Novofem film-coated tablets

Novofem

film-coated tablets

Estradiol hemihydrate and norethisterone acetate

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 Novofem is and what it is used for

2. Before you take Novofem

3. How to take Novofem

4. Possible side effects

5. How to store Novofem

6. Further information

What Novofem is and what it is used for

Novofem belongs to a group of hormone replacement therapy (HRT) medicines, called sequential combined HRT, which are taken

every day without interruptions.

Novofem contains two hormones, an estrogen (estradiol) and a progestogen (norethisterone acetate).

The estradiol in Novofem is identical to the estradiol produced in the ovaries of women, and is classified as a natural

oestrogen. Norethisterone acetate is a synthetic progestagen, which acts in a similar manner as progesterone, another important female sex

hormone.

Novofem is prescribed:

• To relieve unpleasant symptoms of menopause like hot flushes, night sweats, vaginal dryness in postmenopausal women who still
  
  have their womb


• For the prevention of osteoporosis (thinning of the bones), in postmenopausal women if they are at high risk of future fractures
  
  and are unable to take other medicines for this purpose.

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

Before you take Novofem

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.

For more information about the safety of HRT, see section 4 “Possible side effects”

Be sure to:

• 
  Go for regular breast screening and cervical 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.

Do not take Novofem

If any of the following applies to you, talk to your doctor. Do not start taking Novofem:

• If you have, have had or suspect having breast cancer


• If you have, have had or suspect having cancer of the womb lining (endometrial cancer), or any other oestrogen dependent
  cancer


• If you have abnormal vaginal bleeding of an unknown cause


• If you have endometrial hyperplasia (excessive growth of the womb lining) that is not being treated


• If you have or previously have had a blood clot in the blood vessels of the legs or the lungs (like deep vein thrombosis
  or pulmonary embolism)


• If you have recently had a heart attack, stroke, or have angina pectoris which causes discomfort, pressure or pain in
  the chest


• If you have or have had liver problems and your liver tests have not returned to normal


• If you are allergic (hypersensitive) to estradiol, norethisterone acetate or any other ingredients in Novofem
  tablets (listed in section 6, “Further information”)


• If you have porphyria (liver enzyme disease).

Take special care with Novofem

If you have (or have had) any of the following conditions, tell your doctor. Your doctor may want to follow you more closely.

Rarely, these conditions may come back or get worse during treatment with Novofem

• If you have or have had leiomyoma (benign tumours of the womb) or endometriosis, a condition in which the lining of
  the uterus (womb) grows outside the uterus, causing pain or bleeding


• If you have a history of blood clots (thrombosis) or have risk factors for blood clots (these risk factors and symptoms
  for a blood clot are listed in section 4,“Possible side effects”)


• If you have risk factors for development of oestrogen dependent tumours, such as immediate relatives (mother, sister,
  maternal or paternal grandmother) with breast and/or endometrial cancer


• If you have high blood pressure


• If you have a liver disorders such as liver adenoma (a benign tumour)


• If you have diabetes mellitus with or without vascular disorders


• If you have gallstones


• If you have migraine or severe headache


• If you have systemic lupus erythematosus (SLE) – an autoimmune disease


• If you previous have had endometrial hyperplasia


• If you have epilepsy


• I you have asthma


• If you have otosclerosis (progressive hearing loss).

If you need a blood test, tell your doctor that you are taking Novofem since oestrogen can affect the results of
certain laboratory results.

If you are going to have surgery, talk to your doctor. You may need to stop taking these tablets 4 to 6 weeks before the
operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start treatment again.

Stop taking Novofem

If you are experiencing any of the following conditions below, stop taking Novofem, and contact your doctor immediately

• If you get a migraine-type headache for the first time


• If you develop yellow skin or eyes (jaundice) or other liver problems


• If you have a significant increase in blood pressure


• If you get blood clots called “deep vein thrombosis” (see also section 4, “Possible side effects”)


• If you become pregnant


• If you experience any of the conditions listed in section 2, “Before you take Novofem”.

