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This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.


Novo Nordisk Limited

2nd Floor, 2 Hume Street, Dublin 2, Ireland
Telephone: +353 1 678 5989
Telephone: 1850 665 665
Fax: +353 1 676 3259
Medical Information e-mail: info@novonordisk.ie


Patient Information Leaflet last updated on medicines.ie: 03/02/2014
XPIL Estrofem 2mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Estrofem® 2 mg film-coated tablets

Estradiol (as hemihydrate)

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Estrofem® is and what it is used for
2. Before you take Estrofem®
3. How to take Estrofem®
4. Possible side effects
5. How to store Estrofem®
6. Further information.

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1. What Estrofem® is and what it is used for

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/progestogen 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. You should only be prescribed Estrofem® if your symptoms seriously hinder your daily life.
  • Prevention of osteoporosis
    (thinning of the bones), if you are at high risk of future fracture and if you are unable to take other medications for this purpose.

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

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2. Before you take 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 you have a premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, your doctor should ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary.

Once you have started on Estrofem® you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Estrofem®.

Go for regular breast screening, as recommended by your doctor.

Do not take Estrofem®

If any of the following apply to you. If you are not sure about any of the points below, talk to your doctor before taking Estrofem®.

Do not take Estrofem®

  • If you have or have ever had breast cancer, or if you are suspected of having it.
  • If you have or have had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it.
  • If you have any unexplained vaginal bleeding.
  • If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
  • If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
  • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
  • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
  • If you have or have ever had a liver disease and your liver function tests have not returned to normal.
  • If you have a rare blood problem called ‘porphyria’ which is passed down in families (inherited).
  • If you are allergic (hypersensitive) to estradiol or any of the other ingredients of Estrofem® (listed in section 6, Further information).

If any of the above conditions appear for the first time while taking Estrofem®, stop taking it at once and consult your doctor immediately.

When to take special care with Estrofem®

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Estrofem®. If so, you should see your doctor more often for check-ups:

  • fibroids inside your womb
  • growth of womb lining outside your 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)’)
  • 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 your blood (triglycerides)
  • fluid retention due to cardiac or kidney problems.

Stop taking Estrofem® and see a doctor immediately

If you notice any of the following when taking HRT:

  • any of the conditions mentioned in the ‘DO NOT take Estrofem®’ section
  • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
  • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
  • migraine-like headaches which happen for the first time
  • if you become pregnant
  • if you notice signs of a blood clot, such as:
    • painful swelling and redness of the legs
    • sudden chest pain
    • 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 your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Talk to your 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 progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen 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 progestogen.

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

You will have a bleed once a month (so-called withdrawal bleed) while taking Estrofem®. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:

  • carries on for more than the first 6 months
  • starts after you have been taking Estrofem® more than 6 months
  • carries on after you have stopped taking Estrofem®

see your doctor as soon as possible.

Breast cancer

Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take 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-progestogen HRT over 5 years, there will be 13 to 23 cases in 1,000 users (i.e. 4 to 6 extra 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.

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.

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 apply to you:

  • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, ‘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 ‘Stop taking Estrofem® 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-progestogen 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-progestogen 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 your doctor for advice.

Using other medicines

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 your doctor or pharmacist if you are taking or have 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.

Driving and using machines

Estrofem® has no known effect on the ability to drive or use machines.

Important information about some of the ingredients of Estrofem®:

Estrofem® contains lactose monohydrate. If you have an intolerance to some sugars, contact your doctor before taking Estrofem®.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Estrofem®, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Estrofem® is for use in postmenopausal women only. If you become pregnant, stop taking Estrofem® and contact your doctor.

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3. How to take Estrofem®

Always take Estrofem® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

If your womb has been removed or if you have no vaginal bleeding and you are not taking other hormone therapy products, you can start treatment on any convenient day.

Take one tablet every day, at about the same time each day.

Once you have finished 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 “USER INSTRUCTIONS” at the end of the package leaflet.

Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short as necessary. Talk to your doctor if you think this dose is too strong or not strong enough.

If you have had your womb removed, your doctor will not prescribe a progestogen (another female hormone) in addition unless you have had a condition called endometriosis (deposition of uterine tissue outside the womb).

If you have taken other HRT products until now, ask your doctor or pharmacist when you should start taking Estrofem®.

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 section 2 ‘HRT and cancer’, ‘Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)’ for more information).

If you take more Estrofem® than you should:

If you have taken more Estrofem® than you should, talk to a doctor or pharmacist. An overdose of Estrofem® could make you feel sick or vomit.

If you forget to take Estrofem®:

If you forget to take your 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 you still have your womb.

If you stop taking Estrofem®:

If you want to stop taking Estrofem®, talk to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.

If you have any further questions on the use of this product ask your doctor or pharmacist.

If you need to have surgery:

If you are going to have surgery, tell the surgeon that you are taking Estrofem®. You may need to stop taking Estrofem® about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, ‘Blood clots in a vein’). Ask your doctor when you can start taking Estrofem® again.

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4. Possible side effects

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 section 2.

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 below 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
  • Irregular vaginal bleeding*
  • Oedema (retention of fluid)
  • Weight increase or weight decrease.

Uncommon side effects

  • Dizziness
  • Palpitations
  • Abnormal vision
  • Blood clots in the veins (venous embolism)
  • Heartburn (dyspepsia)
  • Vomiting
  • Flatulence or bloating
  • Gallstones
  • Itching or hives (urticaria).

Very rare side effects

  • Migraine, worse than before
  • Stroke
  • Insomnia (being unable to sleep)
  • Epilepsy
  • Changes in libido
  • Vaginal infection caused by a fungus
  • Deterioration of asthma
  • Anxiety
  • Fatigue
  • Contact lens intolerance
  • Acne
  • Premenstrual-like syndrome
  • 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:
    • Discoloration 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).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

IRELAND:

FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland
Tel:+353 1 6764971
Fax:+353 1 6762517
Website:www.imb.ie
e-mail:imbpharmacovigilance@imb.ie
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5. How to store Estrofem®

Keep out of the reach and sight of children.

Do not use Estrofem® after the expiry date, which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store below 25° C.

Do not refrigerate.

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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6. Further information

What Estrofem® contains

The active substance is estradiol 2 mg (as estradiol hemihydrate).

Other ingredients are: lactose monohydrate, maize starch, hydroxypropylcellulose, talc and magnesium stearate.

The film-coating contains: hypromellose, talc, titanium dioxide (E171), macrogol 400, indigo carmine (E132).

What Estrofem® looks like and contents of the pack

The film-coated tablets are blue, round with a diameter of 6 mm. The tablets are imprinted NOVO 280 on one side.

Pack size available:

1×28 film-coated tablets

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Further information on Estrofem® is available to the medical and allied professions from:

Novo Nordisk Limited
2nd Floor
2 Hume Street
Dublin 2
Phone:(01) 6785989
Fax:(01) 6763259
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This leaflet was last approved in: 01/2014

Estrofem® is a registered trademark owned by Novo Nordisk FemCare AG, Switzerland.

© 2014

Novo Nordisk A/S

USER INSTRUCTIONS

How to use the calendar pack

1. Set the day reminder

Turn the inner disc to set the day of the week opposite the little plastic tab.

2. Take the first day’s tablet

Break the plastic tab and tip out the first tablet.

3. Move the dial every day

On the next day, simply move the transparent dial clockwise 1 space as indicated by the arrow. Tip out the next tablet. Remember to take only 1 tablet once a day.

You can only turn the transparent dial after the tablet in the opening has been removed.

8-2822-11-001-3



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Active Ingredients

 
   Estradiol Hemihydrate