PREMONTN TABLET

Manufacturer : CIP-CIPLA LTD
Composition : NORETHISTERONE-5MG
Dose Form : TABLET
Description : PREMONT-N TAB
Route Of Administration : ORAL
Pack : 10
Out of stock
SKU
PRE0390
₹58.50
Manufacturer : CIP-CIPLA LTD
Composition : NORETHISTERONE-5MG
Dose Form : TABLET
Description : PREMONT-N TAB
Route Of Administration : ORAL
Pack : 10

Drug Ingredient Information

NORETHISTERONE-5MG

NORETHISTERONE

Information for patients
Drug Information Norethisterone is a combined oral contraceptive pill (‘the Pill’). You take it to stop getting pregnant. This contraceptive contains two types of female sex hormones, oestrogen and progestogen. These hormones prevent an egg being released from your ovaries so you can’t get pregnant. Also, Norethisterone makes the fluid (mucus) in your cervix thicker which makes it more difficult for sperm to enter the womb. Norethisterone is a 21-day Pill - you take one each day for 21 days, followed by 7 days when you take no pills. The benefits of taking the Pill include: it is one of the most reliable reversible methods of contraception if used correctly it doesn’t interrupt sex it usually makes your periods regular, lighter and less painful it may help with pre-menstrual symptoms. Norethisterone will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this. Norethisterone needs to be taken as directed to prevent pregnancy.
Drug Alert
Alert Your doctor will ask about you and your family’s medical problems and check your blood pressure. You may also need other checks, such as a breast examination but only if these are necessary for you or you have any special concerns
Before Consuming the Medicine
Avoid Drug You will need regular check-ups with your doctor or family planning nurse, usually when you need another prescription of the Pill. You should go for regular cervical smear tests. Check your breasts and nipples every month for changes – tell your doctor if you can see or feel anything odd, such as lumps or dimpling of the skin. If you need a blood test tell your doctor that you are taking the Pill, because the Pill can affect the results of some tests. If you’re going to have an operation, make sure your doctor knows about it. You may need to stop taking the Pill about 4–6 weeks before the operation. This is to reduce the risk of a blood clot (see section 2.1). Your doctor will tell you when you can start taking the Pill again
Drug Special Care The Pill may slightly increase your risk of having a blood clot (called a thrombosis), especially in the first year of taking it. A clot in a leg vein – a deep vein thrombosis (or DVT) – is not always serious. However, if it moves up the veins to the lungs, it can cause chest pain, breathlessness, collapse or even death. This is called a ‘pulmonary embolism’ and is very rare. Your chances of having a blood clot are only increased slightly by taking the Pill. Of 100,000 women who are not on the Pill and not pregnant, about 5 will have a blood clot in a year. Of 100,000 women taking a Pill such as Norethisterone, about 15 will have a blood clot in a year. You are more at risk of having a blood clot in your veins: as you get older if you are seriously overweight if you smoke if you or any of your close family have had blood clots if you have any blood clotting problem that needs treatment with a medicine such as warfarin if you’re off your feet for a long time because of major surgery, injury or illness if you have had one or more miscarriages if you have recently had a baby ?Tell your doctor if any of these risk factors apply to you. Taking the Pill may add to this risk so Norethisterone may not be suitable for you. Signs of a blood clot include: painful swelling in your leg sudden chest pain, difficulty breathing sudden changes in eyesight (such as loss of vision or blurred vision) ?See a doctor as soon as possible. Do not take any more Norethisterone until your doctor says you can. Use another method of contraception, such as condoms, in the meantime. Very rarely, blood clots can also form in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). In healthy young women the chance of having a heart attack or stroke is extremely small. You are more at risk of having a heart attack or stroke: as you get older if you have high blood pressure if you smoke or drink too much alcohol if you have high levels of fat in your blood or are seriously overweight if you have an irregular heartbeat (atrial fibrillation), problems with heart valves or heart failure if you or someone in your close family has had a heart attack or stroke at a young age if you have migraines if you have diabetes if you have a blood problem called sickle cell anaemia ?Tell your doctor if any of these risk factors apply to you. Taking the Pill may add to this risk so Norethisterone may not be suitable for you. Signs of a heart attack or stroke include: sudden crushing pains in your chest which may reach your left arm sudden weakness or numbness in one side or part of your body severe headache or migraine for the first time or worse than normal slurred speech or any other difficulties affecting your speech any sudden changes to your eyesight (such as loss of vision or blurred vision) Do not take Norethisterone if any of the following apply to you: If you are breast feeding and your baby is less than 6 weeks old If you have breast or liver cancer If you have an irregular heartbeat (atrial fibrillation), problems with heart valves or heart failure If you have ever had a problem with your blood circulation. This includes blood clots, for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism), or a heart attack or stroke If you have any conditions which make you more at risk of a blood clot (thrombosis – see section 2.1), such as having an operation and being off your feet for a long time If you have very high blood pressure If you smoke 15 or more cigarettes a day and you are 35 years old or more If you have migraines which affect your vision If you have had diabetes for more than 20 years or have diabetes with secondary problems If you have or have recently had a severe liver disease If you have the disease Systemic Lupus Erythematosus (SLE) with or without Raynaud’s disease If you are allergic (hypersensitive) to any of the ingredients in Norethisterone. ?If you suffer from any of these, or get them for the first time while taking Norethisterone, contact your doctor as soon as possible. Do not take Norethisterone as it may put your health at risk.
