Novofem Film-coated Tablets
What Novofem Is And What Is Novofem Used For
What is Novofem used for?
This is a sequential combination drug used for Hormone Replacement Therapy ( HRT ) and is taken daily without interruption.
Novofem is used for women whose menstruation has stopped ( menopause ), at least 6 months after their last natural menstrual period.
It contains two hormones
- An estrogen (estradiol).
- A progestogen (norethisterone acetate).
Estradiol in Novofem is identical to the estradiol produced in a woman’s ovaries and is considered a natural estrogen.
Norethisterone acetate is a synthetic progestogen, which acts similarly to the corpus luteum hormone ( progesterone ), another important female sex hormone.
what is novofem used for:
Relieve symptoms during and after menopause
When menstruation ends ( menopause ), the woman’s estrogen decreases. It can cause problems such as sweating and hot flashes.
Novofem relieves these symptoms after menopause. Novofem should only be used if the problems cause problems in daily life.
Prevent osteoporosis
After menopause, some women suffer from osteoporosis. Discuss all possible options with your doctor.
If you have an increased risk of fractures (bone fractures) and other medicines that are not suitable for you, you can use Novofem to prevent osteoporosis after menopause.
Experience in the treatment of women older than 65 years is limited.
What You Need To Know Before You Take Novofem
Medical Background And Regular Check-ups
The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT may be different. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask about your own and your family’s medical background. Your doctor may do a general medical and gynecological examination, which also includes the examination of your breasts.
Once you have started treatment with Novofem, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the Novofem benefits and risks of continued treatment.
Perform regular examinations of the breasts according to the doctor’s recommendations.
Do not take Novofem
If any of the following apply to you. If you are not sure, talk to your doctor before taking Novofem.
Do not take:
- If you have or have had breast cancer or there is a suspicion that you may have it.
- If you have or have had estrogen-dependent cancer, such as cancer of the uterine lining (endometrium), or if there is a suspicion of such cancer.
- If you have unexpected genital bleeding that has not been investigated by a doctor.
- If you have severe thickening of the uterine lining ( endometrial hyperplasia ) and are not treated for it.
- If you have or have had a blood clot in a vein (venous thromboembolism ) in your legs (deep vein thrombosis ) or in your lungs ( pulmonary embolism ).
- If you have a coagulation disorder, a condition with an increased risk of blood clots (lack of protein C, protein S, or antithrombin).
- If you have or have had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina.
- If you have or have had any liver disease and still have abnormal liver values.
- If you are allergic (hypersensitive) to estradiol, norethisterone acetate, or any of the other ingredients of Novofem (listed in section 6 “Contents of the pack and other information”).
- If you have porphyria, a rare inherited blood disorder.
If any of the above affects you for the first time when you use Novofem, stop taking Novofem and contact your doctor immediately.
Warnings And Cautions
Talk to your doctor if you have had any of the following problems before starting treatment. They may recur or worsen during treatment with Novofem. Should this occur, you should have more frequent check-ups with a doctor:
- If you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis, or have had endometrial hyperplasia (severe thickening of the uterine lining)
- If you have an increased risk of getting a blood clot (see below “Blood clots in a vein (venous thromboembolism )”)
- If a close relative has had breast cancer or other estrogen-dependent cancer
- High blood pressure
- Liver disease eg liver adenoma (benign tumor )
- Diabetes
- Gallstone disease
- If you get a migraine or severe headache
- If you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
- Epilepsy
- Asthma
- Otosclerosis (ossification of the middle ear leading to a hearing loss)
- Hypertriglyceridemia (elevated blood lipids)
- Fluid retention due to heart or kidney disease
- Hypothyroidism (the thyroid gland does not produce enough thyroid hormones) and you are treated with thyroid hormone
- Hereditary angioedema (recurrent severe swelling), or if you have had occasional swelling of the hands, face, feet, lips, eyes, tongue, throat (blockage of the respiratory tract), or digestive tract
- Lactose intolerance.
