PRIMOLUT-N TABLET

• Heavy Menstrual Bleeding (Menorrhagia): Primolut-N reduces prolonged and heavy menstrual bleeding by regulating the growth and shedding of the womb lining.
• Painful Periods (Dysmenorrhoea): Primolut-N tablet helps alleviate pain and severe cramps associated with menstruation.
• Delaying Periods: One of the most common uses of Primolut-N tablet is postponing menstruation. Most individuals use this during travel, holidays, or special events. It is essential to know that a proper Primolut-N dosage is necessary to delay menstruation. Use only under medical supervision.
• Endometriosis: Primolut-N helps manage symptoms of endometriosis (a condition where uterine tissue grows outside the womb, causing pain and irregular bleeding).
• Premenstrual Syndrome (PMS): The Primolut-N tablet can help manage severe PMS symptoms, such as bloating, breast tenderness, and mood swings.
• Irregular Periods: It helps regulate the menstrual cycle and treat infrequent or unpredictable periods.

• If you are allergic to Norethisterone or any other ingredients in the tablet, do not use.
• If you are pregnant or suspect you might be pregnant or breastfeeding, talk to your doctor before you use the Primolut-N tablet.
• If you have had severe problems with the way your liver works, and your liver function is still abnormal. Symptoms of liver disease may include, for example, yellowing of the skin and/or itching all over your body
• If you have a history of blood clots (thrombosis - deep vein thrombosis or pulmonary embolism) in your legs, lungs, or other organs, or a history of jaundice or skin allergies such as pruritus or if you have severe or multiple risk factors for developing blood clots
• If you have a history of, are suspected of, or have confirmed breast, genital, or hormone-dependent cancer.
• If you have or have had a heart attack, stroke, or severe liver disease, or have a condition that may be a sign of future heart attack, stroke, or severe liver disease.
• If you have unexplained vaginal bleeding that a doctor has not diagnosed.
• If you have a history of jaundice or severe itching during a previous pregnancy.
• If you suffer from migraines with visual or neurological symptoms (such as flashing lights, difficulty speaking, weakness, or numbness in any part of your body).
• If you are suffering from disorders of lipid metabolism or have abnormal cholesterol levels.
• If you have diabetes with damage to your blood vessels, eyes, kidneys, or nerves.
• If you have ever had a liver tumour (whether benign or malignant).
• If you are taking certain hepatitis C medicines (combinations containing ombitasvir, paritaprevir, ritonavir, or dasabuvir).

• 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 sense of smell, taste, or touch
• Unusual pain or swelling in your leg(s) or arms
• Sharp pains in your chest or sudden shortness of breath
• Crushing pain or a feeling of heaviness or tightness in your chest
• Coughing for no apparent reason
• One side of your body suddenly becomes very weak or numb
• You become pregnant
• You develop jaundice (yellowing of the skin or eyes) or other liver problems
• You develop itching all over the body (pruritus)
• Your doctor finds that your blood pressure has risen significantly

• Vaginal bleeding, including spotting
• Periods that are much shorter than normal, with reduced blood flow

• Headache
• Feeling sick (nausea)
• Absence of a period (amenorrhoea)
• Swelling of the body due to water retention (oedema)

• Migraine

• Allergic reactions, including skin rash or hives

• Visual disturbances
• Difficulty in breathing

• Worsening of depression
• Dizziness
• Abdominal pain
• Jaundice
• Cholestasis (a liver condition where the flow of bile is blocked)