Drug Drug Interactions Some medicines can stop Norethisterone from working properly – for example: some medicines used to treat epilepsy certain antibiotics griseofulvin (for fungal infections) certain sedatives (called ‘barbiturates’) St. John’s Wort (a herbal remedy) certain laxatives and charcoal If you do need to take one of these medicines, Norethisterone may not be suitable for you or you may need to use extra contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long. Norethisterone can also affect how well other medicines work. For example, if you have diabetes, you may need to take more insulin or other anti-diabetic drugs while you take Norethisterone. Your doctor will tell you if this is necessary
Drug Pregnancy Interaction Do not start to use Norethisterone if you are pregnant. If you think you might be pregnant while taking Norethisterone, do a pregnancy test to confirm that you are before you stop taking it
Drug Breast feeding Interaction If you are breast-feeding, your doctor or family planning nurse may advise you not to take Norethisterone. Talk to them about alternative contraception. Breast-feeding may not stop you getting pregnant.
Drug Machinery Interaction Norethisterone has no known effect on the ability to drive or use machines
Drug More Information The Pill reduces your risk of cancer of the ovary and womb if used for a long time. However, it also seems to slightly increase your risk of cancer of the cervix – although this may be due to having sex without a condom, rather than the Pill. All women should have regular smear tests. If you have breast cancer, or have had it in the past, you should not take the Pill. The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on the Pill, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent Pill users are small. For example: Of 10,000 women who have never taken the Pill, about 16 will have breast cancer by the time they are 35 years old. Of 10,000 women who take the Pill for 5 years in their early twenties, about 17–18 will have breast cancer by the time they are 35 years old. Of 10,000 women who have never taken the Pill, about 100 will have breast cancer by the time they are 45 years old. Of 10,000 women who take the Pill for 5 years in their early thirties, about 111 will have breast cancer by the time they are 45 years old. Your risk of breast cancer is higher: as you get older if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are seriously overweight ?See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel. Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely, the Pill has also been linked with some forms of liver cancer in women who have taken it for a long time. ?See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or eyes (jaundice). You may need to stop taking Norethisterone. Some of the conditions listed below can be made worse by taking the Pill. Or they may mean it is less suitable for you. You may still be able to take Norethisterone but you need to take special care and have check-ups more often. Tell your doctor or family planning nurse if any of these apply to you: If you have problems with your heart, circulation or blood clotting, such as high blood pressure If you have diabetes without secondary problems If you have gall bladder problems If you have porphyria If you have a history of migraines If you have brown patches on your face or body (chloasma) as you may need to keep out of the sun If you have had any of the following problems while pregnant or during previous Pill use, such as itchy skin or blister-like rash, yellowing of skin or eyes, hearing problem, systemic lupus erythematosus (SLE), severe headaches ?Tell your doctor or family planning nurse if any of these apply to you. Also tell them if you get any of these for the first time while taking the Pill, or if any get worse or come back, because you may need to stop taking Norethisterone and use another method of contraception, such as condoms If you start a new strip of pills late, or make your ‘week off’ longer than eight days, you may not be protected from pregnancy. If you had sex in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days 3.4 A lost pill If you lose a pill, just take a pill of the same colour from a spare strip. Then take all the other pills from your current strip as usual. You can then keep the opened spare strip in case you lose any more pills. _____________________________________________________________ 3.5 If you are sick or have diarrhoea If you are sick or have very bad diarrhoea, your body may not get its usual dose of hormones from that pill. If you have been sick within 2 hours of taking Norethisterone, just take a pill of the same colour from a spare strip. Carry on taking your pills as normal if you can. You won’t need to use extra contraception. If you are still sick or have diarrhoea for more than 1 day, follow the instructions for a missed pill – see section 3.3, A missed pill. ?Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception. _____________________________________________________________ 3.6 Missed a period – could you be pregnant? Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the chemist or get a free test at your family planning clinic or doctor’s surgery. If you are pregnant, stop taking Norethisterone and see your doctor. If you want to delay having a period, finish the strip of pills you are taking. Start the next strip the next day without a break. Pill taking should then continue as usual. When you use the second strip, you may have some unexpected bleeding or spotting on the days that you take the pill, but don’t worry. Take the next strip after the usual 7 day break even if you are still bleeding or spotting
How to take the Medicine
Consumption Info There are no special instructions about food and drink while on Norethisterone.If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Norethisterone As a new user or starting the Pill again after a break Either take your first Norethisterone pill up to and including day 5 of your next period (counting the first day of your period as day 1). This way, you will have contraceptive protection with your first pill. Or start taking Norethisterone at any time, if you are sure you are not already pregnant. But then you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly. Changing to Norethisterone from another contraceptive If you are currently taking another Pill and you are taking it correctly, you can start Norethisterone at any time, if you are sure you are not already pregnant. There is no need to wait for your next period to start and you don’t need extra contraception. If you are currently using a non-hormonal method and your period started more than 5 days ago, you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly. Starting Norethisterone after a miscarriage or abortion If you have had a miscarriage or an abortion, your doctor may tell you to start taking Norethisterone straight away. This means that you will have contraceptive protection with your first pill. Contraception after having a baby If you have just had a baby, your doctor may tell you to start taking Norethisterone 21 days after the birth. This means that you will have contraceptive protection with your first pill. If you start Norethisterone after this, you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly
Drug quanitty Norethisterone comes in a strip of 21 pills, each marked with a day of the week. Take your pill at the same time every day. Start by taking a white pill marked with the correct day of the week. Follow the direction of the arrows on the strip. Take one white pill each day, until you have finished all of them. Then take a peach-coloured pill marked with the correct day of the week Follow the direction of the arrows on the strip. Take one peach-coloured pill each day, until you have finished all of them. Swallow each pill whole, with water if necessary. Do not chew the pill. Then have seven pill-free days After you have taken al 21 pills in the strip, you have seven days when you take no pills. So if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week. Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills. You don’t need to use extra contraception during these seven pill-free days – as long as you have taken your pills correctly and start the next strip of pills on time
Drug Dose To prevent pregnancy, always take Norethisterone as described below. Check with your doctor or family planning nurse if you are not sure Then start your next strip Start taking your next strip of Norethisterone after the seven pill-free days – even if you are still bleeding. Always start the new strip on time. As long as you take Norethisterone correctly, you will always start each new strip on the same day of the week.