You should contact a doctor immediately and discontinue treatment with Novofem if any of the following occur:
- Some of what is mentioned in the section “Do not take Novofem”.
- If the skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease.
- If your blood pressure rises sharply (symptoms may include headache, fatigue, and dizziness).
- If you are experiencing migraine-like headaches for the first time.
- If you become pregnant.
- If you get symptoms of a blood clot, such as:
- Painful swelling and redness of the legs
- Sudden chest pain
- Breathing difficulties
For further information, see below “Blood clots in a vein (venous thromboembolism )”.
Does Novofem stop periods?
Note: Novofem is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
HRT and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
The use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining and cancer of the uterine lining.
The progestogen in Novofem protects you against this extra risk.
Comparison
For women with the uterus left who do not take HRT, an average of 5 out of 1,000 women aged 50-65 will be diagnosed with endometrial cancer.
For women aged 50–65 who have the uterus left and who take HRT with estrogen alone, 10–60 women out of 1,000 users will be diagnosed with endometrial cancer (ie between 5–55 extra cases) depending on Novofem dosage one and how long it is taken.
Unexpected bleeding
You will have bleeding once a month (so-called dropout bleeding) when you take Novofem. But if you get unexpected bleeding or splashing bleeding in addition to your monthly bleeding, and these:
- Lasts longer than 6 months
- Starts after taking Novofem for 6 months
- Continues after you stop taking Novofem
you should see a doctor as soon as possible.
Breast cancer
Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen, or with estrogen alone, increases the risk of breast cancer. The increased risk depends on how long you use Novofem HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used Novofem HRT for more than 5 years.
Comparison
- For women aged 50 to 54 who do not take HRT, an average of 13 to 17 out of 1,000 will be diagnosed with breast cancer over 5 years.
- In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1,000 users (ie 0-3 extra cases) will occur.
- In women who are 50 years old and start taking HRT with estrogen-progestogen for 5 years, there will be 21 cases per 1,000 users (ie 4-8 extra cases).
- Among women aged 50–59 who do not use Novofem HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over 10 years.
- In women who are 50 years old and start taking HRT with estrogen alone for 10 years, 34 cases per 1,000 users (ie 7 extra cases) will occur.
- In women who are 50 years old and start taking HRT with estrogen-progestogen for 10 years, 48 cases per 1,000 users (ie 21 extra cases) will occur.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- Indentations or pits
- Changes in the nipple
- Nodules you can see or feel
It is also recommended that you participate in a mammogram when you are called. At the mammogram, you must tell the nurse/healthcare professional who performs the examination that you are using HRT, as this medicine may increase the density of the breasts.
An increased density in the breasts can make it more difficult to detect lumps on mammography images.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much rare than breast cancer. The use of HRT with estrogen alone or combined estrogen progestogens has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2000 aged 50 to 54 who do not take HRT for 5 years. For women who have taken HRT for 5 years, there will be about 3 cases per 2000 users (ie about 1 extra case).
How HRT affects the heart and blood circulation
Blood clots in a vein (venous thromboembolism )
The risk of blood clots in the veins is 1.3–3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.
You are more likely to get a blood clot in a vein if any of the following apply to you. Tell your doctor if any of the following apply to you:
- You have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)
- You are severely overweight ( BMI over 30 kg / m 2 )
- You have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- If a close relative has had a blood clot in the bone, lung, or another organ
- You have SLE (systemic lupus erythematosus)
- You have cancer.
The symptoms of blood clots are described in the section “You should contact a doctor immediately and discontinue treatment with Novofem”.
Comparison
For women in their 50s who do not take HRT, an average of 4-7 out of 1,000 people are expected to have a blood clot in a vein over 5 years.
For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9-12 out of 1,000 users are expected to get a blood clot in a vein (ie 5 extra cases).
