1 mg / 0.5 mg film-coated tablets
estradiol / norethisterone acetate
What Noresmea is and what it is used for
Noresmea is a preparation used for continuous hormonal replacement therapy ( Hormone Replacement Therapy, HRT ). It contains two female sex hormones; estrogen and progestogen. Noresmea is used for women whose menstruation has stopped ( menopause ), at least 1 year after their last natural menstruation.
Noresmea is used to:
- Relieve symptoms during and after menopauseWhen menstruation ends ( menopause ), the woman’s estrogen decreases . It can cause problems such as sweating and hot flashes. Noresmea relieves these symptoms after menopause . Noresmea should only be used if the problems cause problems in daily life.
- Prevent osteoporosisAfter 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 Noresmea to prevent osteoporosis after menopause .
Noresmea is prescribed for women who have their uterus left and who had their last period more than a year ago.
Experience in the treatment of women older than 65 years with Noresmea is limited.
Estradiol and norethisterone acetate found in Noresmea may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Noresmea
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 Noresmea, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.
Get regular check-ups of your breasts according to your doctor’s recommendations.
Do not take Noresmea
if any of the following apply to you. If you are not sure, talk to your doctor before taking Noresmea.
- If you have, have had or suspect you may have breast cancer .
- 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 endometrial hyperplasia (severe thickening of the uterine lining) and are not being 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 recently had a disease caused by a blood clot 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 have porphyria , a rare inherited blood disorder.
- If you are allergic to estradiol, norethisterone acetate or any of the other ingredients of this medicine (listed in section 6).
If any of the above affects you for the first time when you use Noresmea, stop taking Noresmea and contact your doctor immediately.
Warnings and cautions
Talk to your doctor or pharmacist before taking Noresmea.
Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Noresmea. Should these 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)
- increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)
- increased risk of developing estrogen-dependent cancer (eg if you have a mother, sister or grandmother / grandmother who has had breast cancer)
- high blood pressure
- liver disease eg liver adenoma (benign tumor )
- diabetes
- gallstone disease
- migraine or severe headache
- systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
- epilepsy
- asthma
- otosclerosis (ossification of the middle ear leading to hearing loss)
- hypertriglyceridemia (elevated blood lipids)
- fluid retention due to heart or kidney disease
- lactose intolerance.
You should contact your doctor immediately and discontinue treatment with Noresmea if any of the following occur:
- any of the things mentioned in the section “Do not take Noresmea”
- if 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 or 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 more information, see below “Blood clots in a vein ( thrombosis )”.
Note: Noresmea 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 Noresmea protects you against this extra risk.
Irregular DNA bleeding
Irregular spotting or spotting may occur during the first 3-6 months of taking Noresmea.
But about the bleeding
- lasts longer than 6 months
- begins after taking Noresmea for 6 months
- continues after you stop taking Noresmeayou 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 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 HRT for more than 5 years.
Comparison
Of 1,000 women aged 50 to 54 who do not take HRT, an average of 13 to 17 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, 21 cases per 1,000 users (ie 4-8 extra cases) will occur.
Among women aged 50–59 who do not use 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 of the nipple
- nodules you can see or feel.
It is also recommended that you participate in a mammography examination when you are called to do so. 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 the mammography images.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much more rare than breast cancer. 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 2,000 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 2,000 users (ie about 1 extra case).
How HRT affects the heart and blood circulation
Blood clots in a vein ( thrombosis )
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 other organ
- you have SLE (systemic lupus erythematosus)
- you have cancer.
The symptoms of a blood clot are described in the section “You should contact a doctor immediately and discontinue treatment with Noresmea if any of the following occur”.
Comparison
For women in their 50s who do not take HRT, an average of 4–7 out of 1,000 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-progestin, 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 people are expected to have a stroke over 5 years. For women in their 50s who take HRT, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases) over 5 years.
Other conditions
Using HRT 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 Noresmea
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the way Noresmea works, which may lead to irregular bleeding. The following applies:
- antiepileptic drugs (eg phenobarbital, phenytoin and carbamazepine)
- drugs against tuberculosis (eg rifampicin and rifabutin)
- medicines for HIV infection (eg nevirapine, efavirenz, ritonavir and nelfinavir)
- herbal medicine containing St. John’s wort ( Hypericum perforatum )
- medicines for hepatitis C infections (eg telaprevir).
Other medicines may increase the effect of Noresmea:
- medicines containing ketoconazole (antifungal agents).
