Nozinan® Tablets levomepromazine maleate Consumer Medicine Information (CMI)
What is in this leaflet Before you take it Tell your doctor or pharmacist if you are pregnant or intend to This leaflet answers some common become pregnant. questions about Nozinan. When you must not take it Like most medicines of this kind, Nozinan is not recommended to be It does not contain all the available Do not take Nozinan if you have: used during pregnancy. Your doctor information. It does not take the or pharmacist will discuss the risks place of talking to your doctor or • liver disease and benefits of taking it if you are pharmacist. • heart disease pregnant. All medicines have risks and benefits. • urinary or prostate problems Tell your doctor or pharmacist if Your doctor has weighed the risks of you are breastfeeding or planning • increased pressure in the eye you taking this medicine against the to breastfeed. (glaucoma) benefits he expects it will have for It is not known whether Nozinan you. • a history of a lack of white blood passes into breast milk. Your doctor If you have any concerns about cells (agranulocytosis) or pharmacist will discuss the risks and benefits of taking it if you are taking this medicine, ask your Do not take Nozinan if you are breastfeeding or planning to doctor or pharmacist. allergic to it or any of the breastfeed. Keep this leaflet with the medicine. ingredients listed at the end of this leaflet. You may need to read it again. Tell your doctor or pharmacist if Some symptoms of an allergic you have or have had any medical reaction include skin rash, itching, conditions, especially the following: shortness of breath or swelling of the • heart disease face, lips or tongue, which may cause What Nozinan is used difficulty in swallowing or breathing. • liver disease • kidney disease Do not take it if you are for • an underactive thyroid gland, breastfeeding or planning to causing a decrease in breastfeed. Nozinan is a type of neuroleptic used metabolism in both psychiatry and severe pain. Nozinan may pass into breast milk and there is a possibility your baby • phaeochromocytoma - a rare It is not known exactly how Nozinan may be affected. tumour of the adrenal gland has these effects. which sits near the kidneys. Do not take it after the expiry date The effect of Nozinan is to relieve (EXP) printed on the pack. • disease of the muscles causing severe pain without making you feel If you take it after the expiry date has drooping eyelids, double vision, sick or vomit. It relieves the anxiety passed, it may not work as well. difficulty in speaking and and distress associated with severe swallowing and sometimes pain. Nozinan can also be used to Do not take it if the packaging is muscle weakness in the arms or treat schizophrenia. damaged or shows signs of legs (myasthenia gravis) tampering. Your doctor, however, may prescribe • slow or irregular heartbeats or Nozinan for another purpose. palpitations or have a family Before you start to take it Ask your doctor if you have any history of these questions about why it has been Tell your doctor or pharmacist if • low levels of potassium, calcium prescribed for you. you have allergies to: or magnesium in your blood This medicine is only available with a • any of the ingredients listed at • blood clots doctor’s prescription. the end of this leaflet • diabetes or risk factors for There is no evidence that this • any other substances, such as developing diabetes medicine is addictive. foods, preservatives or dyes. • Parkinson’s disease • dementia
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• epilepsy How to take it Ask your doctor or pharmacist if • if you have a high consumption you are not sure how long to take of alcohol the medicine for. Follow all directions given to you Tell your doctor or pharmacist if by your doctor and pharmacist you plan to have surgery. carefully. If you forget to take it If you have not told your doctor or They may differ from the information Do not try to make up for missed pharmacist about any of the above, contained in this leaflet. doses by taking more than one dose tell them before you take Nozinan. If you do not understand the at a time. instructions on the pack, ask your This may increase the chance of Taking other medicines doctor or pharmacist for help. getting an unwanted side effect. If it is almost time for your next Tell your doctor or pharmacist if How much to take dose, skip the dose you missed and you are taking any other take the next dose when you are Your doctor or pharmacist will tell medicines, including any that you meant to. buy without a prescription from you how much Nozinan you will need your pharmacy, supermarket or to take each day. This depends on Do not take a double dose to make health food store. your condition. up for the dose you have missed. Some medicines may interfere with Adult dose: If there is still a long time to go Nozinan. These include: The usual recommended dose for before your