Primolut-nor

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Primolut-Nor

5 mg, tablets

Norethisterone acetate

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Primolut-Nor and what is it used for
• 2. Important information before using Primolut-Nor
• 3. How to use 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), a synthetic equivalent of the natural female hormone (progesterone).

Indications for use of Primolut-Nor

Functional bleeding disorders, endometriosis.

2. Important information before using Primolut-Nor

Primolut-Nor should not be used if any of the following conditions are present.
If any of the following conditions occur during treatment with Primolut-Nor, the use of the medicine should be stopped immediately.

When not to use 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 venous or arterial thromboembolic disorders (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, such as 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 is currently or has been in the past a hormone-dependent tumor (breast or genital cancer).

Primolut-Nor should not be used 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 you use Primolut-Nor in any of the following cases, close medical supervision is necessary. Therefore, before starting to take Primolut-Nor, you should inform your doctor about the presence of:

• smoking habits,
• diabetes (a metabolic disease with high blood sugar levels),
• obesity,
• high blood pressure,
• heart valve defects or heart rhythm disorders,
• superficial vein inflammation,
• varicose veins,
• cases of thrombosis, heart attack, or stroke in close relatives;
• migraine,
• epilepsy,
• increased blood fat 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 spots, so-called chloasma) currently or in the past; you should then 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 hives with 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 thrombus 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 no medicine is used, e.g., 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 higher in the postpartum period.
Thrombosis 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 use Primolut-Nor" and "Warnings and precautions". You should also remember the points about close relatives);
• a breast lump is found;
• you plan to use 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 using 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 using Primolut-Nor and contact a doctor as soon as possible if you notice the following symptoms:
• jaundice (yellowing of the skin, white of the eyes - these 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, thromboembolic disorders, 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 heart attack or stroke in a young age in close relatives;
• 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 using the medicine. The doctor will tell you when to restart Primolut-Nor. This usually happens about 2 weeks after you are back on your feet.
• smoking. It is recommended to quit smoking when using Primolut-Nor, especially if you are over 35 years old;
• increased blood fat levels (cholesterol or triglycerides);
• high blood pressure;
• migraine;
• heart problems (valve defects, 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 who use oral contraceptives, breast cancer is slightly more common than in women of the same age who do not use them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women using hormonal contraception are more frequently 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 oral contraceptives. You should regularly examine your breasts and contact a doctor if you feel any lump.
In women using 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 you experience severe abdominal pain, you should inform your doctor as soon as possible.
There are reports of more frequent occurrence of cervical cancer in women who use 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.
Some medicines may affect the level of Primolut-Nor in your blood, may 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 (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 cyclosporine
• 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 used if you have hepatitis C and are 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 restart Primolut-Nor about 2 weeks after finishing treatment. See "When not to use Primolut-Nor".
Laboratory tests
Before undergoing a blood test, you should inform your doctor or laboratory staff that you are using 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 a doctor before using this medicine.
Using Primolut-Nor during pregnancy is contraindicated.
Primolut-Nor should not be used 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 been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Primolut-Nor

This medicine should always be used as directed by your doctor. 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 oral contraceptives. If you suspect that you are pregnant despite using contraception, you should stop using the medicine until the situation is clarified.
How to use Primolut-Nor

• Functional bleeding disorders You should take one tablet of Primolut-Nor 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, you should take the tablets for the full 10 days. Within 2 to 4 days after finishing the treatment, withdrawal bleeding will occur, comparable in terms of abundance and duration to a normal menstrual period.

Sometimes, after initial cessation of bleeding, minor bleeding may occur. You should also continue to take the medicine in this case.
If, despite proper use of the medicine, the vaginal bleeding does not stop, you should consider other conditions. 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 use.

If the bleeding does not stop, you should contact a doctor.

In order 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 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 tablet of Primolut-Nor 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, you should consider reducing the dose to the initial dose. The 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 tablets of Primolut-Nor 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 directed. 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

In case of any further doubts about the use of this medicine, you should consult a 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 the 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 any side effects not listed in this leaflet occur, you should tell your doctor or pharmacist.
Side effects occur more frequently during the first few months of using 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 using Primolut-Nor, although not all cases could be confirmed to be related to the use of the medicine.
The following side effects are listed by organ system and frequency.

• Very common (occurring in 10 or more people out of 100)
• uterine/vaginal bleeding, including spotting,
• scanty menstrual periods.

Common (occurring in 1 to 10 people out of 100)

• headache,
• nausea,
• absence of bleeding,
• edema.

Uncommon (occurring in 1 to 10 people out of 1,000)

• migraine.

Rare (occurring in 1 to 10 people out of 10,000)

• allergic reactions,
• hives,
• rash.

Very rare (occurring in less than 1 person out of 10,000)

• visual disturbances,
• shortness of breath.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the medicine.

5. How to store Primolut-Nor

Keep out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use after the expiry date stated on the packaging. 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 of norethisterone acetate ( Norethisterone acetate).
• The other ingredients are: lactose monohydrate, cornstarch, povidone 25000, talc, magnesium stearate.

What Primolut-Nor looks like and what the packaging contains

Primolut-Nor tablets are white, round with a cross sign on one side.
They are available in packaging containing 30 tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer:

Marketing authorization 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish marketing authorization number: 724247.5

Parallel import authorization number: 133/22

Date of leaflet approval:21.03.2022
[Information about the trademark]