Norethisterone 5mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Norethisterone 5mg Tablets Norethisterone
Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Norethisterone 5mg
Tablets. In the rest of this leaflet it is called
Norethisterone Tablets.
In this leaflet:
1. What Norethisterone Tablets are and what they are used for
2. Before you take Norethisterone Tablets
3. How to take Norethisterone Tablets
4. Possible side effects
5. How to store Norethisterone Tablets
6. Further information
1. WHAT NORETHISTERONE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Norethisterone Tablets is norethisterone. Norethisterone belongs to a group of medicines called progestogens which are female sex hormones. These medicines work by mimicking the effects of female sex hormones producedby the body.
Norethisterone Tablets are used to treat a number of disorders of the menstmal cycle including:
• pre-menstrual symptoms (such as headache, migraine, breast discomfort, water retention or changed behaviour before a period is due)
• abnormal, heavy or continuous bleeding from the uterus (womb) not related to a period
• heavy bleeding during a period
• painful periods
• endometriosis (a painful condition in which the type of tissue lining of the womb aso occurs outside the womb)
Norethisterone Tablets are also used in advanced breast cancer and can be used to postpone a period.
2. BEFORE YOU TAKE NORETHISTERONE TABLETS
Your doctor will discuss your medical and family history with you. Your doctor will also need to check your blood pressure and make sure you are not pregnant. You may also need additional checks, such as a breast examination, that will be specific to your medical needs and/or concerns.
Do not take Norethisterone Tablets if you:
• have ever had a reaction to or been told that you are allergic to norethisterone or any of the other ingredients in the tablets (see ‘What Norethisterone Tablets contain' in section 6)
• are pregnant or suspect that you may be
• are breastfeeding
• have ever had a problem with your blood circulation. This includes a blood clot (thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart attack), brain (stroke) or any other parts of the body
• any symptoms of a blood clot, such as chest pain, unexplained and often sudden shortness of breath and/or cough
• any condition which makes you more at risk of a blood clot (thrombosis)
• have or have had a high risk of disease of your arteries
• have ever suffered from a migraine with visual disturbances
• have liver disease (or are recovering from one) and the blood tests show that your liver is not yet working normally
• have had jaundice (yellowing of the skin and whites of the eyes)
• have/have hada tumour in the liver
• have diabetes with damaged blood vessels
• have or have had cancer of the breast or of the cervix, vagina, womb, ovaries or fallopian tubes, unless you have been prescribed Norethisterone Tablets as part of the treatment for one of these conditions
• have abnormal bleeding from the vagina of unknown cause
• a condition called endometrial hyperplasia
which has not been treated.
• have porphyria (an inherited blood disorder)
In addition, do not take Norethisterone 5mg tablets if you have had any of the following conditions when you were pregnant:
• yellowing of the skin (idiopathic jaundice of pregnancy)
• itching of the whole body (pruritus of pregnancy)
If any of the above statements apply to you, you should not take Norethisterone Tablets.
Norethisterone Tablets should not be taken by
children or the elderly.
Speak to your doctor before taking
Nbrethisterone Tablets if you:
• smoke
• are suffering from diabetes mellitus or have to control the amount of sugar in your diet
• are obese (BMI >30kg/m2)
• have high blood pressure
• have heart or kidney disease
• have had a thrombosis/embolism or anyone in your close family has had a thromboss, a heart attack or a stroke at a young age
• suffer from migraine attacks
• have asthma
• have fits (epilepsy)
• you have an inflammation of your veins (superficial phlebitis)
• you have varicose veins
• anyone in your immediate family has had breast cancer
• you have previously had a condition called chloasma where the skin on your face may develop brownish blotches. You may be advised to avoid exposure to the sun and to ultraviolet light while you are taking Norethsterone 5mg
• suffer from depression or have in the past
• or someone in your close family has ever had high blood levels of cholesterol or
• have liver problems, including recurrent jaundice, or gall bladder problems
• have certain rare medical conditions such as systemic lupus erythematosus (SLE), sickle cell disease, Crohn’s disease or ulcerative colitis
• have haemolytic uremic syndrome (‘HUS)'
• have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria, or Sydenham's chorea)
• have hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing oestrogens may induce or worsen symptoms of angioedema
• are a woman with ovarian cysts
• are a woman with a history of ectopic pregnancy
• have any other condition which may be worsened by the retention of fluid
• are immobile or have recently had surgery or have been involved in an accident which reduces your mobility, as there s an increased risk of developing a blood clot in these situations
• are due to have surgery in future which might cause immobility, particularly surgery to your abdomen or lower limbs
• if you have an intolerance to some types of sugar (galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
should speak toyour doctor before^aking
Norethsterone Tablets.
Norethisterone Tablets and blood clots:
The main ingredient in Norethsterone Tablets (progestogen) is partly converted into oestrogen so you should also consider the general warnings given for combined oral contraceptive pills (“the Pill”).
Do not take Norethisterone Tablets if you have a blood clot or have any medical condition which makes you more at risk of developing dots.
