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Home , Norethisterone, Progestogen (medication)

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PACKAGE LEAFLET: INFORMATION FOR list carefully to see if any of these apply to same time: THE USER you. Consult your doctor if you are not • to treat epilepsy (e.g. sure. , ) • Antibiotic medicines to treat an infection 5mg Tablets Do not take Norethisterone Tablets: • if you are allergic to norethisterone, or (e.g. tetracyclines, , Norethisterone other similar medicines, or any co-trimoxazole) of the other ingredients of this • Antiviral medicines to treat HIV (e.g. (listed in section 6) ritonavir, nelfinavir) • if you are pregnant or think you might • Anticancer medicines be pregnant. Your doctor may give you a • Herbal preparations containing St John’s test before starting treatment wort () or if you miss a period during treatment • , sometimes used in • if you have now or have ever had any Cushing’s Syndrome. (not a period) for which • Ciclosporin (for suppressing the immune your doctor could not find a cause. system) • if you or a member of your family have • Non-steroidal anti-inflammatory drugs ever had a problem with blood clots, (NSAIDs) for treating pain and including deep vein (DVT). inflammation • if you have now or have had in the past, • Medicines for high . a heart attack or angina. Norethisterone Tablets can also interfere • if you have problems. with some laboratory tests, so tell your • if you have ever had a pregnancy where doctor if you are having any blood tests or Read all of this leaflet carefully before you had jaundice, or an itchy rash hospital investigations. you start using this medicine because it known as pemphigoid gestationis. This Tell your doctor or pharmacist if you are contains important information for you. rash appears as small blisters on your taking any other medicines not listed • Keep this leaflet. You may need to read it abdomen. above, including those bought without a again. • if you have severe generalised itching prescription. • If you have any further questions, ask all over your body (pruritis) Pregnancy, -feeding and your doctor or pharmacist. • if you have a condition known as If you are pregnant or breast-feeding, • This medicine has been prescribed for porphyria (a rare inherited blood think you may be pregnant or are planning you only. Do not pass it on to others. It disease). to have a baby, ask your doctor for advice may harm them, even if their signs of Warnings and precautions before taking this medicine. illness are the same as yours. Talk to your doctor or pharmacist before Pregnancy • If you get any side effects talk to your taking Norethisterone Tablets if you have Norethisterone Tablets must not be taken doctor or pharmacist. This includes any any of the following conditions. This will if you are pregnant as hormonal medicines possible side effects not listed in this help them decide if Norethisterone Tablets can affect the developing baby. It is leaflet. See section 4. is suitable for you: important you use some form of The name of your medicine is • Epilepsy contraception (e.g. a condom) while taking Norethisterone 5mg Tablets. In the rest of • Migraine Norethisterone Tablets, as it is not a this leaflet it is called Norethisterone • Asthma contraceptive. Tablets. • Heart problems • Kidney problems. Breast-feeding What is in this leaflet: If you are breast-feeding, ask your doctor 1. What Norethisterone Tablets are and Risk of Venous Thromboembolism for advice before taking this medicine, so what they are used for (VTE) they can advise whether you should use 2. What you need to know before you take All women have a small chance of having an alternative method of feeding your Norethisterone Tablets a blood clot in the veins of the leg, in the baby. 3. How to take Norethisterone Tablets or other part of the body. The chances of getting a clot are very slightly Driving and using machines 4. Possible side effects No effect on the ability to drive or use 5. How to store Norethisterone Tablets higher if you are taking a hormone medicine like Norethisterone Tablets. You machinery has been seen with 6. Contents of the pack and other Norethisterone Tablets. information are more likely to get a clot whether or not you are taking Norethisterone Tablets if you: Norethisterone Tablets contains lactose 1. What Norethisterone Tablets are • are very overweight Lactose is a type of sugar. If you have and what they are used for • have systemic lupus erythematosus. been told by your doctor that you have an (This is a condition where the immune intolerance to some sugars, contact your Norethisterone Tablets is one of a group of system attacks healthy tissues, typically doctor before taking this medicine. medicines called ‘’. causing symptoms such as painful joints Progestogens are similar to the natural and muscles, tiredness, fever and 3. How to take Norethisterone Tablets female hormone . rashes). Always take this medicine exactly as your Norethisterone