Primolut Nor 5 mg tablets (norethisterone acetate) – bleeding disorders, amenorrhoea, delaying a period and endometriosis

Primolut Nor (Primolut-Nor-5) is a tablet medicine containing 5 mg norethisterone acetate, a synthetic hormone from the progestogen group with an effect similar to the natural female hormone progesterone.

It is used to treat uterine bleeding disorders, absence of periods (amenorrhoea), to relieve premenstrual symptoms, to delay a period and to treat endometriosis. Dosing differs depending on the reason for use and is always set by the doctor. Primolut Nor is not a contraceptive – non-hormonal protection against pregnancy is needed during treatment.

What is Primolut Nor used for and how is it taken in different gynaecological conditions?

Key facts about the medicine

What is Primolut Nor used for?

According to the official leaflet, Primolut Nor is used for:

• treatment of uterine bleeding disorders (not caused by organ damage);
• absence of periods – primary or secondary amenorrhoea (after prior oestrogen treatment determined by the doctor);
• relief of premenstrual symptoms and mastopathy (headache, low mood, fluid retention, breast tenderness);
• delaying a period;
• treatment of endometriosis.

Before use for absent periods or for delaying a period, pregnancy must be excluded; in amenorrhoea the doctor also excludes a prolactinoma.

How is it used and dosed?

• Swallow the tablets whole with enough liquid.
• The score line on the tablet is not intended for breaking.
• If you are sexually active, use non-hormonal (barrier) contraception such as a condom during treatment. If you suspect pregnancy, stop the medicine until your doctor clarifies the situation.
• If bleeding continues despite correct use, other causes must be investigated – contact your doctor.

Special patient groups

• Breastfeeding women: the medicine must not be taken.
• Liver disease: must not be taken with severe liver disease until liver function values have normalised, or with liver tumours.
• Risk factors for thrombosis (age, obesity, smoking, family history, prolonged immobility, surgery): a doctor’s assessment is needed before starting treatment.

Contraindications – when the medicine must not be used

Do not take Primolut Nor:

• if you are allergic to norethisterone or any of the excipients;
• if you are pregnant or suspect pregnancy;
• if you are breastfeeding;
• if you have or have had a heart attack or stroke, angina pectoris or a transient ischaemic attack;
• if you have several risk factors for blood clots;
• if you have or have had migraine with focal neurological symptoms (disturbed vision or speech, weakness or numbness of parts of the body);
• if you have diabetes with blood vessel damage;
• if you have or have had severe liver disease and liver function values are not yet normal;
• if you have or have had a benign or malignant liver tumour;
• if you have or have had a sex-hormone-dependent malignant tumour (e.g. breast or genital cancer);
• if you have hepatitis C and take ombitasvir/paritaprevir/ritonavir and dasabuvir.

Precautions and warnings

Talk to your doctor before use, or if your condition worsens during treatment, if you: smoke; have diabetes, obesity or high blood pressure; have heart valve disease or atrial fibrillation; have had a blood clot or a close relative has; have superficial vein inflammation or varicose veins; you or a close relative have had breast cancer; have chloasma, depression, migraine, epilepsy, raised blood fats, liver or gallbladder disease, Crohn’s disease or ulcerative colitis, systemic lupus erythematosus, haemolytic uraemic syndrome, sickle cell anaemia or hereditary angioedema.

• Thrombosis: part of the hormone is converted into oestrogen, so warnings for combined oral contraceptives are taken into account. The risk of a blood clot rises with age, obesity, smoking (especially over 35), prolonged immobility, surgery and family tendency. Before planned surgery, contact your doctor at least 6 weeks in advance.
• Tumours: in users of preparations with the same hormone, benign and, even more rarely, malignant liver tumours have been reported; severe abdominal pain requires urgent examination. Check your breasts regularly.
• The medicine contains lactose – if you have an intolerance to some sugars, contact your doctor.
• Tell the laboratory you are taking the medicine, as it may affect some test results.

