Consumer Medicine Information
Please read this leaflet carefully before you start to use Primolut N. This leaflet will provide information about the benefits and risks of using Primolut N. It will also advise you about how to take Primolut N properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor or pharmacist.
Keep this leaflet in a handy place; you may wish to refer to it again before you have finished taking the tablets.
It is important to remember that Primolut N is a PRESCRIPTION ONLY MEDICINE - you should only use Primolut N tablets as directed by your doctor.
PRIMOLUT N contains the active ingredient norethisterone 5mg. The other ingredients contained in Primolut N are lactose monohydrate, maize starch, and magnesium stearate. The AUST R number for Primolut N is 10706 for the bottles and 134491 for the blister strip.
Primolut N comes in glass bottles or blister strips containing 30 tablets.
WHAT IS PRIMOLUT N USED FOR AND HOW DOES IT WORK?
Primolut N is a so-called progestogen, a hormonal product having similarity with the natural female hormone progesterone. Primolut N is used for timing of menstruation and to treat disturbances of the monthly bleeding (dysfunctional bleeding), lack of the monthly bleeding (primary and secondary amenorrhoea), premenstrual complaints (premenstrual syndrome), in combination with oestrogen hormone replacement therapy, and endometriosis (a disease leading to complaints caused by womb-lining tissue growing outside the womb, the use of Primolut N leads to shrinking of this unwanted tissue).
WHEN SHOULD YOU NOT USE PRIMOLUT N?
Do not take Primolut N:
If you are hypersensitive (allergic) to norethisterone or any of the other ingredients of Primolut N.
If you are pregnant or think you might be pregnant.
If you are breast-feeding.
If you have a disorder affecting the blood circulation (thromboembolic processes). In particular those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack) or the brain (stroke) or other parts of the body. [ See "Primolut N and thrombosis" below]
If you suffer or have suffered from any disease of the heart or blood vessels.
If you have diabetes mellitus with blood vessel damage.
If you suffer or have suffered from a severe liver disease (as long as your liver function values have not returned to normal). Symptoms of a liver disease may be, for instance, yellowing of the skin and/or itching of the whole body.
If you have or have had a benign or malignant liver tumor.
If you suffer or have suffered from a malignant sex hormone-dependent tumor such as cancer of the breast or the genital organs.
If you suffer from a condition called Dubin-Johnson syndrome or Rotor syndrome.
If you have vaginal bleeding or blood in your urine for which a cause has not been identified.
If you have breast disease for which a cause has not been identified.
If you have had 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.
Do not take the tablets if the pack appears to have been tampered with or the tablets don’t look right.
WHAT DO YOU NEED TO KNOW BEFORE USING PRIMOLUT N?
If Primolut N is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use Primolut N:
you have diabetes
you are overweight
you have had a thrombosis/embolism (blood clot or artery blocked by a moving clot or substance) [see “Primolut N and thrombosis” below]
anyone in your immediate family has had a thrombosis i.e. a moving blood clot in the circulation (venous thromboembolism in a sibling or a parent at a relatively early age) [see “Primolut N and thrombosis“ below]
you have high blood pressure
anyone in your immediate family has had breast cancer
you have liver disease or a liver tumor [see” Primolut N and cancer” below]
you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
you have a history of psychic depression
you have epilepsy
you suffer from migraine
you have asthma
you have kidney disease
you have heart disease
If any of the above conditions appear for the first time, recur or worsen while using Primolut N, you should contact your doctor.
Primolut N and thrombosis
Thrombosis is the formation of a blood clot that may block a blood vessel.
Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep venous thrombosis is a rare occurrence. It has been concluded from epidemiological surveys that the use of oral estrogen/progestogen containing ovulation inhibitors is attended by an increased incidence of thromboembolic diseases. Therefore, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases.
It is generally recognised that the risk for venous thromboembolism increases for example with increasing age, if you are overweight, if you have had venous thromboembolism or if anyone in your immediate family has had a thrombosis (venous thromboembolism in a sibling or a parent at a relatively early age). The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use Primolut N the risk may be yet higher. Tell your doctor you are using Primolut N well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking Primolut N several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking Primolut N again after you are back on your feet.
