POLARAMINE® Repetabs (Red and Colour Free), Tablets (Red and Colour Free) and Syrup Dexchlorpheniramine maleate

Consumer Medicine Information

What is in this leaflet? Polaramine can also be used to treat • You are also taking medicines drug reactions. used to treat depression such as monoamine oxidase inhibitor This leaflet answers some common Polaramine belongs to a class of (MAOI). questions about Polaramine. It does medicines known as antihistamines. not contain all of the available Taking Polaramine together with Antihistamines help reduce allergic information. It does not take the a MAOI may exaggerate the symptoms by preventing the effects place of talking to your doctor or effects of Polaramine and cause a of a substance called histamine. pharmacist. severe drop in your blood Histamine is produced by the body in pressure. All medicines have risks and response to foreign substances which benefits. Your doctor or pharmacist the body is allergic to. Do not give Polaramine Syrup to has weighed the risks of you taking children under 2 years of age. Polaramine against the benefits they Your doctor or pharmacist may have Do not give Polaramine Tablets expect it will have for you. prescribed Polaramine for another reason. and Repetabs to children less than If you have any concerns about 12 years. taking this medicine, ask your Ask your doctor or pharmacist if Do not take Polaramine after the doctor or pharmacist. you have any questions about why Polaramine has been prescribed expiry date (EXP) printed on the Keep this leaflet with the medicine. for you. pack. You may need to read it again. There is no evidence that Polaramine Do not take Polaramine if the is addictive. packaging is torn or shows signs of tampering. If you are not sure whether you What POLARAMINE is should start using Polaramine, talk used for Before you take to your doctor or pharmacist. Polaramine relieves symptoms POLARAMINE Before you start to take it associated with allergic rhinitis (including hayfever), such as When you must not take it Tell your doctor or pharmacist if sneezing, runny or itchy nose, and you have allergies to any other burning or itchy eyes. Do not take Polaramine if: medicines, any other substances Polaramine may also be used to • you are allergic to it or any of such as foods, dyes or preservatives relieve symptoms associated with the ingredients listed at the end hives (also known as chronic of this leaflet. urticaria. These symptoms include Some of the symptoms of an itching, redness and lumps on the allergic reaction may include skin skin. rash, difficulty in breathing or faintness.

POLARAMINE® Repetabs (Red and Colour Free), Tablets (Red and Colour Free) and Syrup Published by MIMS/myDr November 2008 1 Tell your doctor or pharmacist if • medicines used to treat Do not crush or chew the you are pregnant or intend to depression such as tricyclic Repetabs. become pregnant. antidepressants This will affect the slow release If you are in the third trimester of • strong / narcotic pain killers, such timing. pregnancy, you must tell your doctor as codeine, morphine and Do not take more than 2 doses of you are taking Polaramine because dextropropoxyphene the Repetabs in 24 hours. newborn babies may have severe • some medicines used to help you reactions to antihistamine. Polaramine Syrup sleep Adults and children over 12 years: Tell your doctor or pharmacist if • some medicines used to treat you are breast-feeding or plan to anxiety 5mL every 6 hours breast-feed. • some medicines used to stop Children 6 to 12 years: 2 to 4mL Polaramine may be transferred in blood clotting, such as warfarin every 6 to 8 hours breast milk to your baby. These medicines may be affected by Children 4 to 6 years: 1.75 to 2mL Tell your doctor or pharmacist if Polaramine, or may affect how well every 6 to 8 hours you have or have had any medical it works. You may need different conditions, especially the following: Children 2 to 4 years: 1.25 to 1.75mL amounts of your medicine, or you every 6 to 8 hours • seizures may need to take different medicines. • liver or kidney disease Your doctor or pharmacist will Do not give Polaramine Syrup to • an overactive thyroid gland advise you. children under 2 years of age. • heart disease Your doctor or pharmacist has more Take Polaramine exactly as your • high blood pressure information on medicines to be doctor or pharmacist has told you to. • raised pressure in the eye careful with or avoid while taking If you take the wrong dose, • Polaramine. prostate problems Polaramine may not work as well and • difficulty passing urine you may not get relief from your • a narrowing or blockage between symptoms. the stomach and small intestine How to take which causes vomiting of How to take it undigested food POLARAMINE • peptic ulcer Swallow the tablet whole with a glass of water. If you have not told your doctor or How much to take pharmacist about any of the above, Do not crush or chew the tell them before you start taking Polaramine Tablets (Red or Colour Repetabs. Polaramine. Free) These tablets have a special coating. Adults and children over 12 years: If you crush or chew them, it will Taking other medicines One Polaramine tablet every 6 hours affect the coating and may not work as well. Tell your doctor or pharmacist if After initial relief is obtained, dosage may be reduced to 1 tablet as you are taking any other When to take it medicines, including medicines required. that you buy without a Polaramine Repetabs (Red or It does not matter if you take prescription from a pharmacy, Colour Free) Polaramine before or after food. supermarket or health food shop. Some medicines should not be taken Adults and children over 12 years: How long to take it with Polaramine. These include: One Polaramine Repetab tablet swallowed whole, every 12 hours. monoamine oxidase inhibitor Continue taking Polaramine until (MAOI). After initial relief is obtained, dosage your symptoms have resolved. These medicines may be affected by may be reduced to 1 tablet as Polaramine and may cause a decrease required. If you forget to take it in blood pressure. Do not give Polaramine Tablets If it is almost time for your next and Repetabs to children under 12 Polaramine may interfere with other dose, skip the dose you missed and years of age. medicines. These include: take your next dose when you are • alcohol meant to. Do not take a double dose to make up for the dose you missed

