CONSUMER MEDICINE INFORMATION - Medsafe

1 Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATIONPARACETAMOL + CODEINEP aracetamol 500 mg, codeine Phosphate 8 mg TabletsWhat is in this leafletThis leaflet answers some common questions about paracetamol + does not contain all the available INFORMATION . It does not take the place of talking to your doctor or medicines have risks and doctor will haveweighed the risks ofyou taking paracetamol + Codeineagainstthe benefits he/sheexpects it will have for youhave any concerns about taking this MEDICINE , ask your doctor or this leaflet with the may need to read it paracetamol + Codeineis used forParacetamol + Codeineis usedby adults and children aged 12 years and abovefor the temporary relief of pain and discomfort associated with: headache migraine headache tension headache period pain back pain muscle pain arthritis toothache dental procedures neuralgia sore throat cold and flu symptomsin adults only(18 years and older) paracetamol and codeine work together to stop the pain messages from getting through to the brain.

2 paracetamol also helpsreduce your doctor if you have any questions about why this MEDICINE has been prescribed for doctor may have prescribed it for another MEDICINE is available only with a doctor s you take paracetamol + CodeineWhen you must not take itDo not take paracetamol + Codeineif you havean allergy to: any MEDICINE containing paracetamol , codeine or any other opiates any of the ingredients listed at the end of this leafletSome of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the not give this MEDICINE to a childunder 12 years of + codeine is not suitable for use in children younger than 12 not take paracetamol + codeine if you are taking any other paracetamol containing not take paracetamol + Codeineif youhave: acute breathing difficulties such as bronchitis, unstable asthma or emphysema chronic constipation a drinking problem (alcoholism)

3 Diarrhoea caused by poisoning or a condition known as pseudomembranous colitis severe liver problemsDo not take paracetamol + codeine ifyou are under 18 years old and have had your tonsils and/or adenoids removed to treatobstructive sleep apnoea and have difficulty breathing for the treatment of cough or cold symptomsDo not take paracetamol + codeine during labour, especially if the baby is medication contains codeine , which may produce withdrawal effects in the new not breast-feed if you are taking this active ingredient codeinepasses into breast milkand there is a possibility that your baby may be not take this MEDICINE after the expiry date printed on the pack or ifthe packaging is torn or shows signsof it has expired or is damaged, return itto your pharmacist for you are not sure whether youshould start taking this MEDICINE ,talk to your you start to take itTell your doctor if you have allergies to any other medicines, foods,preservatives or 2 of 4 Tell your doctor if you have or havehad any of the following medicalconditions: lung, kidney or liver problems head injury or a condition where there is raised pressure to the head prostate problems low blood pressure underactive thyroid gland or problems with your adrenal glandsTell your doctor if you have a history of drug abuseor if you drink your doctor if you have had recent gastrointestinal tract you have not told your doctorabout any of the above, tell him/herbefore you start taking paracetamol + other medicinesTell your doctor or pharmacist ifyou are taking any other medicines,including any that you get withouta prescription from your pharmacy,supermarket or health food medicines and paracetamol + Codeinemay interfere with each other.

4 Theseinclude: other pain relief medication medicines which thin the blood such as warfarin medicines used to treat epilepsy chloramphenicol, an antibiotic used to treat infections rifampicin, a MEDICINE used to treat tuberculosis and certain types of infection cholestyramine (to reduce blood fat levels) medicines used to treat diarrhoea, nausea or vomitingsuch as metoclopramide and domperidone any MEDICINE causing sleepiness or drowsiness tranquillisers (medicines for anxiety and nerves) cimetidine, a MEDICINE used to treat gastric ulcers and acid secretion some medicines used to treatdepression including Monoamine Oxidase Inhibitors(MAOIs) medicines used to treathigh blood pressure zidovudine, used for the treatment of HIV medicines used as sedatives or to treat anxietyThese medicines may be affected by paracetamol + Codeineor may affect howwell it works. You may need differentamounts of your medicines, or youmay need to take different doctor and pharmacist have more INFORMATION on medicines to be carefulwith or avoid while taking this to take paracetamol + CodeineFollow all directions given to you by your doctor or pharmacist may differ from the INFORMATION contained in this you do not understand theinstructions on the carton, askyour doctor or pharmacist for much to takeIt is importantthat you take paracetamol + codeine exactly as advised by your doctor.