The risk of thromboembolism is also increased shortly after childbirth.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke).
If you develop high blood pressure while using Primolut N, you may be told to stop using it.
Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal.
If you notice possible signs of a thrombosis, stop taking Primolut N and consult your doctor immediately (See also "WHEN SHOULD YOU CONTACT YOUR DOCTOR?")
Primolut N and cancer
In rare cases benign liver tumors and even more rarely, malignant liver tumors have been reported in users of hormonal substances such as the one contained in Primolut N. These tumors may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your abdomen.
Primolut N and other medicines
Some medicines may stop Primolut N from working properly. These include medicines that increase the metabolism of Primolut N, e.g. some of those used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (e.g. rifampicin, rifabutin); and antibiotics (e.g. griseofulvin) for some other infectious diseases, and also the herbal medicine St John’s wort.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, including medicines bought from a pharmacy, health food store or supermarket.
Primolut N and breastfeeding
You must not use Primolut N during breast-feeding.
Primolut N and pregnancy
You must not use Primolut N if you are pregnant or think you might be pregnant.
Primolut N and ability to drive
There are no known effects.
WHEN SHOULD YOU CONTACT YOUR DOCTOR?
When you are using Primolut N, your doctor will tell you to return for regular check-ups.
Contact your doctor as soon as possible if:
you notice any changes in your health, especially involving any of the items mentioned in this leaflet (see also: "Do not take Primolut N" and "WHAT DO YOU NEED TO KNOW BEFORE USING PRIMOLUT N?"; do not forget about the items related to your immediate family);
you feel a lump in your breast;
you are going to use other medications (see "Primolut N and other medicines");
you are to be immobilised or are to have surgery (consult your doctor at least six weeks in advance);
you have unusual, heavy vaginal bleeding;
you have been experiencing unusually severe headaches;
you are experiencing abnormal vision;
you have severe stomach pain.
Stop taking tablets and see your doctor immediately if you notice possible signs of thrombosis:
an unusual cough;
severe pain in the chest which may reach the left arm;
any unusual, severe, or prolonged headache or migraine attack;
partial or complete loss of vision, or double vision;
slurring or speech disability;
sudden changes to your hearing, sense of smell, or taste;
dizziness or fainting;
weakness or numbness in any part of your body;
severe pain in your abdomen;
severe pain or swelling in either of your legs.
The situations and symptoms mentioned above are described and explained in more detail elsewhere in this leaflet.
How to take Primolut N
The tablets are to be swallowed whole with some liquid.
If you have sexual intercourse, you should use non-hormonal methods (e.g. barrier methods) of contraception. If you think you might have fallen pregnant despite such protective measures, stop taking the tablets and see your doctor. He/she will check you are not pregnant before you can recommence tablet taking.
Your doctor will advise you on how to take your tablets. The dosage will vary depending on why you have been given this medicine. The following dosages are recommended:
Dysfunctional bleeding (Disturbances of your period)
Take 1 tablet 3 times daily for 10 days. In most cases bleeding will stop within 1 to 3 days, but Primolut N must be taken for the full 10 days. About 2 to 4 days after you stop taking the tablets, withdrawal bleeding will occur with the intensity and duration of normal menstruation.
Occasionally, slight bleeding may reoccur after the initial bleeding stops. If this happens do not stop taking the tablets. Keep taking the tablets for the full 10 days.
If vaginal bleeding does not stop, despite taking the tablets correctly or if, after an initial suspension of bleeding, fairly heavy bleeding reoccurs while you are taking the tablets, you should contact your doctor. Your doctor will need to consider other causes for the bleeding. To prevent dysfunctional bleeding from re-occurring your doctor may decide that you should take Primolut N regularly (1 tablet 1 to 2 times daily from the 16th to the 25th day of the cycle (1st day of the cycle = 1st day of the last bleeding). Withdrawal bleeding occurs a few days after the last tablet intake. If you are unsure about when to take the tablets ask your pharmacist or doctor.
Primary and secondary amenorrhoea (lack of a period)
Hormone treatment of secondary amenorrhoea can be carried out only after the exclusion of pregnancy. Primary or secondary amenorrhoea is sometimes caused by a prolactinoma (an alteration of a gland in the brain producing increased amounts of a hormone-like substance) which needs to be excluded by your doctor before starting treatment with Primolut N.