Interactions with other medicines, alcohol and food

The effectiveness of the medicine may be reduced, or unexpected bleeding caused, by medicines for: epilepsy (primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (rifampicin), HIV and hepatitis C (ritonavir, nevirapine, efavirenz), fungal infections (griseofulvin, itraconazole, voriconazole, fluconazole), bacterial infections (clarithromycin, erythromycin), heart disease and blood pressure (verapamil, diltiazem), arthritis (etoricoxib), pulmonary hypertension (bosentan), as well as herbal products containing St John’s wort and grapefruit juice.

Primolut Nor may affect the action of ciclosporin, lamotrigine (possible increase in seizures), theophylline and tizanidine. It must not be taken with ombitasvir/paritaprevir/ritonavir and dasabuvir; treatment can be resumed about 2 weeks after those medicines are finished.

Pregnancy and breastfeeding

Primolut Nor must not be taken during pregnancy, if pregnancy is suspected, or while breastfeeding. If you suspect pregnancy during treatment, stop the medicine and contact your doctor.

Driving and using machines

No studies have been carried out on the effect of the medicine on the ability to drive and use machines.

Possible side effects

• Very common (more than 1 in 10; when treating endometriosis): uterine/vaginal bleeding including spotting; scanty periods.
• Common (up to 1 in 10): headache, nausea, swelling; absence of periods (when treating endometriosis).
• Uncommon (up to 1 in 100): migraine.
• Rare (up to 1 in 1,000): hypersensitivity reactions, hives, rash, breast tenderness, changes in libido.
• Very rare (up to 1 in 10,000): visual disturbances, difficulty breathing.

Side effects are more frequent in the first months and gradually decrease. Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: no serious side effects have been reported after taking several tablets at once; nausea, vomiting or vaginal bleeding may occur. If a child has taken the medicine, ask a doctor for advice.
• Missed dose: take only the last missed tablet as soon as possible and continue the next day at the usual time. Do not take a double dose – effectiveness may be reduced.
• Stopping: there are no specific withdrawal symptoms, but the complaints for which the medicine was prescribed may return.

Composition, packaging and manufacturer

• Active substance: 5 mg norethisterone acetate per tablet.
• Excipients: lactose monohydrate, maize starch, talc, povidone 25, magnesium stearate.
• Appearance: white, round tablets with two crossed lines on one side and a hexagon with “AP” on the other; the score line is not intended for breaking.
• Pack: 2 PVC/Al blisters of 15 tablets (30 tablets) in a carton.
• Marketing authorisation holder: Bayer d.o.o. Belgrade; manufacturer: Bayer Weimar GmbH und Co. KG, Weimar, Germany. Authorisation number: 515-01-04651-21-001 of 15 November 2022.

Storage

• Keep out of the sight and reach of children.
• No special temperature storage conditions; keep in the original package to protect from light.
• Do not use after the expiry date; return unused medicine to a pharmacy.

Frequently asked questions

How is Primolut Nor taken to delay a period?

According to the leaflet, start about 3 days before the expected period: 1 tablet 2–3 times daily for no longer than 10 to 14 days. Bleeding occurs 2–3 days after stopping. For this purpose the medicine is used only when pregnancy has been excluded.

Does Primolut Nor protect against pregnancy?

No. The leaflet advises sexually active women to use non-hormonal (barrier) contraception, such as a condom, instead of oral contraceptives during treatment. The medicine must not be taken during pregnancy.

The bleeding stopped after two days – can I stop the medicine?

For bleeding disorders the medicine is taken regularly for all 10 days, even if bleeding stops earlier. Light bleeding during treatment is not a reason to stop; if bleeding does not stop despite correct use, contact your doctor.

Does Primolut Nor increase the risk of thrombosis?

Because part of norethisterone is converted into oestrogen, the warnings for combined oral contraceptives apply, including the risk of blood clots. It must not be taken after a previous thrombosis or with several risk factors, and it should be stopped immediately and a doctor contacted if signs of thrombosis appear.

Related information

For additional care and support with women's health concerns, see also the Ovaries, menopause and PMS category – products in this category do not replace the medicine you have been prescribed.

Sources

• ALIMS – Patient Information Leaflet Primolut-Nor-5, 5 mg tablets (November 2022, in Serbian)
• ALIMS – Summary of Product Characteristics Primolut-Nor-5, 5 mg tablets (in Serbian)

Sources checked on: 23 October 2026.