ESTROFEM 2mg. (Oestradiol Valelate) 28 Tablets

ESTROFEM 2mg. (Oestradiol Valelate)

Size: 2mg.  28 tablet.

Estrofem 2mg. tablets contain oestradiol valerate, used to replace the loss of oestrogen at menopause to relieve symptoms of menopause. Estrofem also stimulates the development of female sexual characteristics for male to female transsexuals in transgender hormone therapy.

INDICATIONS: oestrogen hormonal therapy

PACKAGE CONTENTS: 1 plastic calendar pack of 28 tablets each with oestradiol valerate 2 mg. in each tablet – total 28 tablets in one box.

DESCRIPTION:

Estrofem 2mg. tablets are an oestrogen hormone replacement therapy (HRT) used to substitute the lack of oestrogen production by the ovaries which occure during menopause or following surgical removal of the ovaries. It is used to relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Estrofem 2mg. tablets are also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Estrofem stimulates the development of female sexual characteristics, and is used as the oestrogen component of transgender hormone therapy for male to female transsexuals.

Estrofem contains the active ingredient oestradiol valerate, a prodrug (or precursor) of 17 beta-oestradiol, the major and most active form of oestrogen produced by the ovaries, and is used for hormone replacement therapy (HRT).

Estrofem 2mg. tablets substitute for the loss of oestrogen production by the ovaries that occurs during menopause or following surgical removal of the ovaries. Estrofem contains oestradiol, an active form of the female hormone oestrogen that alleviates menopausal symptoms, such as hot flushes, night sweats, sleeplessness, dry vagina, headaches, mood swings, lack of concentration loss of energy and bone loss (osteoporosis).

Estrofem 2mg. tablets can be used as part of a gender reassignment program for male to female transsexuals, by providing a source of oestradiol, the most active form of the female hormone oestrogen. Estrofem 2 mg stimulate the development of female secondary sexual characteristics, such as breast development and also induce metabolic changes such as fat distribution to redefine the general body shape.

Indications: oestrogen hormon replacement therapy

Side effects: the most frequently reported side effects when taking Estrofem tablets 2mg are breast tenderness, breast pain, abdominal pain, nausea, oedema, and headache, skin rash and itching, insomnia and depression. More severe side effects include changes in liver function at higher doses and increased risk of dementia if initiated in women aged 65 or older.

Health risks: long-term HRT with Estrofem does have associated health risks, including an increased risk of breast cancer, endometrial cancer, stroke and deep vein thrombosis. For women with an intact uterus adding a progestogen to an oestrogen replacement regimen like Estrofem for at least 10 days per cycle is recommended to reduce the risk of endometrial cancer.

Contraindications:  you should not use Estrofem 2 mg tablets if you:

• are allergic to oestradiol valerate or any ingredients in Estrofem
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have deep venous thrombosis, thromboembolic disorders, cerebral vascular accident associated with oestrogen use
• have abnormal genital bleeding of unknown cause
• are pregnant or planning to become pregnant
• are taking other medications that may interact with Estrofem, such as anticonvulsants like phenytoin and carbamazepin, barbiturates, anti-infectives like rifampicin, rifabutin, nevirapine, antibiotics like penicillin,.
• are a diabetic taking antidiabetics or insulin, without discussion with your doctor, as Estrofem may affect your glucose tolerance

Use and dosage: you should take Estrofem 2 mg tablets with a glass of water once a day, preferably at the same time each day, until all 28 tablets have been taken. The dose you take depends on your condition and should be as recommended by your doctor. When you have finished each pack, start the next pack immediately. You can start taking Estrofem tablets on any convenient day unless you are still having menstrual bleeding, in which case take the first tablet on day 5 of bleeding.

Length of treatment: each pack of Estrofem 2 mg tablets is a calendar pack of 28 tablets. You should take Estrofem tablets 2mg for as long as your doctor recommends.

Missed dose: if you miss a dose of Estrofem 2 mg tablets take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose. Do not take a double dose. If you forget to take a tablet for more than 12 to 24 hours, irregular bleeding may occur.

Package Contents: 1 plastic calendar pack of 28 tablets each with oestradiol valerate 2 mg in each tablet – total 28 tablets in one box.

Active ingredient: oestradiol valerate 2 mg in each tablet

Manufacturer: Novo Nordisk

Storage: keep Estrofem 2mg. 28  tablets in their calendar pack until used. Store at room temperature below 25°C, keep away from direct sunlight and do not refrigerate.

For More information

What Estrofem 2mg. is used for

Estrofem 2mg. is a hormone replacement therapy (HRT) that is used for the short-term symptomatic treatment of women who have had their womb surgically removed (which is called hysterectomy) and who have signs and symptoms of estrogen deficiency.

A woman’s last menstrual period is called the menopause and usually occurs between the ages of 45 and 55 years. Around the time of the menopause, the body slowly stops producing the two sex hormones called estrogen and progesterone. Periods become irregular until they finally stop.

If a woman has surgical or natural menopause the production of these hormones is diminished or stopped.