Bleeding with Novofem

Novofem will cause a menstruation-like monthly bleeding, which usually occurs at the beginning of a new pack. If the periods
get heavier than normal you should tell your doctor However, some women may also experience breakthrough bleeding or spotting during the first few months of taking Novofem. This kind of bleeding is different from the menstruation-like bleeding. If you have any breakthrough bleeding or spotting that continues for longer than the first few months or starts after some time on HRT or continues even if you have stopped taking Novofem, you
should tell your doctor as soon as possible.

Using other medicines

Some medicines may reduce the effect of Novofem

• Medicines used for epilepsy (such as phenobarbital, phenytoin, and carbamazepine)


• Medicines used for tuberculosis (such as rifampicin and rifabutin)


• Medicines used for HIV infections (such as nevirapine, efavirenz, ritonavir and nelfinavir)


• Antiinfectives medicines (e.g. penicillins, tetracycline)


• Herbal products with St John’s Wort (Hypericum perforatum).

Novofem may enhance the effects and side effects of imipramine (antidepressant) and may have an impact on a concomitant

treatment with cyclosporine.

If you have diabetes your requirement for insulin or oral antidiabetics may be changed when taking Novofem.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not
prescribed.

Pregnancy and breast-feeding

Do not take Novofem if you suspect being pregnant, are pregnant or breast-feeding.

Driving and using machines

Novofem does not affect the use of any machines or the ability to drive safely.

Important information about some of the ingredients of Novofem

Novofem contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Novofem

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

If you are not switching from another hormone replacement therapy you can start treatment with Novofemon any convenient day. If you are switching from another hormone replacement therapy ask your doctor when you should start treatment with Novofem.

Take one tablet once a day, at about the same time each day

Each pack contains 28 tablets

Days 1 - 16 Take one red tablet everyday for 16 days


Days 16 - 28 Take one white tablet everyday for 12 days

Take the tablets with a glass of water. Once you have finished the pack, start a new pack continuing the treatment without interruption. A menstruation-like bleeding usually occurs at the beginning of a new pack.

For further information on the use of the calendar pack see “USER INSTRUCTIONS” in the beginning of the package leaflet.

Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms. Talk to your doctor if you do not experience symptom relief after 3 months of treatment. You should only continue treatment as long as the benefit outweighs the risk.

If you take more Novofem than you should

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

If you forget to take Novofem

Do not take a double dose to make up for forgotten individual doses. If you forget to take a tablet one day, discard the tablet and continue treatment as before. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.

If you stop taking Novofem

If you would like to stop your treatment with Novofem for any reason, please discuss your decision with your doctor, who 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.

Possible side effects

Like all medicines, Novofem can have side effects, although not everybody gets them.

Allergic reactions (rare side effect - May affect up to 1 in 1000 women)

Though it is a rare event, allergic reactions may occur (which may include one or more of the following symptoms: flushing, skin rash, itching, hives, swelling, difficulty breathing, fever, palpitations and/or low blood pressure). If one of the mentioned symptoms appears stop taking Novofem and seek immediate medical help

Very common side effects:

May affect more than 1 in 10 women

• Headache


• Breast tenderness.

Common side effects:

May affect up to 1 in 10 women

• Increased blood pressure, aggravated hypertension


• Vaginal infection with a fungus (e.g. thrush)


• Dizziness, sleeplessness, depression


• Dyspepsia (indigestion), abdominal pain, flatulence


• Nausea (feeling sick)


• Rash, itching


• Vaginal bleeding (see section 2 subsection “Bleeding with Novofem”)


• Aggravation of uterine fibroids (benign tumour of the womb)


• Oedema (swelling of hands, ankles and feet)


• Weight increase.

Uncommon side effects:

May affect up to 1 in 100 women

• Migraine


• Changes in libido (changes in sexual desire)


• Peripheral embolism


• Vomiting (being sick)


• Gallbladder disease or gallstones


• Hair loss


• Muscle cramps.

Rare side effects

May affect up to 1 in 1,000 women

• Allergic reactions


• Nervousness


• Vertigo


• Diarrhoea


• Bloating


• Acne


• Uterine fibroid (benign tumour of the womb).