Tablets contains the • have had a blood clot in the veins or called norethisterone as the doctor has told you. Check with your before doctor if you are not sure. active ingredient. Norethisterone Tablets • have relatives who have had blood clots has many uses. • are unable to move for long periods of The recommended dose will depend on You can take Norethisterone Tablets to time (for example after an operation) the condition you are being treated for. treat or manage: • have a serious injury or have major This information can also be found on the • Heavy periods surgery label on the box the tablets come in. The • Painful periods • have a history of repeated . following information will help you see • Irregular periods or periods that are what the usual dose is for a particular Tell your doctor if you have just had an problem. more frequent than normal operation or if you are going to have an • Premenstrual tension (PMT) operation while taking Norethisterone Taking Norethisterone Tablets for heavy • (where tissue from your Tablets. Section 4 of this leaflet (‘Possible bleeding and other period problems - womb is found outside your womb) side effects’) also has more information on You will usually take 1 3 times a day • Breast . the warning signs of blood clots. (15 mg) for 10 days. A few days after you Your doctor may also prescribe stop taking the tablets you will usually Other medicines and Norethisterone have bleeding like a period. To stop your Norethisterone Tablets if you want to delay Tablets your next period. periods causing problems again, your Tell your doctor or pharmacist if you are doctor may tell you to take Norethisterone 2. What you need to know before you taking, have recently taken or might take Tablets for a few days after your next two take Norethisterone Tablets any other medicines periods. You will probably take 1 tablet This includes the following medicines, as twice a day (10 mg) for 8 days. You will Norethisterone Tablets may not be suitable the effect of Norethisterone Tablets may need to start taking these tablets 19 days for all women. Please read the following be altered when they are taken at the after your last period began.

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ARTWORK CHECK BOX

PRODUCT : Norethisterone 5mg - 30 tablets CUSTOMER : Wockhardt UK FP CODE: FP2060 / FP2972 PLANT LOCATION : Daman (Kadiaya) DIMENSIONS : (w)148 x (h)260mm PHARMACODE No. : 2588 SAP CODE No. : 222748 TEXT FONT SIZE : 8 pt. FILE NAME : Norethisterone 5mg_Leaflet_104373-6.ai SOFTWARE : Adobe Illustrator CS5 TYPEFACES : Helvetica 57 Medium Condensed / 77 Bold Condensed ARTWORK (DETAILS) 10th & 11th January, 2017 RECEIVED ON : PROOF REVISION : R 1st PDF sent on - 16TH JAN. 2017 Process R 2nd PDF sent on - 18TH JAN. 2017 Black R 3rd PDF sent on - 3RD MARCH 2017 CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text Taking Norethisterone Tablets for Symptoms of a deep-vein thrombosis By reporting side effects you can help premenstrual tension - You will usually (DVT): provide more information on the safety of take one 5 mg tablet a day for 10 days, • You have severe pain, tenderness or this medicine. starting 16 days after your last period swelling in your calf, ankle or foot began. • You have purple discolouration of the 5. How to store norethisterone tablets Taking Norethisterone Tablets for skin of the leg or the skin becomes red Keep this medicine out of the sight and endometriosis - You will usually take 1 and warm to touch of children tablet 3 times (15 mg) a day for at least 6 If you get any of these symptoms, you months. If you have any irregular bleeding should stop taking the tablets and see or spotting, your doctor may increase the your doctor immediately. dose to 4 or 5 tablets (20-25 mg) a day Reasons for seeking medical advice until this bleeding stops. during treatment Taking Norethisterone Tablets for It is important to see your doctor - You will usually take 8 straightaway if you get: tablets (40 mg) a day. Your doctor may • Yellowing of the skin or whites of the increase this to 12 tablets (60 mg). eyes (jaundice) • Migraine for the very first time Taking Norethisterone Tablets to delay your periods - You will usually take 1 Your doctor may also decide to stop tablet 3 times (15 mg) a day. You need to treatment if your blood pressure gets too high. start taking the tablets 3 days before your Other side effects period is due to start. Your period will usually You can also get the following side effects start within 3 days of finishing the tablets. with medicines like Norethisterone Tablets: • Do not use this medicine after the expiry If you do not have a period after you Effects on the reproductive system and date which is stated on the carton. The finish a course of Norethisterone : bleeding and spotting between expiry date refers to the last day of that Tablets, check with your doctor in case periods, lack of periods (amenorrhoea), month. you are pregnant. unexpected or unusual vaginal bleeding, • Do not use this