Primolut-nor

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Primolut-Nor (Примолут-Нор),

5 mg, tablets

Norethisterone acetate
Primolut-Nor and Примолут-Нор are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Primolut-Nor and what is it used for
• 2. Important information before taking Primolut-Nor
• 3. How to take Primolut-Nor
• 4. Possible side effects
• 5. How to store Primolut-Nor
• 6. Contents of the packaging and other information

1. What is Primolut-Nor and what is it used for

Primolut-Nor contains a progestogen (norethisterone acetate), an artificial equivalent of the natural female hormone (progesterone).

Indications for use of Primolut-Nor

Functional bleeding, endometriosis.

2. Important information before taking Primolut-Nor

Primolut-Nor should not be taken if any of the following conditions are present.
In the event of the occurrence of any of the following conditions during treatment with Primolut-Nor, the use of the medicine should be stopped immediately.

When not to take Primolut-Nor

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if pregnancy is confirmed or suspected;
• if the woman is breastfeeding;
• if there are currently or have been in the past thromboembolic or thrombotic disorders of the veins or arteries (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction) or stroke;
• if there have been or are currently symptoms of thrombosis (e.g., transient ischemic attack, angina pectoris);
• if there have been or are currently cerebrovascular incidents;
• if there is a serious risk factor or multiple risk factors for venous or arterial thrombosis;
• if there has been migraine with focal neurological symptoms, e.g., visual disturbances, speech disturbances, numbness, or weakness of a body part;
• if there is diabetes with vascular complications;
• if there has been or is currently severe liver disease (until liver function test results return to normal);
• if there have been or are currently benign or malignant liver tumors;
• if there has been or is currently a hormone-dependent tumor (breast or genital cancer).

Primolut-Nor should not be taken if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir + paritaprevir + ritonavir and dasabuvir (see also "Primolut-Nor and other medicines").

Warnings and precautions

Before starting to take Primolut-Nor, you should discuss it with your doctor or pharmacist.
The sex hormone (progesterone) contained in this medicine is partially converted to estrogen. Therefore, in addition to the warnings related to the use of Primolut-Nor, you should also consider the general warnings related to the use of combined oral contraceptives.
If Primolut-Nor is used in any of the following cases, special and systematic medical supervision is necessary. Therefore, before starting to take Primolut-Nor, the patient should inform the doctor about the presence of:

• smoking habits,
• diabetes (a metabolic disease with elevated blood sugar levels),
• obesity,
• high blood pressure,
• valvular heart disease or heart rhythm disorders,
• superficial vein inflammation,
• varicose veins,
• cases of thrombosis, myocardial infarction, or stroke in close relatives;
• migraine,
• epilepsy,
• increased blood lipid levels (hypertriglyceridemia) or a positive family history for this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis,
• breast cancer in close relatives,
• depression,
• liver or gallbladder disease,
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• systemic lupus erythematosus (SLE),
• hemolytic-uremic syndrome (a blood clotting disorder that causes kidney failure),
• sickle cell anemia,
• diseases that occurred for the first time or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, pregnancy herpes, Sydenham's chorea),
• skin discoloration (yellow-brown pigment changes, so-called chloasma) currently or in the past; in this case, you should avoid excessive sun exposure or ultraviolet radiation,
• hereditary angioedema. In case of symptoms of angioedema, such as facial swelling, tongue or throat swelling, and (or) difficulty swallowing or shortness of breath, you should consult a doctor immediately (estrogens may cause or worsen symptoms of this disease).

If any of the above symptoms occur for the first time, recur, or worsen during treatment with Primolut-Nor, you should contact your doctor.

Oral contraception and thrombosis

Thrombosis involves the formation of a blood clot that can block blood vessels. Epidemiological studies indicate that the use of oral contraceptives containing estrogen/progestogen is associated with an increased frequency of thromboembolic complications compared to women who do not use oral contraceptives.
Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis of the legs). If a fragment of the clot breaks off from the site where it forms, it can block the arteries in the lungs and cause pulmonary embolism. Deep vein thrombosis is rare; it can occur even when not taking the medicine, e.g., during pregnancy. The risk of thrombosis is higher in women taking hormonal medicines than in others, but not as high as during pregnancy.
The increased risk of thromboembolic disease occurs in the postpartum period. Blood clots can also, although very rarely, occur in the blood vessels of the heart (causing a heart attack) or brain (causing a stroke). Extremely rarely, they occur in the liver, intestine, kidney, or eye.

