5 mg tablets
norethisterone acetate
What Primolut-Nor is and what it is used for
Norethisterone acetate is a substance that mimics the female corpus luteum hormone ( progesterone ), which is formed in the ovaries during the second half of the normal menstrual cycle.
Primolut-Nor is used to correct the bleeding pattern in the menstrual cycle such as heavy bleeding, irregular or absent bleeding ( amenorrhea ), to delay menstruation, or relieve problems that may occur before menstruation, so-called PMS, premenstrual disorders. Primolut-Nor is also used in the treatment of endometriosis, ie. when the uterine lining is found outside the uterus.
What you need to know before using Primolut-Nor
Do not use Primolut-Nor
Before starting treatment, you should undergo a thorough medical and gynecological examination including cervical tests and breast examinations.
Vaginal bleeding of unknown cause should be investigated before starting treatment.
Pregnancy should be ruled out before starting treatment. If expected monthly bleeding does not occur, pregnancy must be ruled out before starting a new course of treatment. In case of menstrual delay, Primolut-Nor should only be used in those cycles where it is known with certainty that an early pregnancy does not exist.
Do not use Primolut-Nor:
Do not use Primolut-Nor if you have any of the conditions listed below. Also, stop using Primolut-Nor immediately if any of these conditions occur while you are using the preparation.
- if you are allergic to norethisterone or any of the other ingredients of this medicine (see section 6)
- if you are pregnant or suspect you may be pregnant
- if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs ( pulmonary embolism ), or any other organ
- if you know you have a disease that affects blood coagulation – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies
- if you need to have an operation or if you stay in bed for a longer period (see section “Primolut-Nor and blood clots”)
- if you have (or have had) a heart attack or stroke (stroke)
- if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
- if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- severe diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood ( cholesterol or triglycerides )
- a condition called hyperhomocysteinemia
- if you have (or have had) a type of migraine called “migraine with aura”
- if you have (or have had) liver disease and your liver function is not yet normal
- if you have (or have had) a tumor in your liver
- if you have (or have had) or if you suspect you may have hormone-dependent breast cancer or genital cancer
- if you have unexplained vaginal bleeding
Do not use Primolut-Nor if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section Other medicines and Primolut-Nor).
Warnings and cautions
The active substance contained in this product is partially converted to estrogen. Therefore, certain warnings given in connection with the use of combined oral contraceptives should be taken into account. This applies, for example, to the risk of blood clots.
Tell your doctor if any of the following conditions apply to you.
In some situations, you need to be especially careful when taking Primolut-Nor, and your doctor may need to examine you regularly. Also, consult your doctor if any of the conditions listed below occur for the first time, recur or worsen while you are using Primolut-Nor:
- if a close relative has or has had breast cancer
- if you have any liver or bile disease
- if you have diabetes (a metabolic disease with elevated blood sugar levels)
- if you suffer from depression
- if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
- if you have hemolytic-uremic syndrome (HUS – a disorder of blood coagulation that leads to kidney failure )
- if you have sickle cell anemia (a hereditary disease of the red blood cells )
- if you have high blood fats ( hypertriglyceridemia ) or a hereditary condition. Hypertriglyceridemia has been linked to an increased risk of developing pancreatitis ( inflammation of the pancreas)
- if you need to have an operation or stay in bed for a longer period (see section 2 “Primolut-Nor and Blood Clots”)
- if you have just given birth, you are at increased risk of getting blood clots. Ask your doctor how soon after giving birth you can start using Primolut-Nor
- if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
- if you have varicose veins
- if you have epilepsy (see “Other medicines and Primolut-Nor”)
- if you have a systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)
- if you have a disease that first appeared during pregnancy or during previous use of sex hormones (eg hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (pregnancy herpes), a nerve disease that causes sudden twitching in the body (Sydenhams Korea ))
- if you have or have had chloasma (a discoloration of the skin, especially on the face or neck, so-called “pregnancy spots”). In this case, avoid direct exposure to sunlight or ultraviolet light
- If you have hereditary angioedema, estrogen-containing products may cause or worsen the symptoms. You should see a doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or pharynx, and/or difficulty swallowing or hives together with difficulty breathing
- if you smoke
- if you are overweight (body mass index or BMI over 30 kg / m 2 )
- if you have high blood pressure that is not controlled with treatment
- if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )
- if you or a close relative has had a heart attack or stroke at a young age (younger than 50 years)
- if you or someone in your family has had a blood clot in your legs, lungs, or other organs at a young age (eg under 50 years of age). In this case, you may have a hereditary blood-clotting disease
- if you have migraines
Primolut-Nor and blood clots
The risk of blood clots with temporary or continuous use of Primolut-Nor is not known. If you use combined hormonal contraceptives, the risk of a blood clot increases compared to if you did not take such a preparation. In rare cases, a blood clot can block the blood vessels and cause serious problems
Blood clots can form
- in veins (called venous thrombosis, venous thromboembolism, or VTE)
- in arteries (called arterial thrombosis, arterial thromboembolism, or ATE)
It is not always possible to fully recover from blood clots. In rare cases, they can have serious lasting effects and, in very rare cases, be fatal.