Excess Drug Consumption It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms
Forgot Drug Consumption Missing pills or starting a strip late may make your pill less effective. The chance of pregnancy after missing pills depends on when pills are missed and how many pills are missed. Missing one pill anywhere in your strip or starting a new strip one day late is not a problem. Missing more than one or starting a strip more than one day late may affect your contraceptive cover. It is more risky to start a strip late and miss more than one pill. How many pil s have you missed? . One pil Take the missed pill straight away, and further pills as usual. This may mean taking two pills in one day. Continue taking the rest of the strip as usual. Don’t worry - your contraceptive protection should not be reduced. Two or more pil s Take the most recently missed pill straight away Leave any earlier missed pills in the strip Take your next pill at the usual time. This may mean taking two pills in one day Continue taking the rest of the strip as usual. Use extra precautions (condoms, for instance) for the next 7 days. Check how many pills are left in the strip after the most recently missed pill 7 or more pil s left in the pack Fewer than 7 pil s left in the pack Use extra precautions for the next 7 days Use extra precautions for the next 7 days When you have finished the strip, leave the When you finish the strip, start the next strip the usual 7-day break before starting the next next day without a break. strip. If you do not have a withdrawal bleed after you If you have missed any pil s from the first have finished the second strip, do a pregnancy test week of your strip and you had sex in that week, you could become pregnant. Contact your doctor, family planning nurse or pharmacist for advice as soon as possible. They may recommend you use emergency contraception. If you have missed any of the pills in a strip, and you do not bleed in the first pill-free break, you may be pregnant. Contact your doctor or family planning clinic, or do a pregnancy test yourself
Stop Drug Consumption If you are planning a baby, it’s best to use another method of contraception after stopping Norethisterone until you have had a proper period. Your doctor or midwife relies on the date of your last natural period to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight away
Possible Side Effects
General Information increased blood pressure hives (urticaria), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. These may be signs of allergy. ?If you think you may have any of these, see a doctor straight away. You may need to stop taking Norethisterone.
Common Drug Side Effects Signs of a blood clot in a vein include: painful swelling in your leg sudden chest pain, difficulty breathing sudden changes in eyesight (such as loss of vision or blurred vision). Signs of heart attack or stroke include: a severe headache or migraine for the first time, or worse than normal sudden changes in eyesight (such as loss of vision or blurred vision) sudden weakness or numbness in one side or part of your body slurred speech or any other difficulties affecting your speech sudden crushing pains in your chest which may reach your left arm. Signs of breast cancer include: dimpling of the skin changes in the nipple any lumps you can see or feel. Signs of severe liver problems include: severe pain in your upper abdomen yellow skin or eyes (jaundice) Headache
Rare Drug Side Effects Swollen hands, ankles or feet Depression; feeling irritable Stomach cramps and bloating Acne Tender breasts
Very Rare Drug Side Effects Migraine (see a doctor as soon as possible if this is your first migraine or it’s worse than usual) Painful or sore breasts Mood changes Rash; patches of darkened skin (which may not disappear) Hair thinning (alopecia), excessive hair growth Nausea, vomiting Changes in appetite Weight gain or loss Change in sex drive Vaginal thrush (fungal infection) No withdrawal periods Bleeding and spotting between your periods for the first few months (though this usually stops when your body adjusts to Norethisterone) – see section 4.3, Bleeding between periods should not last long. Contact lenses may feel uncomfortable
Drug Side Effects Symptoms Gynaecological problems: Vaginal problems, such as more secretions Heavy or unusual periods Fibroids (disorder of the womb) may get worse Delayed return to fertility after stopping the Pill Cancer of the cervix (vaginal discharge that smells and contains blood, unusual vaginal bleeding, pelvic pain, painful sex) Breast problems such as fuller breasts; producing a milky fluid from the nipples, reduced amount of breast milk (if breast feeding) Oily skin Small red blisters or pimples on the hands or arms, red painful lumpy swellings on the legs Stomach ache Premenstrual syndrome (PMS) Gallstones A problem with the nervous system (chorea). ?Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects which you think may be due to Norethisterone. Also tell them if any existing conditions get worse while you are taking Norethisterone. Usually you should only have a withdrawal bleed like a period during the seven pill-free days. However, a few women have a little unexpected bleeding or spotting while they are taking Norethisterone, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Norethisterone as usual. The problem should disappear after the first few strips. You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines. ?Make an appointment to see your doctor if you get breakthrough bleeding or spotting that: carries on for more than the first few months starts after you’ve been taking Norethisterone for a while carries on even after you’ve stopped taking Norethisterone.
How to Store the Medicine
How to Store the Medicine Keep all medicines out of the reach and sight of children. Store Norethisterone below 25°C. Store it in the original package to protect it from light and moisture. Do not use Norethisterone after the expiry date shown on the strip. The expiry date refers to the last day of that month. Do not throw away any medicines down a drain or into a bin. Ask your pharmacist what to do with any medicines you do not want. This will help to protect the environment

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