next dose, take it as • medicines for Parkinson’s disease adults with terminal pain is half to soon as you remember, and then go such as levodopa two Nozinan 25 mg tablets every 4 to back to taking it as you would normally. • other antipsychotics 8 hours. • sedatives (medicines that help you The usual recommended daily dose If you are not sure what to do, ask sleep) for adults with schizophrenia is half your doctor or pharmacist. to two Nozinan 25mg tablets. This is If you have trouble remembering • hypnotics (medicines that help usually divided into three doses. you relax or reduce stress) when to take your medicine, ask Your doctor may have prescribed a your pharmacist for hints. • medicines that affect heart rhythm different dose. (such as disopyramide, amiodarone, beta-blockers, Ask your doctor or pharmacist if If you take too much verapamil, diltiazem) you are unsure of the correct dose (overdose) for you. • medicines that cause low levels of They will tell you exactly how much Immediately telephone your potassium in your blood (such as to take. doctor, or the Poisons Information diuretics, stimulant laxatives) Centre (New Zealand 0800 Follow the instructions they give • desferrioxamine (removes excess POISON or 0800 764766), or go to you. iron from the body) Accident and Emergency at your If you take the wrong dose, Nozinan nearest hospital, if you think you • adrenaline (sends more oxygen to may not work as well and your or anyone else may have taken too the brain and muscles) problem may not improve. much Nozinan. • medicines metabolised by Do this even if there are no signs of CYP2D6 (such as amitriptyline How to take it discomfort or poisoning. or amitriptylinoxide) You may need urgent medical Swallow the tablets whole with a attention. • medicines that lower blood full glass of water or other liquid. pressure (such as guanethidine) If you take too many Nozinan tablets, you will probably feel very sleepy or • some cough and cold preparations When to take it or eye drops containing atropine dizzy, you may faint or your and atropine-like substances Take Nozinan tablets every 4 to 8 heartbeat may become irregular. hours irrespective of meals, or as • medicines used to treat mood prescribed by your doctor. swings and depression, including lithium If you are not sure when to take it, Your doctor or pharmacist has more ask your doctor or pharmacist. While you are taking it information on medicines to be careful with or to avoid while taking How long to take it Nozinan. Things you must do Continue taking the tablets until your doctor tells you to stop. Tell all the doctors, dentists and pharmacists who are treating you that you are taking Nozinan. Page 2 NOZINAN®
If you are about to be started on Side effects • hormone imbalance which may any new medicine, tell your doctor cause breast enlargement and and pharmacist that you are taking impotence in men or unusual All medicines have some unwanted Nozinan. secretion of breast milk in non- side effects. Sometimes they are breastfeeding women, loss of If you plan to have surgery that serious, but most of the time they are menstrual periods and frigidity needs a general anaesthetic, tell not. Your doctor has weighed the your doctor or dentist that you are risks of using this medicine against • feeling tired,weak,confused and taking this medicine. the benefits he expects it will have have muscles that ache, are stiff for you. or do not work well. This may be due to low sodium levels in Things you must not do Do not be alarmed by this list of your blood possible side effects. Do not take more than the You may not experience any of them. • feeling unwell, confused and/or recommended dose unless your weak, feeling sick (nausea), loss doctor tells you to. Tell your doctor or pharmacist as of appetite, feeling irritable. soon as possible if you do not feel This could be something called Do not give this medicine to anyone well while you are taking Nozinan. a syndrome of inappropriate else, even if they have the same It helps most people with severe pain anti-diuretic hormone secretion condition as you. or schizophrenia, but it may have (SIADH) unwanted side effects in a few Do not use this medicine to treat • feelings of confusion, people. any other complaints unless your indifference or nervousness doctor tells you to. Tell your doctor or pharmacist if • mood changes Do not stop taking Nozinan, or you notice any of the following and lower the dosage, without checking they worry you: • inability to control movement of certain muscles in your body with your doctor. • drowsiness Your doctor may want you to • restlessness or difficulty sitting gradually reduce the amount you are • weakness still using before stopping completely. • dry mouth Tell your doctor immediately, or Do not stop taking your tablets These are mild side effects of this go to Accident and Emergency at because you are feeling better, medicine and usually short-lived. your nearest hospital if you notice