Active ingredient
- estradiol hemihydrate
- norethisterone acetate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 03132/0141.
Novofem film-coated tablets
Package leaflet: Information for the user
Novofem® film-coated tablets
Estradiol/norethisterone acetate
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Novofem® is and what it is used for
2. What you need to know before you take Novofem®
3. How to take Novofem®
4. Possible side effects
5. How to store Novofem®
6. Contents of the pack and other 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 used in 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 used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Novofem® alleviates these symptoms after menopause. You will only be prescribed Novofem® if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Novofem® to prevent osteoporosis after menopause.
The experience of treating women older than 65 years is limited.
2. What you need to know before you take Novofem®
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 will 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 Novofem®, 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 Novofem®.
Go for regular breast screening, as recommended by your doctor.
Do not take Novofem®
If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Novofem®.
Do not take Novofem®:
If any of the above conditions appear for the first time while taking Novofem®, stop taking it at once and consult your doctor immediately.
Warnings and precautions
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 Novofem®. If so, you should see your doctor more often for check-ups:
Stop taking Novofem® and see a doctor immediately
If you notice any of the following when taking HRT:
Note: Novofem® is not a contraceptive. If it is 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. Speak 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).
The progestagen in Novofem® protects you from this 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 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 Novofem®. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:
see your 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 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.
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. an extra 4 to 6 cases).
Regularly check your breasts. See your doctor if you notice any changes such as:
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 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 (venous thromboembolism)
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:
For signs of a blood clot, see ‘Stop taking Novofem® 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-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. an extra 5 cases).
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.
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. an extra 3 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. Speak to your doctor for advice.
Using other medicines
Some medicines may interfere with the effect of Novofem®. This might lead to irregular bleeding. This applies to the following medicines:
Other medicines may increase the effects of Novofem®:
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 including medicines obtained without a prescription, herbal medicines or other natural products.
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.
Taking Novofem® with food and drink
The tablets can be taken with or without food and drink.
Pregnancy and breast-feeding
Pregnancy: Novofem® is for use in postmenopausal women only. If you become pregnant, stop taking Novofem® and contact your doctor.
Breast-feeding: You should not take Novofem® if you are breast-feeding.
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 an intolerance to some sugars, contact your doctor before taking Novofem®.
3. How to take Novofem®
Always take this medicine exactly as your doctor has told you. 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 every day for 16 days
Days 17 - 28 Take one white tablet every day 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.
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.
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 oestrogens may cause breast tenderness, nausea, vomiting and/or irregular vaginal bleeding (metrorrhagia). Overdosage of progestagens may lead to depressive mood, fatigue, acne and growth of body or facial hair (hirsutism).
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 taking Novofem®, 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 medicine, 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 Novofem®. You may need to stop taking Novofem® about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, ‘Blood clots in a vein (venous thromboembolism)’). Ask your doctor when you can start taking Novofem® again.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them.
The following diseases are reported more often in women using HRT compared to women not using HRT:
For more information about these side effects, see section 2, ‘What you need to know before you take Novofem®’.
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 heartbeat), 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.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Other side effects of combined HRT
The following side effects have been reported with other HRTs:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Novofem®
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 it from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Novofem® contains
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 x 28 film-coated tablets
3 x 28 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
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 revised in: 02/2016
Novofem®, Novofemme® and Duofemme™ are trademarks owned by Novo Nordisk Health Care AG
© 2016
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.
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