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Estrofem, Estrace (Estradiol)

Brand name: Estrofem, Estrace

Generic Name : Estradiol

Manufacturer : Novo Nordisk

Medicine Category : Female Hormones : Oestrogens & Progesterones & Related Synthetic Drugs

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Category X : Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

What is it used for ?

- Symptoms of the menopause
- Used to help prevent the development of osteoporosis

How does it work ?

Estradiol is a naturally occurring form of the main female sex hormone, oestrogen. It is responsible for the development and maintenance of the reproductive system and secondary sexual characteristics in women. Certain parts of the body such as the vagina, bones and breasts rely on oestrogens to function normally. When the levels of oestrogen are low, these tissues can slowly degenerate.

Oestrogen (in this case in the form of estradiol) is supplemented to counteract the detrimental effects experienced with low levels of oestrogen (particularly at menopause). This is known as hormone replacement therapy (HRT). HRT is used to help reduce the symptoms of menopause such as hot flushes, mood swings and vaginal dryness. It may also be used as long term treatment to prevent bone loss (osteoporosis) that is experienced after menopause.

HRT is usually given in conjunction with another hormone called progesterone which acts to prevent overstimulation of the lining of the womb (endometrium) by oestrogen. This preparation contains estradiol alone and should therefore only be used as a single medicine in women who have had their womb removed surgically (hysterectomy). Women who still have their wombs should also receive a progesterone replacement in conjunction with this medicine.

This preparation is implanted under the skin to release oestrogen slowly into the body over a period of months.

How should Estrofem, Estrace (Estradiol) be used?

Take Estrofem exactly as prescribed. Do not share it with anyone else.

If you are taking calcium supplements as a part of the treatment to help prevent brittle bones, check with your doctor about how much to take.

You should take a few moments to read the patient package insert provided with your prescription.

If you are using Estrofem vaginal cream, apply it as follows:

Remove cap from tube.
Screw nozzle end of applicator onto tube.
Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Use the marked stopping points on the applicator as a guide.
Unscrew applicator from tube.
Lie on back with knees drawn up. Gently insert applicator deeply into the vagina and press plunger downward to its original position.
To cleanse the applicator, pull the plunger to remove it from the barrel, then wash with mild soap and warm water. Do not boil or use hot water.


In women with an intact uterus, long-term use of oestrogen therapy will require the addition of a progestogen to prevent the risk of over-growth (hyperplasia) and possible cancer of the lining of the womb (endometrium).

It is important to be aware that all women taking HRT appear to have a small increase in the risk of being diagnosed with breast cancer, compared with women who do not take HRT. However, this risk must be weighed against the benefits of taking HRT, such as prevention of osteoporosis. You should discuss the risks and benefits of HRT with your doctor before starting treatment. Women on HRT are advised to have regular breast examinations and mammograms, and to practice breast self-examination.

This medicine may interfere with some laboratory tests such as thyroid function tests.
Women with a history of irregular brown patches of skin on the face and elsewhere (chloasma) during pregnancy or when taking oral contraceptives should avoid exposure to the sun while using this medicine.

Use with caution in

Anaemia caused by a hereditary blood disorder where abnormal haemoglobin is produced (sickle cell anaemia)
Decreased kidney function
- Elderly people
- Endometriosis
- Epilepsy
- Fibroids of the uterus
- Heart failure
- High blood pressure (hypertension)
- History of benign breast lumps (fibrocystic breast disease)
- History of small lumps or swellings in the breasts (breast nodules)
- People with prolonged immobility or after major surgery or trauma
- Personal or family history of blood clots in the veins (venous thromboembolism)
- Severe obesity
- Treatment of migraine