unless advised by your doctor. any of the following: Tell your doctor or pharmacist • high temperature, sweating, Things to be careful of immediately if you notice any of the following: pale complexion, difficulty in passing urine If you feel light-headed, dizzy or • dizziness, feeling faint or loss of faint, get up slowly when getting • convulsions, fits or seizures alertness out of bed or standing up. • pain in the stomach with severe, • skin irritation or rash especially Be careful driving or operating colicky stomach pain with after going out into the sun, machinery until you know how bloating, cramps, vomiting, which may result in burning Nozinan affects you. bloody diarrhoea It may cause dizziness or light- • fever, ulcers in the mouth or • sudden severe headache, loss of headedness in some people, throat, sore throat or any other vision and/or coordination, especially after the first dose. Make infection shortness of breath, chest pain, sure you know how you react to it • tremors or shaking, muscle numbness or swelling in the before you drive a car, operate stiffness arms and legs machinery, or do anything else that • constipation, which may These may be serious side effects of could be dangerous if you feel dizzy. become severe and stop food Nozinan. You may need urgent Be careful if you are over 65 and moving through the bowel medical attention. Serious side effects unwell or taking other medicines. • unwanted or persistent are uncommon. Some people may experience side erections If any of the following happen, stop effects such as drowsiness, confusion, • irregular or fast heart beat taking this medicine and tell your dizziness and unsteadiness, which doctor immediately, or go to may increase the risk of a fall. • symptoms of high blood sugar levels such as excessive thirst, Accident and Emergency at your The effects of alcohol could be increased appetite with weight nearest hospital: made worse while taking Nozinan. loss, feeling tired, passing large • swelling of the face, lips, mouth Avoid alcohol while taking amounts of urine or throat, which may cause Nozinan. • symptoms of jaundice such as difficultly in swallowing or yellowing of the skin and/or breathing. eyes • hives • feeling particularly hot or cold • fainting Page 3 NOZINAN®
• yellowing of the skin and eyes Disposal Nozinan does not contain gluten, (jaundice) sucrose, lactose, tartrazine or any These are very serious side effects. If If your doctor or pharmacist tells other azo dyes. you have them, you may have had a you to stop taking Nozinan, or the medicine has passed its expiry date, serious allergic reaction to Nozinan. Manufacturer/Sponsor You may need urgent medical ask your pharmacist what to do attention or hospitalisation. with any that are left over. sanofi –aventis new zealand limited Level 8, These side effects are very rare. Return any unused medicine to your pharmacist. 56 Cawley Street Tell your doctor or pharmacist if Ellerslie you notice anything else that is Auckland making you feel unwell. This leaflet was prepared in October Other side effects not listed above 2018. may occur in some consumers. Product description ® Registered Trademark Do not be alarmed by this list of possible side effects. nozinan-ccsiv3-cmiv7-02oct18 You may not experience any of them. What it looks like Ask your doctor or pharmacist to Nozinan is available in two strengths answer any questions you may of tablets: have. Nozinan 25 mg - white, rounded faced, round, breakable tablet, marked “L 25” Nozinan 100 mg - white, rounded faced, round, breakable tablet, After taking it marked “L 100”. The 25 mg strength is available in If you have any queries about any boxes of 100 tablets. aspect of your medicine, or any The 100 mg strength is available in questions regarding the boxes of 100 tablets. information in this leaflet, discuss them with your doctor or pharmacist. Ingredients Active Ingredient: Storage Nozinan 25 mg – 25 mg Keep your tablets in the blister levomepromazine maleate per tablet pack, inside the box in which they Nozinan 100 mg – 100 mg came until it is time to take them. levomepromazine maleate per tablet. If you take the tablets out of the box Inactive Ingredients: or the blister pack they may not keep The 25 mg tablets also contain: well. • potato starch Keep the medicine in a cool, dry • calcium hydrogen phosphate place where the temperature stays dihydrate below 25C. • sodium laurilsulfate Do not store it or any other medicine in the bathroom, near a • magnesium stearate sink, or on a windowsill. • polyvinyl acetate Do not leave it in the car. • macrogol 6000. Heat and damp can destroy some medicines. The 100 mg tablets also contain: Keep it where children cannot • potato starch reach it. • calcium carbonate A locked cupboard at least one-and- • sodium laurilsulfate a-half metres above the ground is a good place to store medicines. • stearic acid • polyvinyl acetate • macrogol 6000.
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