Very rare side effects:

May affect up to 1 in 10,000 women

• Hyperplasia of endometrium (excessive growth of the lining of the womb)


• Increased body and facial hair.

Effects on the skin

Brown patches on the face, skin rashes including red inflammation on the hands or the legs (erythema multiforme), formation of tender, red nodules on the front of the legs/knees (erythema nodosum) or a bruise-like rash.

Other side effects of HRT

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

Effects on your risk of developing cancer

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking oestrogen plus progestogen HRT is higher than for oestrogen-only HRT (but oestrogen plus progestogen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below).

For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT.

Your risk of breast cancer is also higher:

• If you have a close relative (mother, sister or grandmother) who has had breast cancer


• If you are seriously overweight.

Compare

Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).

If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).

For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).

If they take oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases)

If you notice any changes in your breast, such as:

• Dimpling of the skin


• Changes in the nipple


• Any lumps you can see or feel.

Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking oestrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestogen as well as the oestrogen helps to lower the extra risk.

If you still have your womb, your doctor may prescribe a progestogen as well as oestrogen. If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without a progestogen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen.

Your product, Novofem, contains a progestogen.

Compare

Looking at women who still have a uterus and who are not taking HRT – on average 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

For women who take oestrogen-only HRT, the number will be 2 to 12 times higher, depending on the dose and how long you take it.

The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:

• Carries on for more than the first few months


• Starts after you’ve been on HRT for a while


• Carries on even after you’ve stopped taking HRT.

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. Some studies have indicated that taking HRT for more than 5 years may increase the risk of ovarian cancer.

Effects on your heart or circulation

Blood clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

• If you are seriously overweight


• If you have had a blood clot before


• If any of your close family have had blood clots


• If you have had one or more miscarriages


• If you have any blood clotting problem that needs treatment with a medicine such as warfarin


• If you’re off your feet for a long time because of major surgery, injury or illness


• If you have a rare condition called SLE.

If any of these things apply to you, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get:

• Painful swelling in your leg


• Sudden chest pain


• Difficulty breathing.

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:

• A pain in your chest that spreads to your arm or neck.

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

• Getting older


• High blood pressure


• Smoking


• Drinking too much alcohol


• An irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:

• Unexplained migraine-type headaches, with or without disturbed vision.

See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Dementia

There is no evidence that HRT improves processes of knowing, thinking, learning and judging (cognitive function). From a clinical study there is some evidence for an increased risk of dementia among women older than 65 years, who were using another oestrogen/progestogen combination than the one in Novofem. It is not known whether this applies to younger women and to women taking other HRT preparations.

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.

How to store Novofem

Keep out of the reach and sight of children.

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

Do not store above 25°C. Do not refrigerate. Keep the container in the outer carton in order to protect from light.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Novofem contains

• The active substances are estradiol and norethisterone acetate.
  
  The red film-coated tablets contain: estradiol 1 mg (as estradiol hemihydrate).
  
  The white film-coated tablets contain: estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.


• The other ingredients are: lactose monohydrate, maize starch, gelatine, talc and magnesium stearate.
  
  
  Film-coating (red tablets) contain: hypromellose, talc, titanium dioxide (E171), propylene glycol and red iron oxide (E172).
  
  
  Film-coating (white tablets) contain: hypromellose, triacetin and talc.

What Novofem looks like and contents of the pack

The film-coated tablets are round with a diameter of 6 mm. The red tablets are engraved with NOVO 282.

The white tablets are engraved with NOVO 283.

Each pack of 28 tablets contains 16 red tablets and 12 white tablets

Pack sizes available:

1x28 film-coated tablets

3x28 film-coated tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Novo Nordisk Limited

Broadfield Park

Brighton Road

Crawley

West Sussex

RH11 9RT

Manufacturer:

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

This leaflet was last approved in: 12/2008

Novofem is a trademark owned by Novo Nordisk FemCare AG, Switzerland

© 2002/2008

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 one space as indicated by the arrow. Tip out the next tablet. Remember to take only one tablet once a day

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

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