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Home , Antihistamine, Promethazine

Phenergan® (fen-er-gan) hydrochloride (PRO-meth-ar-zine HIGH-dro (h)-CLOR-ride) Consumer Information (CMI)

What is in this leaflet help reduce allergic Do not take Phenergan if you are symptoms by preventing the effects also taking or have recently (within This leaflet answers some common of a substance called . the last 14 days) taken monoamine questions about Phenergan. Histamine is produced by the body in oxidase inhibitors, a type of response to foreign substances that medicine used to treat depression. It does not contain all the available the body is allergic to. information. It does not take the Do not take Phenergan if you have place of talking to your pharmacist or Your pharmacist or doctor may have jaundice. doctor. recommended Phenergan for another Do not take this medicine if you reason. All have risks and are receiving or have received high benefits. Your pharmacist or doctor Ask your pharmacist or doctor if doses of other CNS has weighed the risks of you taking you have any questions about this (for example, Phenergan against the benefits they medicine. that are used to treat and expect it will have for you. Phenergan must not be used in disorders). If you have any concerns about children under 2 years of age, due Do not take this medicine if you taking this medicine, ask your to the potential for fatal have slowed breathing or heart pharmacist or doctor. respiratory depression. rate of any cause. Keep this leaflet with the medicine. This medicine may affect your Any person who is unconscious or ability to drive a car or operate in a coma must not be treated with You may need to read it again. machinery. Phenergan. Do not give Phenergan to newborn or premature babies. What Phenergan is Before you take it Do not use for children less than used for two years of age, due to the potential for fatal respiratory Phenergan is an used to When you must not take it depression. treat a number of conditions: Do not take Phenergan if you have Do not take Phenergan if you are • - allergic contact an to: pregnant or plan to become , , hayfever, bites • any medicine containing pregnant. and stings promethazine hydrochloride It may affect your developing baby if • respiratory symptoms due to • any of the ingredients listed at the you take it during . Your allergies - runny nose end of this leaflet pharmacist or doctor will discuss the benefits and possible risks of taking • and vomiting - motion Some of the symptoms of an allergic the medicine during pregnancy. sickness reaction may include: Do not take Phenergan if you are • assists in the management of the • shortness of breath or plan to symptoms of chicken pox and • wheezing or difficulty breathing breastfeed. measles by acting as a • swelling of the face, lips, tongue It passes into the breast milk and • for short-term use in adults for or other parts of the body there is a possibility that the baby on the advice of a may be affected. pharmacist or doctor - do not use • rash, itching or hives on the skin for more than 7-10 days

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Do not take Phenergan after the Phenergan may delay the early They may differ from the expiry date (EXP) printed on the diagnosis of intestinal blockage information contained in this leaflet. pack. through preventing vomiting. Phenergan tablets are recommended If you take this medicine after the Phenergan may mask the warning for adults and children over 6 years expiry date has passed, it may not signs of ototoxicity e.g. salicylates of age. work as well. (damage to the inner ear) Phenergan is recommended for Do not take Phenergan if the children 2-5 years of age. Taking other medicines packaging is torn or shows signs of Allergic Disorder tampering. Tell your pharmacist or doctor if Adults: One to three 25mg tablets as you are taking any other a single dose at night, or one to two Before you start to take it medicines, including any that you 10mg tablets, two to three times buy without a prescription from Tell your pharmacist or doctor if daily. you have allergies to: your pharmacy, supermarket or health food shop. Children 6-12 years: One to two • any other medicines 10mg tablets, or 10 to 25mL of the Some medicines and Phenergan may • any other substances, such as elixir as a single dose at night, or one interfere with each other. Phenergan foods, preservatives or dyes 10mg tablet, or 10mL of the elixir, may increase the sedative effect of two to three times daily. Tell your pharmacist or doctor if some drugs. These include: you have or have had any medical Children 2-5 years: 5-15mL of elixir • medicines used to treat conditions, especially the following: as a single dose at night, or 5mL of depression, especially elixir, two to three times daily. • or disease monoamine oxidase inhibitors Sedation • epilepsy and For short term use in adults on the • cardiovascular disease • medicines used to help you sleep or relax ( and advice of a pharmacist or doctor. • blood pressure problems ) Adults: One to three 25mg tablets as • bladder problems • agents such as a single dose at night. • breathing problems those used to treat Parkinson’s Travel Sickness disease. • glaucoma - an eye condition Adults: One 25mg tablet. • problems • , medicines Children 6-12 years: One 10mg used to treat pain • ulcer or blockage tablet or 10mL of the elixir. • other antihistamines Tell your doctor if you plan to have Children 2-5 years: 5mL of elixir. • surgery. To be taken the night before travel Tell your pharmacist or doctor if These medicines may be affected by and repeated after 6 to 8 hours on the you take sedatives. Phenergan or may affect how well it following day if required. works. You may need different Tell your pharmacist or doctor if Nausea and Vomiting amounts of your medicines, or you you are pregnant or intend to may need to take different medicines. Adults: One 25mg tablet every 4 to 6 become pregnant. hours to a maximum daily dose of Your pharmacist and doctor will Phenergan is not recommended for four 25mg tablets. have more information on medicines use during pregnancy. If there is a to be careful with or avoid while Children 6-12 years: One 10mg need to consider Phenergan during taking this medicine. tablet or 10mL of the elixir, every 4 your pregnancy, your pharmacist or to 6 hours to a maximum daily dose doctor will discuss with you the of two 10mg tablets or 25mL of the benefits and risks of taking it. elixir. Do not take Phenergan if you are How to take it Children 2-5 years: 5mL of elixir breastfeeding or plan to every 4 to 6 hours to a maximum breastfeed. How much to take daily dose of 15mL. It passes into the breast milk and If you do not understand the Follow all directions given to you there is a possibility that the baby instructions on the carton or the by your pharmacist or doctor may be affected. label, ask your pharmacist or carefully. doctor for help.

