MY PILL KIT TABLET

Manufacturer : ARI-ARISTO PHARMACEUTICALS
Composition : ETHINYLESTRADIOL-0.035MG+CYPROTERONE-2MG
Dose Form : TABLET
Description : MY PILL KIT TAB
Route Of Administration : ORAL
Pack : 1
Out of stock
SKU
MYP0002
₹255.00
Manufacturer : ARI-ARISTO PHARMACEUTICALS
Composition : ETHINYLESTRADIOL-0.035MG+CYPROTERONE-2MG
Dose Form : TABLET
Description : MY PILL KIT TAB
Route Of Administration : ORAL
Pack : 1

Drug Ingredient Information

ETHINYLESTRADIOL-0.035MG+CYPROTERONE-2MG

ETHINYLESTRADIOL

Information for patients
Drug Information Ethinylestradiol belongs to a group of medicines called oestrogens (female sex hormones). Ethinylestradiol is a synthetic (man-made) oestrogen. Oestrogens are a group of naturally occurring hormones which have a wide range of actions in the body. These include effects on the development of the body and maintaining the menstrual cycle (periods) in women. During the menopause (sometimes called “the change of life”) a woman’s body slowly produces less oestrogen. This may cause hot flushes, night sweats, mood swings and dryness in the vagina. Over a long time it may also cause a thinning of the bones, which may be more likely to then break (osteoporosis). Ethinylestradiol is used for: •Hormone Replacement Therapy (HRT) -This is the most common use of Ethinylestradiol. The tablets replace the naturally occurring oestrogen if not enough is being produced. This can be in older women going through, or after the menopause or in younger women whose ovaries have not developed properly. •Period Problems –You may be prescribed Ethinylestradiol if you are suffering from problems associated with your periods. If you still have your womb and are prescribed an oestrogen, such as Ethinylestradiol, then your doctor should normally prescribe a progestogen as well. • Osteoporosis -Women who have passed through the menopause and are at a high risk of future fractures may be prescribed Ethinylestradiol if they are unable to take other medicines for this condition. •Prostate Cancer – Oestrogen is also a naturally occurring hormone in men and Ethinylestradiol may be prescribed to treat men suffering from prostate cancer.
Drug Alert
Alert •You still have your womb. If this is the case the ethinylestradiol should normally be taken with another type of hormone tablet to reduce the risk of cancer in the lining of the womb. If you suffer from fibroids (growths in the womb) they may be made worse by ethinylestradiol •You are diabetic – Ethinylestradiol may effect how your body controls sugar and therefore your diabetic treatment may need adjusting •You have had any problems with your kidneys •You have ever suffered from hearing loss •You suffer from asthma •You wear contact lenses •You have been told by your doctor that you suffer from increased blood lipids Safety of HRT As well as benefits, HRT has some risks which you may wish to discuss with your doctor when you are deciding whether to start HRT, or whether to carry on taking it. Medical check-ups Before you start using HRT, your doctor should ask you about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen and may do an internal examination -but only if these examinations are necessary for you, or if you have any special concerns. Once you have started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT. Be sure to: •Go for regular breast screening and cervical smear tests •Regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel
Before Consuming the Medicine
Avoid Drug •You are allergic to ethinylestradiol •You are allergic to any of the other ingredients in Ethinylestradiol (see section 6) •You have ever had heart disease or any problems with your heart or circulation. This includes any blood clots (thrombosis), problems with your blood (e.g. sickle cell, polycythaemia or porphyria), varicose veins, migraine, high blood pressure, heart attack, stroke or angina •You have or have had breast cancer •You have or have had a tumour that may be affected by oestrogen e.g. endometrial cancer (cancer or the womb) •You suffer from a condition where the lining of the womb builds up more than usual (endometrial hyperplasia) •You suffer from unexplained vaginal bleeding •You have ever had liver or gall bladder disease. This includes gallstones or jaundice due to pregnancy or the contraceptive pill.If any of the above applies to you talk to your doctor or pharmacist.
Drug Special Care Effects on your heart or circulation -Heart disease HRT is not recommended for women who have or have recently had heart disease. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT. HRT will not help to prevent heart disease. Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain. If you get: A pain in your chest that spreads to your arm or neck. See a doctor as soon as possible and do not take any more HRTuntil your doctor says you can. This paincould be a sign of heart disease. -Stroke Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include: •Getting older •High blood pressure •Smoking •Drinking too much alcohol •An irregular heartbeat. If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT. Compare: -Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke. -For women in their 50s who are taking HRT. -Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke. -For women in their 60s who are taking HRT. If you get: Unexplained migraine-type headaches, with or without disturbed vision. See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke. -Blood clots HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it. These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE. You are more likely to get a blood clot if: •You are seriously overweight •You have had a blood clot before •Any of your close family have had blood clots •You have had one or more miscarriages •You have any blood clotting problem that needs treatment with a medicine such as warfarin •You’re off your feet for a long time because of major surgery, injury or illness •You have a rare condition called SLE If any of these things apply to you, talk to your doctor to see if you should take HRT. Compare: -Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot. -For women in their 50s who are taking HRT. -Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot. -For women in their 60s who are taking HRT, the figure would be 17 in 1000. If you get: •painful swelling in your leg •sudden chest pain •difficulty breathing. You must see a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot -Surgery If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again. Effects on your risk of developing cancer -Breast cancer Women who have breast cancer, or have had breast cancer in the past, should not take HRT. Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who is still having periods over that time and not taking HRT. The risk for a woman who is taking oestrogen plus progestogen HRT is higher than for oestrogen-only HRT (but oestrogen plus progestogen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below). For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT. Your risk of breast cancer is also higher if you: •have a close relative (mother, sister or grandmother) who has had breast cancer •are seriously overweight. Compare: -Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65. -For women who start taking oestrogen-only HRT at age 50 and take it for 5 years. -If they take oestrogen-only HRT for 10 years, -For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years. -If they take oestrogen plus progestogen HRT for 10 years. If you notice any changes in your breast, e.g: •dimpling of the skin •changes in the nipple •any lumps you can see or feel Make an appointment to see your doctor as soon as possible. -Endometrial cancer (cancer of the lining of the womb) Taking oestrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the oestrogen helps to lower the extra risk. If you still have your womb, your doctor will usually prescribe a progestogen as well as oestrogen. These may be prescribed separately, or as a combined HRT product. If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without a progestogen. If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen. Ethinylestradiol Tablets is an oestrogen-only product. Compare -Looking at women who still have a uterus and who are not taking HRT - on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65. -For women who take oestrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it. -The addition of a progestogen to oestrogenonly HRT substantially reduces the risk of endometrial cancer. If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT. If the bleeding or spotting: •carries on for more than the first few months •starts after you’ve been on HRT for a while •carries on even after you’ve stopped taking HRT. You must make an appointment to see your doctor. It could be a sign that your endometrium has become thicker. -Ovarian cancer Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way. -Dementia HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.
Drug Drug Interactions •Medicines to thin the blood (e.g. warfarin, pheninidone or acenocoumarol) •Medicines for tuberculosis (e.g. rifampicin or rifabutin) •Medicines for fungal infections (e.g. nevirapine, efavirenz, ritonavir or nelfinavir) •Medicines for your breathing (e.g. theophylline) •Medicines for epilepsy (e.g. phenytoin, phenobarbitol, carbamazepine and lamotrigine) •Medicines for narcolepsy (e.g. modafinil) •Medicines for the treatment of depression (e.g. imipramine or St John’s Wort) •Any other medicine, including medicines obtained without a prescription.
Drug Pregnancy Interaction Do not take Ethinylestradiol if you are pregnant or breast feeding. If you become pregnant whilst taking Ethinylestradiol you should stop taking your tablets immediately and talk to your doctor.
Drug Breast feeding Interaction Do not take Ethinylestradiol if you are pregnant or breast feeding. If you become pregnant whilst taking Ethinylestradiol you should stop taking your tablets immediately and talk to your doctor.
Drug Machinery Interaction
Drug More Information
How to take the Medicine
Consumption Info Once you are taking this medicine: •Regularly check your breasts for any changes. If you notice dimpling of the skin, changes in the nipple, or any lumps you must see your doctor as soon as possible. •Go for regular breast screening •Go for cervical smear tests •See your doctor for regular check-ups (at least once a year). At these check-ups, your doctor will discuss with you the benefits and risks of continuing to take HRT.
Drug quanitty Hormone Replacement Therapy •10 to 50 micrograms daily on a cyclical basis (three weeks on and one week off). •If you have a womb a progestogen should normally also be prescribed to lower the risk of endometrial cancer. Your doctor will explain this to you if necessary. Period Disorders •20 to 50 micrograms daily from day 5 to day 25 of each cycle. •A progestogen should be given daily in addition, either throughout the cycle or from day 15 to day 25 of the cycle. Your doctor will explain this to you if necessary. •As Ethinylestradiol tablets are usually taken on a cyclical basis direct switching from other oestrogen-only HRT preparations taken cyclically is possible. Prostate Cancer 150 micrograms to 1.5 milligrams daily.
Drug Dose Your tablets should be taken once a day and at the same time each day. They should be swallowed whole with a drink of water. The dose you have been prescribed will depend on the condition being treated. The following are usual doses.
Excess Drug Consumption If you have taken too many tablets, contact the nearest hospital casualty department or your doctor immediately. Take this leaflet and any remaining tablets with you to show the doctor. Taking too many tablets at once may make you feel sick or be sick. It can also make women have a period afterwards.
Forgot Drug Consumption •Do not take a double dose to make up for a missed dose. Simply take the next dose as planned. •Forgetting a dose may increase the chances of breakthrough bleeding in woman with an intact womb.
Stop Drug Consumption Do not stop taking Ethinylestradiol without first talking to your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Possible Side Effects
General Information •Unexpected migraine, with or without disturbed vision (these headaches could be an early warning sign of a stroke) •Painful swelling in your leg , sudden chest pain or difficulty breathing (these problems may be a sign of a blood clot) •A pain in your chest that spreads to your arm and neck (this pain could be a sign of heart disease) See your doctor as soon as possible if you get any of the following symptoms: •If you notice any changes in your breast such as a lump, dimpling in the skin or the nipple changing •If bleeding or spotting carries on for more than the first few months, or starts after you have been taking the tablets for a while •If bleeding or spotting carries on even after you’ve stopped taking HRT.
Common Drug Side Effects •You may feel or be sick •You may get headaches or migraine •You may have mood changes •Your breasts may become tender, enlarge or leak •Your eyes may hurt if you wear contact lenses •You may get a skin rash, including skin discolouration known as chloasma •You may be more likely to have high blood pressure, blood clots, gallstones or jaundice •You may get unexplained pains, particularly in your calves. •You may retain fluid and put on weight •You may have high levels of calcium building up in the blood, particularly if you have a malignant tumour •If you suffer from endometriosis or fibroids they may become worse •Men may develop breasts, their testicles may stop working, may look more female and become impotent during treatment.
Rare Drug Side Effects
Very Rare Drug Side Effects
Drug Side Effects Symptoms
How to Store the Medicine
How to Store the Medicine Keep out of the reach and sight of children. Do not use Ethinylestradiol after the expiry date on the container. The expiry date refers to the last day of that month. Store below 25°C. Keep your tablets in the container they came in. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