Not to be used in

- Blood clot in the blood vessels (acute thromboembolism)
- Blood clot lodged in a vein of the leg (deep vein thrombosis)
- Breastfeeding
- Cancer that is responsive to female hormones (oestrogen dependent neoplasia) eg endometrial cancer
- Children
- High levels of protein and fat compounds (lipoproteins) in the blood (hyperlipoproteinaemia)
- History of jaundice during pregnancy or due to steroid use
- History of severe itch or an itchy blistering disorder of the skin (pemphigoid gestationis) during pregnancy
- Inherited disorder of bile excretion that causes jaundice (Rotor syndrome)
- Jaundice caused by thickened or hardened bile that the body cannot pass from the liver (cholestatic jaundice)
- Life long inherited blood diseases which can cause a variety of symptoms, including mental health problems (porphyrias)
- Metabolic disorder that runs in families and causes mild jaundice (Dubin-Johnson syndrome)
- Moderate to severe high blood pressure (hypertension)
- Overgrowth of the lining of the womb (endometrial hyperplasia)
- Pregnancy
- Severe liver disease
- Vaginal bleeding of unknown cause

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

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 in pregnancy. Seek medical advice from your doctor.
- The use of this medicine during breastfeeding is not recommended. Seek medical advice from your doctor.

Side effects

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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

- Rash
- Changes in mood
- Yellowing of the skin and eyes (jaundice)
- Breast tenderness/swelling
- Nausea and vomiting
- The presence of tissue similar to the lining of the uterus at other sites in the pelvis (endometriosis)
- Excessive fluid retention in the body tissues, resulting in swelling (oedema)
- Formation of a blood clot (thrombus) in one point of the circulation which detaches and lodges at another point (thromboembolism)
- Gallstones
- Weight changes
- High blood pressure (hypertension)
- Headache/migraine
- Menstrual spotting between periods
- Increase in the size of uterine fibroids
- Irregular brown patches on the skin of the face and elsewhere (chloasma)
- Discomfort when wearing contact lenses

The side effects listed above may not include all of the side effects reported by the drug'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.

How can this medicine affect other medicines?

Most interactions have been demonstrated with the oral contraceptive pill (also containing oestrogens), and not specifically for the oestrogens used in hormone replacement dosages. The following are therefore only theoretical interactions rather than proven effects.

Oestrogen supplementation may cause a decreased tolerance for glucose. This may effect the dosage of insulin or oral antidiabetic medicines that are required by people with diabetes.

Recommended dosage

Your doctor will start therapy with this medication at a low dose. He or she will want to check you periodically at 3- to 6-month intervals to determine the need for continued therapy.

Estrofem Tablets

Hot Flashes Associated with Menopause

The usual dosage is 0.3 to 1.25 milligrams daily. If you are still having periods, the doctor will start the Estrofem on the fifth day of your cycle, have you take it for 3 weeks, then give you 1 week off.

Tissue Degeneration in the Vagina

The usual dosage is 0.3 to 1.25 milligrams or more daily. The drug is taken cyclically (3 weeks on and 1 week off).

Low Estrogen Levels Due to Reduced Ovary Function

The usual dosage is 2.5 to 7.5 milligrams daily, taken in several small doses, for 20 days, followed by a 10-day rest period. If you do not have your period by the end of this time, the same dosage schedule is repeated.

If you start to bleed before the end of the 10-day period your doctor will start you on another 20-day cycle, with an oral progestin added during the last 5 days. If you start to bleed before the second cycle is over, stop taking the medication and tell your doctor.

Ovary Removal or Ovarian Failure

The usual dosage is 1.25 milligrams daily, cyclically (3 weeks on and 1 week off). Your doctor will adjust the dosage according to the severity of your symptoms and your response to treatment.

Prevention of Osteoporosis (Loss of Bone Mass)

The usual dosage is 0.625 milligram daily, taken cyclically (3 weeks on and 1 week off).

Advanced Androgen-Dependent Cancer of the Prostate, for Relief of Symptoms Only

The usual dosage is 1.25 to 2.5 milligrams 3 times daily.

Breast Cancer (for Relief of Symptoms Only) in Appropriately Selected Women and Men with Metastatic Disease

The suggested dosage is 10 milligrams 3 times daily for a period of at least 3 months. Tell your doctor if you have any unusual bleeding.


Any medication taken in excess can have serious consequences. If you suspect an overdose of Estrofem, seek medical attention immediately.

Symptoms of conjugated estrogen overdose may include:
Nausea, vomiting, withdrawal bleeding

When you miss a dose

Take the forgotten dose as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Never try to "catch up" by doubling the dose.


Store at room temperature.

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