HOW TO FEEL A BLOOD CLOTH AGAIN
Seek medical attention immediately if you notice any of the following signs or symptoms:
Blood clot in the leg (deep vein thrombosis ): swelling of a leg or along a vein in the leg or foot, especially if you also experience pain or tenderness in the leg that is only felt when standing or walking; increased heat in the affected leg or discoloration of the skin on the leg, e.g. pale, red or blue.
Pulmonary thrombosis ( pulmonary embolism ): sudden unexplained shortness of breath or rapid breathing; sudden cough for no apparent reason that could cause you to cough up blood; severe chest pain that may increase with deep breathing; severe instability or dizziness; rapid or irregular heartbeat; severe pain in the abdomen.
Blood clot in the eye ( retinal venous thrombosis ): immediate vision loss or painless blurred vision that can lead to vision loss.
Myocardial infarction: chest pain, discomfort, pressure, heaviness; pressure or feeling of fullness in the chest, arm, or below the sternum; feeling satiated, indigestion or feeling of suffocation; discomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomen; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety or shortness of breath; a fast or irregular heartbeat.
Stroke: sudden weakness or numbness in the face, arms, or legs, especially on one side of the body; sudden confusion, difficulty speaking or understanding; sudden vision problems in one or both eyes; sudden difficulty walking, dizziness, loss of balance or coordination; sudden, severe or prolonged headache without known cause; unconsciousness or fainting with or without seizures.
Blood clots that block other blood vessels: swelling and slight blue discoloration of an arm or leg; severe pain in the abdomen ( acute abdomen).
BLOOD CLOTS IN A FRIEND
What can happen if a blood clot forms in a vein?
The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the vein (venous thrombosis ). However, these side effects are rare. If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT). If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism. In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal venous thrombosis ).
When is the risk of developing a blood clot in a vein greatest?
The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk can also be higher if you start again with a combined hormonal contraceptive (same product or another product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it is always slightly higher than if you do not use a combined hormonal contraceptive.
When you stop using a combined hormonal contraceptive, the risk of a blood clot returns to normal within a few weeks.
How big is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking. However, the overall risk of a blood clot in the leg or lungs (DVT or PE) is small.
Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 develop a blood clot in a year.
It is not yet known how the risk of blood clots when using Primolut-Nor can be compared to the risk of a combined hormonal contraceptive containing levonorgestrel.
| Risk of developing a blood clot during a year | |
| Women who do not use combined pills/patches/rings and who are not pregnant | About 2 out of 10,000 women |
| Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate | About 5-7 out of 10,000 women |
| Women using Primolut-Nor | Currently not known. |
Factors that may increase the risk of a blood clot in a vein
The risk of a blood clot is small but some conditions increase the risk. The risk is higher:
if you are overweight (body mass index or BMI over 30 kg / m 2 ); if you or someone in your family has had a blood clot in your legs, lungs, or other organs at a young age (eg under 50 years of age); if you need to have surgery, or if you stay in bed for a long period due to an injury or illness, or if your leg is plastered; when you get older (especially if you are over about 35 years old); if you gave birth a few weeks ago; for air travel (> 4 hours), especially if you have any of the other factors listed here.
BLOOD CLOTS IN AN ART
What can happen if a blood clot forms in an artery?
In the same way as a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. lead to a heart attack or a stroke.
Factors that may increase the risk of a blood clot in an artery
The risk of a blood clot is small but some conditions increase the risk. The risk is higher:
with increasing age (after about 35 years of age); if you smoke; if you are overweight; if you have high blood pressure that is not controlled with treatment; if you or a close relative has had a heart attack or stroke at a young age (younger than 50 years); if you or a close relative have high blood fats ( cholesterol or triglycerides ); if you get migraines, especially migraines with an aura; if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation ); if you have diabetes.
