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WHAT PRIMOLUT-NOR IS AND WHAT IT IS USED FOR
Primolut-Nor is a so-called progestin, a synthetic hormonal product with properties common to the natural female hormone progesterone. It also has a residual androgenic (male sex hormone) effect. Primolut-Nor is used to delay menstruation and to treat menstrual disorders (dysfunctional bleeding), lack of menstruation (primary and secondary amenorrhea), premenstrual complaints (premenstrual syndrome), cycle-related breast complaints (cyclic mastopathy) and endometriosis (a disease leading to complications caused by the growth of the lining of the uterus outside the uterus).
2. BEFORE YOU TAKE PRIMOLUT-NOR
Do not take Primolut-Nor:
if you are allergic (hypersensitive) to norethisterone acetate or any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or think you may be pregnant.
if you are breast-feeding.
if you have (or have ever had) a heart attack or stroke (caused by a blood clot or a ruptured blood vessel in the brain).
you have (or have ever had) an illness that may be an indication (a) of a future heart attack (for example, angina pectoris, which causes severe chest pain that may spread to the left arm) or (b) for a stroke (e.g. , a mild stroke without residual effects (so-called transient ischemic attack).
you have severe or multiple risk factors for blood clots.
you have (or have ever had) a certain type of migraine (with so-called focal neurological symptoms such as visual symptoms, speech impairment or weakness or numbness in any part of the body).
if you have diabetes with damaged blood vessels.
if you have or have had severe liver disease and your doctor has informed you that your liver function tests have not yet returned to normal. Symptoms of liver disease may include, for example, yellowing of the skin and / or itching all over the body.
if you have or have had a benign or malignant liver tumor.
If any of the above conditions occur for the first time while you are taking Primolut-Nor, stop taking it immediately and tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Primolut-Nor.
The sex steroid (progesterone) contained in this product is partially converted to estrogen. Therefore, the general warnings regarding the use of combined oral contraceptives should be further considered for Primolut-Nor.
In some situations, special care should be taken while taking Primolut-Nor and your doctor may need to see you regularly. Consult it before using Primolut-Nor if any of the following conditions apply to you or if any of them occur or worsen while you are taking Primolut-Nor:
if you smoke;
if you have diabetes;
if you are significantly overweight;
if you have high blood pressure;
if you have a heart valve disorder or a specific heart rhythm disorder;
if you have had thrombosis / embolism;
if any of your close relatives have had thrombosis (venous thromboembolism in a sibling or parent at a relatively young age), heart attack or stroke at a young age;
if you have inflammation of your veins (superficial phlebitis);
if you have varicose veins;
if any of your close relatives have had breast cancer;
if you have or have had chloasma (yellowish-brown pigmentation spots on the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet rays;
if you have a history of depression;
if you suffer from migraines;
if you have epilepsy (see 'Other medicines and Primolut-Nor');
if you or any of your close relatives have had high blood levels of cholesterol or triglycerides (fatty substances);
if you have liver or gallbladder disease;
if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
if you have systemic lupus erythematosus (or SLE, a disease of the immune system);
if you have haemolytic uraemic syndrome (or "HUS") a blood clotting disorder that causes kidney failure ();
if you have sickle cell anemia;
if you have a condition that first appears or gets worse during pregnancy or previous use of sex hormones (eg hearing loss; a metabolic disease called porphyria; a skin condition called gestational herpes; a neurological disease called Sidenheim's chorea );
if you have hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or throat and / or difficulty swallowing, or hives accompanied by difficulty breathing. Products containing estrogen can provoke or worsen the symptoms of angioedema.
If any of the above conditions first appear, reappears or worsen while you are taking Primolut-Nor, you must notify
The risk of developing venous or arterial blood clots (eg deep vein thrombosis, pulmonary embolism, heart attack) or stroke increases:
if you are overweight;
if someone in your family has ever had a blood clot (thrombosis in the leg, lung 'pulmonary embolism' or elsewhere), a heart attack or stroke at a young age, or if you or any of your relatives have been diagnosed or suspected to have hereditary blood clotting disorder, the risk of blood clots increases. In this case, you should consult a specialist before deciding to use any combined oral contraceptive. Some blood factors that may be indicative of a predisposition to venous or arterial thrombosis include resistance to activated protein C (APC), hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticarpidiol antibodies). antibodies, lupus anticoagulant);
with prolonged immobilization (for example, when you have a cast or splinted leg or legs), major surgery, any leg surgery, or major injury. In these situations, it is better to stop taking the pill (if surgery is planned, it should be stopped at least four weeks in advance) and not to start again until two weeks after you are back on your feet;
if you smoke (the risk increases the more you smoke and the older you get, especially in women over the age of 35). When using the pill, you should stop smoking, especially if you are over 35 years old;
if you or any of your close relatives have or have had high levels of cholesterol or triglycerides (fatty substances) in your blood;
if you have high blood pressure. If you develop high blood pressure while taking birth control pills, you may be told to stop using them;
if you suffer from migraines;
if you have a heart valve disorder or a certain heart rhythm disorder.