POLARAMINE® Repetabs (Red and Colour Free), Tablets (Red and Colour Free) and Syrup Published by MIMS/myDr November 2008 2 If there is still a long time to go Do not drink alcohol while taking Ask your doctor or pharmacist any before your next dose, take it as Polaramine. questions you may have. soon as you remember, and then go The effects of alcohol can be Tell your doctor or pharmacist as back to taking your medicine as increased by some antihistamine soon as possible if you do not feel you would normally medicines, including Polaramine. If well while you are taking If you are not sure what to do, ask you drink alcohol, the drowsiness, Polaramine. your doctor or pharmacist dizziness or light-headedness may It helps most people with allergies, become worse. If you have trouble remembering but it may have unwanted side effects to take your medicine, ask your If you feel tired, drowsy, dizzy or in a few people. pharmacist for some hints light-headed, do not drive a vehicle If you are over 60 years of age you or operate machinery. may have an increased chance of If you take too much As with some other antihistamine getting side effects medicines, Polaramine may cause (overdose) tiredness, drowsiness, dizziness or Tell your doctor or pharmacist if you notice any of the following and Immediately telephone your light-headedness in some people. they worry you: doctor, pharmacist or Poisons • Information Centre (13 11 26) for Things to be careful of sleepiness advice, or go to casualty at your • upset stomach nearest hospital, if you think that Protect your skin when you are in • loss of appetite you or anyone else may have taken the sun, especially between 10am • thickening of mucus too much Polaramine and 3pm. • stuffy nose Do this even if there are no signs of If you are outdoors, wear • tight chest discomfort or poisoning. protective clothing and use a 30+ • You may need urgent medical sunscreen. dry mouth, nose or throat attention. Polaramine may cause your skin to These are mild side effects of If you take too much Polaramine, be more sensitive than it is normally. medicines, and usually short lived. you may feel dizzy or light-headed If your mouth continues to feel dry Tell your doctor immediately if and may have difficulty breathing. for more than 2 weeks check with you notice any of the following: your doctor or dentist. • wheezing or being short of breath Antihistamines may cause dryness of • fast, pounding or irregular heart the mouth, nose and throat beats While you are taking Stop taking Polaramine 48 hours • skin rash before you have any skin tests. POLARAMINE • tiredness, headache, dizziness, Antihistamines may interfere with spinning sensation, with the results of skin tests Things you must do yellowing of the skin and/or eyes • unable or difficulty passing urine Tell all doctors, dentists and • passing urine more often than pharmacists who are treating you usual that you are taking Polaramine. Side effects • hallucinations If you become pregnant while All medicines may have some • tingling or numbness in the hands taking Polaramine, tell your doctor unwanted side effects. Sometimes or feet, also known as 'pins and they are serious, but most of the needles' Things you must not do times they are not. Your doctor or These may be serious side effects. pharmacist has weighed the risk of Do not give Polaramine to anyone You may need urgent medical else, even if their symptoms seem using this medicine against the attention. Serious side effects are similar to yours. benefit they expect it will have for rare. you. Do not take Polaramine to treat If any of the following happen, stop any other complaints unless your Do not be alarmed by this list of taking Polaramine and tell your doctor or pharmacist says to. possible side effects. doctor immediately, or go to You may not experience any of them. Accident and Emergency at your nearest hospital: All medicines have side effects. You may need medical treatment if you • chest pain get some of the side effects • sudden signs of allergy such as rash, hives

