Primolut-nor

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this 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 brand names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms appear identical.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the 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 progestagen (norethisterone acetate), a synthetic analogue of the natural female hormone (progesterone).
Indications for Primolut-Nor
Dysfunctional uterine bleeding, endometriosis.

2. Important information before using Primolut-Nor

Do not use Primolut-Nor if any of the conditions described below apply.
If any of the following conditions occur during treatment with Primolut-Nor,
treatment must be stopped immediately.
When not to use Primolut-Nor

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if pregnancy has been confirmed or suspected;
• if the woman is breastfeeding;
• if there are currently present or have occurred in the past venous or arterial thromboembolic disorders (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or stroke;
• if there have been in the past or are currently present symptoms suggestive of thrombosis (e.g. transient ischaemic attack, angina pectoris);
• if there have been in the past or are currently present cerebrovascular incidents;
• if there is a serious risk factor or multiple risk factors for venous or arterial thrombosis;
• if migraine with focal neurological symptoms has occurred, such as visual disturbances, speech disturbances, numbness or partial paralysis;
• if diabetes with vascular complications is present;
• if there has been in the past or is currently present severe liver disease (until liver function tests return to normal values);
• if benign or malignant liver tumours have occurred in the past or are currently present;
• if hormone-dependent cancer (e.g. breast or genital organs cancer) has been diagnosed currently or in the past.

Do not use Primolut-Nor if the patient has hepatitis C and is taking medications
containing ombitasvir + paritaprevir + ritonavir and dasabuvir (see also section "Primolut-Nor and
other medicines").
Warnings and precautions
Before starting Primolut-Nor, discuss this with your doctor or pharmacist.
The sex hormone (progesterone) contained in this medicine is partially converted into
estrogen. Therefore, in addition to the warnings related to the use of Primolut-Nor, general
warnings related to combined oral contraceptives should also be considered.
If Primolut-Nor is used in any of the situations listed below, special and regular medical monitoring is required. Therefore, before starting Primolut-Nor, the patient should inform the doctor about the presence of:

• tobacco smoking,
• diabetes (a metabolic disorder with elevated blood sugar levels),
• obesity,
• high blood pressure,
• heart valve disorder or cardiac arrhythmia,
• superficial phlebitis,
• varicose veins,
• history of thrombosis, heart attack or stroke in close relatives,
• migraine,
• epilepsy,
• elevated blood lipid levels (hypertriglyceridemia) or a positive family history for this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis,
• family history of breast cancer,
• depression,
• liver or gallbladder disease,
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• systemic lupus erythematosus (SLE),
• hemolytic-uremic syndrome (blood clotting disorders causing kidney failure),
• sickle cell anemia,
• diseases that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham's chorea),
• skin pigmentation disorders (yellowish-brown pigmentation changes, so-called chloasma) currently or in the past; in such cases, excessive exposure to sunlight or ultraviolet radiation should be avoided,
• hereditary angioedema. If symptoms of angioedema occur, such as swelling of the face, tongue or throat and (or) difficulty swallowing or urticaria with breathing difficulties, immediate medical advice must be sought (estrogens may cause or worsen symptoms of this disease).

If any of the symptoms listed above occur for the first time, recur or worsen
during treatment with Primolut-Nor, contact your doctor.
Oral contraception and thrombosis
Thrombosis involves the formation of a blood clot that may block blood vessels.
Epidemiological studies indicate that the use of combined oral contraceptives containing
estrogen/progestogen is associated with an increased frequency of thromboembolic
complications compared to women not using any combined oral contraceptives.
Thrombosis sometimes occurs in the deep veins of the lower limbs (deep vein thrombosis of the lower limbs). If a fragment of the clot detaches from its site of formation, it may block arteries in the lungs, causing so-called pulmonary embolism. Deep vein thrombosis is rare; it may occur even when not using medication, e.g. during pregnancy. The risk of thrombosis is higher in women using hormonal medications than in others, but not as high as during pregnancy.
The risk of thromboembolic disease is increased in the postpartum period.
Clots may also, although very rarely, occur in blood vessels of the heart (causing
myocardial infarction) or brain (causing stroke). Exceptionally rare cases may occur in the liver, intestine, kidney or eye.
When to contact your doctor