Primolut-Nor and cancer
Breast cancer has been observed slightly more often in women using combined oral contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who use combined contraceptive pills because they are more often examined by doctors. The risk of breast tumors gradually decreases after stopping treatment with combined hormonal contraceptives. You must check your breasts regularly and you should contact your doctor if you feel any lumps.
In rare cases, benign liver tumors and even more uncommon, malignant liver tumors have been reported in users of hormone-containing drugs such as Primolut-Nor. These tumors can cause internal bleeding.
The most important risk factor for cervical cancer is human papillomavirus infection ( condyloma ). Some studies have shown that long-term use of birth control pills can contribute to an increased risk of cervical cancer. However, it is not clear to what extent this is due to other factors such as sexual habits or the human papillomavirus.
The above-mentioned tumor can be life-threatening or can have a fatal outcome.
Contact your doctor immediately if you experience severe abdominal pain.
Other medicines and Primolut-Nor
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as the treatment effect may be affected if Primolut-Nor is taken at the same time as other medicines.
Some medicines
- may affect the blood concentration of Primolut-Nor
- can make Primolut-Nor less effective
- may cause unexpected bleeding.
This applies
- drugs for the treatment of:
- epilepsy (eg primidone, phenytoin , barbiturate , carbamazepine, oxcarbazepine, topiramate, felbamate)
- tuberculosis (eg rifampicin, rifabutin)
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, eg ritonavir, nevirapine, efavirenz)
- fungal infections (griseofulvin, azoles, eg itraconazole, voriconazole, fluconazole )
- bacterial infections ( macrolides, eg clarithromycin, erythromycin)
- certain heart diseases, high blood pressure (calcium channel blockers, eg verapamil, diltiazem )
- arthritis, osteoarthritis (etoricoxib)
- high blood pressure in the blood vessels of the lungs ( bosentan )
- (traditional) herbal medicines containing St. John’s wort
- grapefruit juice
Primolut-Nor may affect the effects of other medicines, such as:
- medicines containing cyclosporine
- epilepsy drugs containing lamotrigine (may lead to an increased incidence of seizures)
- theophylline (used to treat respiratory problems)
- tizanidine (used to treat muscle pain and/or muscle cramps).
Do not use Primolut-Nor if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may lead to elevated liver values (increases in the liver enzyme ALAT ). Primolut-Nor can be reinstated approximately 2 weeks after the end of this treatment. See section “Do not use Primolut-Nor”.
Laboratory samples
If you need to take a blood sample, tell your doctor or laboratory staff that you are taking Primolut-Nor as this may affect the results of some tests.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Primolut-Nor if you are pregnant or if you suspect you may be pregnant.
Do not use Primolut-Nor while breastfeeding.
Driving and using machines
There are no known effects of Primolut-Nor on the ability to drive or use machines.
How to use Primolut-Nor
Always take Primolut-Nor exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Swallow the tablets whole along with the liquid.
If you have intercourse, you should use non-hormonal contraceptive methods (such as condoms) instead of taking birth control pills. If you suspect that you have become pregnant despite using protection, treatment must be stopped until your condition has been clarified by your doctor.
The following dosages are recommended:
Dysfunctional bleeding (abnormal bleeding)
Take a Primolut-Nor 5 mg tablet twice daily for 10 days. In most cases, this stops the uterine bleeding (uterine bleeding), which is not caused by anatomical abnormalities such as mucosal polyps or muscle knots, within 1 to 3 days, but to ensure the effectiveness of treatment, Primolut-Nor 5 mg must be taken for all 10 days. . Approximately 2 to 4 days after the end of treatment, bleeding occurs, which is of the same amount and duration as during a normal menstrual period.
In some cases, small hemorrhages may occur after the initial hemorrhage has stopped. If this happens, do not stop or stop taking your tablets completely.
If the vaginal bleeding does not stop even though you have taken your tablets properly, pathological conditions and causes unrelated to the genitals must be considered, as it usually requires other measures. This also applies when heavy bleeding occurs while you are taking your tablets after the original bleeding has stopped.
»If the following happens, consult your doctor.
