Children's Paedamin Antihistamine Oral Liquid Decongestant and Antihistamine Children 6-12 years

Consumer Medicine Information

What is in this leaflet? • Itchy, watery eyes Before you give • Nasal congestion Children's Paedamin This leaflet answers some common Children's Paedamin Decongestant Decongestant and questions about Children's and Antihistamine contains Antihistamine Paedamin® Decongestant and Diphenhydramine Hydrochloride Antihistamine. and Phenylephrine Hydrochloride. When you must not give it It does not contain all the available Diphenhydramine Hydrochloride Do not use Children's Paedamin information. It does not take the belongs to a group of medicines Decongestant and Antihistamine if place of talking to your doctor or called 'antihistamines'. you/ your child have an allergy to: pharmacist. Antihistamines help reduce allergic All medicines have risks and symptoms, such as sneezing, runny • any medicine containing benefits. Your doctor or pharmacist nose or itchy, watery eyes, by Diphenhydramine has weighed the risks of you/your preventing the effects of a substance Hydrochloride or other child taking Children's Paedamin called histamine. Histamine is antihistamines Decongestant and Antihistamine produced by the body in response to • any medicine containing against the benefits they expect it foreign substances that the body is Phenylephrine Hydrochloride will have for you. allergic to. • any of the ingredients listed at If you have any concerns about Phenylephrine Hydrochloride the end of this leaflet taking this medicine, ask your belongs to a group of medicines Some of the symptoms of an doctor or pharmacist. called decongestants. allergic reaction may include: Keep this leaflet with the It works by reducing congestion in • shortness of breath medicine. the upper respiratory tract, • wheezing or difficulty breathing You may need to read it again. including the nose, nasal passages • swelling of the face, lips, tongue and sinuses, and making it easier to or other parts of the body breathe. • rash, itching or hives on the skin Ask your pharmacist or doctor if Do not take this medicine if you What Children's you have any questions about this have or have had any of the Paedamin medicine. following medical conditions: Decongestant and Your pharmacist or doctor may Antihistamine is used have given it for another reason. • narrow angle glaucoma (high for pressure in the eyes) • stomach or duodenal ulcer, or Children's Paedamin Decongestant other stomach problems and Antihistamine is used to • enlarged prostate provide fast relief from the • bladder problems symptoms of colds and allergies • very high blood pressure including: • severe coronary artery disease • Runny nose (heart disease caused by poor • Sneezing

Children's Paedamin Antihistamine Oral Liquid Published by MIMS October 2018 1 blood flow or narrowing of the Tell your pharmacist or doctor if different amounts of your blood vessels of the heart) you take sedatives. medicines, or you may need to take Do not take Children's Paedamin Tell your pharmacist or doctor if different medicines. Decongestant and Antihistamine you are pregnant or plan to Your pharmacist and doctor will become pregnant. if you are also taking monoamine have more information on oxidase inhibitors (MAOI's) or Your pharmacist or doctor will medicines to be careful with or have taken monoamine oxidase discuss the benefits and possible avoid while taking this medicine. inhibitors in the last 14 days. risks of taking the medicine during Monoamine oxidase inhibitors are pregnancy. a type of medicine used to treat depression. If you have not told your pharmacist or doctor about any Do not take Children's Paedamin How to give Children's of the above, tell him/her before Paedamin Decongestant and Antihistamine you start taking Children's if you are breastfeeding or plan to Paedamin Decongestant and Decongestant and breastfeed. Antihistamine. Antihistamine It passes into the breast milk and there is a possibility that the baby Taking other medicines Follow all directions given to you may be affected. by your pharmacist or doctor Tell your pharmacist or doctor if carefully. Do not give Children's Paedamin you/your child are taking any They may differ from the Decongestant and Antihistamine other medicines, including any information contained in this leaflet. to children under 6 years of age. that you get without a If you do not understand the Use in children aged 6 to 11 years prescription from your instructions on the box/bottle, ask only on the advice of a doctor, pharmacy, supermarket or health your pharmacist or doctor for pharmacist or nurse practitioner. food shop. help. Do not take this medicine after Some medicines and Children's the expiry date printed on the Paedamin Decongestant and How much to give pack or if the packaging is torn or Antihistamine may interfere with shows signs of tampering. each other. If it has expired or is damaged, return it to your pharmacist for These include: disposal. • medicines used to treat If you are not sure whether you depression, especially should start taking this medicine, monoamine oxidase inhibitors talk to your pharmacist or doctor. and tricyclic antidepressants Adults and children over 12 years - • medicines used to help you 15mL every 6 hours when Before you start to give it sleep or relax (sedatives and necessary. hypnotics) Tell your doctor if you/your child Do not give more than the • opioid analgesics, medicines have allergies to any other recommended dose. medicines, foods, preservatives or used to treat pain Do not administer to children dyes. • medicines used to treat heart under 6 years of age. Tell your doctor if you/your child conditions Use in children aged 6 to 11 years have or have had any of the • medicines used to treat high only on the advice of a doctor, following medical conditions: blood pressure pharmacist or nurse practitioner. • kidney or liver disease • medicines used to treat urinary • epilepsy tract infections and bladder When to give it • high blood pressure problems Give Children's Paedamin • medicines used to treat • overactive thyroid gland Decongestant and Antihistamine 6- behavioural disorders • diabetes 8 hourly as necessary. It does not • • prostate problems pseudoephedrine, a medicine matter if you give Children's used to treat congestion • heart disease and poor blood Paedamin Decongestant and • appetite suppressants flow in the blood vessels of the Antihistamine before or after food. heart These medicines may be affected by • glaucoma (high pressure in the Children's Paedamin Decongestant eyes) and Antihistamine or may affect how well it works. You may need