CYPROTERONE

Information for patients
Drug Information Cyproteron 100mg is a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens) and reduces the amount of male sex hormones produced by the body Cyproteron 100mg is used in men to treat prostate cancer.
Drug Alert
Alert liver diseases (including previous or existing liver tumours (unless these are due to secondary cancers caused by prostate cancer), Dubin-Johnson Syndrome or Rotor Syndrome) any type of cancer (other than cancer of the prostate gland) ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt wasting diseases (diseases involving an unintended loss of weight or muscle) except for prostate cancer that cannot be operated on blood clots (thrombosis or embolism)
Before Consuming the Medicine
Avoid Drug liver diseases (including previous or existing liver tumours (unless these are due to secondary cancers caused by prostate cancer), Dubin-Johnson Syndrome or Rotor Syndrome) any type of cancer (other than cancer of the prostate gland) ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt wasting diseases (diseases involving an unintended loss of weight or muscle) except for prostate cancer that cannot be operated on blood clots (thrombosis or embolism) you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of this medicine (see Section 6: Further information) • you are under 18 years old if your testes or bones are not yet fully formed
Drug Special Care Several blood tests or checks may be required while you are taking this medicine: • • • • • • • • liver problems, some of them severe or even fatal, have been reported with cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests before and during treatment to monitor this and may stop your treatment if necessary. See also section 4 ‘Possible side effects’. using medicines such as Cyproteron has very rarely been linked to the development of benign (non- malignant) liver tumours and with some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway blood clots have been reported in patients taking this medicine which may also be linked to the reason you are taking Cyproteron. Tell your doctor if any of the following apply to you, as you may be at an increased risk of getting a blood clot. If you have: - a history of blood clots, strokes or heart attacks - abnormal red blood cells (sickle –cell anaemia) - severe diabetes that affects your blood circulation if you suffer from severe depression, this may get worse whilst you are taking Cyproteron. (See your doctor if you are affected by this) effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine. See also section 4 ‘Possible side effects’. shortness of breath has been reported in patients taking this medicine at high doses (300mg daily) Cyproteron can alter the sugar levels in your blood. If you are diabetic, check your blood sugar levels regularly. Your doctor may alter the dose of medicine used to treat your diabetes Your doctor will check the function of your adrenal glands, as they may become suppressed during treatment with Cyproteron. Symptoms may include tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles, abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea.
Drug Drug Interactions Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Some medicines may stop Cyproteron from working properly. Also, Cyproteron may change the way other medicines you are taking are broken down in your body. Tell your doctor if you take any other medicines regularly, especially: • medicines such as rifampicin for the treatment of tuberculosis • medicines such as phenytoin used to treat epilepsy or other illnesses • products containing the herbal remedy commonly known as St John’s wort (Hypericum perforatum) • medicines such as ketoconazole, itraconazole, clotrimazole for the treatment of fungal conditions • medicines such as ritonavir used to treat HIV infections • cholesterol-lowering drugs such as statins. Cyproteron may make the side effects of statins worse, for example the breakdown of muscle • medicines such as glitazones used to treat diabetes. If you are diabetic your doctor may need to alter the dose of medicine required to treat your diabetes. See also Section 2 ‘Take Special Care with Cyproteron 100mg’.
Drug Pregnancy Interaction no data available
Drug Breast feeding Interaction no data available
Drug Machinery Interaction You may feel tired and weak during treatment. If affected, do not drive, operate machinery or do anything where these symptoms may put either yourself or others at risk