• Regular check-ups: During treatment with Primolut-Nor, your doctor will inform you about the need for regular medical examinations.
• Contact your doctor immediately if:
• you notice concerning changes in your health, especially those mentioned in this leaflet (see also "When not to use Primolut-Nor" and "Warnings and precautions". Also remember the points regarding close relatives);
• a breast lump is detected;
• you plan to take other medicines (see also "Primolut-Nor and other medicines");
• immobilization or planned surgical procedure is expected (inform your doctor at least 4 weeks in advance);
• heavy vaginal bleeding occurs.
• Stop taking Primolut-Nor immediately and consult your doctor if potential symptoms of thrombosis are observed:
• cough without apparent cause;
• pain or pressure in the chest, possibly radiating to the left arm;
• shortness of breath;
• more frequent, extremely severe or prolonged headaches or migraine attack;
• partial or complete loss of vision or double vision;
• slurred speech or loss of speech;
• sudden sensory disturbances (hearing, smell or touch);
• dizziness or fainting;
• numbness or partial paralysis of any body part;
• severe pain or swelling in the legs.
• Also discontinue Primolut-Nor and contact your doctor as soon as possible if the following symptoms occur:
• jaundice (yellowing of the skin or whites of the eyes, which may be signs of hepatitis);
• severe, generalized itching;
• high blood pressure;
• pregnancy.

The situations and symptoms listed above are described in more detail in other
sections of this leaflet.
Occasionally, thrombosis may lead to disability or death.
The risk of developing venous or arterial thromboembolic complications, thromboembolic disorders or cerebrovascular incidents increases with:

• age;
• overweight;
• family history of thrombosis in leg, lung (pulmonary embolism) or other organ at a young age;
• family history of myocardial infarction or stroke at a young age;
• need for surgery, prolonged immobilization, or serious accident. It is important to inform your doctor that you are taking Primolut-Nor, as treatment may need to be discontinued. Your doctor will advise when to restart Primolut-Nor. Usually, this occurs about 2 weeks after resuming normal mobility.
• smoking. It is recommended to stop smoking when taking Primolut-Nor, especially if over 35 years of age;
• increased blood lipid levels (cholesterol or triglycerides);
• high blood pressure;
• migraine;
• heart problems (valvular disease, cardiac arrhythmia).

If symptoms suggesting thrombosis occur, stop taking the tablets and
consult your doctor immediately (see "When to contact your doctor").
Oral contraception and cancer
Breast cancer occurs slightly more frequently in women taking combined oral contraceptives than in women of the same age who do not use them. It is not known whether this difference is solely due to the use of hormonal contraceptives. The reason may also be that women using hormonal contraception undergo more frequent examinations, leading to earlier detection of breast cancer. This difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping combined oral contraceptives. Regular breast self-examination is recommended, and any lump should prompt immediate consultation with a doctor.
Rare cases of benign or, even more rarely, malignant liver tumours have been reported in women using combined oral contraceptives, which may lead to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, inform your doctor as soon as possible.
There are reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to tablet use but rather to sexual behaviour or other factors, such as human papillomavirus infection.
Primolut-Nor and other medicines
Inform your doctor about all medicines currently or recently taken, as well as those planned for future use.
Your doctor will advise whether additional contraceptive methods are needed and, if so, for how long.
Some medicines may affect the blood concentration of Primolut-Nor, may reduce its
effectiveness and may cause unexpected bleeding.
These include:

• medicines used to treat:
  o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
  o tuberculosis (e.g. rifampicin)
  o HIV or hepatitis C virus infection (protease inhibitors or non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  o fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole)
  o bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin)
  o certain heart diseases, hypertension (calcium channel blockers, e.g. verapamil, diltiazem)
  o arthritis, osteoarthritis (etoricoxib)
  o pulmonary hypertension (bosentan)
• herbal preparations containing St John's wort ( Hypericum perforatum ), mainly used for treating depressive mood
• grapefruit juice

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

• those containing cyclosporine
• antiepileptic - lamotrigine (may lead to increased frequency of seizures)
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and (or) muscle spasms)

