PRIMOLUT 10 mg Tabletka

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1. Primolut Nor 10 mg tablets
   1. What is Primolut Nor and what is it used for
   2. Cosa deve sapere prima di prendere 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

Primolut Nor 10 mg tablets

noretisterone acetate

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Primolut Nor is and what it is used for
• 2. What you need to know before you take 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 norethisterone acetate, which belongs to the group of progestins, a group of
products similar to the natural female hormone progesterone.
This medicine is used for the treatment of:

• functional metrorrhagia (uterine bleeding outside of menstrual periods) and prophylaxis of recurrences (i.e. the reappearance of this disorder after it has been treated with therapy);
• primary amenorrhea (complete absence of the menstrual cycle) and secondary amenorrhea (cessation of the menstrual cycle);
• premenstrual syndrome (the symptoms that precede the onset of the menstrual cycle);
• endometriosis (presence of uterine mucosa in abnormal locations);
• polymenorrhea (interval between one menstruation and the next shorter than normal).

2. Cosa deve sapere prima di prendere Primolut Nor

Do not take Primolut Nor

• if you are allergic to noretisterone acetate or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant;
• if you are breastfeeding;
• if you have suffered from severe impairment of liver function and liver function is still abnormal. Symptoms of liver disease may include, for example, yellowing of the skin and/or itching all over the body.
• if you suffer from or have suffered in the past from liver tumors (benign or malignant);
• if you suffer from or have suffered in the past from blood clots in a vein or an artery (thrombosis), in a deep vein (deep vein thrombosis), in a blood vessel of the lung (embolism

pulmonary), myocardial infarction or cerebrovascular accidents (stroke caused by a blood clot or rupture of a blood vessel in the brain);

• if you have a disease that may be a sign of a future heart attack (for example, angina pectoris causing severe chest pain that may radiate to the left arm) or stroke (for example, a minor stroke with no residual effects, a so-called transient ischemic attack);
• if you have a certain form of migraine with so-called focal neurological symptoms such as vision problems, difficulty speaking, weakness or numbness in any part of the body;
• if you have risk factors that are severe or multiple for developing blood clots (venous and arterial thrombosis) (see “Warnings and precautions”);
• if you suffer from diabetes with damage to blood vessels;
• if you suffer from hormone-dependent tumors (e.g. breast or genital tumors) confirmed or suspected.

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”)
If any of the above conditions occur for the first time while you are using
Primolut Nor, stop treatment immediately and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Primolut Nor.
Before starting or resuming treatment with Primolut Nor, your doctor will perform a thorough
general and gynecological examination, including a breast exam, abdominal exam and a Pap smear
(Pap test), and blood pressure check. Pregnancy must also be ruled out.
As a precaution, your doctor will decide which checks you should undergo and how often.
The progestin contained in this medicine is partially converted into estrogen. Consequently, the general
warnings associated with the use of combined oral contraceptivescontaining
estro/progestins must be further considered for Primolut Nor.
In some situations you must be particularly careful while using Primolut Nor, and it may be that
your doctor needs to visit you regularly. You should consult your doctor before starting to use Primolut Nor,
if any of the following conditions apply to you or if any of these conditions develop or
worsen during the use of Primolut Nor:

• if you smoke;
• if you have diabetes (a metabolic disease with high blood sugar levels);
• if you are overweight;
• if you have high levels of fat in your blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• if you have high blood pressure;
• if you have heart problems (valve disorders, heart rhythm disturbances);
• if you have a history of thrombosis/thromboembolism (blood clot);
• if you have cases of thrombosis in the family (thromboembolism in a brother/sister or a parent at a relatively young age), heart attack or stroke at a young age;

• if you have inflammation of the veins (superficial thrombophlebitis);
• if you have varicose veins;
• if you have cases of breast cancer in the family;
• if you have a history of chloasma (yellow-brown patches on the skin, especially on the face); in this case, avoid excessive exposure to the sun or ultraviolet rays;
• if you have a history of depression; if depression recurs severely, stop taking Primolut Nor:
• if you suffer from migraine;
• if you suffer from epilepsy (see “Other medicines and Primolut Nor”);
• if you have high levels of cholesterol or triglycerides (fats in the blood);
• if you have a liver or gallbladder disease (jaundice and/or pruritus from cholestasis; formation of gallstones);
• if you have Crohn's disease or ulcerative colitis (inflammatory bowel diseases);
• if you suffer from systemic lupus erythematosus (SLE, an autoimmune disease);
• if you suffer from hemolytic uremic syndrome (HUS, a disease that causes damage to the kidneys);
• if you have sickle cell anemia;
• if you have a disease that first appeared during pregnancy or a previous use of steroid hormones (e.g., hearing loss from otosclerosis, a blood disease called porphyria, skin rash called herpes gravidarum, a nerve disease called Sydenham's chorea);
• if you have hereditary angioedema. If you experience symptoms of angioedema such as swelling of the face, tongue and/or pharynx and/or difficulty swallowing or hives with difficulty breathing, seek medical attention immediately. Medicines containing estrogens can cause or worsen the symptoms of angioedema.