The risk of blood clots occurring in the veins and arteries is slightly greater in women who take the combined oral contraceptive pill than in women who don't. People do not always fully recover from such blood clots, which can cause strokes, heart attacks and bleeding into the brain (subarachnoid haemorrhage). In very rare cases these blood clots can be fatal.
You are more at risk of having a blood clot:
• as you get older
• if you're off your feet for a long time because ofmajor surgery, injury or illness
• if you smoke
• if you or any of your close family have had blood clots
• if you are overweight (BMI > 30kg/m2)
• if you have a disorder of blood fat (lipid) metabolism
• if you have a blood disorder
• if you have high blood pressure
• if you suffer from migraines
• if you have a heart valve disorder or a particular
• if you have recently had a baby
• if you have diabetes
• if you have certain medical conditions such as systemic lupus erythematosus (SLE), sickle cell disease, Crohn’s disease or ulcerative colitis
Tell your doctor if any of these apply to you.
Taking NorethisteroneTablets may add to this risk so it may not be suitable for you.
To reduce the risk of blood clots, treatment with Norethisterone Tablets must be stopped:
• sx weeks before any panned major operation
• before any surgery to the legs
• before medicattreatment for varicose veins
• if you are going to be immobilised for a long time (e.g. if you need bed-rest after an accident or operation, or if you have a paster cast on a broken leg)
Signs of a blood clot include:
• a migraine for the first time or one that is worse than normal
• unusually frequent or severe headaches
• any sudden changes to your eyesight (such as loss of vision or blurred vision)
• any sudden changes to your hearing, speech, sense of smell, taste or touch
• pain or swelling in your leg
• stabbing pain when you breathe
• coughing for no apparent reason
• breathlessness
• pain and tightness in the chest
• sudden weakness or numbness in one side or part of your body
• dizziness or fainting.
See a doctor as soon as possible if you notice any possible signs of blood clot. Do not take any more Norethisterone Tablets until your doctor says you can.
Taking other medicines
Taking another medicine while you are taking Norethisterone Tablets can affect how it or the other medicine works. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you may have bought yourself without a prescription.
Please particularly check with your doctor if you are
• the herbal remedy St John's Wort
• medicines taken for diabetes such as glibenclamide
• lamotrigine, eslicarbazepine, rufinamide, carbamazepine, oxcarbazepine, phenytoin, topiramate and barbiturates, used for epilepsy
• griseofulvin, an antifungal medicine
• rifamycins used to treat tuberculosis
• nevirapine, nelfinavir, ritonavir and amprenavir used to treat viral infections
• cidosporin, a medicine used after transplant
• blood thinners, such as coumarins or phenindione
• selegiline used to treat Parkinsons Disease
• sugammadex and tizanidine, muscle relaxants
• atorvastatin, a statin, for lowering blood pressure
• sitaxentan, an antihypertensive.
If you have any doubts about whether you should take this medicine then talk to your doctor.
Please be ready to give the following information:
|
Product Name |
Reference Number |
|
Norethisterone 5mg Tablets |
29831/0152 |
This is a service provided by the Royal National Institute of Blind People.
Pregnancy and breast-feeding
Noretliisterone Tablets can affect the unborn child. You should not take Norethisterone Tablets if you are pregnant or wish to become pregnant.
If your period is late white you are taking these tablets, tell your doctor or pharmacist. You will need to have a pregnancy test before you start your next course of treatment.
Norethisterone passes into breast milk.
You should not breast-feed whilst taking Norethisterone Tablets.
Driving and using machines
Norethisterone Tablets should not affect your ability to drive or use machines.
Important information for patients with an intolerance to some sugars
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. You should not take Norethisterone Tablets if you have certain types of intolerance.
3. HOW TO TAKE NORETHISTERONE TABLETS
Your doctor will decide the dose which is best for you. Always follow your doctor's instructions completely, and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.
Unless instructed differently, take your tablets with a glass of water.
To treat pre-menstrual symptoms
For pre-menstrual symptoms the usual dose is two or three tablets a day from the 19th to the 26th day of your menstrual cycle (counting the first day of your period as day one). You may need to take treatment for several months.
To treat abnormal, heavy or continuous bleeding from the womb
For abnormal, heavy or continuous bleeding from the womb the usual dose is one tablet three times daily for ten days.
Bleeding usually stops within one to three days. Once you have finished a course of Norethisterone Tablets, you will usually have a withdrawal bleed two to four days after taking the last tablet.
If there is no rise of morning temperature in the second half of the cycle, the abnormal bleeding may recur. To try and
prevent this take one tablet twice daily from the 19th to the 26th day of your menstrual cycle (counting the first day of your period as day one).
To treat prolonged or heavy periods
For prolonged or heavy periods the usual dose is one tablet Two or three times a day from the 19th to the 26th day of your menstrual cycle (counting the first day of your period as day one).