Do not use Primolut-Nor if the patient has hepatitis C and is taking antiviral
medications containing ombitasvir + paritaprevir + ritonavir and dasabuvir, as this may
cause elevated liver function test results (increased liver enzyme AlAT activity).
Primolut-Nor may be restarted approximately 2 weeks after completion of treatment. See section "When not to use Primolut-Nor".
Laboratory tests
Before undergoing blood tests, inform your doctor or laboratory staff that you are taking Primolut-Nor, as it may affect test results.
Primolut-Nor with food and drink
Tablets should be swallowed whole, with a small amount of liquid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Use of Primolut-Nor during pregnancy is contraindicated.
Primolut-Nor should not be used during breastfeeding.
Driving and operating machinery
The effect of Primolut-Nor on the ability to drive motor vehicles and operate mechanical equipment in motion is unknown.
Primolut-Nor contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Primolut-Nor

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor.
The tablets should be swallowed whole with a small amount of liquid.
If contraception is required, non-hormonal contraceptive methods (e.g. condoms) should be used instead of hormonal contraceptives. If pregnancy is suspected despite contraceptive use, treatment with this medicine should be discontinued until the situation has been clarified.

How to take Primolut-Nor

• Bleeding due to functional disorders
  Take one tablet of Primolut-Nor three times daily for 10 days. In most cases, this will stop uterine bleeding not associated with organic changes within 1 to 3 days. However, to ensure effective treatment, Primolut-Nor should be taken for the full 10-day period. Withdrawal bleeding comparable in amount and duration to a normal menstrual period will occur 2 to 4 days after stopping treatment.

Occasionally, slight bleeding may occur after initial cessation of bleeding. In such cases, continue taking the medicine as prescribed.
If vaginal bleeding does not stop despite correct use of the medicine, other conditions should be considered and appropriate investigations are recommended. This also applies to cases where relatively heavy bleeding recurs during treatment after an initial cessation.
If bleeding does not stop, consult your doctor.
To prevent recurrence of functional bleeding in patients with anovulatory cycles, Primolut-Nor may be used prophylactically (1 tablet once or twice daily from day 16 to day 25 of the cycle (day 1 of the cycle = first day of last menstrual bleeding)). Withdrawal bleeding will occur several days after taking the last tablet.

• Endometriosis
  Treatment should be started between day 1 and day 5 of the cycle with 1 tablet of Primolut-Nor taken twice daily. In case of spotting, the dose may be increased to 2 tablets twice daily. If bleeding stops, consider reducing the dose back to the initial dose. Treatment should be continued for at least 4 to 6 months. When taken continuously, ovulation and menstruation usually do not occur. If the effect of the medicine seems too strong or too weak, consult your doctor.

Taking more Primolut-Nor than recommended
There are no reports of severe adverse effects following the ingestion of multiple tablets of Primolut-Nor at once. If more medicine has been taken than recommended, or if someone else has taken it, inform your doctor.

Missed dose of Primolut-Nor
Do not take a double dose to make up for a missed dose.
The effectiveness of Primolut-Nor may be reduced if a tablet is missed. If a dose is missed, take the missed tablet as soon as possible and then take the next dose at the usual time.

Stopping Primolut-Nor
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
The medicine may be discontinued at any time. There are no specific withdrawal symptoms associated with stopping Primolut-Nor. However, there may be a recurrence of the original symptoms.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse symptoms worsen or if any adverse reactions not listed in the leaflet occur,
you should inform your doctor or pharmacist.
Adverse reactions occur more frequently during the first few months of treatment with
Primolut-Nor and usually subside during continued therapy. In addition to the adverse reactions
listed in the section "Warnings and precautions", the following adverse reactions have been observed
in patients treated with Primolut-Nor, although in some cases a causal relationship with the use of the medicine
could not be confirmed.
The adverse reactions listed below are classified by organ systems and frequency of occurrence.

Very common – affects 10 or more out of 100 people

• Uterine/vaginal bleeding, including spotting*,
• Scanty menstruation*

Common – affects 1 to 10 out of 100 people

• Headache
• Nausea
• Absence of bleeding*
• Oedema

Uncommon – affects 1 to 10 out of 1,000 people

• Migraine

Rare – affects 1 to 10 out of 10,000 people

• Hypersensitivity reactions
• Urticaria
• Rash

Very rare – affects less than 1 out of 10,000 people

• Visual disturbances
• Dyspnoea

* in the indication "endometriosis"

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Primolut-Nor

Keep this medicine 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 carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Primolut-Nor contains
The active substance is 5 mg of norethisterone acetate (Norethisteroni acetas).
The other ingredients are: monohydrate lactose, corn starch, 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, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Bulgaria, 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 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Bulgaria, country of export: 9900329
Parallel Import Licence Number: 155/22