If any of the conditions listed above occur for the first time, recur or
worsen while you are using Primolut Nor, contact your doctor.
Primolut Nor and venous and arterial blood clots (thrombosis)
The progestin contained in this medicine is partially converted into estrogen, therefore comparable
to a progestin/estrogen combination. Consequently, the general warnings associated with the use of
combined oral contraceptivesapply to Primolut Nor.
The use of Primolut Nor, as with Combined Oral Contraceptives, is associated with an increased risk
of venous thromboembolism (VTE) compared to non-use. This increased risk is
however lower than the risk of VTE associated with pregnancy.
VTE can be life-threatening or fatal.
Venous thromboembolism (VTE) manifesting as deep vein thrombosis and/or pulmonary
embolism may occur during the use of all combined oral contraceptives.
Very rarely, thrombosis in other vascular districts has been reported in users of combined oral
contraceptives, for example, hepatic, mesenteric, cerebral, renal or retinal artery or vein. There is
no consensus on whether the occurrence of these events is associated with the use of combined oral
contraceptives.

The symptoms of thrombotic/thromboembolic venous or arterial events or stroke may include:

• unusual and/or swelling of one leg;
• severe and sudden chest pain, regardless of radiation to the left arm;
• sudden difficulty breathing;
• sudden onset of cough;
• unusual, severe and prolonged headache;
• sudden partial or complete loss of vision;
• double vision;
• slurred speech or aphasia (loss of ability to produce or understand language);
• dizziness;
• collapse with or without focal seizures (the seizure starts in a specific part of the brain);
• sudden weakness or numbness very marked on one side or part of the body;
• motor disturbances;
• “acute” abdomen (severe pathological condition at the abdominal level).

The possibility of a synergistic increase in the risk of thrombosis must be taken into consideration in
women with a combination of risk factors or who show a greater severity of a single
risk factor. This increased risk may be greater than a simple cumulative risk of the factors. If a
risk-benefit assessment is negative, a combined oral contraceptive should not be prescribed (see section “Do not take Primolut Nor”).
The risk of thrombotic/thromboembolic venous or arterial events or stroke increases
with:

• age;
• obesity (body mass index greater than 30 kg/m²);
• positive family history (arterial or venous thromboembolism in a brother/sister or parent at a relatively young age);
• prolonged immobilization, major surgery, any leg surgery or severe trauma;
• smoking (the risk increases further for heavy smokers and with increasing age, especially for women over 35 years of age);
• dyslipoproteinemia (high levels of lipids in the blood);
• hypertension (high blood pressure);
• migraine;
• valvulopathy (heart valve disease);
• atrial fibrillation (irregular heartbeat).

Tell your doctor if any of the above situations apply to you.
There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.
Other medical conditions that have been associated with adverse vascular events include:

• diabetes mellitus;
• systemic lupus erythematosus (an autoimmune disease);
• hemolytic uremic syndrome (HUS), which causes damage to the kidneys;
• chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• drepanocytosis (sickle cell anemia).

If you experience an increase in the frequency and severity of migraine (which may be prodromal
of a cerebrovascular event) you should consult your doctor immediately.
If your blood tests have shown that you have Activated Protein C resistance, hyperhomocysteinemia
(excessive concentration of homocysteine in the blood), antithrombin III deficiency, protein C deficiency,
protein S deficiency or antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant), you may
have a hereditary or acquired predisposition to venous or arterial thrombosis.

Contact your doctor as soon as possible if:

• you notice any change in your state of health, especially with regard to the situations described in the sections “Do not take Primolut Nor” and “Warnings and precautions”;
• you feel a lump in your breast;
• you are taking other medicines (see “Other medicines and Primolut Nor”);
• you have unusual vaginal bleeding.