Heart disease (Heart attack)
There is no evidence that HRT prevents heart attacks. For women over 60 who take HRT with estrogen-progestogen, the risk of developing heart disease is slightly higher than for those who do not take HRT.
Stroke
The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.
Comparison
For women in their 50s who do not take HRT, an average of 8 out of 1,000 are expected to have a stroke over 5 years.
For women in their 50s who take HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases).
Other conditions
The use of HRT preparations does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Other medicines and Novofem
Some medicines may affect the way Novofem works, which may lead to irregular bleeding. The following applies:
- Medicines for epilepsy (eg phenobarbital, phenytoin, and carbamazepine).
- Medicines for tuberculosis (eg rifampicin and rifabutin).
- Medicines for HIV infection (eg nevirapine , efavirenz, ritonavir and nelfinavir).
- Medicines for hepatitis C infection (such as telaprevir).
- An herbal medicine containing St. John’s wort ( Hypericum perforatum ).
Other medicines may increase the effect of Novofem:
- Medicines containing ketoconazole (antifungal agent).
Novofem may affect ciclosporin when used concomitantly.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
Results from blood tests analyze
If you need to take a blood sample, tell your doctor or the person taking the blood sample that you are taking Novofem, as this may affect the results of some tests.
Novofem With Food And Drink
The tablets can be taken with or without food and drink.
Pregnancy And Breastfeeding
Novofem and pregnancy:
- Novofem is for women whose period has stopped.
- If you become pregnant, stop taking Novofem and consult a doctor.
- Breastfeeding: You should not use Novofem if you are breastfeeding.
Driving And Using Machines
Novofem hrt has no known influence on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the possible side effects of Novofem that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects of Novofem can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important Information About A Substance In Novofem
Novofem hrt contains lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Novofem.
How To Take Novofem hrt?
How long does Novofem take to work?
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Unless you are switching from another HRT product, you can start treatment with Novofem on any day. If you are switching from another HRT product, ask your doctor how long does novofem take to work and when to start treatment with Novofem.
Take one tablet daily at about the same time.
Each pack contains 28 tablets.
- Day 1–16 Take one red tablet every day for 16 days
- Day 17–28 Take one white tablet every day for 12 days
Take the tablets with a glass of water.
Once you have completed a package, start on a new package without interruption. Menstrual-like bleeding usually occurs when you start on a new pack.
For further information on how to use calendar packaging, see INSTRUCTIONS FOR USE at the end of the package leaflet.
Your doctor will strive to give you the lowest Novofem dosage which will give you relief of symptoms, and you should use Novofem for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the Novofem dosage is too high.
Contact your doctor if you do not get symptom relief after 3 months of treatment. You should only continue treatment as long as the Novofem benefits outweigh the risks.
If You Take More Novofem Than You Should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. An estrogen overdose can cause
- Chest tightness
- Nausea
- Vomiting
- Irregular vaginal bleeding ( metrorrhagia )
Overdose of progestogens can lead to
- Depression
- Fatigue
- Acne
- Heavy hair growth on the face and body ( hirsutism ).
If You Forget To Take Novofem
If you forget to take your tablet, you should take it within 12 hours from the usual time. If more than 12 hours have passed, take the next tablet, as usual, the next day. Do not take a double dose to make up for a forgotten tablet.
Missing a dose can increase the likelihood of breakthrough bleeding and splashing bleeding.
If You Stop Taking Novofem
If you want to stop taking Novofem, first discuss this with your doctor. The doctor will explain what it means to stop taking the tablets and inform about other alternatives.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
If you need surgery
If you are going to have surgery, tell your surgeon that you are taking Novofem. You may need to stop taking Novofem for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein (venous thromboembolism )”). Ask your doctor when it is appropriate to start taking Novofem again.
Possible Novofem Side Effects
Side effects of Novofem
Like all medicines, Novofem side effects cause some problems, although not everybody gets them.