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Do not take more than the This may be harmful. should protect your skin from recommended dose. If you are not sure what to do, ask exposure to bright sunlight. Use this only as your pharmacist or doctor. Tell any other doctors, dentists, recommended. Do not exceed the If you have trouble remembering and pharmacists who are treating recommended dose. There have to take your medicine, ask your you that you are taking Phenergan. been case reports of promethazine pharmacist for some hints. If you are about to be started on abuse. any new medicine, tell your Use in the Elderly If you take too much pharmacist or doctor that you are If you are over 65 years of age, talk (overdose) taking Phenergan. to you pharmacist or doctor about Immediately telephone your doctor If you plan to have surgery that how much to take. or the Poisons Information Centre needs a general anaesthetic, tell Elderly patients are more likely to (in Australia, call 13 11 26; in New your doctor or dentist that you are have side effects from taking these Zealand, call 0800 764 766) for taking this medicine. medicines. advice or go to Accident and If you become pregnant while you Emergency at the nearest hospital, are taking this medicine, stop How to take it if you think that you or anyone else taking it and tell your doctor may have taken too much immediately. Tablets Phenergan. Talk to your pharmacist or doctor Swallow Phenergan tablets whole Do this even if there are no signs of if your symptoms do not improve. with a full glass of water. discomfort or poisoning. Your pharmacist or doctor will assess Elixir You may need urgent medical your condition and decide if you Measure out the amount of elixir to attention. should continue to take the medicine. be taken. If you take too much Phenergan, you may experience: Things you must not do How long to take it Adults Do not give Phenergan to anyone Phenergan should not usually be else, even if they have the same • drowsiness taken for more than 10 days in a condition as you. row. If your symptoms persist, see • convulsions and/or tremors Do not take Phenergan to treat any your pharmacist or doctor for • difficulty breathing other complaints unless your advice. • unconsciousness pharmacist or doctor tells you to. If you forget to take it • acute anxiety Do not drink alcohol while taking Phenergan. If you are taking Phenergan for an • hallucinations allergic disorder and you forget to Children The sedation effects of alcohol may be increased. take your bedtime dose, you may • over - excitement need to take your dose in two or Do not take more than the three smaller doses during the • shaky and unsteady movements recommended dose unless your following day. • convulsions and/or tremors pharmacist or doctor tells you to. Check with your pharmacist or • hallucinations Things to be careful of doctor. • difficulty breathing Phenergan is a known sedative and If you are taking Phenergan for • unconsciousness travel sickness or nausea and may cause drowsiness in some • high fever vomiting, take your dose as soon as people and may affect your ability you remember. to drive and operate machines. If you are taking Phenergan for Make sure you know how you react sedation, take your dose as soon as While you are taking it to Phenergan before you drive a car, you remember. operate machinery, or do anything else that could be dangerous if you Be careful because you may still be Things you must do are drowsy. If this occurs do not affected in the morning. Phenergan may cause your skin to drive or operate machinery. Do not take a double dose to make be more sensitive to the sun. You up for the dose that you missed.

