Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Oestraclin spray:
Store Oestraclin spray at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom or near an open flame. Do not use Oestraclin spray after the expiration date. Keep Oestraclin spray out of the reach of children and away from pets.
Overdose of Oestraclin in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Patients who have taken more Oestraclin than recommended should consult a physician or pharmacist. An overdose of Oestraclin could make patients feel sick or vomit.
What should I avoid while taking Oestraclin?
Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using Oestraclin.
Grapefruit may interact with Oestraclin and lead to unwanted side effects. Avoid the use of grapefruit products.
Avoid using creams, lotions, or powders on the skin where you apply the patch, or it may not stick to your skin.
Oestraclin warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
PATIENT PACKAGE INSERT
Vaginal Cream,
Oral Tablets, and Transdermal System
This information describes when and how to use estrogens, and the risks and benefits of estrogen treatment.
Estrogens have important benefits but also some risks. You must decide, with your doctor, whether the risks to you of estrogen use are acceptable because of their benefits. If you use estrogens, check with your doctor to be sure you are using the lowest possible dose that works, and that you dont use them longer than necessary. How long you need to use estrogens will depend on the reason for use.
Additional Information for the Oestraclin System: The Oestraclin system that your doctor has prescribed for you releases small amounts of Oestraclin through the skin in a continuous way. Oestraclin is the same hormone that your ovaries produce abundantly before menopause. The dose of Oestraclin you require will depend upon your individual response. The dose is adjusted by the size of the Oestraclin system used: the systems are avaialble in 4 sizes.
What should I discuss with my healthcare provider before taking Oestraclin?
For all patients taking Oestraclin (Oestraclin vaginal insert):
If you have an allergy to Oestraclin or any other part of Oestraclin (Oestraclin vaginal insert).
If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
If you have had any of these health problems: Bleeding disorder, blood clots, a higher risk of having a blood clot, breast cancer, liver problems or liver tumor, heart attack, stroke, or a tumor where estrogen makes it grow.
If you have unexplained vaginal bleeding.
If you are pregnant or may be pregnant. Do not take Oestraclin (Oestraclin vaginal insert) if you are pregnant.
If you are breast-feeding or plan to breast-feed.
Children:
If the patient is a child. This medicine is not approved for use in children.
This is not a list of all drugs or health problems that interact with Oestraclin (Oestraclin vaginal insert).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Oestraclin (Oestraclin vaginal insert) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Oestraclin precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Before taking Oestraclin: Medical History and Regular Check-ups: The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. In case of premature menopause, the risks of using HRT may be different. Please talk to the doctor.
Before starting (or restarting) HRT, the doctor should ask about the patient’s and her family’s medical history. The doctor may decide to perform a physical examination. This may include an examination of the breasts and/or an internal examination, if necessary.
Once on Oestraclin therapy, the patient should see the doctor for regular check-ups (at least once a year). At these check-ups, discuss with the doctor the benefits and risks of continuing with Oestraclin. Go for regular breast screening, as recommended by the doctor.
When to take special care with Oestraclin: Tell the doctor if the patient has a history of any of the following problems, before starting the treatment, as these may return or become worse during treatment with Oestraclin. If so, the patient should see the doctor more often for check-ups: fibroids inside the womb; growth of womb lining outside the womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia); increased risk of developing blood clots as follows); increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer); high blood pressure; a liver disorder, such as a benign liver tumour; diabetes; gallstones; migraine or severe headaches; a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE); epilepsy; asthma; a disease affecting the eardrum and hearing (otosclerosis); a very high level of fat in the blood (triglycerides); fluid retention due to cardiac or kidney problems.
Stop taking Oestraclin: Stop taking Oestraclin and see a doctor immediately if the patient notices any of the following when taking HRT: any of the conditions mentioned in Contraindications; yellowing of the skin or the whites of the eyes (jaundice) as these may be signs of a liver disease; a large rise in the blood pressure (symptoms may be headache, tiredness, dizziness); migraine-like headaches which happen for the first time; if the patient becomes pregnant; signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, and difficulty in breathing.
For more information, see Blood Clots in a Vein (Thrombosis) as follows.
Note: Oestraclin is not a contraceptive. If it has been less than 12 months since the last menstrual period or if under 50 years old, the patient may still need to use additional contraception to prevent pregnancy. Talk to the doctor for advice.
HRT and Cancer:Excessive Thickening of the Lining of the Womb (Endometrial Hyperplasia) and Cancer of the Lining of the Womb (Endometrial Cancer): Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).
Taking a progestagen in addition to the oestrogen for at least 12 days of each 28 day cycle protects from this extra risk. The doctor will prescribe a progestagen separately if the patient still has the womb. If the womb was removed (a hysterectomy), discuss with the doctor whether Oestraclin can be safely taken without a progestagen.
Compare: In women who still have a womb and who are not taking HRT, on average, 5 in 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1,000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken.
Unexpected Bleeding: The patient will have a bleed once a month (so-called withdrawal bleed) while taking Oestraclin. But, if the patient has unexpected bleeding or drops of blood (spotting) besides the monthly bleeding, which: carries on for more than the first 6 months, starts after the patient has been taking Oestraclin more than 6 months, carries on after the patient has stopped taking Oestraclin, see the doctor as soon as possible.
Breast Cancer: Evidence suggests that taking combined oestrogen-progestagen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long the patient takes HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Compare: Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1,000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestagen HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e. 4 to 6 extra cases).
Regularly check the breasts. See the doctor if the patient notices any changes such as: dimpling of the skin, changes in the nipple, any lumps the patient can see or feel.
Ovarian Cancer: Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average, about 2 women in 1,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for over 5 years, there will be between 2 and 3 cases per 1,000 users (i.e. up to 1 extra case).
Effect of HRT on Heart and Circulation:Blood Clots in a Vein (Thrombosis): The risk of blood clots in the veins is about 1.3- to 3-times higher in HRT users than in non-users, especially during the first year of taking it. Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
The patient is more likely to get a blood clot in the veins as she gets older and if any of the following applies. Inform the doctor if any of these situations applies: unable to walk for a long time because of major surgery, injury or illness; seriously overweight (BMI >30 kg/m²); any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots; if any of the close relatives has ever had a blood clot in the leg, lung or another organ; systemic lupus erythematosus (SLE); cancer.
For signs of a blood clot, see Stop taking Oestraclin previously mentioned, and see a doctor immediately.
Compare: Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. 5 extra cases).
For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1,000 users (i.e. 1 extra case).
Heart Disease (Heart Attack): There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.
For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Stroke: The risk of getting stroke is about 1.5-times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.
Compare: Looking at women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. 3 extra cases).
Other Conditions: HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Talk to the doctor for advice.
Important information about some of the ingredients of Oestraclin: Oestraclin contains lactose monohydrate. If the patient has an intolerance to some sugars, contact the doctor before taking Oestraclin.
Laboratory Tests: If the patient needs a blood test, tell the doctor or the laboratory staff that Oestraclin is being taken, because this medicine can affect the results of some tests.
Driving and Using Machines: Oestraclin has no known effect on the ability to drive or use machines.
What happens if I miss a dose of Oestraclin?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Call your doctor for instructions if you miss an appointment for your Oestraclin injection.
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References
DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
