Primolut-N Tablets

What Primolut N is Used For :

• Primolut N contains norethisterone, a hormonal product having similarity with the natural female hormone progesterone. Because the active ingredient in Primolut N, norethisterone, is converted to oestrogen in the body, some of the information in this leaflet is based on experience with oestrogen containing oral contraceptives.
• However, Primolut N is not to be used as a contraceptive. It will not prevent you from falling pregnant.

Primolut N is used to treat :

• Irregular menstrual periods with heavy and/or persistent bleeding that has no identified cause
• Lack of menstrual bleeding
• Premenstrual complaints (premenstrual syndrome)
• Menopausal complaints in combination with oestrogen as part of hormone replacement therapy,
• Endometriosis (a disease leading to complaints caused by womb-lining tissue growing outside the womb
• Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
• Before You Take Primolut N When you must not take it
• Do not take Primolut N if you have an allergy to:
• norethisterone, the active ingredient in Primolut N
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include :

• Shortness of breath
• Wheezing or difficulty breathing
• Swelling of the face, lips, tongue or other parts of the body
• Rash, itching or hives on the skin.

Details :

• Do not take this medicine if you are pregnant or think you might be pregnant. It may affect your developing baby if you take it during pregnancy.
• Do not breastfeed if you are taking this medicine. The active ingredient in Primolut N passes into breast milk and there is a possibility that your baby may be affected.
• Do not give this medicine to a child.

• Do not take Primolut N if you have or have had a blood clot in :
  • The blood vessels of the legs (deep vein thrombosis)
  • The lungs (pulmonary embolism)
  • The heart (heart attack)
  • The brain (stroke)
  • Other parts of the body

• Do not take Primolut N if you are concerned about an increased risk of blood clots. Blood clots are rare. Very occasionally blood clots may cause serious permanent disabilities, or may even be fatal.
• You are more at risk of having a blood clot when you take hormonal medicines such as Primolut N.
• Do not take Primolut N if you are concerned about an increased risk of blood clots because of age or smoking. The risk of having a heart attack or stroke increases as you get older. It also increases if you smoke.

Do not take Primolut N if you have or have had :

• Angina (chest pain)
• Mini stroke (also known as a TIA or transient ischaemic attack)
• Any disease of the heart or blood vessels.
• High risk for a blood clot
• Migraine, accompanied by visual symptoms, speech disability, or weakness or numbness in any part of your body
• Diabetes mellitus with blood vessel damage.
• Severe liver disease (and your liver function values have not returned to normal). Symptoms of a liver disease include, yellowing of the skin and/or itching of the whole body.
• Benign or malignant liver tumors.
• Malignant sex hormone-dependent tumors such as cancer of the breast or the genital organs.
• A condition called Dubin-Johnson syndrome or Rotor syndrome.
• Vaginal bleeding or blood in your urine for which a cause has not been identified.
• Breast disease for which a cause has not been identified.
• A miscarriage.
• If any of these conditions appear for the first time while using Primolut N, stop taking it at once and consult your doctor.