Stop treatment immediately if:

• the onset for the first time or worsening of migraines or an increase in the frequency of headaches of unusual intensity;
• sudden disturbances of vision or hearing or other disturbances of perception;
• first symptoms of thrombophlebitis or thromboembolism, e.g. unusual pain or swelling in the legs, stabbing pain during breathing or cough without apparent cause;
• feeling of pain and tightness in the chest;
• surgery and immobilization: six weeks before surgery and for the duration of immobilization, such as in case of accidents;
• onset of jaundice, hepatitis, generalized itching;
• significant increase in blood pressure;
• pregnancy.

If there are changes in endocrine and liver function tests, stop treatment and repeat
tests after about 2 months.

Primolut Nor and cancer
Breast cancer is observed with a slightly higher frequency in women who use
the combined pill, but it is not known whether this is due to the treatment. For example, it is possible that in
women who use the pill, a greater number of tumors are diagnosed because they undergo
more frequent medical checks. The risk of developing breast cancer decreases gradually
after discontinuation of combined hormonal contraception. It is important that you regularly
check your breasts and contact your doctor if you feel any lumps.
Rare cases of benign and, even more rarely, malignant liver tumors have been observed in women taking hormone substances.
These tumors can cause internal bleeding.

The most important risk factor for cervical cancer is infection with the human papillomavirus
(HPV). Some studies suggest an increased risk of cervical cancer in users of
contraceptives for long periods, but it is still controversial to what extent sexual behavior or
other factors such as human papillomavirus increase this risk.
Malignant tumors can be life-threatening or fatal.

Contact your doctor immediately if you experience severe abdominal pain.
Other medicines and Primolut Nor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Some medicines

• may have an influence on the levels in the blood of Primolut Nor
• may make it less effective
• may cause unexpected bleeding. These include:
• medicines used for the treatment of: o epilepsy(e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine topiramate, felbamate) o tuberculosis(e.g. rifampicin) o HIV and hepatitis C infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, e.g. ritonavir, nevirapine, efavirenz) o fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole) o bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin) o certain heart conditions, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem) or arthritis, osteoarthritis (etoricoxib) or high blood pressure in the blood vessels of the lung (bosentan)
• St John's Wort (Hypericum perforatum, used mainly for the treatment of depressive states).
• Grapefruit juice

Primolut Nor can affect the effectof other medicines, for example:

• Medicines containing cyclosporine
• the antiepileptic lamotrigine (this may lead to an increase in the frequency of seizures)
• theophylline (used for the treatment of breathing problems)
• tizanidine (used for the treatment of 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 cause an increase in blood test results related to liver function (increased liver enzyme ALT). Taking
Primolut Nor can be resumed approximately 2 weeks after the conclusion of this treatment. See
the paragraph “Do not take Primolut Nor”.

Laboratory tests
The use of Primolut Nor may affect the results of some laboratory tests. Tell your doctor if
you need to undergo blood or urine tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Primolut Nor if you are pregnant, suspect you are, or are breastfeeding with breast
milk.

Driving and using machines
Primolut Nor does not impair the ability to drive vehicles or operate machinery.

Primolut Nor contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Primolut Nor

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts consult your doctor or pharmacist.

Dosage, method and duration of administration
The tablets must be swallowed with a little liquid.
The effectiveness of Primolut Nor may be reduced if not all tablets are taken according to the instructions.
What contraceptive measures should be used non-hormonal methods (excluding the rhythm method and the basal temperature method). If, during treatment, withdrawal bleeding does not occur at regular intervals of approximately 28 days, the possibility of pregnancy should be considered, despite the use of contraceptive measures. In this case
immediately stop treatment until this has been ruled out.
The recommended treatment regimens are:

• Functional metrorrhagiaWith the intake of half a tablet of Primolut Nor (= 5 mg) three times a day for 10 days, in most cases the uterine bleeding not associated with organic lesions stops within 1-3 days; however, to guarantee the full success of the treatment, it is necessary to take Primolut Nor regularly for the entire period of 10 days. Approximately 2-4 days after the end of treatment, a withdrawal bleeding occurs, corresponding in quantity and duration to a normal menstrual flow. Mild bleeding during tablet intakeOccasionally, after the initial cessation of bleeding, slight bleeding may occur. Even in these cases, do not interrupt or discontinue taking the tablets. Failure to stop bleeding, heavy breakthrough bleedingIf, despite regular intake of the tablets, the bleeding does not stop, an organic cause or an extra-genital factor should be suspected, which generally requires other therapeutic measures. The same applies if, after an initial cessation of bleeding, rather intense bleeding recurs during tablet intake.

