Novofem Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Novofem®
film-coated tablets
Estradiol and norethisterone acetate
Read this entire 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
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- 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 use Novofem®
4. Possible side effects
5. How to store Novofem®
6. Further information
1. WHAT NOVOFEM® IS AND WHAT IT IS USED FOR
Novofem® is a sequential combined Hormone Replacement Therapy (HRT) which is taken every day without interruption. Novofem® is suitable for postmenopausal women with at least 6 months since their last natural period. Novofem® contains 2 hormones, an oestrogen (estradiol) and a progestagen (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 indicated
• 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.
The experience of treating women older than 65 years is limited.
2. BEFORE YOU TAKE NOVOFEM®
Medical 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. Before you start (or restart) 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 have started on Novofem®, you should see your doctor for regular check-ups (at least once a year). At these checkups, your doctor may discuss the benefits and risks of continuing with Novofem®.
As well as regular check-ups with your doctor, be sure to:
• 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.
• Go for regular breast screening (mammography) and cervical smear tests.
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 any vaginal bleeding
and the cause is not known.
• If you have endometrial hyperplasia (excessive growth of the womb lining) that is not being treated.
• If you have or have had blood clots in a vein (venous thromboembolism), 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 have 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 function 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
(a metabolic disease with disturbed production of blood pigments).
Take special care with Novofem®
If you have (or have had) any of the following conditions, tell your doctor before you start the treatment. Your doctor may want to monitor you more closely. These conditions may in rare cases 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 risk factors for developing blood clots (see 'Blood clots in a vein') (these risk factors and symptoms for a blood clot are listed in section 4 Other side effects of combined HRT).
• If you have a very high level of fat in your blood (triglycerides).
• 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 disorder 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 previously have had endometrial hyperplasia (excessive growth of the lining of the womb).
• If you have epilepsy.
• If you have asthma.
• If you have otosclerosis
(progressive hearing loss).
• If you have fluid retention due to cardiac or kidney problems.
If you are 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.
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 your blood pressure goes up significantly while you are taking Novofem® (symptoms of high blood pressure e.g. headache, tiredness and dizziness).
• If you get signs of a blood clot (painful swelling and redness of the legs, sudden chest pain, difficulty in breathing).
• If you become pregnant.
• If you experience any of the conditions listed in section
2 Before you take Novofem®.
Novofem® and cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer)
In women with an intact womb taking oestrogen-only HRT over a longer time, the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer) is increased. Taking a progestagen in addition to the oestrogen, such as Novofem®, helps to lower the extra risk.
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 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.
Breast cancer
Evidence suggests that taking combined oestrogen-progestagen and possibly also oestrogen-only HRT increases the risk of breast cancer. This depends on how long you take HRT. The additional risk is visible within a few years. However, it returns to normal within a few
years (at most 5) after stopping treatment.
Compare
Women aged 50 to 79 who are not taking HRT, on average 9 to 14 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 20 cases in 1,000 users (i.e. an extra 4 to 6 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 in
1.000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years there will be 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 (venous thromboembolism)
HRT increases the risk of blood clots in the veins 1.3- to 3-fold, 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 generally more likely to get a blood clot in your veins if one or more of the following applies to you:
• You are older
• You are pregnant or have recently had a baby
• You use oestrogens
• You or any of your close relatives have ever had a blood clot in the leg, lung or another organ
• You are seriously overweight
• You have systemic lupus erythematosus (SLE)
• You have a blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots (anticoagulant)
• You are unable to walk or stand for a long time because of major surgery, injury or illness (prolonged immobilisation)
• You have cancer
For signs of a blood clot, see
"Stop taking Novofem®" and see
a doctor immediately.
Compare
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 in 1,000 users (i.e. an extra 5 cases).
Compare
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. an extra 3 cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack. Women over the age of 60 years taking oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.
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.
Other conditions
HRT will not prevent memory loss. The risk of probable memory loss may be somewhat higher in women who start using any kind of HRT after the age of 65.