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If you have a single dose at • faintness If any of the following happen, tell bedtime, you may still be affected • headache your doctor immediately or go to in the morning. Accident and Emergency at your • nightmares in children Phenergan may interfere with nearest hospital: • increased sensitivity of the skin to urine and produce • wheezing or difficulty breathing sun. false-positive or false-negative • swelling of the face, lips, tongue These are mild side effects of the results. or other parts of the body medicine and are short-lived. A very serious and potentially life- • skin rashes threatening health problem called Tell your pharmacist or doctor The above list includes very serious neuroleptic malignant syndrome immediately if you notice any of side effects. You may need urgent (NMS) may happen. Stop the following: medical attention or hospitalisation. treatment and call your doctor • fever These side effects are very rare. right away if you have high fever, • difficulty breathing muscle cramps or stiffness, Tell your pharmacist or doctor if dizziness, very bad headache, fast • irregular heart beat you notice anything that is making heartbeat, confusion, agitation, • jaundice - yellow tinge to skin or you feel unwell. hallucinations, or are sweating a eyes Other side effects not listed above lot. • tremors or convulsions may occur in some patients. Avoid alcohol. • tinnitus - buzzing, hissing, Do not be alarmed by the lists of Children and the elderly are ringing or other persistent noise possible side effects. especially sensitive to the effects of in the ears You may not experience any of them. antihistamines. • (fits) Ask your pharmacist or doctor if • hallucinations you have any questions. • extreme happiness, excitation Side effects • hysteria • nervousness and irritability Phenergan may have unwanted side After taking effects in some people. All medicines • agitation Phenergan can have side effects. Sometimes • anxiety they are serious, most of the time Storage • twitching or jerking muscles they are not. You may need medical Keep your medicine in the pack treatment if you get some of the side • muscle cramps or stiffness until it is time to take it. effects. • dizziness, If you take your medicine out of the Tell your pharmacist or doctor as • faintness pack it will not keep as well. soon as possible if you do not feel • severe headache well while you are taking Keep your tablets in a cool dry Phenergan. • confusion place where the temperature stays below 30°C. Tell your pharmacist or doctor if • excessive sweating Keep your elixir in a cool dry you notice any of the following and • difficulty passing urine they worry you: place, protected from light, where • inability to sleep the temperature stays below 25°C. • dry mouth, nose & throat • frequent infections such as fever, Do not store Phenergan or any • stomach upset severe chills, sore throat or mouth other medicine in the bathroom or • loss of appetite ulcers. This may indicate a lack near a sink. Do not leave it in the of white blood cells. • nausea or vomiting car on hot days or on window sills. • unusual bleeding or bruising • diarrhoea or Heat and dampness can destroy some • involuntary upward movement of medicines. • tiredness or sleepiness the eyes, staring Keep it where children cannot • restlessness The above list includes serious side reach it. • blurred vision effects that may require medical A locked cupboard at least one-and- • incoordination attention. Serious side effects are a-half metres above the ground is a rare. • fatigue good place to store medicines.

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Disposal • maltitol solution If your pharmacist or doctor tells • acesulfame potassium you to stop taking Phenergan or if • sodium benzoate it has passed the expiry date, ask • sodium citrate your pharmacist what to do with any left over. • citric acid • sodium sulfite What it looks like • sodium metabisulfite Phenergan Tablets are available in • ascorbic acid two strengths: • caramel • 10mg - round and pale blue • orange juice flavour tablets, with 'PN 10' embossed on one side. Sponsor • 25mg - round and pale blue Phenergan Tablets and Elixir are tablets, with 'PN 25' embossed on supplied in Australia by: one side. -aventis australia pty ltd Both tablet strengths are available in blister packs of 50 tablets and 25 12-24 Talavera Road tablets (New Zealand only). Macquarie Park NS0W 2113 Phenergan Elixir is a clear, bright, golden, syrupy liquid. Phenergan Phenergan Tablets and Elixir are elixir is available in a 100mL bottle. supplied in New Zealand by: Ingredients sanofi-aventis new zealand limited Phenergan Tablets Level 8, Active ingredient: 56 Cawley Street • 10mg tablets - 10mg of Ellerslie promethazine hydrochloride per Auckland tablet • 25mg tablets - 25mg of Australian Registration promethazine hydrochloride per Numbers: tablet Phenergan 10mg tablets Inactive ingredients: AUST R 80159 The 10mg and 25mg tablets also Phenergan 25mg tablets contain: AUST R 80160 • Lactose Phenergan Elixir 1mg/mL • starch maize AUST R 61576 • povidone

• stearate This leaflet was updated in • hypromellose December 2020. • macrogol 200 (R)Registered Trademark • blue opaspray phenergan gluv4-cmiv10-18dec20 Phenergan Elixir Active ingredient: Phenergan elixir contains 1mg/mL of promethazine hydrochloride. Inactive ingredients: Phenergan elixir also contains:

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