Your doctor will prescribe you an estrogen (usually for 14 days) before you begin treatment with Primolut N. You then take 1 tablet of Primolut N 1 to 2 times daily for 10 days. Withdrawal bleeding occurs a few days after taking the last tablet.
If sufficient estrogen production by your body has been achieved, your doctor may try to stop the estrogen treatment and to induce cyclical bleeding by just administering 1 tablet of Primolut N twice daily from the 16th to the 25th day of the cycle. If you are unsure about when to take the tablets ask your doctor or pharmacist.
One tablet of Primolut N taken 1 to 3 times daily during the 2nd half (luteal phase) of the cycle may relieve or improve premenstrual symptoms such as headaches, depressive moods, water retention, and a feeling of tension in the breasts.
Timing of menstruation
Monthly menstrual bleeding can be delayed by taking Primolut N. However, this method should be used by you only if you are not at risk of pregnancy during the treatment cycle.
Dosage: Take 1 tablet Primolut N 2 to 3 times daily for no longer than 10 to 14 days, beginning about 3 days before expected menstruation. Bleeding will occur 2 to 3 days after you stop taking the tablets.
Treatment should begin between the first and 5th day of the cycle with 1 tablet Primolut N twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding stops, dose reduction to the initial dose should be considered. Treatment is to be continued for at least 4 to 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur. After discontinuation of hormone treatment withdrawal bleeding will occur.
IF YOU FORGET TO TAKE PRIMOLUT N:
The efficacy of Primolut N could be reduced if you forget to take a tablet as directed. You should only take the last missed tablet, as soon as you remember, and then continue tablet intake at your usual time on the next day.
Do not take a double dose to make up for forgotten individual doses.
WHAT HAPPENS ONCE YOU STOP TAKING PRIMOLUT N:
There are no specific withdrawal symptoms if you stop Primolut N but there is the possibility that the original complaints might re-occur.
Like all medicines, Primolut N can have side effects. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Primolut N.
Undesirable effects are more common during the first months after the start of intake of Primolut N, and subside with duration of treatment. In addition to the adverse effects listed in the section entitled “WHAT DO YOU NEED TO KNOW BEFORE USING PRIMOLUT N?” the following undesirable effects have been reported in users of Primolut N, although these effects may not necessarily be caused by Primolut N:
In the indication of endometriosis, changes in bleeding pattern including irregular bleeding, scanty bleeding and the absence of bleeding may occur.
Other side effects that have been reported in users of Primolut N are:
Abnormal vision, nausea, headache, fluid retention, migraine, shortness of breath and hypersensitivity reactions (e.g rash, hives).
The following events although not reported for Primolut N, have been associated with the use of other progestogens:
Anaphylaxis and anaphylactoid-like reactions, thrombophlebitis and pulmonary embolism, nervousness, problems with sleeping, drowsiness, tiredness, depression, dizziness and tremor. Some patients may complain of pre-menstrual type depression. Hives, itchiness, rash, acne, hirsutism, hair loss and sweating.
Irregular uterine bleeding, spotting and lack of menstruation. Breast tenderness and discharge. Changes in cervical excretions and secretions. High fever, Cushing’s syndrome, weight gain. Moderate elevation of blood pressure, transient elevation of certain liver enzymes, elevations of serum calcium and potassium levels, and increases in white cell and platelet counts.
Do not be alarmed by this list of possible side effects. You may not experience any of them. This is not a complete list of side effects. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
IF YOU TAKE MORE PRIMOLUT N THAN YOU SHOULD:
You should not take more tablets than your doctor tells you to.
There have been no reports of serious harmful effects from taking too many Primolut N tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken Primolut N, ask your doctor for advice.
STORING PRIMOLUT N
PRIMOLUT N should be stored below 30°C. It should not be used after the expiry date printed on the bottle or blister and outer box.
WHERE TO GO FOR FURTHER INFORMATION
Should you have any questions on the use of PRIMOLUT N you should discuss these with your doctor.
Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
DATE OF INFORMATION
This document was prepared in November 2007.