• Prophylaxis of relapsesTo prevent relapses (i.e. the reappearance of this disorder after it has been treated with therapy) in patients with anovulatory cycles, Primolut Nor can be administered for prophylactic purposes (1/2 tablet
• 5 mg - 1-2 times a day from the 16th to the 25th day of the cycle [1st day of the cycle = 1st day of the last menstruation]). Withdrawal bleeding will occur a few days after taking the last tablet.
• Primary and secondary amenorrheaHormonal treatment of secondary amenorrhea should only be started after excluding pregnancy. Sometimes, primary or secondary amenorrhea is caused by a prolactinoma (a benign pituitary tumor that determines an increased production of the prolactin hormone) whose presence must be excluded by the doctor before starting treatment with Primolut Nor, because it could increase in size. Before starting treatment with Primolut Nor, the doctor will prescribe an estrogen (for example for 14 days). Subsequently, take half a tablet of Primolut Nor 10 mg (= 5 mg) 1-2 times a day for 10 days. Withdrawal bleeding will occur a few days after taking the last tablet. If sufficient endogenous estrogen production has been obtained, the doctor will assess whether to discontinue treatment with estrogens and to induce a cyclic bleeding by taking half a tablet of Primolut Nor 10 mg twice a day from the 16th to the 25th day of the cycle.
• Premenstrual syndromeHalf a tablet of Primolut Nor 10 mg taken 1-3 times a day during the luteal phase of the cycle (i.e. the second part of the cycle from ovulation to the start of the next menstruation) can relieve or improve premenstrual symptoms such as headache, depressed mood, fluid retention and breast tenderness.
• PolymenorrheaIn the case of too frequent menstrual flows, menstruation can be postponed by administering Primolut Nor. However, this method should be limited to patients who are not at risk of pregnancy during the treatment cycle. Dosage: one half tablet of Primolut Nor 10 mg (= 5 mg) 2-3 times a day for no more than 10-14 days, starting approximately 3 days before the expected date of menstruation. Menstruation will occur 2-3 days after stopping treatment.
• EndometriosisTreatment should begin between the 1st and 5th day of the cycle with half a tablet of Primolut Nor 10 mg (= 5 mg) twice a day, possibly increasing the dose to one tablet a day in the presence of spotting, after which it will be possible to return to the initial dosage. Treatment should continue for at least 4-6 months. By taking the medicine every day without interruption, both ovulation and menstruation will normally be absent.

If you take more Primolut Nor than you should
No cases of overdose have been reported.
If you accidentally take an excessive dose of Primolut Nor, immediately inform your doctor or
go to the nearest hospital.

If you forget to take Promolut Nor
Take only the forgotten tablet as soon as you remember and then continue taking the
tablets at the usual time the next day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are more common during the first few months of taking Primolut Nor and tend to
disappear with continued treatment.

• Very common side effects(may affect more than 1 in 10 people) Uterine/vaginal bleeding, including slight intermenstrual bleeding (spotting), hypomenorrhea (reduction in menstrual flow).
• Common side effects(may affect up to 1 in 10 people) Headache, nausea, amenorrhea* (absence of menstruation), generalised swelling (oedema).
• Uncommon side effects(may affect up to 1 in 100 people) Migraine.
• Rare side effects(may affect up to 1 in 1,000 people) Hypersensitivity reactions, urticaria, skin rash.
• Very rare side effects(may affect up to 1 in 10,000 people) Visual disturbances, dyspnea (difficulty breathing). * in the indication Endometriosis.

Other reported side effects are:

• changes in libido,
• dizziness,
• nervous irritation phenomena,
• hirsutism (excessive hair growth),
• changes in liver function tests and haemagglutination tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Primolut Nor

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Primolut Nor contains

• The active ingredient is: norethisterone acetate. 1 tablet contains 10 mg of norethisterone acetate.
• The other ingredients are: lactose monohydrate, corn starch, povidone 25, talc, magnesium stearate.

Description of the appearance of Primolut Nor and contents of the pack
30 tablets of 10 mg in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer AG, Kaiser-Wilhelm-Allee 1 - 51373 Leverkusen (Germany)
Local Representative: Bayer S.p.A. - Viale Certosa, 130 - 20156 Milano (MI)

Manufacturer

• Bayer Weimar GmbH und Co. KG - Weimar, Germany