Bleeding with Novofem®
Novofem® will cause a menstruationlike monthly bleeding (period), 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, starts after some time on Novofem®, 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)
• Anti-infective medicines (e.g. penicillins, tetracycline)
• Herbal products with St John's Wort (Hypericum perforatum)
Other medicines may increase the effects of Novofem®:
• Drugs containing ketoconazole (a fungicide)
Novofem® may have an impact on a concomitant treatment with cyclosporine.
Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, even those not prescribed.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking Novofem®, because this medicine can affect the results of some tests.
Pregnancy and breast-feeding Pregnancy: You should not take Novofem® if you are pregnant.
If you become pregnant while using Novofem® you should stop the treatment immediately and contact your doctor. Breast-feeding: You should not use Novofem® if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
Novofem® has no known effect on the ability to drive or use machines.
Important information about some of the ingredients in 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.
3. HOWTO USE 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 Novofem® on 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 17 - 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 (period) usually occurs at the beginning of a new pack.
For further information on the use of the calendar pack see USER INSTRUCTIONS at the end of the package leaflet.
The lowest effective dose that gives you symptom relief should be used for the shortest duration when treating menopausal symptoms. Talk to your doctor if you do not experience symptom relief after 3 months of treatment. You should
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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®
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, 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 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Novofem® can have side effects, although not everybody gets them.
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 Novofem® 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) Very common side effects
• Headache
• Breast tenderness
Common side effects
• 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
• Migraine
• Changes in libido (changes in sexual desire)
• Peripheral embolism and thrombosis (blood clot)
• Vomiting (being sick)
• Gallbladder disease or gallstones
• Hair loss (alopecia)
• Muscle cramps
Rare side effects
• Allergic reactions
• Nervousness
• Vertigo (dizziness)
• Diarrhoea
• Bloating
• Acne
• Uterine fibroid (benign tumour of the womb)
Very rare side effects
• Endometrial hyperplasia (excessive growth of the lining of the womb)
• Increased body and facial hair
Other side effects of combined
HRT
The following diseases are reported
more often in women using HRT
compared to women not using HRT
• Breast cancer (see also section 2 Novofem® and cancer, Breast cancer for more information).
• Excessive growth or cancer of the lining of the womb (endometrial hyperplasia or cancer) (see also section 2 Novofem® and cancer, Excessive growth of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer) for more information).
• Ovarian cancer. (see also section 2 Novofem® and cancer, Ovarian cancer for more information).
• Blood clots in the veins of the legs or lungs (venous thromboembolism) (see also section 2 Effects of HRT on heart and circulation, Blood clots in
a vein (venous thromboembolism) for more information)
• Heart disease (see also section 2 Effects of HRT on heart and circulation, Heart disease (heart attack) for more information)
• Stroke (see also section 2 Effects of HRT on heart and circulation, Stroke for more information).
• Skin and subcutaneous disorders:
- Darkening of the skin (chloasma)
- Severe condition of the skin that may affect the mouth and other parts of the body (erythema multiforme)
- Red-purple swellings on the shins, thighs and, less commonly, the arms. Joint and muscle pains and fever may also occur (erythema nodosum)
- Purple or red-brown spots visible through the skin (vascular purpura)
• Probable memory loss if HRT is started over the age of 65 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. 5. HOWTO 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 outer carton after 'EXP' 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. 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, hydroxypropylcellulose, 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:
1 x28 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 3 City Place Beehive Ring Road Gatwick
West Sussex, RH6 0PA
Manufacturer:
Novo Nordisk A/S Novo Alle
DK-2880 Bagsrard Denmark
This medicinal product is authorised in the Member States of the EEA under the following names:
Member States of the EEA: Novofem® - except for France: Novofemme®
Spain: Duofemme®
This leaflet was last approved in: 06/2014
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.
Novofem® is a trademark owned by Novo Nordisk FemCare AG, Switzerland
© 2014
Novo Nordisk A/S
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