Primolut N Norethisterone

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Description

What is Primolut N and what it is used for?

Primolut N contains norethisterone, which belongs to a group of medicines called progestogens, which are female hormones.

Primolut N can be used in several different circumstances:

  • to treat irregular, painful or heavy periods
  • to treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found)
  • to treat premenstrual syndrome (also known as premenstrual tension, PMS or PMT)
  • to delay periods

What you need to know before you take Primolut N

Your doctor will discuss your medical and family history with you. Your doctor will also need to check your blood pressure and make sure you are not pregnant. You may also need additional checks, such as a breast examination, that will be specific to your medical needs and/or concerns.

Do not take Primolut N:

  • if you are allergic to norethisterone or any of the other ingredients of this medicine (listed in section 6).
  • if you are pregnant or if you think you might be pregnant
  • if you are breast-feeding

or:

  • if you have ever had a problem with your blood circulation. This includes a blood clot (thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart attack), brain (stroke) or any other parts of the body
  • if you have any symptoms of a blood clot, such as chest pain, unexplained and often sudden shortness of breath and/or cough
  • if you have any condition which makes you more at risk of a blood clot (thrombosis)
  • if you have ever suffered migraine with visual disturbance
  • if you have (or are recovering from) a liver disease and the blood tests show that your liver is not yet working normally
  • if you have (or have ever had) liver tumours
  • if you have diabetes with damaged blood vessels
  • if you have any type of cancer which might be made worse by exposure to female sex hormones (including breast cancer)
  • if you have problems with genital bleeding for which the cause is not yet known
  • if you have a condition called endometrial hyperplasia which has not been treated.

Do not use Primolut N if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section “Other medicines and Primolut N”).

In addition, do not take Primolut N if you have had any of the following conditions when you were pregnant:

  • yellowing of the skin (idiopathic jaundice of pregnancy)
  • itching of the whole body (pruritus of pregnancy)
  • Tell your doctor if any of these apply to you and do not take Primolut N.

 

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Reasons for stopping Primolut N immediately:

Stop taking Primolut N and speak to your doctor immediately if you experience any of the following:

  • migraine for the first time
  • unusually bad headaches, occurring more often than before
  • sudden changes to your eyesight, hearing or speech
  • sudden changes to your senses of smell, taste or touch
  • symptoms of blood clot formation or symptoms of inflammation of the veins combined with the formation of blood clots (thrombophlebitis):
    • unusual pains in your leg(s)
    • unusual swelling of your arms or legs
    • sharp pains in your chest or sudden shortness of breath
    • crushing pains or feelings of heaviness or tightness in your chest
    • coughing for no apparent reason
    • one side of your body suddenly becoming very weak or numb

 

Primolut N must also be stopped immediately if:

  • you become pregnant
  • you develop jaundice or other liver problems
  • you develop itching (pruritus)
  • your doctor finds that your blood pressure is too high

Additional information

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5MG

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