Primolut N general information

What is Primolut N used for?

Primolut N tablets 5mg are used to treat several conditions that are the result of a lack of progesterone including menstrual disorders like: menorrhagia (heavy prolonged menstrual bleeding) secondary amenorrhoea (menstrual periods that have stopped, are absent or irregular); dysmenorrhoea (painful periods); premenstrual syndrome, including cyclical mastopathy (premenstrual breast swelling and tenderness); dysfunctional or abnormal uterine bleeding, which occurs during the menstrual cycle instead of at the end.  Primolut N tablets 5mg are also used to treat endometriosis (growth of endometrial tissue outside the uterus causing pain and bleeding) and shift the timing of menstruation to help manage irregular menstrual cycles.

How does Primolut N work?

Primolut N tablets 5mg contain norethisterone a first generation synthetic progestogen that has similar action in the menstrual cycle as the natural hormone progesterone.  Endogenous (naturally produced) progesterone is produced by the ovaries during the second phase of the menstrual cycle.  It acts on the endometrium (lining of the uterus) converting the proliferating phase to the secretory phase.  This causes the endometrium, which has thickened in response to oestrogen during the first half of the cycle, to stop growing and start secreting hormones and other proteins needed to maintain a pregnancy, if conception occurs; if not, levels of oestrogen and progesterone fall and the endometrium is shed (menstruation).  The action of norethisterone in Primolut N 5 helps re-establish a regular menstrual cycle in conditions where a lack of endogenous progesterone causes menstrual problems, such as in secondary amenorrhoea and abnormal uterine bleeding.

What does Primolut N contain?

Primolut N tablets 5mg contain the active ingredient norethisterone, a synthetic progestogen used to treat menstrual dysfunction and endometriosis.  They also contain lactose monohydrate, maize starch, magnesium stearate.

Treating endometriosis with Primolut N

Primolut N tablets 5mg contain norethisterone, a first generation synthetic progestogen that has similar action in the menstrual cycle as the natural hormone progesterone.  During a normal menstrual cycle, progesterone (produced by the ovaries) acts on the endometrium and causes it to stop growing and start secreting hormones and other proteins needed to maintain a pregnancy, if conception occurs.  If not, levels of oestrogen and progesterone fall and the endometrium is shed (menstruation).  Endometriosis is the growth of endometrial tissue outside the uterus which behaves in the same way as uterine endometrium, including its response to progesterone.  Primolut N tablets 5mg acts on the endometrium in all its locations to stop it growing, which alleviates symptoms of endometriosis including pain and bleeding.

Treating menstrual problems with Primolut N

Primolut N tablets 5mg contain norethisterone, a first generation synthetic progestogen that has similar action in the menstrual cycle as the natural hormone progesterone.  A normal menstrual cycle is dependent on the interaction of several hormones, including oestrogen and progesterone produced by the ovaries as well other regulating hormones produced by the pituitary gland.  If any of these hormones are not produced in the correct amounts this can disrupt the cycle and cause problems like amenorrhoea (menstrual periods that have stopped, are absent or irregular) and abnormal uterine bleeding during the menstrual cycle instead of at the end.  Primolut N tablets 5mg can re-establish a regular menstrual cycle by helping to restore natural hormone levels.

What are the side effects of Primolut N?

The most commonly reported side effects when taking Primolut N tablets 5mg include: irregular uterine and vaginal bleeding or spotting, headache, nausea, oedema.

When should Primolut N not be used?

You should not use Primolut N tablets 5mg if you:

• are allergic to norethisterone or any ingredients in Primolut N
• are pregnant or are breastfeeding
• have liver disease or liver tumours
• any sex-hormone dependent tumours
• have or there is a family history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, or prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
• have migraine or diabetes with vascular involvement
• have chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) if so, avoid the sun or ultraviolet radiation
• are taking medicines that interact with Primolut N, including anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, nevirapine, efavirenz, St. John’s wort, the immunosuppressant cyclosporine, oral antidiabetics

What medications interact with Primolut N?

Several medications interact with Primolut N tablets 5mg and should either not be taken while you are taking Primolut N or only after discussion and instruction from your doctor:

• Drugs that affect Primolut N: phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, nevirapine, efavirenz, St. John’s wort
• Drugs that are affected by Primolut N: the immunosuppressant cyclosporine, oral antidiabetics

How should Primolut N be taken?

You should take your Primolut N tablets 5mg swallowed whole with a glass of water, with or without food, once, twice or three times daily.  The dose you take, how often at what stage of the menstrual cycle and for how long, depends on what you are being treated for and your doctor’s recommendation.  You should continue to take your Primolut N tablets 5mg for several monthly menstrual cycles, as recommended by your doctor.

How long should you take Primolut N?

You should continue to take your Primolut N tablets 5mg for several monthly menstrual cycles, as recommended by your doctor.

Missed dose of Primolut N

If you miss a dose of Primolut N tablets 5mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Primolut N be stored?

You should store your Primolut N tablets 5mg in the blister pack until use.  Store in a cool dry place below 30°C.