Other General Warnings

• You are pregnant, think you might be pregnant, or are currently breastfeeding, as Primolut-N is not considered safe in these situations.
• You smoke, especially if you are over the age of 35, as this increases the risk of side effects.
• You have diabetes. Primolut-N can affect your blood sugar levels, so your doctor may check it before and during treatment.
• You are overweight (BMI of 30 or above).
• You have high blood pressure.
• You have a heart valve disorder or a heart rhythm disorder.
• You or someone in your close family has had a blood clot (thrombosis or embolism), a heart attack, or a stroke at a young age.
• You suffer from migraines, asthma, or kidney problems.
• You suffer from epilepsy
• You have inflammation of your veins (superficial phlebitis) or varicose veins.
• Anyone in your immediate family has had breast cancer.
• You have previously had chloasma (brownish facial skin patches). You may be advised to avoid sunlight and other sources of ultraviolet light while taking Primolut-N.
• You have previously suffered from depression.
• You or someone in your close family has had high blood cholesterol or triglycerides (fatty substances). High levels of these have been linked to inflammation of the pancreas (pancreatitis).
• You have a liver or gall bladder disease, or a history of gallstones.
• You have rare medical conditions such as systemic lupus erythematosus (SLE), sickle cell disease, Crohn's disease, or ulcerative colitis.
• You have haemolytic uraemic syndrome (HUS), a rare condition that affects the blood and kidneys.
• You have had a condition that started or worsened during pregnancy or earlier use of hormone medicines (such as hearing loss, porphyria, or Sydenham's chorea).
• You have hereditary angioedema. Contact your doctor immediately if you develop swelling of the face, tongue, or throat, difficulty in swallowing, or hives with difficulty breathing.
• You have an intolerance to certain sugars (such as galactose intolerance, Lactase deficiency, or glucose-galactose malabsorption).
• You are taking any other medicines, including herbal supplements (see "Interactions" section).
• You are scheduled for surgery, or will be confined to bed for a long period (such as after an injury), as your doctor may advise stopping Primolut-N before this to reduce the risk of blood clots.
• You have a known allergy to Norethisterone or any other ingredients in the Primolut-N tablet.
• You develop new or worsening headaches, sudden vision changes, or a significant rise in blood pressure while taking the medication.

• It is essential to note that the Primolut-N dosage varies depending on the condition being treated. So, always follow your doctor's prescription.
• Swallow the prescribed Primolut-N tablet whole with a full glass of water.
• It is advised to take the tablet either with or without food.
• To delay periods, take one Primolut-N tablet three times a day, starting 3 days before your expected period.
• You can continue taking Primolut-n tablet for as long as you wish to delay periods (up to a maximum of 14 days).
• Once you stop taking the tablet, your periods will resume within 2-3 days.
• For other conditions, such as heavy bleeding, the dose of Primolut-N and its duration may vary.

• Store Primolut-N tablets below 25°C in a cool, dry place.
• Keep them in the original pack to protect them from light and moisture.
• Keep all medicines out of the reach of children and pets.
• Do not use the tablets after the expiry date printed on the pack.

• Primolut-N is NOT a birth control pill. You must use a non-hormonal contraceptive, like condoms, to prevent pregnancy while taking it.
• Always take the exact dosage prescribed by your doctor, and never exceed the recommended dose to avoid increasing your risk of side effects.
• This medicine is intended for short-term use, especially for delaying periods, and should not be used long-term without your doctor’s approval.
• Before starting, inform your doctor about your complete medical history (especially diabetes or depression) and any other medicines or supplements you are taking.
• Do not take Primolut-N if you are breastfeeding. The hormone passes into your breast milk and can harm your baby. It is not recommended for use during breastfeeding.
• If you experience frequent or heavy spotting between periods while taking the tablet, be sure to let your doctor know.
• When using the tablet to postpone your period, make sure to start taking it a few days before your period is due, exactly as instructed by your doctor.

Overdose

Missed a Dose

How Does It Work?

• The active ingredient in Primolut N is Norethisterone, a man-made version of the female hormone progesterone. In a natural menstrual cycle, a drop in progesterone levels signals the breakdown and shedding of the womb lining, resulting in menstruation. Primolut N works by artificially maintaining high levels of this progesterone-like hormone in your body.
• This effectively tricks your system into maintaining the uterine lining instead of shedding it. By preventing the breakdown of this lining, the medication can successfully postpone the start of a period for a desired length of time. This same mechanism also provides stability to the uterine lining, which is why it is an effective treatment for managing conditions such as heavy, painful, or irregular menstrual bleeding. Mimicking the body's own hormonal signals helps to regulate the entire menstrual process, offering control and relief from various gynaecological issues.

Interactions with other drugs

Interactions with food items

• You can take Primolut-N Tablet with or without food, but taking it after a meal may help prevent nausea or stomach discomfort.
• Avoid drinking alcohol in excess, as it can worsen side effects like dizziness or headache.
• Limit foods high in saturated fats and sugar to maintain hormonal balance and overall health.
• Eat a balanced diet rich in fruits, vegetables, and whole grains to support your body while on hormonal treatment.
• Drink plenty of water throughout the day to stay hydrated and reduce bloating or water retention.
• Avoid consuming grapefruit or grapefruit juice while taking this medicine, as it may interfere with how your body processes the hormone.
• If you are prone to nausea, eat small, frequent meals rather than large ones.
• Do not skip meals, as it can cause hormonal fluctuations and affect the medicine’s effectiveness.
• Avoid caffeine in excess, as it can worsen symptoms like anxiety or restlessness that sometimes occur with hormonal medicines.