The following diseases are more common in women who take HRT than those who do not:
- Breast cancer
- Severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
- Ovarian cancer ( ovarian cancer )
- Blood clots in veins in bones or lungs (venous thromboembolism )
- Heart disease
- Stroke
- Probable memory loss, if treatment with HRT is started after the age of 65.
See section 2 “What you need to know before you take Novofem” for more information on these Novofem side effects.
(uncommon side effects of Novofem – may affect up to 1 in 100 people)
- Hypersensitivity/allergy
Although a less common side effect of Novofem, hypersensitivity/allergy may occur.
Signs of hypersensitivity/allergy may include one or more of the following symptoms:
- Hives
- Itching
- Swelling
- Difficulty breathing
- Low blood pressure (pale, cold skin, palpitations)
- Dizziness
- Sweating
These may be signs of a so-called anaphylactic reaction/shock. If you get any of the listed symptoms, stop taking Novofem immediately and contact a doctor immediately.
Very common Novofem side effects (may affect more than 1 user in 10)
- Headache
- Tenderness in the breasts.
Common Novofem side effects (may affect up to 1 in 10 people)
- Increased blood pressure, worsening of high blood pressure
- Fungal infection of the abdomen
- Dizziness, insomnia, depression
- Indigestion, abdominal pain, gas in the stomach
- Nausea
- Skin rash, itching
- Vaginal bleeding (see section 2, subheading “Irregular bleeding”)
- Deterioration of uterine fibroid (benign genital tumor )
- Edema (swollen hands, ankles, and feet)
- Weight gain.
Uncommon Novofem side effects (may affect up to 1 in 100 people)
- Migraine
- Altered sexual desire ( libido )
- Blood clot ( peripheral embolism, thrombosis )
- Vomiting
- Gallbladder disease, gallstones
- Hair loss
- Muscle cramps.
Rare Novofem side effects (may affect up to 1 in 1,000 people)
- Allergic reaction
- Nervousness
- Dizziness
- Diarrhea
- Driving up
- Acne
- Uterine fibroid (benign tumor of the abdomen).
Has been reported (occurs in an unknown number of users):
- Severe thickening of the uterine lining ( endometrial hyperplasia )
- Increased hair growth on the body and face
- Anxiety
- Visual disturbances
- Seborrhea (increased sebum formation in the skin’s sebaceous glands, which gives the skin an oily appearance)
- Itching in the abdomen.
Other side effects are HRT combination products
The following Novofem side effects have been reported with other HRTs:
- Various skin diseases:
- Dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
- Painful reddish-purple bumps on the skin (erythema nodosum)
- Annular redness or sore rash (erythema multiforme)
- Red or purple discolorations on the skin and/or mucous membranes ( vascular purpura)
- Dry eyes
- Changes in the tear film composition.
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 the carton after “EXP”. The expiration date is the last day of the specified month.
- Do not store above 25 ° C. Store in a cold place.
- Store the container in the outer carton. Sensitive to 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.
Contents Of The Pack And Other Information
Content Declaration
- 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
- Corn starch
- Hydroxypropyl cellulose
- Talc
- Magnesium stearate
- Film coating:
- (Red tablet) contains hypromellose
- Talc, titanium dioxide (E171)
- Propylene glycol
- Red iron oxide (E172)
- Film coating (white tablet) contains
- Hypromellose,
- Triacetate,
- Talc
What The Medicine Looks Like And Contents Of The Pack
- The film-coated tablets are round with a diameter of 6 mm. The red tablets are labeled NOVO 282. The white tablets are labeled NOVO 283.
- Each pack of 28 tablets contains 16 red tablets and 12 white tablets.
- Pack sizes:
- 1 x 28 film-coated tablets
- 3 x 28 film-coated tablets
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd
Denmark
This medicinal product is authorized under the European Economic Area under the names:
All countries (excerpt below): Novofem
France: Novofemme
Spain: Duofemme.