who are pregnant or breastfeeding.

· Women with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Cyclo-Progynova tablets contain lactose).

 

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

· This medicine should not be used by women who are pregnant or breastfeeding. You should stop taking this medicine and consult your doctor immediately if you think you could be pregnant during treatment.

· A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while taking this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). Seek further medical advice from your doctor.

 

Possible side effects of Cyclo-Progynova

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the important information section above. Just because a side effect is stated here, it does not mean that all women using this medicine will experience that or any side effect.

· Gut disturbances, such as nausea and vomiting, abdominal pain, bloating, flatulence, indigestion.

· Menstrual bleeding or spotting. See important information above.

· Vaginal thrush.

· Increase in the size of uterine fibroids.

· Breast pain, tenderness or enlargement.

· Fluid retention, causing swelling (oedema).

· Headache or migraine.

· Premenstrual-like symptoms.

· Depression, anxiety, irritability or mood changes.

· Changes in sex drive.

· Fatigue.

· Dizziness.

· Weight changes.

· Leg cramps.

· Rise in blood pressure.

· Steepening of corneal curvature, which may make contact lenses uncomfortable.

· Skin reactions such as rash and itching.

· Irregular brown patches on the skin, usually of the face (chloasma).

· Disturbance in liver function and jaundice.

· Gallbladder disease.

· Inflammation of the pancreas (pancreatitis).

· Blood clots in the blood vessels (eg, DVT, pulmonary embolism, stroke, heart attack - see important information above).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

 

How can Cyclo-Progynova affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

The following medicines may potentially reduce the blood level and effect of this medicine, which could cause irregular menstrual bleeding or your symptoms to come back:

· aprepitant

·  bosentan

· barbiturates

·  carbamazepine

· cobicistat

·  crizotinib

·  dabrafenib

· efavirenz

·  eslicarbazepine

· fosaprepitant

· fosphenytoin

· modafinil

· nevirapine

· oxcarbazepine

· phenobarbital

·  phenytoin

·  primidone

· rifabutin

·  rifampicin

·  ritonavir

· rufinamide

· telaprevir

· the herbal remedy St John's wort (Hypericum perforatum)

·  topiramate

· vemurafenib.

Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this medicine. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this medicine.

This medicine may oppose the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are taking HRT, but this is particularly important if you are also taking medicines for high blood pressure.

This medicine may also oppose the fluid-losing effect of diuretic medicines.

This medicine may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the medicine may not be recommended for women who take lamotrigine on its own for epilepsy.

This medicine may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects:

· aminophylline

· ropinirole

· selegiline

· theophylline

· tizanidine.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK that contain estradiol in combination with norgestrel.