To prevent a recurrence of dysfunctional bleeding (if you do not have menstrual cycles with ovulation), your doctor may decide to take Primolut-Nor 5 mg tablets as prophylaxis (1 tablet 1 to 2 times daily from the 16th to 25th cycle) day (first day of the cycle = first day of the last bleeding) The breakthrough bleeding occurs a few days after you take the last tablet.
Primary and secondary amenorrhea (irregular or missed periods)
Hormone therapy for secondary amenorrhea can only be done after the exclusion of pregnancy. Primary or secondary amenorrhea is sometimes caused by a prolactinoma (a change in a gland in the brain that produces increased amounts of a hormone-like substance called prolactin ) that must be ruled out by your doctor before starting treatment with Primolut-Nor. Your doctor will prescribe estrogen to you (eg for 14 days) before starting Primolut-Nor 5 mg. Then take 1 tablet of Primolut-Nor 5 mg 1 to 2 times daily for 10 days. The breakthrough bleeding occurs within a few days after you take the last tablet. If adequate estrogen production has been achieved in your body, you can try to stop the estrogen treatment and start the bleeding cycle by taking 1 tablet of Primolut-Nor 5 mg twice daily from the 16th to the 25th day of the cycle.
Premenstrual Disorders (PMS)
One tablet of Primolut-Nor 5 mg 1 to 2 times daily during the second half (luteal phase) of the cycle can relieve or improve premenstrual symptoms such as headache, depression, water retention, and chest tightness.
Menstrual shift
Menstrual bleeding can be delayed by using Primolut-Nor 5 mg. However, this method should only be used if you are not at risk of becoming pregnant during the treatment cycle. Take 1 tablet of Primolut-Nor 5 mg twice daily for a maximum of 10 to 14 days, starting approximately 3 days before your expected period. Bleeding will start 2 to 3 days after the end of the medication.
Endometriosis
Start treatment between the 1st and 5th day of the cycle with 1 tablet of Primolut-Nor 5 mg twice daily. If splashing occurs, the dose can be increased to 2 tablets twice daily. If the bleeding stops, you should consider returning to the original dose. Continue treatment for at least 4 to 6 months. With an uninterrupted daily intake, there is usually no ovulation or menstruation. The breakthrough bleeding will occur after the hormone treatment has been completed.
If you take more Primolut-Nor than you should
If you have taken too much medicine, always contact a doctor or hospital.
Symptoms of overdose may include nausea, vomiting, or vaginal bleeding.
If you forget to take Primolut-Nor
The effect of Primolut-Nor may be impaired if you forget to take a tablet as directed. The last missed tablet should be taken as soon as you remember, then continue taking the tablet at the usual time the following day.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Primolut-Nor
There are no special symptoms if you stop taking Primolut-Nor, but there is a risk that you will regain your original symptoms.
Possible side effects
Like all medicines, Primolut-Nor can cause side effects, although not everybody gets them.
Side effects are more common during the first months of treatment with Primolut-Nor and decrease with continued treatment. In addition to the side effects listed in the section “Take special care with Primolut-Nor”, the following side effects have been reported.
Very common (may affect more than 1 user in 10):
- Uterine / Vaginal bleeding including spotting *
- Sparse menstruation (hypomenorrhea) *
Common (may affect up to 1 in 10 people):
- Headache
- Nausea
- Missed periods ( amenorrhea ) *
- Generalized swelling ( edema )
Uncommon (may affect up to 1 in 100 people):
- Migraine
- Acne and seborrhea
- Decreased sex drive
Rare (may affect up to 1 in 1,000 people):
- Hypersensitivity reaction
- Urticaria _ _ _
- Rash
- Itching
Very rare (may affect up to 1 in 10,000 people):
- Visual disturbances
- Shortness of breath ( dyspnoea )
Has been reported (occurs in an unknown number of users):
- Depression
- Impact on liver function
* if used to treat uterine lining outside the uterus ( endometriosis )
How to store Primolut-Nor
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
The expiration date is the last day of the specified month.
Store in the original package. 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 substance is norethisterone acetate.
- The other ingredients are lactose monohydrate, corn starch, povidone 25000, talc, and magnesium stearate.
What the medicine looks like and the contents of the pack
Primolut-Nor is available in blister packs of 20 and 30 tablets.
Marketing Authorisation Holder
Bayer AB
Gustav III: s Boulevard 56
169 74 Solna
Manufacturer:
Bayer Weimar GmbH and Co. KG
99427 Weimar
Germany