5 Adults and Children over 12 yearsThe usual dose for adults and children over 12 yearsis 1 to 2 tablets every 4 6 hours as required. Do not take more than 8tablets in 24 doctor may however have prescribed a different to take itSwallow the tablets wholewith a full glass of + Codeinetablets may be broken in half if your doctor has prescribed a half to take itIf you are not sure when to take paracetamol + codeine tablets, ask your doctor or pharmacist for you forget to take itIf it is almost time for your nextdose, skip the dose you missed and take your next dose when you aremeant , take it as soon as youremember, and then go back totaking your MEDICINE as you not take a double dose to make up for the dose that you may increase the chance of you getting an unwanted side you are not sure what to do, ask your pharmacist or doctor. If you have trouble remembering totake your MEDICINE , ask yourpharmacist for some you take too much(overdose)Immediately telephone your doctoror the National Poisons INFORMATION Centre (0800 POISON or 0800 764 766) for advice, or goto Accident and Emergency at the nearest hospital, if you think that you or anyone else may have takentoo much paracetamol + codeine .

6 Do thiseven if there are no signs ofdiscomfort or may need urgent you are takingParacetamol + CodeineThings you must doTell any other doctors,dentists, and pharmacists who treat you that youare taking this 3 of 4If you are going to have surgery, tell the surgeon or anaesthetist that youare taking paracetamol + you become pregnant while takingthis MEDICINE , tell your you are about to have any bloodtests, tell your doctor that you aretaking this may interfere with the results ofsome you must not doDo not take more than therecommended dose unless yourdoctor tells you not take more than 8 tablets a not give your MEDICINE to anyoneelse, even if they have the samecondition as notdrink alcohol while you are taking this alcohol when taking paracetamol + Codeinecan increase the risk of side not take high doses of themedicine for long periods of timeunless your doctor tells you more than the recommended dose may cause liver + codeine may be habit forming if taken in high doses for extended periods of ask your doctor or pharmacist if you are concerned about to be careful ofBe careful driving or operatingmachinery until you know howParacetamol + Codeineaffects MEDICINE may cause dizziness or light headedness in some people, especially after the first dose.

7 Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you feel should not ride bikes if affected and should be supervised to avoid potential you feel light-headed, dizzy orfaint when getting out of bed orstanding up, get up up slowly, especially whenyou get up from bed or chairs, will helpyour body get used to the change inposition and blood pressure. If thisproblem continues or gets worse, talkto your effectsTell your doctor or pharmacist assoon as possible if you do not feel well while you are taking paracetamol + medicines can have side they are serious, most of the time they are not. You may needmedical attention if you get some of the side not be alarmed by the followinglists of side effects. You may notexperience any of your doctor or pharmacist toanswer any questions you may your doctor or pharmacist ifyou notice any of the following and they worry you: constipation nausea, vomiting indigestion drowsiness dizziness sweating skin rash, facial flushing dryness of the mouthThe above list includes the morecommon side effects of your your doctor as soon as possibleif you notice any of the following: tiredness, headache, being short of breath when exercising, dizziness andlooking pale unusual or extreme mood swings frequent infections such as fever, severe chills, sore throat or mouth ulcers bleeding or bruising more easily than normal difficulty in passing urine, increased frequency in urination, pain when passing urine, spasms in the bladderThe above list includes serious sideeffects that may require medicalattention.

8 Serious side effects are any of the following happen, tell your doctor immediately or go toAccident and Emergency at yournearest hospital: wheezing or difficulty breathing swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing hives severe upper stomach pain, with nausea and vomitingThe above list includes very seriousside effects. You may need urgentmedical attention or side effects are very your doctor or pharmacist ifyou notice anything that is makingyou feel side effects not listed above may also occur in some taking paracetamol + CodeineStorageKeep your tabletsin the blister packuntil it is time to you take the tabletsout of the blisterthey may not keep your tabletsin a cool dry place wherethe temperature stays below 25 not store paracetamol + Codeineor anyother MEDICINE in the bathroom ornear a sink. Do not leave it on awindow sill or in the and dampness can destroy some medicineswhere children cannot locked cupboard at least one-and-Page 4 of 4a half metres above the ground is a goodplace to store your doctor tells you to stop takingthis MEDICINE or the expiry date haspassed, ask your pharmacist what todo with any MEDICINE that is descriptionWhat it looks likeParacetamol + codeine tablets are white, round, 13 mm in diameter and 4 mm thick, with MYL on one side and a P above the breakline and a C below the breakline on the other + Codeinetablets contain 500 mg of paracetamol and 8 mg of codeineas the active tabletsalso contain.

9 Maize starch pregelatinised starch potassium sorbate povidone purified talc stearic acidThis MEDICINE does not contain lactose,sucrose, gluten, tartrazine or any azo you want to know moreShould you have any questions regarding this product, please contact your pharmacist or supplies this medicineDistributed in New Zealand by:Mylan New Zealand Ltd, PO Box 11183, Ellerslie, : (09) 579 2792 Date of Information26 April 2018(based on data sheet dated 26 April 2018).