The active substance is estradiol 1 mg or 2 mg (as estradiol hemihydrate).
Excipients/Inactive Ingredients: Tab 1 mg: lactose monohydrate, maize starch, hydroxypropylcellulose, talc and magnesium stearate.
The film-coating contains: hypromellose, talc, titanium dioxide (E171), propylene glycol and red iron oxide (E172).
Tab 2 mg: lactose monohydrate, maize starch, hydroxypropylcellulose, talc and magnesium stearate. Film-coating: Hypromellose, talc, titanium dioxide (E171), macrogol 400 and indigo carmine (E132).
Estrofem is a Hormone Replacement Therapy (HRT). It contains the female hormone estradiol.
Estrofem is used in postmenopausal women, particularly in women who have had their womb removed (have had a hysterectomy) and therefore do not require combined oestrogen/progestagen therapy.
Estrofem is used for: Relief of symptoms occurring after menopause: During the menopause, the amount of oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest ('hot flushes'). Estrofem alleviates these symptoms after menopause. Estrofem should only be prescribed if the symptoms seriously hinder the patient's daily life.
Prevention of osteoporosis: (thinning of the bones), if the patient is at high risk of future fracture and if unable to take other medications for this purpose.
There is only limited experience of treating women older than 65 years.
Always take Estrofem exactly as told by the doctor. Check with the doctor or pharmacist if unsure.
If the womb has been removed or if the patient has no vaginal bleeding and is not taking other hormone therapy products, treatment can be started on any convenient day.
Take one tablet every day, at about the same time each day. After finishing all the 28 tablets in the pack, start a new pack continuing the treatment without interruption.
For instructions on the use of the calendar pack, see Cautions for Usage.
The doctor will aim to prescribe the lowest dose to treat the symptoms for as short as necessary. Talk to the doctor if the patient thinks this dose is too strong or not strong enough.
If the patient has had the womb removed, the doctor will not prescribe a progestagen (another female hormone) in addition unless the patient has had a condition called endometriosis (deposition of uterine tissue outside the womb).
If the patient has taken other HRT products until now, ask the doctor or pharmacist when the patient should start taking Estrofem.
If the patient gets breakthrough bleeding or spotting, it is usually nothing to worry about, especially during the first few months of taking HRT (see Precautions).
If the patient forgets to take Estrofem: If the patient forgets to take the tablet at the usual time, take it within the next 12 hours. If more than 12 hours have gone by, skip the missed dose and start again as normal the next day. Do not take a double dose to make up for a forgotten tablet. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting, if the patient still has her womb.
If the patient stops taking Estrofem: If the patient wants to stop taking Estrofem, talk to the doctor first. The doctor will explain the effects of stopping treatment and discuss other possibilities with the patient.
If patient has any further questions on the use of this product, ask the doctor or pharmacist.
If the patient needs to have surgery: If the patient is going to have surgery, tell the surgeon that the patient is taking Estrofem. The patient may need to stop taking Estrofem about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see Precautions). Ask the doctor when the patient can start taking Estrofem again.
Patients who have taken more Estrofem than recommended should talk to a doctor or pharmacist. An overdose of Estrofem could make patients feel sick or vomit.
Do not take Estrofem: If any of the following applies. If patient is not sure about any of the points as follows, talk to the doctor before taking Estrofem.
Do not take Estrofem: If patient has or has ever had breast cancer, or if suspected of having it.
If the patient has or has had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if the patient is suspected of having it.
If patient has any unexplained vaginal bleeding.
If patient has excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
If patient has or has ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
If patient has a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
If patient has or recently has had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
If patient has or has ever had a liver disease and the liver function tests have not returned to normal.
If patient has a rare blood problem called 'porphyria' which is passed down in families (inherited).
If patient is allergic (hypersensitive) to estradiol or any of the other ingredients of Estrofem (listed in Description).
If any of the previously mentioned conditions appear for the first time while taking Estrofem, patient should stop taking it at once and consult a doctor immediately.
Before taking Estrofem: 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. If the patient has a 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 Estrofem 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 Estrofem.
Go for regular breast screening, as recommended by the doctor.
When to take special care with Estrofem: Tell the doctor if the patient has ever had any of the following problems, before starting the treatment, as these may return or become worse during treatment with Estrofem. 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 (see Blood clots in a vein (thrombosis) 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 Estrofem 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; if patient notices 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).
