PRIMOLUT N 5 mg 30 Tablets Buy Online Norethisterone
What is PRIMOLUT N used for and how does it work
PRIMOLUT N contains norethisterone, a progestogen, which is a synthetic hormonal product similar to the natural female hormone progesterone.
What is PRIMOLUT N used for?
PRIMOLUT N is used for timing of menstruation and to treat disturbances in monthly bleeding (dysfunctional bleeding), premenstrual complaints (premenstrual syndrome), menstrual cycle related complaints of the breast (cyclical mastopathy), endometriosis (a disease caused by unwanted womb-lining tissue growth outside the womb) and heavy menstrual bleeding (menorrhagia).
Before you use PRIMOLUT N
Do not use PRIMOLUT N if you have any of the following conditions listed below. If any of these apply to you, tell your doctor before starting to use PRIMOLUT N.
You must not use PRIMOLUT N if:
• you are hypersensitive (allergic) to norethisterone or any of the other ingredients of PRIMOLUT N.
• you are pregnant or think you might be pregnant.
• you are breast-feeding.
• 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), the brain (stroke), or other parts of the body.
• you have diabetes mellitus with blood vessel damage.
• you suffer or have suffered from a severe liver disease and you have been told by your doctor that your liver function values have not yet returned to normal. Symptoms of a liver disease may be, for instance, yellowing of the skin and/or itching of the whole body.
• you have or have had a benign or malignant liver tumour.
• you suffer or have suffered from a malignant sex hormone-dependent tumour such as cancer of the breast or the genital organs.
If any of these conditions appear for the first time while using PRIMOLUT N, stop taking it at once and consult your doctor.
Tell your doctor if:
If any of the conditions listed below are present, appear for the first time, recur or worsen during treatment, close observation may be necessary so be sure to tell your doctor if any of these apply before starting PRIMOLUT N.
• you smoke
• you have diabetes, the requirement for oral anti-diabetics or insulin can change
• you are overweight
• you have had a thrombosis/embolism
• you have high blood pressure
• anyone in your immediate family has had thrombosis (venous thromboembolism in a sibling or parent at a relatively early age)
• anyone in your immediate family has had breast cancer
• you have liver disease
• 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 depression
Your doctor will discuss the benefits and risks of starting or continuing to use PRIMOLUT N and determine if you should be closely supervised.
What else you should know
Norethisterone, the active ingredient of PRIMOLUT N, also has oestrogenic properties due to its partial conversion to ethinyloestradiol (an oestrogen with similarity to a female hormone). There were no corresponding oestrogen-related safety relevant findings during the long period of post-marketing surveillance.
• PRIMOLUT N and thrombosis
Thrombosis is the formation of a blood clot which 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. Oral contraceptive studies (which also contain progestogen) show an increased risk of thrombosis, so this risk should be kept in mind).
It is generally recognised that the risk for venous thromboembolism increases for example with increasing age, if you are overweight, if you have had a 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 even 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 thrombosis, stop taking PRIMOLUT N and consult your doctor immediately.
• PRIMOLUT N and cancer
In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of hormonal substances such as the one contained in PRIMOLUT N. These tumours 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 are used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and for tuberculosis (e.g. rifampicin, rifabutin); or antibiotics against infectious diseases (e.g. griseofulvin), and the herbal remedy St.John's wort (primarily used for the treatment of depression).
PRIMOLUT N may interfere with the working of other medicines, e.g. medicines containing cyclosporin.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, including over-the counter medicines, and ask your doctor for advice before taking any other medicines.
• PRIMOLUT N laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking PRIMOLUT N because it can affect the results of some tests.
• Taking PRIMOLUT N with food and drink
The tablets are to be swallowed whole with some liquid.
• PRIMOLUT N and breast feeding
You must not use PRIMOLUT N if you are 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 the ability to drive and use machines
There are no known effects.
How to use PRIMOLUT N properly
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 instead of taking a contraceptive pill. If you think you might have become pregnant despite the protective measures, the treatment must be interrupted until the situation has been clarified by your doctor.
The following dosages are recommended for the specific complaint, however, your doctor will prescribe the dose that is appropriate for your condition.
• Dysfunctional bleeding
1 tablet 3 times daily for 10 days. Usually bleeding stops within 1 to 3 days.
About 2 to 4 days after completion of the treatment, withdrawal bleeding will occur which is similar to the intensity and duration of normal menstruation. Occasionally, slight bleeding may occur after the initial suspension of bleeding. If this happens tablet-taking should not be interrupted or stopped.