Children's Paedamin Antihistamine Oral Liquid Published by MIMS October 2018 2 How long to give it for Things you must not do Do not be alarmed by the following lists of side effects. You If symptoms persist for more than Do not drink alcohol while taking may not experience any of them. 48 hours or are accompanied by Children's Paedamin Decongestant and Antihistamine. Ask your pharmacist or doctor to high fever, consult your doctor. answer any questions you may The sedating effects of alcohol may have. If you forget to give it be increased. Tell your pharmacist or doctor if Do not give Children's Paedamin If it is almost time for the next dose, you notice any of the following Decongestant and Antihistamine and they worry you: just take the next dose when you are to treat any other complaints meant to. Otherwise, take it as soon unless your pharmacist or doctor • drowsiness or sleepiness as you remember, and then go back tells you to. • dry mouth, nose and throat to taking the medicine as Do not give your medicine to • constipation recommended. anyone else, even if they have the • nervousness and irritability Do not take a double dose to same condition as you. • hallucinations make up for the dose that you Do not give more than the • twitching or jerking muscles missed. recommended dose unless your This may increase the chance of you pharmacist or doctor tells you to. • fast heart beat getting an unwanted side effect. • difficulty sleeping If you are not sure what to do, ask Things to be careful of • excitability your pharmacist or doctor. Be careful driving or operating • restlessness machinery until you know how • dizziness If you give too much Children's Paedamin • fear or anxiety (overdose) Decongestant and Antihistamine • tremor Immediately telephone your affects you. • skin rashes doctor or the Poisons Information This medicine may cause Centre (in Australia, call 13 11 drowsiness in some people. If this • urinary retention 26; in New Zealand, call 0800 764 happens, do not drive or operate The above list includes the more 766) for advice or go to Accident machinery. common side effects of your and Emergency at the nearest Children's Paedamin Decongestant medicine. hospital, if you think that you or anyone else may have taken too and Antihistamine contains 10.5g of They are usually mild and short- much Children's Paedamin sorbitol per maximum daily dose in lived. Decongestant and Antihistamine. adults. Products containing sorbitol Children and people over 65 years Do this even if there are no signs may have a laxative effect or cause of age may have an increased of discomfort or poisoning. diarrhoea. chance of getting side effects. Tell your doctor as soon as possible if you notice any of the following: While you are giving Side Effects Children's Paedamin • difficult or painful urination Decongestant and Tell your pharmacist or doctor as • seizures (fits) Antihistamine soon as possible if you/your child The above list includes serious do not feel well while you are side effects that may require taking Children's Paedamin medical attention. These side Things you must do Decongestant and Antihistamine. effects are rare. Tell your Talk to your pharmacist or This medicine helps most people pharmacist or doctor if you notice doctor if your child's symptoms with the symptoms of colds and anything that is making you feel do not improve. allergies, but it may have unwanted unwell. side effects in a few people. All Your pharmacist or doctor will Other side effects not listed above medicines can have side effects. assess your condition and decide if may also occur in some people. you should continue to take the Sometimes they are serious, most of medicine. the time they are not. You may need medical attention if you get some of the side effects.

Children's Paedamin Antihistamine Oral Liquid Published by MIMS October 2018 3 After using Children's sodium benzoate, sodium Paedamin cyclamate, sodium citrate, citric Decongestant and acid monohydrate, saccharin sodium and hydroxybenzoates Antihistamine (methylparaben, ethylparaben, propylparaben). Storage This medicine does not contain Keep your medicine in the alcohol, sugar, lactose, gluten or original pack until it is time to colourants. take it. Keep your medicine in a cool dry Supplier place where the temperature stays below 25°C. Children's Paedamin Decongestant and Antihistamine Oral Liquid Do not store Children's Paedamin AUST R 160400 is supplied in Decongestant and Antihistamine or any other medicine in the Australia by: bathroom or near a sink. Care Pharmaceuticals Pty Ltd, Do not leave it on a window sill or Suite 302, 75 Grafton Street, in the car. Bondi Junction, NSW 2022 Heat and dampness can destroy This leaflet was prepared in some medicines. 08/2012. Keep it where children cannot reach it. A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.

Disposal Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.

Product Description

What it looks like Children's Paedamin Decongestant and Antihistamine is a clear colourless oral liquid available in a 200mL PET bottle.

Ingredients Each 1mL of Children's Paedamin Decongestant and Antihistamine contains the active ingredients: • Diphenhydramine Hydrochloride 2.5mg • Phenylephrine Hydrochloride 500mcg Children's Paedamin Decongestant and Antihistamine also contains glycerol, water, sorbitol solution, Children's Paedamin Antihistamine Oral Liquid Published by MIMS October 2018 4