Estrofem 2mg. replaces the hormone called estrogen which your body stops making after surgical or natural menopause.

The falling or reduced hormone levels may cause you to experience uncomfortable symptoms such as hot flushes, night sweats, sleeplessness, dry vagina, urinary problems, headaches, mood swings, lack of concentration or loss of energy.

The estrogen in Estrofem 2mg. relieves the symptoms caused by a lack of estrogen.

If you have not had a hysterectomy your doctor may prescribe another medicine (a progesterone type medicine called a ‘progestagen’) to be taken with Estrofem 2mg. for 10-14 days of your 28 day cycle. It is very important to take both medications exactly the way your doctor has prescribed.

If you have any questions about the combination of the two medicines please talk to your doctor.

Your doctor may have prescribed Estrofem 2mg. for another reason. Ask your doctor if you have any questions about why Estrofem 2mg. has been prescribed for you.

Before you take Estrofem 2mg.

When you must not take it

Do not take Estrofem 2mg. if:

• you are pregnant or suspect you may be pregnant, or you are breast-feeding
• you know or suspect you have, or you have had, a tumour which depends on hormones (e.g. cancer of the breast or the lining of the womb)
• you know or suspect you have, or you have had, breast cancer
• you have recently developed liver disease; or you have a history of liver disease where your blood test results have not returned to normal
• you have porphyria (a rare disease of blood pigments)
• you have any unexplained vaginal bleeding
• you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• you know that you are allergic to any of the ingredients in Estrofem 2mg.
• you have or ever had any kind of blood clots
• you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• you have pain in your calf and your leg is swelling
• it is after the expiry date (‘Expiry’) printed on the pack
• the packaging is torn or shows signs of tampering

Before you start to take it

Medical check-ups

Before you start taking HRT, your doctor should ask 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’ve 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 pap 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

There is only limited experience of treating women older than 65 years with Estrofem 2mg..

Tell your doctor if:

• you have not had a hysterectomy, because another medicine may be more suitable for you
• you have previously taken estrogen by itself for menopausal symptoms and have not had a hysterectomy. The long-term use of estrogen without a progesterone can increase the risk of cancer of the lining of the womb
• you have a family history of blood clots
• you are to be hospitalised or undergoing surgery, particularly where you are or will be off your feet for a long time. You may need to stop taking Estrofem 2mg. 4 to 6 weeks before your operation, to reduce the risk of a blood clot
• you have an intolerance to some specific sugars e.g. lactose (found in milk and milk products). Estrofem 2mg. tablets contain lactose

Tell your doctor if you have or have had any medical conditions, especially the following:

• fibroids of the womb or endometriosis and you have not had a hysterectomy. Fibroids may increase in size while taking Estrofem 2mg. and symptoms of endometriosis may worsen
• a history of excessive growth of the cells which line the womb
• family history of hormone-dependent cancer e.g. cancer of the breast or of the lining of the womb
• increased risk of developing blood clots (see Blood clots in a vein (thrombosis))
• high blood pressure
• inflammation of the pancreas due to high levels of blood fats (triglycerides)
• hereditary or acquired angioedema
• systemic lupus erythematosus (SLE)
• epilepsy, migraine, severe headache
• diabetes
• asthma
• gallstones
• a liver disorder, such as a benign liver tumour
• heart disease
• kidney disease
• fluid retention (oedema)
• otosclerosis (hearing loss sometimes linked to pregnancy)

This is because you will need to be seen regularly by your doctor while you are taking Estrofem 2mg..

HRT and cancer

Endometrial hyperplasia endometrial cancer)

Taking estrogen-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 estrogen for at least 10 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestagen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product 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 estrogen-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

You will have a bleed once a month (so-called withdrawal bleed) while taking Estrofem 2mg..

See your doctor as soon as possible if you have not had a hysterectomy and you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:

• carries on for more than the first 6 months, or
• starts after you have been taking Estrofem 2mg. more than 6 months, or
• carries on after you have stopped taking Estrofem 2mg..

Breast cancer

Evidence shows that taking combined estrogen-progestagen or estrogen-only hormone replacement therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The additional risk becomes clear within 3 years of use. After stopping HRT the extra risk will decrease with time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.

Compare

Women aged 50 to 54 who are not taking HRT, on average, 13 to 17 in 1,000 will be diagnosed with breast cancer over a 5-year period.

For women aged 50 who start taking estrogen-only HRT for 5 years, there will be 16-17 cases in 1,000 users (i.e. an extra 0 to 3 cases).

For women aged 50 who start taking estrogen-progestagen HRT for 5 years, there will be 21 cases in 1,000 users (i.e. an extra 4 to 8 cases).

Women aged 50 to 59 who are not taking HRT, on average, 27 in 1,000 will be diagnosed with breast cancer over a 10-year period.

For women aged 50 who start taking estrogen-only HRT for 10 years, there will be 34 cases in 1,000 users (i.e. an extra 7 cases).