Noresmea may affect cyclosporine when used concomitantly.
Results from blood test analyze
If you need to take a blood sample, tell your doctor, or the person taking the blood sample, that you are taking Noresmea as it may affect the results of some tests.
Noresmea with food and drink
The tablets can be taken with or without food and drink.
Pregnancy and breastfeeding
- PregnancyNoresmea is for women whose menstruation has stopped. If you become pregnant, stop taking Noresmea and contact your doctor.
- Breast-feedingYou should not use Noresmea if you are breast-feeding.
Driving and using machines
Noresmea 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 factors 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 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.
Noresmea contains lactose
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 Noresmea
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Take one tablet daily at about the same time without pausing between tablets
When you start taking Noresmea, take the first tablet where the day of the week is indicated on the tablet map. Then follow the direction of the arrows from the first tablet and take one tablet every day, until the tablet map is finished. When you have taken all 28 tablets in calendar pack one, you continue immediately without interruption with the next pack.
You can start treatment with Noresmea on any day. However, if you switch from an HRT preparation when you have your monthly bleeding, you should start treatment immediately after the bleeding has stopped.
Your doctor should strive for you to take the lowest dose that gives you symptom relief and that you should use Noresmea for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.
If you need surgery
If you are having surgery, tell your surgeon that you are taking Noresmea. You may need to stop taking Noresmea for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis ) ” ). Ask your doctor when it is appropriate to start taking Noresmea again.
If you take more Noresmea 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. Overdose of Noresmea may cause nausea and vomiting.
If you forget to take Noresmea
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, skip this dose and 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 spotting if you still have your uterus.
If you stop taking Noresmea
If you want to stop taking Noresmea, you should 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 on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity/allergy (uncommon: may affect up to 1 in 100 people)
Although less common, hypersensitivity/allergy may occur and 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 Noresmea immediately and seek medical advice immediately.
See section 2, “What you need to know before you take Noresmea”, for more information on these side effects.
The following diseases are more common in women who take HRT than in 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 for more information on these side effects .
The following side effects have been observed during treatment with the active substances in Noresmea:
Very common: may affect more than 1 user in 10
- chest pain or tenderness in the breasts
- vaginal bleeding.
Common: may affect up to 1 in 10 users
- fungal infection of the vagina
- inflammation of the vagina
- weight gain due to accumulation of fluid in the body
- depression or worsening of current depression
- headache
- migraine or worsening of current migraine
- nausea
- back pain
- breast enlargement or tightness in the breasts (breast edema)
- uterine fibroid (benign tumor ), worsening or recurrence of tumor
- swollen arms and legs (peripheral edema )
- weight gain.
Uncommon: may affect up to 1 in 100 people
- allergic reaction
- nervousness
- superficial venous inflammation (superficial thrombophlebitis )
- abdominal pain, tension or discomfort in the stomach, flatulence
- hair loss, increased hair growth on body and face, acne
- itching
- hives ( urticaria )
- no effect
- leg cramps.
Rare: may affect up to 1 in 1,000 users
- blood clots in the blood vessels of the legs or lungs (deep vein thrombosis , pulmonary embolism ).
Very rare: may affect up to 1 in 10,000 people
- cancer of the uterine lining (endometrial cancer), severe thickening of the uterine lining ( endometrial hyperplasia )
- insomnia
- anxiety
- altered sex drive
- dizziness
- visual disturbances
- increased blood pressure or worsening of high blood pressure
- heart attack and stroke
- heartburn
- vomiting
- gallbladder disease
- gallstones , deterioration or new occurrence of gallstones
- strong secretion of sebum
- rash
- acute or recurrent edema ( angioneurotic edema )
- itching in the abdomen
- weight loss.
The following side effects have been reported for other HRT with estrogen-progestogen:
- gallbladder disease
- 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).
How to store Noresmea
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 blister and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
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 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg.
- The other ingredients are: lactose monohydrate , corn starch, copovidone, talc and magnesium stearate.
- The film coating contains: hypromellose, hydroxypropylcellulose, talc, hydrogenated cottonseed oil and titanium dioxide.
What the medicine looks like and contents of the pack
Noresmea film-coated tablets are white, round, and biconvex with a diameter of 6 mm.
The tablets are packaged in transparent blister packs of PVC / aluminum.
Pack sizes:
1×28 and 3×28 (84) film-coated tablets in calendar pack.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, German