Very rarely, thrombosis can cause serious permanent damage or can even be fatal.
If you notice possible signs of thrombosis, stop taking Primolut-Nor and talk to your doctor straight away (see also section 'When should you contact your doctor?').
Primolut-Nor and cancer
Breast cancer is slightly more common in women taking combination pills, but it is not known if this is due to the treatment itself. For example, perhaps the reason is that women who take combination pills are more likely to have tumors because they are tested more often by their doctor. The risk of developing breast cancer gradually decreases after stopping the use of combined hormonal contraceptives. It is important to check your breasts regularly and you should contact your doctor immediately if you feel a lump.
In rare cases, benign liver tumors have been reported, and even less frequently, malignant liver tumors in women using hormonal substances, such as those contained in Primolut-Nor. These tumors can cause internal bleeding.
The most important risk factor for cervical cancer is persistent infection with the human papilloma virus (HPV). Some studies show that long-term use of the pill increases a woman's risk of developing cervical cancer. However, it is not clear to what extent sexual behavior or other factors such as the human papilloma virus increase this risk.
The aforementioned tumors can be life-threatening or can be fatal.
Contact your doctor immediately if you have severe abdominal pain.
Other drugs and Primolut-Nor
Some medicines may reduce the effectiveness of Primolut-Nor. These are medicines that increase the metabolism of Primolut-Nor, such as medicines used to treat epilepsy (eg primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine) and tuberculosis (eg rifampicin, rifabutin), or antibiotics for infections. griseofulvin), as well as the herb St. John's wort (mainly used to treat depression).
Primolut-Nor may interfere with other medicines, e.g. medicines containing cyclosporine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Ask your doctor or pharmacist for advice before taking any medicine.
If you need to have a blood test, tell your doctor or laboratory staff that you are taking Primolut-Nor, as it may affect the results of some tests.
Primolut-Nor 5 with food and drinks
The tablets should be taken whole with some liquid.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not
If you take more Primolut-Nor than you should:
You should not take more tablets than your doctor has told you to.
There have been no reports of adverse effects from taking too many Primolut-Nor tablets at one time. If you take several tablets at once, nausea, vomiting or vaginal bleeding may occur. If you take too many tablets or find that a child has taken Primolut-Nor, seek medical advice.
If you forget to take Primolut-Nor:
The effectiveness of Primolut-Nor may be reduced if you forget to take a tablet as prescribed. As soon as you remember, you should take only the last missed tablet, and then continue to take the tablets at the usual time the next day.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Primolut-Nor:
There are no specific symptoms to stop if you stop taking Primolut-Nor, but there is a possibility that the initial complaints may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Adverse reactions are more common during the first months of treatment with Primolut-Nor and resolve with continued treatment. In addition to the side effects listed in the “Warnings and Precautions” section, the following side effects have been reported with Primolut-Nor, although it is not always possible to confirm that the cause is Primolut-Nor. The following are possible side effects on systems in the body where they may occur and the frequency of them:
Very common (10 or more in every 100 patients may get them):
Uterine / vaginal bleeding, including spotting *;
Weak menstruation (Hypomenorrhea) *.
Common (between 1 and 10 in every 100 patients may get them):
Lack of menstruation (Amenorrhea) *;
Generalized edema (Edema).
Uncommon (between 1 and 10 in every 1000 patients who may get them):
Rare (between 1 and 10 in every 10,000 patients may get them):
Nettle fever (Urticaria);
Very rare (less than 1 in 10,000 patients may get them):
Shortness of breath (Dyspnoea).
* if taken for endometriosis.
5. HOW TO STORE PRIMOLUT-NOR
Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. PACKAGING CONTENTS AND ADDITIONAL INFORMATION
What Primolut-Nor contains
The active substance is: norethisterone acetate.
The other ingredients are: lactose monohydrate, corn starch, polyvidone 25,000, talc, magnesium stearate.
What Primolut-Nor looks like and contents of the pack
Primolut-Nor 5 mg tablets are available in blister packs consisting of a clear film of polyvinyl chloride and metal aluminum foil (the frosted side is heat-sealed) or in brown glass vials with a protective cap made of polyethylene.
Primolut-Nor 5 mg: 30 tablets x 5 mg
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