Primolut-nor

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Primolut-Nor, 5 mg, tablets

(Norethisterone acetate)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 adverse reactions, including any adverse reactions not listed in this leaflet, they should inform 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 pack and other information

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

Primolut-Nor contains a progestogen (norethisterone acetate), a synthetic 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. If any of these conditions occur during treatment with Primolut-Nor, the medicine should be stopped immediately.

When not to take Primolut-Nor

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

• smoking;
• diabetes (a metabolic disease with high blood sugar levels);
• obesity;
• high blood pressure;
• valvular heart disease or heart rhythm disorders;
• superficial vein inflammation;
• varicose veins;
• 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, herpes gestationis, Sydenham's chorea);
• skin discoloration (yellow-brown pigment changes, so-called chloasma) currently or in the past; in this case, excessive sun exposure or ultraviolet radiation should be avoided;
• hereditary angioedema. If symptoms of angioedema occur, such as facial swelling, tongue or throat swelling, and (or) difficulty swallowing or hives with shortness of breath, medical attention should be sought 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, the patient should consult their doctor.

Oral contraception and thrombosis

Thrombosis is 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 incidence of thromboembolic complications compared to women who do not use oral contraceptives. Thrombosis can occur 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 risk of thromboembolic disease is higher 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). They can occur exceptionally rarely in the liver, intestine, kidney, or eye.

When to contact a doctor

• Regular check-ups During treatment with Primolut-Nor, the doctor will inform the patient about the need for regular medical check-ups.
• The patient should contact their doctor immediately if:
• they notice worrying changes in their health, especially if they concern the conditions listed in this leaflet (see also "When not to take Primolut-Nor" and "Warnings and precautions". The patient should also remember the points related to their close relatives);
• a breast lump is detected;
• they plan to take other medicines (see also "Primolut-Nor and other medicines");
• they are going to be immobilized or plan to have surgery (they should inform their doctor at least 4 weeks in advance);
• they experience heavy vaginal bleeding.
• The patient should stop taking Primolut-Nor and consult their doctor immediately if they notice potential symptoms of thrombosis:
• unexplained cough;
• chest pain or tightness, 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 organs (hearing, smell, or touch);
• dizziness or fainting;
• numbness or weakness of a body part;
• severe pain or swelling of the legs.
• The patient should also stop taking Primolut-Nor and contact their doctor as soon as possible if they 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. Thrombosis can rarely cause disability or death. The risk of venous or arterial thrombotic events, thromboembolic events, or cerebrovascular incidents increases with:

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

If symptoms suggesting thrombosis occur, the patient should stop taking the tablets and consult their doctor immediately (see "When to contact a doctor").

Oral contraception and cancer

In women taking oral contraceptives, breast cancer is slightly more common 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 frequently examined and breast cancer is detected earlier. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping oral contraceptives. Regular breast exams should be performed, and the doctor should be consulted if any lump is felt. In women taking combined oral contraceptives, rare cases of benign or, even more rarely, malignant liver tumors have been reported, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, the doctor should be informed as soon as possible. There are reports of a more frequent occurrence of cervical cancer in women taking oral contraceptives for a long time. However, this relationship may not be related to taking the tablets but to sexual behavior or other factors, such as human papillomavirus infection.

Primolut-Nor and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor will provide information on whether additional contraceptive methods should be used and, if so, for how long. Some medicines may affect the level of Primolut-Nor in the blood, may reduce itseffectiveness, and 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, such as:

• those containing cyclosporin
• antiepileptic drugs - lamotrigine (may lead to an increased frequency of seizure attacks)
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and (or) muscle spasms) 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). Primolut-Nor can be resumed about 2 weeks after the end of treatment. See "When not to take Primolut-Nor".

Laboratory tests Before undergoing a blood test, the patient should inform their doctor or laboratory staff about 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 and use machines is not known.

Primolut-Nor contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Primolut-Nor

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

• Functional bleeding The patient 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 the treatment, Primolut-Nor tablets should be taken for the full 10 days. Within 2 to 4 days after the end of treatment, withdrawal bleeding will occur, comparable in abundance and duration to a normal menstrual period. Sometimes, after initial cessation of bleeding, minor bleeding may occur. In this case as well, the patient should continue taking the medicine. If, despite proper use of the medicine, the vaginal bleeding does not stop, other conditions should be considered. Appropriate tests are then recommended. This also applies to cases where, after initial cessation of bleeding, a relatively heavy recurrence of bleeding occurs during tablet intake.

If the bleeding does not stop, the patient should contact their doctor.

To prevent recurrent functional bleeding in patients with anovulatory cycles, Primolut-Nor can be taken prophylactically (1 tablet 1 to 2 times a day from the 16th to the 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 the bleeding stops, the dose should be considered for reduction 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 the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Overdose of Primolut-Nor

There are no reports of serious adverse reactions after taking multiple Primolut-Nor tablets at once. If a higher dose of the medicine is taken than recommended or if someone else takes it, the doctor should be informed.

Missing a dose of Primolut-Nor

A double dose should not be taken to make up for a missed dose. The effectiveness of Primolut-Nor may be reduced if the patient forgets to take a tablet as recommended. If a dose of the medicine is missed, the patient should take the last missed tablet as soon as possible and take the next one at the usual time.

Stopping Primolut-Nor

If there are any further doubts about taking this medicine, the patient should consult their 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, Primolut-Nor can cause side effects, although not everybody gets them. If any of the side effects get worse or if any side effects not listed in this leaflet occur, the patient should tell their 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 related to the medicine. The following side effects are listed according to organ system and frequency.

• Very common (affecting 10 or more people in 100)
• Uterine/vaginal bleeding, including spotting*
• Scanty menstrual periods*

Common (affecting 1 to 10 people in 100)

• Headache
• Nausea
• Amenorrhea*
• Edema

Uncommon (affecting 1 to 10 people in 1,000)

• Migraine

Rare (affecting 1 to 10 people in 10,000)

• Hypersensitivity reactions
• Urticaria
• Rash

Very rare (affecting less than 1 person in 10,000)

• Visual disturbances
• Dyspnea

* in the indication "endometriosis" Reporting side effects If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, https://www.urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Primolut-Nor

The medicine should be stored out of sight and reach of children. The blisters should be stored in the outer packaging to protect them from light. Do not use this medicine after the expiry date stated on the carton. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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, talc, magnesium stearate.

What Primolut-Nor looks like and contents of the pack

Primolut-Nor tablets are white, round, and have a cross sign on one side. The pack contains 2 blisters of 15 tablets each in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bayer AG Kaiser-Wilhelm-Allee 1 51373 Leverkusen Germany

Manufacturer:

Bayer Weimar GmbH und Co. KG Döbereinerstrasse 20 99427 Weimar Germany For more detailed information, the patient should consult their doctor or the representative of the marketing authorization holder: Bayer Sp. z o.o. Al. Jerozolimskie 158 02-326 Warsaw tel.: (22) 5723500 fax: (22) 5723555

Date of last revision of the leaflet: March 2023