Primolut-nor

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Primolut-Nor
5 mg, tablets
Norethisteroni acetas
Please read this leaflet carefully before taking this 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Primolut-Nor is and what it is 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 Primolut-Nor is and what it is 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 listed below apply.
If any of the following conditions occur while taking Primolut-Nor, stop using the medicine 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 diagnosed or is suspected;
• if the woman is breastfeeding;
• if there are currently or have previously been venous or arterial thromboembolic disorders (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or stroke;
• if there have been or currently are symptoms indicating thrombosis (e.g. transient ischaemic attack, angina pectoris);
• if there have been or currently are cerebrovascular incidents;
• if there is a serious risk factor or multiple risk factors for venous or arterial thrombosis;
• if the patient has had migraine with focal neurological symptoms such as visual disturbances, speech disturbances, numbness or weakness of part of the body;
• if the patient has diabetes with vascular complications;
• if there has been or currently is severe liver disease (until liver function tests return to normal values);
• if there has been or currently are benign or malignant liver tumours;
• if hormone-dependent cancer (e.g. breast or genital organs) has been diagnosed currently or in the past.

Do not use Primolut-Nor if the patient has hepatitis C and is taking medicines 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 oestrogen. Therefore, in addition to 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 following conditions, special and regular medical monitoring is required. Therefore, before starting Primolut-Nor, the patient should inform the doctor if any of the following apply:

• smoking habit,
• diabetes (a metabolic disorder with elevated blood sugar levels),
• obesity,
• high blood pressure,
• heart valve disorder or cardiac arrhythmia,
• superficial phlebitis,
• varicose veins,
• personal or family history of thrombosis, heart attack or stroke in close relatives,
• migraine,
• epilepsy,
• elevated blood lipid levels (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia 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),
• haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure),
• sickle cell anaemia,
• 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 pigment 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 (oestrogens may induce or worsen symptoms of this disease).

If any of the above-mentioned symptoms 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 oestrogen/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 legs (deep vein thrombosis). If a fragment of the clot detaches, it may block arteries in the lungs, causing pulmonary embolism. Deep vein thrombosis is rare; it may occur even without taking medication, for example during pregnancy.
The risk of thrombosis is higher in women using hormonal medicines 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 rarely, thrombosis may occur in the liver, intestines, kidneys or eyes.

When to contact your doctor

• Regular check-ups: While taking Primolut-Nor, your doctor will inform you about the need for regular medical examinations.
• Contact your doctor immediately if:
  • you notice worrying changes in your health, especially those mentioned in this leaflet (see also “When not to use Primolut-Nor” and “Warnings and precautions”. Remember also the points concerning close relatives);
  • a breast lump is detected;
  • you plan to take other medicines (see also “Primolut-Nor and other medicines”);
  • immobilisation is expected or surgery is planned (inform your doctor at least 4 weeks in advance);
  • heavy vaginal bleeding occurs.
• Stop taking Primolut-Nor immediately and contact your doctor if you notice potential symptoms of thrombosis:
  • 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 disturbances in sensory functions (hearing, smell or touch);
  • dizziness or fainting;
  • numbness or weakness of part of the body;
  • severe pain or swelling in the legs.
• Also stop taking Primolut-Nor and contact your doctor as soon as possible if you notice any of the following symptoms:
  • jaundice (yellowing of the skin or whites of the eyes – possible signs of liver inflammation);
  • 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 venous or arterial thromboembolic complications, thromboembolic disorders or cerebrovascular incidents increases with:

• age;
• overweight;
• family history of blood clots in the leg, lung (pulmonary embolism) or other organs at a young age;
• family history of heart attack or stroke at a young age;
• need for surgery, prolonged immobilisation, or serious accident. It is important to inform your doctor that you are taking Primolut-Nor, as you may need to stop taking this medicine. Your doctor will advise when to restart Primolut-Nor. This is usually about 2 weeks after you are able to walk again.
• smoking. It is recommended to stop smoking while taking Primolut-Nor, especially if over 35 years of age;
• increased blood lipid levels (cholesterol or triglycerides);
• high blood pressure;
• migraine;
• heart problems (valve disorder, 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. It may also be due to the fact that women using hormonal contraception are examined more frequently, leading to earlier detection of breast cancer. The difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping combined oral contraceptives. Regular breast examinations are recommended, and you should contact your doctor if you detect any lump.