When to contact a doctor

• Regular check-ups During treatment with Primolut-Nor, the doctor will inform you about the need for regular medical check-ups.
• You should contact your doctor immediately if:
• you notice worrying changes in your health, especially if they concern the conditions listed in this leaflet (see also "When not to take Primolut-Nor" and "Warnings and precautions". You should also remember the points concerning close relatives);
• a breast lump is found;
• you plan to take other medicines (see also "Primolut-Nor and other medicines");
• you may be immobilized or plan to have surgery (you should inform your doctor at least 4 weeks in advance);
• there is heavy vaginal bleeding.
• You should stop taking Primolut-Nor and consult a doctor if you notice potential symptoms of thrombosis:
• cough without a clear cause;
• feeling of pain or pressure in the chest, which may radiate to the left arm;
• shortness of breath;
• more frequent, extremely severe, or prolonged headaches or migraine attacks;
• partial or complete loss of vision or double vision;
• slurred speech or loss of speech ability;
• sudden disturbances of sensory organ function (hearing, smell, or sensation);
• dizziness or fainting;
• numbness or weakness of a body part;
• severe pain or swelling of the legs.
• You should also stop taking Primolut-Nor and contact your doctor as soon as possible if you notice the following symptoms:
• jaundice (yellowing of the skin, whites of the eyes, which may be symptoms of liver inflammation);
• severe, generalized itching;
• high blood pressure;
• pregnancy.

The situations and symptoms listed above are described in more detail in other parts of this leaflet.
Occasionally, thrombosis can cause disability or death.
The risk of venous or arterial thromboembolic events, thrombotic events, or cerebrovascular incidents increases with:

• age;
• overweight;
• cases of thrombosis in a leg, lung (pulmonary embolism), or other organ in a young age;
• cases of myocardial infarction or stroke in a young age;
• the need for surgery, prolonged immobilization, or a serious accident. It is essential to tell your doctor that you are taking Primolut-Nor, as it may be necessary to stop taking the medicine. The doctor will tell you when to resume taking Primolut-Nor. This usually happens about 2 weeks after you are back on your feet.
• smoking. It is recommended to quit smoking when taking Primolut-Nor, especially if you are over 35 years old;
• increased blood lipid levels (cholesterol or triglycerides);
• high blood pressure;
• migraine;
• heart problems (valvular heart disease, heart rhythm disorders).

In case of symptoms suggesting thrombosis, you should stop taking the tablets and consult a doctor immediately (see "When to contact a doctor").

Oral contraception and cancer

In women taking oral contraceptives, the occurrence of breast cancer is slightly more frequent than in women of the same age who do not take them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women taking hormonal contraceptives are more often examined and breast cancer is detected earlier in them.
The described difference in the frequency of breast cancer decreases gradually and disappears within 10 years after stopping the use of oral contraceptives. You should regularly examine your breasts and contact your doctor if you feel any lump.
In women taking combined oral contraceptives, rare cases of benign or, even more rarely, malignant liver tumors have been reported, which caused life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, you should inform your doctor as soon as possible.
There are reports of a more frequent occurrence of cervical cancer in women who have been taking oral contraceptives for a long time. However, this relationship may not be related to the use of tablets but to sexual behavior or other factors, e.g., human papillomavirus infection.

Primolut-Nor and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The doctor will provide information on whether you should use additional contraceptive methods and, if so, for how long.
Certain medicines may affect the level of Primolut-Nor in your blood, may reduce itseffectivenessand may cause unexpected bleeding.
These include:

• medicines used to treat: epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate) tuberculosis (e.g., rifampicin) HIV or hepatitis C virus infections (so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) fungal infections (griseofulvin, azole antifungal agents, such as itraconazole, voriconazole, fluconazole) bacterial infections (macrolide antibiotics, such as clarithromycin, erythromycin) certain heart diseases, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem) arthritis, degenerative joint disease (etoricoxib) high blood pressure in the blood vessels of the lungs (bosentan)
• preparations containing St. John's wort ( Hypericum perforatum), used mainly to treat depressive moods
• grapefruit juice

Primolut-Nor may affect the action of other medicines, e.g.,:

• containing cyclosporine
• antiepileptic - lamotrigine (may lead to an increased frequency of seizure attacks)
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and (or) muscle cramps)

Primolut-Nor should not be taken if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir + paritaprevir + ritonavir and dasabuvir, as this may cause elevated liver function test results (increased activity of the liver enzyme ALT). You can resume taking Primolut-Nor about 2 weeks after completing treatment. See "When not to take Primolut-Nor".
Laboratory tests
Before undergoing a blood test, you should inform your doctor or laboratory staff that you are taking Primolut-Nor, as it may affect the test results.