POLARAMINE® Repetabs (Red and Colour Free), Tablets (Red and Colour Free) and Syrup Published by MIMS/myDr November 2008 3 • swelling of the face, lips, mouth, Product description • lactose tongue or throat which may • starch-maize cause difficulty in swallowing Polaramine can be bought without a • starch-pregelatinised maize or breathing doctor's prescription. • magnesium stearate • convulsions, fits or seizures Polaramine Repetabs contain: • coma What it looks like Active ingredient: These are very serious side effects. Polaramine comes in three forms: You may need urgent medical 6mg dexchlorpheniramine maleate attention or hospitalisation. Tablets (Red or Colour Free) Inactive Ingredients: All of these side effects are very rare. Repetabs (Red or Colour Free) • carnauba wax Other side effects not listed above Syrup • beeswax - white may also occur in some patients. Polaramine Tablets 2mg Red are • zein Tell your doctor or pharmacist if dark pink, oval tablets with the Flask • gelatin you notice anything that is making and Bowl logo embossed on one • you feel unwell. lactose side, in blister packs of 25 and 50 • starch-maize tablets. • magnesium stearate Polaramine Colour Free Tablets 2mg • acacia are off-white, round, bevelled tablet After taking • calcium sulfate with Flask and Bowl logo on one POLARAMINE • sucrose side, and scored on the other side, in • blister packs of 25 and 50 tablets. butyl hydroxybenzoate • colophony Storage Polaramine Repetabs 6mg Red are • red, oval sugar coated tablets, with a oleic acid Keep your tablets in the blister white Flask and Bowl logo on one • talc - purified pack until it is time to take them. • calcium phosphate If you take your tablets out, they will side, in blister packs of 20 and 40 tablets. • not keep well. neutral white soap Polaramine Colour Free Repetabs • erythrosine Keep the medicines in a cool dry 6mg are white to off white oval • place where the temperature stays sunset yellow FCF. below 25°C. coated tablets, in blister packs of 20 Polaramine Colour Free Repetabs and 40 tablets. contain: Do not store it or any other medicine in the bathroom, or near Polaramine Syrup 2mg/5mL is a Active ingredient: 6mg a sink, or on a window sill. clear, red syrup with an orange like dexchlorpheniramine maleate flavour in a 100 mL bottle. Do not leave it in the car on hot Inactive ingredients: days. • carnauba wax Heat and dampness can destroy some Ingredients • beeswax-white medicines. Polaramine tablets contain: • zein Keep it where children cannot Active ingredient: 2mg • gelatin reach it. dexchlorpheniramine maleate • A locked cupboard at least one-and- lactose a-half metres above the ground is a Inactive ingredients: • starch-maize good place to store medicines • lactose • magnesium stearate • starch-maize • acacia Disposal • gelatin • calcium sulfate • magnesium stearate • colophony If your doctor or pharmacist tells • • you to stop taking the tablets, brilliant scarlet 4R sucrose Repetabs or the Syrup, or they Polaramine Colour Free Tablets • oleic acid have passed the expiry date, ask contain: • talc - purified your pharmacist what to do with • calcium phosphate any that are left over. Active ingredient: 2mg dexchlorpheniramine maleate • neutral white soap • Inactive ingredients: methyl hydroxybenzoate. Polaramine Syrup contains:

POLARAMINE® Repetabs (Red and Colour Free), Tablets (Red and Colour Free) and Syrup Published by MIMS/myDr November 2008 4 Active ingredient: 2mg/5mL dexchlorpheniramine maleate Inactive Ingredients: • sodium citrate • sodium chloride • sucrose • sorbitol • methyl hydroxybenzoate • propyl hydroxybenzoate • menthol • ethanol • water • brilliant scarlet 4R • apricot flavour • blood orange flavour

Sponsor

Schering-Plough Pty Limited Level 4, 66 Waterloo Road North Ryde NSW 2113 AUSTRALIA

Australian Registration Numbers

Red Tablets: AUST R 18198 Red Repetabs: AUST R 18195 Syrup: AUST R 18197 Colour Free tablets: (currently not marketed) AUST R 154653 Colour Free Repetabs: (currently not marketed) AUST R 154654

Date of Preparation

August 2008

POLARAMINE® Repetabs (Red and Colour Free), Tablets (Red and Colour Free) and Syrup Published by MIMS/myDr November 2008 5