Drug More Information If you have an intolerance to some sugars, check with your doctor before taking this medicine. This is because the tablets contain lactose (a type of sugar).
How to take the Medicine
Consumption Info Effects of Cyproteron on sperm After you have been taking this medicine for some months, you may not have any sperm in your ejaculate. You will probably become unable to make anyone pregnant, but note that this does not happen at once. Do not rely on this medicine for contraception at any time. While the overall number of sperm that you produce will be reduced, more of your sperm than usual will be abnormal in shape. Some people think these abnormal sperm might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children. Other changes that have been reported include: • blood clots have been reported in patients taking this medicine but they have not definitely been linked to Cyproteron. See also section 2 ‘Take Special Care with Cyproteron’ • the occurrence of meningiomas (a generally benign tumour of the tissue layer between the brain and the skull) has been reported in association with longer term use (years) of Cyproteron at doses of 25 mg per day and above • dry skin and improvement in acne • temporary patchy loss of body hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour, a female type of pubic hair growth • effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine. Your doctor may arrange for you to have regular blood tests during treatment to monitor this • thinning of the bones (osteoporosis) tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles (often muscle weakness), abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea (suppressed adrenal glands) After stopping treatment After stopping treatment, the decrease in sex drive, reduction in sperm count and breast swelling will generally go back to normal. If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor
Drug quanitty The usual dose range is from 1 tablet once a day (100mg) up to 1 tablet three times a day (300mg).
Drug Dose Your doctor will decide what dose you will take. Always take Cyproteron 100mg exactly as your doctor has told you. You should check with your doctor if you are not sure. Take the tablets after meals and swallow them whole with a drink of water.
Excess Drug Consumption As soon as you can, talk to your doctor who will tell you what you need to do. There have been no reports of serious illness from taking too much Cyproteron in a single dose
Forgot Drug Consumption If you forget to take a dose, take it as soon as you remember and take the next dose when it is due. Do not take a double dose to make up for a forgotten dose
Stop Drug Consumption Do not reduce the dose or stop taking your tablets unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist
Possible Side Effects
General Information Like all medicines, Cyproteron can cause side effects, although not everybody gets them. If you have trouble breathing or swallowing, this may be a sign of a rare allergic reaction - contact your doctor or go to a hospital straight away. These are the possible side effects of Cyproteron, starting with the more common ones
Common Drug Side Effects decreased sex drive impotence reduced sperm reduced volume ofejaculate
Rare Drug Side Effects allergic reaction (possibly causing a rash, itching or more rarely shortness of breath. If you have trouble breathing or swallowing, contact your doctor or go to a hospital straight away) tender lumps in the breasts and oozing of milky fluid from the nipples. These effects usually disappear if treatment is stopped or if the dose of Cyproteron is reduced
Very Rare Drug Side Effects benign (non-malignant) liver tumours, see also section 2 ‘Take Special Care with Cyproteron’ some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway
Drug Side Effects Symptoms weight decrease or increase, which can be associated with fluid retention depressed mood restlessness breast swelling sometimes with tenderness hot flushes, sweating tiredness shortness of breath liver problems, some of them severe or even fatal, have been reported with dosages of 100 mg and above of cyproterone acetate. Your doctor may arrange for you to have regular liver tests during treatment to monitor this and may stop your treatment if necessary
How to Store the Medicine
How to Store the Medicine Keep out of the reach and sight of children. Do not use Cyproteron after the expiry date which is stated on the box after the letters ‘EXP’. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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