PRIMOLUT-NOR

This medicine contains the active ingredient norethisterone which belongs to a group of medicines called progestogens. These medicines are similar to naturally produced hormone in female body, called progesterone when there is not enough of this hormone in the body, or when the higher amount is needed. Norethisterone is prescribed for the treatment or prevention of dysfunctional bleeding from the uterus, primary and secondary amenorrhea, for the alleviation of premenstrual symptoms and painful or heavy periods, endometriosis and particular types of breast cancer.

Is Norethisterone suitable for me?

Norethisterone is not suitable for everyone. Do not use it

• if you are allergic to norethisterone  or to other ingredients of this medicine
• if you have irregular vaginal bleeding of unknown cause
• if you have porphyria (an inherited blood disorder)
• if you have had a thrombosis (a clot in a blood vessel in your leg or lungs)
• if you have had a recent heart attack or suffer from angina
• if you have liver disease or problems
• if you have/have had a tumor in the liver
• if you are pregnant
• if you have severe itching
• if you had cancer of the breast or genital tract

In particular, you must tell the doctor if you:

• are pregnant, planning to get pregnant, or breastfeeding 
• are obese
• have liver problems
• suffer from depression
• have fits (epilepsy)
• have asthma
• suffer from migraine attacks
• have diabetes
• have high blood pressure
• have heart or kidney disease
• have ovarian cysts
• have a history of ectopic pregnancy
• are immobile
• are planning surgery

Norethisterone interacts with other medicines. It is most important that you tell the doctor all the medications and herbal supplements that you are currently taking.

See the package leaflet for a complete list of possible contraindications and warnings.

How should I take Norethisterone?

This medicine is available in form of a tablet.

You should take norethisterone exactly as instructed by your doctor or pharmacist. The dose will be prescribed according to your needs and condition.

• Abnormal bleeding – 1 tablet 3 times a day for 10 days.
• Primary and secondary amenorrhea - 1 tablet 1 to 2 times a day during 10 days.
• Prevention of abnormal bleeding – 1 tablet twice a day from the 19th - 26th day of the cycle.
• Premenstrual Syndrome - 1 to 3 tablets a day from the 19th - 26th day of the cycle.
• Stopping a period - 1 tablet three times a day starting three days before the expected beginning of the period.
• Painful periods - 1 tablet three times a day for 20 days starting on the 5th day of the cycle.
• Heavy periods - 1 tablet two to three times a day from the 19th - 26th day of the cycle.
• Endometriosis - 2 tablets a day starting on the 5th day of your cycle for 4 to 6 months.
• Breast Cancer - 8 tablets a day, the dosage may be increased to 12 tablets a day.

Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor instructed. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day. Do not take two doses together if you miss a dose.

Read the information leaflet provided with your medication for additional information. Talk to your doctor if you have any additional questions.

What are Norethisterone side effects?

Like all medicines norethisterone can cause side effects, including:

• breakthrough bleeding, spotting
• absence of bleeding, abnormal bleeding
• alterations of cervical secretions, cervical erosions, prolonged anovulation
• over production of breast milk
• breast pain and tenderness
• feeling or being sick
• blood clotting disorders(in the lower limbs, lungs or eye)
• inflammation of the veins
• changes in liver function
• depression, headache
• dizziness, tiredness, difficulty in sleeping
• nervousness, drowsiness, loss of concentration
• vision disorders and intolerance to contact lenses
• altered blood levels of cholesterol
• changes in insulin and glucose control
• diabetic cataract
• worsening of diabetes mellitus, sugar in the urine
• acne
• hair growth, hair loss
• rash which may be itchy
• worsening of existing skin conditions
• skin rash, swelling of the face, lips, tongue or throat
• difficulty breathing or swallowing
• fluid retention, bloating, weight gain
• fever
• change in appetite
• deepening of the voice
• changes in the sex drive

Consult a doctor if the side effects are severe. See the package leaflet for a complete list of side effects.