Primolut-Nor with food and drink

The tablets should be swallowed whole, with a small amount of liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Taking Primolut-Nor during pregnancy is contraindicated.
Primolut-Nor should not be taken during breastfeeding.

Driving and using machines

The effect of Primolut-Nor on the ability to drive vehicles and operate machinery is not known.

Primolut-Nor contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Primolut-Nor

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult your doctor.
The tablets should be swallowed whole, with a small amount of liquid.
If contraceptive protection is necessary, you should use non-hormonal contraceptive methods (e.g., condoms) instead of contraceptive tablets. If there is a suspicion that you are pregnant despite taking contraceptives, you should stop taking the medicine until the situation is clarified.
How to take Primolut-Nor

• Functional bleeding You should take one Primolut-Nor tablet 3 times a day for 10 days. In most cases, this will stop the uterine bleeding that is not related to organic changes within 1 to 3 days. However, to ensure the effectiveness of Primolut-Nor treatment, you should take it for the full 10 days. Within 2 to 4 days after completing treatment, withdrawal bleeding will occur, comparable in terms of abundance and duration to a normal menstrual period.

Sometimes, after initial bleeding cessation, minor bleeding may occur. Even in this case, you should continue taking the medicine.
If, despite proper use of the medicine, vaginal bleeding does not stop, you should consider other conditions. Appropriate tests are then recommended. This also applies to cases where, after initial bleeding cessation, a relatively heavy recurrence of bleeding occurs during tablet use.

If bleeding does not stop, you should contact your doctor.

To prevent recurrent functional bleeding in patients with anovulatory cycles, Primolut-Nor can be used prophylactically (1 tablet 1 to 2 times a day from

• 16th to 25th day of the cycle (1st day of the cycle = 1st day of the last menstrual period). Within a few days after taking the last tablet, withdrawal bleeding will occur.
• Endometriosis Treatment should be started between the 1st and 5th day of the cycle with 1 Primolut-Nor tablet taken 2 times a day. In case of spotting, the dose can be increased to 2 tablets taken 2 times a day. If bleeding stops, you should consider reducing the dose to the initial dose. Treatment should be continued for at least 4 to 6 months. With uninterrupted use of the medicine, ovulation and menstruation usually do not occur. If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Using a higher dose of Primolut-Nor than recommended

There are no reports of serious side effects after taking multiple Primolut-Nor tablets at the same time. If you have taken a higher dose of the medicine than recommended or someone else has taken it, you should inform your doctor.

Missing a dose of Primolut-Nor

You should not take a double dose to make up for a missed dose.
The effectiveness of Primolut-Nor may be reduced if you forget to take a tablet as recommended. If you miss a dose, you should take the last missed tablet as soon as possible and take the next one at the usual time.

Stopping Primolut-Nor

If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.
The medicine can be stopped at any time. There are no specific symptoms resulting from stopping Primolut-Nor. However, there is a possibility of recurrence of initial symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects get worse or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects occur more frequently during the first few months of taking Primolut-Nor and subside during treatment. In addition to the side effects listed in "Warnings and precautions", the following side effects have been observed in patients taking Primolut-Nor, although not all cases could be confirmed to be causally related to the medicine.

The following side effects are listed according to organ system and frequency of occurrence.
Very common (may affect up to 1 in 10 people)

• Uterine/vaginal bleeding, including spotting*,
• Scanty menstrual periods*

Common (may affect up to 1 in 100 people)

• Headache
• Nausea
• Absence of bleeding*,
• Edema

Uncommon (may affect up to 1 in 1,000 people)

• Migraine

Rare (may affect up to 1 in 10,000 people)

• Hypersensitivity reactions
• Hives
• Rash

Very rare (may affect up to 1 in 10,000 people)

• Visual disturbances
• Shortness of breath

* in the indication "endometriosis"

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Primolut-Nor

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the box. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Primolut-Nor contains

The active substance of the medicine is 5 mg norethisterone acetate (Norethisterone acetate).
The other ingredients are: lactose monohydrate, cornstarch, povidone 25,000, talc, magnesium stearate.

What Primolut-Nor looks like and contents of the pack

PVC/Al blisters in a cardboard box.
The pack contains 30 tablets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer:

Bayer Weimar GmbH und Co. KG
Doebereinerstrasse 20
99427 Weimar
Germany

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska Street 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska Street 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka Street 190
91-610 Łódź
Marketing authorization number in Bulgaria, the country of export: 9900329

Parallel import authorization number: 155/22 Date of leaflet approval: 04.04.2022

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