medicine if you notice If you take more Norethisterone Tablets changes in discharge from the , any signs of deterioration such as than you should: cervical erosions (this may be seen when discolouration (they should be white). If you take more Norethisterone Tablets you have a smear test), cycles where you • Norethisterone Tablets should not be than you should, contact your doctor don’t ovulate (anovulation), stored above 25°C. The tablets should straight away. and tenderness, a milky discharge from be kept in their original container, in the breast when not pregnant or order to protect from light. If you forget to take Norethisterone (galactorrhoea). Tablets Do not throw away any medicines via Take the tablet as soon as you remember, Effects on the nervous system: wastewater or household waste. Ask your and carry on taking the tablets at the headache, , dizziness, , pharmacist how to throw away medicines normal times. Do not take a double dose difficulty sleeping, confusion, nervousness, you no longer use. These measures will to make up for a forgotten dose. a feeling of intense happiness (euphoria), help protect the environment. feeling sleepy, loss of concentration, vision If you stop taking Norethisterone problems. 6. Contents of the pack and other Tablets information If you have any further questions on the Effects on the stomach and intestines: use of this medicine, ask your doctor or feeling or being sick, constipation, What Norethisterone Tablets contain pharmacist. diarrhoea, dry mouth. The active substance is norethisterone. Effects on the liver: disturbed liver Each tablet contains 5mg. 4. Possible side effects function, yellowing of the skin or whites of The other ingredients are lactose, maize Like all medicines, this medicine can the eyes. starch and stearate. cause side effects, although not everybody Effects on your : altered fat What Norethisterone Tablets look like gets them. levels in the blood, alteration of blood and contents of the pack Reasons for stopping Norethisterone sugar levels, increased levels of insulin Norethisterone Tablets are round, white, Tablets treatment immediately between meals and existing uncoated tablets with “NE 5” on one side Very rarely, Norethisterone Tablets may getting worse, decreased tolerance to and a break line on the other. cause a severe allergic reaction which can some sugars like glucose, adrenergic-like Norethisterone Tablets are available in be life-threatening in some cases. You can effects (e.g. fine hand tremors, sweating, blister packs of 30, 72 and 180 tablets in get some or all of the following symptoms: cramps in the calves at night), effects on foil. Not all pack sizes may be • wheezing the adrenal glands (e.g. Cushingoid marketed. • difficulty breathing syndrome), cloudy vision, sugar in your . Other formats • feeling faint To listen to or request a copy of this leaflet • swelling of the face or tongue Effects on your heart and circulation: in Braille, large print or audio please call, • swelling of the hands and feet blood clots, including clots in the lung, and free of charge: • intense itchy skin rash. swelling in the veins due to blood clots, 0800 198 5000 (UK Only) If you think you are reacting badly to the , heart attacks, congestive heart failure, increased blood pressure, feeling Please be ready to give the following medicine, get emergency medical help information: immediately. your heartbeat, clots in the blood vessels of the retina (this causes visual problems), Product Name Reference The following symptoms could be warning heart beating faster (tachycardia). Number signs of thrombosis (a blood clot) which will need urgent treatment: Effects on your skin and hair: , Norethisterone 5mg Symptoms of a blood clot in the lungs: increase in body or facial hair, hair loss, Tablets 29831/0152 itching, rash, hives. • Sudden, severe, sharp pain in your chest This is a service provided by the Royal • Coughing up blood Miscellaneous: fluid retention and National Institute of Blind People. swelling of hands and ankles, , • You suddenly become short of breath Marketing Authorisation Holder and , raised temperature, change • Your heart beats more rapidly Manufacturer in , changes in sex drive, fatigue, Symptoms of a blood clot in the Marketing Authorisation Holder: increase in (seen in blood tests). (‘a stroke’): Wockhardt UK Ltd, Ash Road North, • You have an unusually severe or long Reporting of side effects Wrexham, LL13 9UF, UK. If you get any side effects, talk to your headache Manufacturer: CP Pharmaceuticals Ltd, doctor, pharmacist or nurse. This includes • Your sight is affected in any way Ash Road North, Wrexham, LL13 9UF, UK. • You find it difficult to speak any possible side effects not listed in this • You collapse or faint leaflet. You can also report side effects This leaflet was revised in 01/2017. • Any part of your body feels weak or directly via the Yellow Card Scheme at 104373/6 numb www.mhra.gov.uk/yellowcard. 222748

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