Note: Estrofem 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 Estrofem 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 Estrofem. 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 Estrofem more than 6 months, carries on after the patient has stopped taking Estrofem, 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 - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-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.
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: the patient is unable to walk for a long time because of major surgery, injury or illness (see Dosage & Administration); the patient is seriously overweight (BMI >30 kg/m2); the patient has 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; the patient has systemic lupus erythematosus (SLE); the patient has cancer.
For signs of a blood clot, see Stop taking Estrofem and see a doctor immediately as previously mentioned.
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 Estrofem: Estrofem contains lactose monohydrate. If the patient has an intolerance to some sugars, contact the doctor before taking Estrofem.
Laboratory tests: If the patient needs a blood test, tell the doctor or the laboratory staff that Estrofem is being taken, because this medicine can affect the results of some tests.
Driving and using machines: Estrofem has no known effect on the ability to drive or use machines.
Estrofem is for use in postmenopausal women only. If the patient becomes pregnant, stop taking Estrofem and contact the doctor.
The following diseases are reported more often in women using HRT compared to women not using HRT: breast cancer; abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer); ovarian cancer; blood clots in the veins of the legs or lungs (venous thromboembolism); heart disease; stroke; probable memory loss if HRT is started over the age of 65.
For more information about these side effects, see Precautions.
Hypersensitivity/allergy (uncommon side effect - affects 1 to 10 users in 1,000). Though it is an uncommon event, hypersensitivity/allergy may occur. Signs of hypersensitivity/allergy may include one or more of the following symptoms: hives, itching, swelling, difficulty in breathing, low blood pressure (paleness and coldness of skin, rapid heart beat), feeling dizzy, sweating, which could be signs of anaphylactic reaction/shock. If one of the mentioned symptoms appears, stop taking Estrofem and seek immediate medical help.
The frequency of possible side effects listed as follows is defined using the following convention: Very common (affects more than 1 user in 10); Common (affects 1 to 10 users in 100); Uncommon (affects 1 to 10 users in 1,000); Rare (affects 1 to 10 users in 10,000); Very rare (affects less than 1 user in 10,000); Not known (frequency cannot be estimated from the available data).
Common side effects: Depression; Headache; Abdominal (stomach) pain; Feeling sick (nausea); Leg cramps; Breast pain, breast tenderness or breast enlargement; Oedema (retention of fluid); Weight increase.
Uncommon side effects: Abnormal vision; Blood clots in the veins (venous embolism); Heartburn (dyspepsia); Vomiting; Flatulence or bloating; Gallstones; Itching or hives (urticaria).
Very rare side effects: Irregular vaginal bleeding*; Migraine, worse than before; Stroke; Insomnia (being unable to sleep); Epilepsy; Changes in libido; Vaginal infection caused by a fungus; Deterioration of asthma; Dizziness; Diarrhoea; Hair loss (alopecia); Increased blood pressure.
*If prescribed for women with a uterus.
The following side effects have been reported with other HRT's: Gall bladder disease; Various skin disorders: Discolouration of the skin especially of the face or neck known as 'pregnancy patches' (chloasma), Painful reddish skin nodules (erythema nodosum), Rash with target-shaped reddening or sores (erythema multiforme).
Some medicines may interfere with the effects of Estrofem. This might lead to irregular bleeding. This applies to the following medicines: Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin); Medicines for tuberculosis (such as rifampicin, rifabutin); Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir); Herbal remedies containing St. John's Wort (Hypericum perforatum).
Please tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.
Taking Estrofem with food and drink: The tablets can be taken with or without food and drink.
How to use the calendar pack: Set the day reminder: Turn the inner disc to set the day of the week opposite the little plastic tab.
Take the first day's tablet: Break the plastic tab and tip out the first tablet.
Move the dial every day: On the next day, simply move the transparent dial clockwise 1 space. Tip out the next tablet. Remember to take only 1 tablet once a day.
The patient can only turn the transparent dial after the tablet in the opening has been removed.
Store below 30°C. Do not refrigerate.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Tab 1 mg (red, round with a diameter of 6 mm, imprinted "NOVO 282" on one side) x 28's. 2 mg (round with a diameter of 6 mm, blue, engraved with "NOVO 280" on one side) x 28's.