For women aged 50 who start taking estrogen-progestagen HRT for 10 years, there will be 48 cases in 1,000 users (i.e. an extra 21 cases).

Regularly check your breasts. See your doctor if you notice any changes such as:

• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.

Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/healthcare professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only or combined estrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users (i.e. about 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.

You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you.

Inform your doctor if any of these situations applies to you:

• you are unable to walk for a long time because of major surgery, injury or illness (see also ‘If you need to have surgery’)
• you are seriously overweight (BMI >30 kg/m²)
• you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.

For signs of a blood clot, see ‘When you must not take it’.

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 estrogen-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 estrogen-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 estrogen-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 estrogen-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 your doctor for advice.

Tell your doctor immediately if any of the following conditions occur (because you may be told to stop taking Estrofem 2mg.):

• yellowing of your skin or eyes, or worsening of your liver function
• significant increase in your blood pressure
• migraine-like headache, and you have not previously had migraines
• sudden development of visual problems
• pregnancy
• or if you experience any of the conditions listed above under ‘When you must not take it’

If you have not told your doctor about any of the above, tell them before you take Estrofem 2mg.. Estrofem 2mg. should only be used to treat symptoms of the menopause that adversely affect your quality of life.

Review the risks and benefits of continued treatment with Estrofem 2mg. at least once a year with your doctor.

Taking other medicines

Tell your doctor if you are taking or plan to take other medicines, including:

• some medicines to help you sleep, including barbiturates
• some medicines for epilepsy e.g. phenytoin and carbamazepine
• some antibiotics and other anti-infective medicines e.g. rifampicin, rifabutin, nevirapine, efavirenz
• some anti-infectives such as ritonavir and nelfinavir, when used at the same time as steroid hormones
• St. John’s Wort – used to treat depression

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. The effect of Estrofem 2mg. can be reduced by other medicines, and may affect your vaginal bleeding pattern.

While you are taking Estrofem 2mg.

You can expect your symptoms to improve within a few months of starting Estrofem 2mg..

If you get breakthrough bleeding or spotting, it is usually nothing to worry about, especially during the first few months of taking HRT (see also ‘Before you start to take it – Unexpected bleeding’ for more information).

Estrofem 2mg. can be stopped at any time. You should discuss this with your doctor.

Estrofem 2mg. is not a contraceptive and will not prevent pregnancy. Estrofem 2mg. is only recommended for women who have signs and symptoms of estrogen deficiency due to surgical or natural menopause and who have had a hysterectomy performed. At your routine check-up, your doctor may reassess your continued need for Estrofem 2mg.. Alternative HRT treatment may be given if troublesome symptoms remain.

If you have any concerns about taking Estrofem 2mg., ask your doctor or pharmacist. If your doctor tells you to stop taking Estrofem 2mg., return any unused medicine to your pharmacist.

Things you must not do

This medicine is for you only. Do not give it to someone else even if they seem to have the same symptoms as you.

Do not take Estrofem 2mg. to treat any other complaints unless your doctor tells you to.

Do not change the way you take Estrofem 2mg., or lower the dosage, without checking with your doctor.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Tell your doctor or pharmacist if you experience any side effects while you are taking Estrofem 2mg. (whether or not they are mentioned below). You may need medical treatment if you experience some of the side effects.

When you start taking Estrofem 2mg. your body has to adjust to new hormone levels. You may experience the following side effects:

• abdominal (stomach) pain, feeling sick (nausea), vomiting, diarrhoea, bloating, flatulence, indigestion
• skin rash or itching, skin reactions, changes in hair growth
• headache, migraine, epilepsy, dizziness
• changes in libido, problems getting to sleep
• breast tenderness, enlargement or pain
• asthma, or worsening of asthma
• gall bladder problems
• leg cramps
• weight increase
• fluid retention (oedema)
• swelling under the skin (angioedema)
• fungal infection of the vagina (thrush)

These side effects are usually temporary and disappear.

Tell your doctor if:

• you think you may be suffering from depression
• you are not feeling well or find any side effect too uncomfortable or unacceptable
• any side effect becomes worse
• you have not had a hysterectomy – vaginal bleeding or spotting suddenly becomes heavier

Tell your doctor immediately if any of the following conditions occur (because you may be told to stop taking Estrofem 2mg.):

• pain in your calf and your leg is swelling
• any kind of blood clots
• yellow colouring of the skin and eyes (jaundice)
• migraine or sudden severe headache, and you have not previously had migraines
• problems with your eyesight which develop suddenly
• marked rise in blood pressure
• if you have not had a hysterectomy – vaginal bleeding or spotting occurring after you have been period-free for some time
• you can see or feel a lump in your breast, or you notice dimpling of the skin or changes in the nipple
• you know or suspect you are pregnant

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

• skin rashes over a large part of the body
• shortness of breath, wheezing
• swelling of the face, lips or tongue
• fast pulse
• sweating

This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

In addition to the possible side effects listed above, ovarian cancer, heart disease, stroke and dementia have been reported with HRT.

Do not be alarmed by these lists of possible side effects. You may not experience any of them.