Benign, and even more rarely malignant, liver tumours have been reported in women using combined oral contraceptives. These tumours may cause life-threatening intra-abdominal bleeding. If you experience severe upper abdominal pain, inform your doctor immediately.

There are reports of an increased incidence of cervical cancer in women who have used combined oral contraceptives for a long time. However, this association may not be related to taking the pills but rather to sexual behaviour or other factors, such as human papillomavirus infection.

Primolut-Nor and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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, reduce its effectiveness, 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 infection (protease inhibitors or non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole)
  • bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin)
  • certain heart conditions, hypertension (calcium channel blockers, e.g. verapamil, diltiazem)
  • arthritis, osteoarthritis (etoricoxib)
  • 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, for example:

• 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 medicines containing ombitasvir + paritaprevir + ritonavir and dasabuwir, as this may lead to elevated liver function test results (increased liver enzyme AlAT activity). Primolut-Nor may be restarted approximately 2 weeks after completion of antiviral 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

Swallow the tablets whole with a small amount of liquid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The 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 and operate machinery 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 the physician. 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 oral contraceptives. If pregnancy is suspected despite contraceptive use, treatment with this medicine should be discontinued until the situation is clarified.

How to use Primolut-Nor

• Bleeding due to functional disorders

Take 1 tablet of Primolut-Nor 3 times daily for 10 days. In most cases, this will stop uterine bleeding unrelated to organic pathology within 1 to 3 days. However, to ensure effective treatment, the tablets should be taken for the full 10-day period. Withdrawal bleeding comparable in amount and duration to normal menstrual bleeding usually occurs 2 to 4 days after completing treatment.
Sometimes, after initial cessation of bleeding, slight bleeding may occur. 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. Appropriate investigations are recommended in such cases, including when relatively heavy bleeding recurs during treatment after initial cessation.
If bleeding does not stop, contact your doctor.

To prevent recurrence of functional bleeding in patients with anovulatory cycles, Primolut-Nor may be used prophylactically (1 tablet 1 to 2 times daily from day 16 to day 25 of the cycle (day 1 of cycle = first day of last menstrual period)). Withdrawal bleeding usually occurs a few days after the last tablet is taken.

• Endometriosis

Treatment should be initiated 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. With uninterrupted use of the medicine, ovulation and menstruation usually do not occur.

If you feel the effect of the medicine is too strong or too weak, consult your doctor.

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

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 tablet at the usual time.

Stopping treatment with 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 is a possibility of recurrence of initial symptoms.

4. Possible adverse reactions

Like all medicines, 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 this 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 taking 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 categorized by organ systems and frequency of occurrence.
Very common: occurs in 10 or more out of 100 people

• Uterine/vaginal bleeding, including spotting*,
• Scanty menstruation*
  Common: occurs in 1 to 10 out of 100 people
• Headache
• Nausea
• Absence of bleeding*
• Edema
  Uncommon: occurs in 1 to 10 out of 1,000 people
• Migraine
  Rare: occurs in 1 to 10 out of 10,000 people
• Hypersensitivity reactions
• Urticaria
• Rash
  Very rare: occurs in less than 1 out of 10,000 people
• Visual disturbances
• Dyspnea

* 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,
pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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,
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Primolut-Nor

Keep the medicine out of the 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 packaging. 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. Such 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: lactose monohydrate, corn starch, povidone 25000, talc, magnesium stearate.

What Primolut-Nor looks like and contents of the pack
Primolut-Nor tablets are white, with a cross debossed on one side and the letters "AP" in a regular hexagon on the other side.
The pack contains 30 tablets (2 blisters of 15 tablets) in a cardboard box.
For further information, contact the marketing authorisation holder or parallel importer:
Marketing authorisation holder in Spain, the country of export:
Bayer Hispania, S.L.
Av. Baix Llobregat, 3 - 5
08970 Sant Joan Despí - Barcelona
Spain
Manufacturer:
Bayer Weimar GmbH und Co. KG
Döbereiner Str. 20
99427 Weimar
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Spain, the country of export: 724247.5
Parallel import authorisation number: 321/25