If vaginal bleeding does not stop, although you have taken your tablets correctly, you should contact your doctor as another type of treatment and/or investigation may be necessary. This also applies when, after an initial cessation of bleeding, fairly heavy bleeding re-occurs during tablet-taking.
To prevent recurrence of dysfunctional bleeding, your doctor may decide that you should take PRIMOLUT N each cycle 1 tablet 1 to 2 times daily from the 16th to the 25th day of the cycle. (The first day of the cycle = the first day of monthly bleeding). Withdrawal bleeding will occur a few days after the last tablet intake.
• Premenstrual syndrome, breast tenderness
Premenstrual symptoms such as headaches, depressive moods, water retention, and a feeling of tension in the breasts may be relieved by the administration of one tablet PRIMOLUT N 1 to 3 times daily during the 2nd half of the menstrual cycle.
• Timing of menstruation
You should use this method only if you are not at risk of pregnancy during the treatment cycle.
1 tablet PRIMOLUT N 2 to 3 times daily for not longer than 10 to 14 days, beginning about 3 days before expected menstruation. A normal period should occur 2 to 3 days after medication has stopped.
Treatment should begin between the 1st and 5th day of the cycle with 1 tablet PRIMOLUT N twice daily. If spotting occurs, the dose can be increased to 2 tablets twice daily. If bleeding ceases, dose reduction to the initial dose should be considered. Treatment continues for at least 4 to 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur. After discontinuation of hormone treatment a withdrawal bleed will occur.
Treatment with PRIMOLUT N 1 tablet 3 times daily from day 5 to 25 of the cycle has been shown to be effective in reducing menstrual blood loss.
--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.
--Effects when treatment with PRIMOLUT N is stopped:
There are no specific withdrawal symptoms if you stop PRIMOLUT N, but there is the possibility that the original complaints might re-occur.
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 have taken too many tablets or discover that a child has taken PRIMOLUT N, ask your doctor for advice.
When using PRIMOLUT N
Tell your doctor immediately if:
You should stop treatment and see your doctor immediately if you get a blood clot while you are taking PRIMOLUT N. Warning signs to look out for are:
• coughing for no apparent reason
• a feeling of pain and tightness in the chest which may reach the left arm
• more frequent unusually severe, or prolonged headache or a first 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
You should also stop taking PRIMOLUT N and see your doctor immediately if you notice:
• jaundice (yellowish skin, whites of the eyes; this may be a sign of hepatitis)
• generalised severe itching (pruritis)
• high blood pressure
• that you are pregnant
The situations and symptoms mentioned above are described and explained in more detail elsewhere in this leaflet.
Tell your doctor if:
Contact your doctor as soon as possible if:
• you notice any changes in your own health, especially involving any of the items mentioned in this leaflet; 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 also "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
When you are using PRIMOLUT N your doctor will tell you to return for regular check-ups.
Like all medicines, PRIMOLUT N can have side-effects, although not everybody gets them.
Tell your doctor if you notice any unwanted side effects, especially if severe or persistent, or if there is a change in your health that you think might be caused by PRIMOLUT N.
Serious reactions associated with the use of PRIMOLUT N are described in the section "Before you use PRIMOLUT N". Please read this section carefully and consult your doctor where appropriate.
Other possible side-effects
During treatment for endometriosis, changes in bleeding pattern may occur including irregular bleeding, scanty bleeding and absence of bleeding.
Side-effects are more common during the first months of treatment with PRIMOLUT N and disappear with continued treatment. In addition to the side-effects listed in the "What else you should know" and "Tell your doctor if" sections, the following side-effects have been reported in users of PRIMOLUT N preparations, although PRIMOLUT N could not always be confirmed as the cause. Listed below are possible side-effects by the parts of the body they affect and by how common they are:
Very common: (10 or more in every 100 patients are likely to get these)
• Uterine/vaginal bleeding including spotting
• Weak periods (hypomenorrhoea)
Common: (between 1 and 10 in every 100 patients are likely to get these)
• Absence of periods (amenorrhoea)
• Generalized swelling (oedema)
Uncommon: (between 1 and 10 in every 1000 patients are likely to get these)
Rare: (between 1 and 10 in every 10,000 patients are likely to get these)
• Hypersensitivity reactions
• Nettle rash (urticaria)
Very rare: (less than 1 in every 10,000 patients is likely to get these)
• Visual disturbances
• Shortness of breath (dyspnoea)
if taken for endometriosis
Do not use after the expiry date stated on the package.
Store all medicines properly and keep them out of reach of children.
Medicines should not be disposed of via the wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.F