To relieve painful periods
For painful periods the usual dose is one tablet three times daily for 20 days, starting on day five of your menstrual cycle (counting the first day of your period as day one). Treatment will usually be needed for three or four cycles.
To treat endometriosis
For endometriosis (a painful condition in which the type of tissue lining of the womb also occurs outside the womb) the usual starting dose is two tablets a day beginning on day five of your menstrual cyde(count]ng the first day of your period as day one), and continuing for a number of weeks. If spotting occurs, the dose may be increased to a total of four or five tablets dak When bleeding stops you may be able to go back to two to three tabes daily. Treatment is usually for four to six months continuously.
To postpone a period
To postpone a period (for example ,in cases of too frequent bleeding, or special circumstances such as a forthcoming operation, travel, sport or a special occasion), the usual dose is one tablet three times daily, starting three days before the expected period, and continued until no further postponement is required.
A normal period should occur two to three days after the last tablet.
To treat advanced breast cancer
For breast cancer; the usual starting dose is eight tablets daily, which may be
increased to 12 tablets daily. Once you have finished a course of norethisterone, you will usually have a menstrual bleed two to four days after taking the last tablet. If you do not have a period, you must make sure that you are not pregnant before taking any more tablets.
If you take more Norethisterone Tablets than
Iyfou should:
you take more Norethisterone Tablets than you should, contact your doctor,
pharmacist or nearest hospital casualty department immediately. Take this leaflet and any remaining tablets with you.
If you miss a dose of Norethisterone Tablets
If you miss a dose of Norethisterone Tablets, take another dose as soon as you
remember. Do not take a double dose to make up for a forgotten dose.
Stopping treatment with Norethisterone Tablets
You should continue to take Norethisterone Tablets for as long as your doctor tells you to. Do not stop taking this medicine without talking to your doctor first.
4. POSSIBLE SIDE EFFECTS
Like many medicines, Norethisterone may cause side effects in some patients, although not everybody gets them.
If you experience any of the following, you should contact your doctor immediately:
• swelling of the face and wheezing , which may be caused by a severe allergic reaction
• 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 senses of smell, taste or touch
• symptoms of blood dot formation or symptoms of inflammation of the veins combined with the formation of blood clots (thrombophlebitis):
• unusual pains in your leg(s)
o unusual swelling of your arms or legs o sharp pains in your chest or sudden shortness of breath
o crushing pains or feelings of heaviness or tightness in your chest o coughing for no apparent reason o one side of your body suddenly becoming very weak or numb
• changes in liver function or jaundice (yellowing of skin and whites of eyes)
• significant rise in blood pressure which may cause persistent headaches
You may need to stop your Norethisterone Tablets if any of the above side effects occur.
Other side effects include:
Reproductive
• breakthrough bleeding, particularly when treatment is continuous over a long period
• your periods may stop, or become irregular, prolonged or heavy
• spotting may be experienced
• breast changes, including breast discomfort
• ovarian cysts
• changes in sex drive
• pre-menstrual (pre-period) symptoms
• possible increase in breast cancer diagnosis
Gut
• feeling sick or being sick
• stomach ache
• inflammation of the gums Skin
• acne
• hair loss
• allergic skin rashes
• itching
• discoloration of the skin General
• increase in calcium levels
• increase in insulin levels
• change in serum lipid and lipoprotein concentrations
• swelling due to fluid retention
• weight gain
• appetite changes
• headache
• dizziness
• depression
• nervousness
• drowsiness, tiredness
• sleeplessness
• high blood sugar
• fever
• hypertension Eye
• worsening of vision in patients who are short sighted
• minor eye changes which may cause difficulties
if you wear contact lenses
If you take Norethisterone Tablets for a long time
If you need to take the tablets for a long time, you may get breakthrough bleeding or an increase in bodyhair might occur.
If you suffer from migraine or epilepsy
If you suffer from migraine or epilepsy, you may find that your condition worsens
If you are due to have surgery to your abdomen or limbs
If you are due to have surgery in the future you may be asked to stop your Norethisterone Tablets four to six weeks beforehand to help prevent a thrombosis.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/Vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NORETHISTERONE TABLETS
Norethisterone Tablets must be kept out of the reach and sight of children.
• Norethisterone Tablets should not be used after the expiry date stated on the carton. The expiry date refers to the last day of that month.
• The tablets should not be used if they show any signs of deterioration such as discolouration
S should be white).
thisterone Tablets should not be stored above 25°C. The tablets should be kept in their original container, in order to protect from light.
Medicines should not be disposed of 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. FURTHER INFORMATION
What Norethisterone Tablets contain
The active substance is norethisterone.
Each tablet contains 5mg.
The other ingredients are lactose, maize starch and magnesium stearate.
What Norethisterone Tablets look like and contents of the pack
Norethisterone Tablets are round, white, uncoated tablets with “NE 5” on one side and a break line on the other.
Norethisterone Tablets are available in blister packs of 30, 72 and 180 tablets in aluminium foil. Not all pack sizes may be marketed.
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was revised in 07/2015.
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