Dozile® DOZILE TABLETS Each tablet contains 25 mg Doxylamine Succinate. Consumer Medicine Information PLEASE READ THIS antihistamine which helps you Tell your doctor if you are taking INFORMATION CAREFULLY sleep. any other medicines, including any BEFORE YOU START TO If you want more information ask that you buy without a prescription TAKE YOUR MEDICINE. your doctor or pharmacist. from your pharmacy, supermarket This information provides a or health food shop. summary of the information In particular, you should tell your available. It does not take the place doctor or pharmacist if you are of talking to your doctor or 3. BEFORE YOU USE using: pharmacist who have more detailed DOZILE TABLETS • Any other medications used to information. Keep this information help you sleep with the medicine, as you may want • You must tell your doctor or • Medication for psychiatric to read it again. pharmacist if you have any of disorders these conditions: - Digestive problems • Any medicine which contains - Glaucoma antihistamine 1. PRODUCT - Prostate problems • Nasal decongestants and pain DESCRIPTION - Problems passing urine relief products from other - Heart problems cough, cold or allergy products Dozile tablets are white tablets with • See a doctor if you are pregnant • Medicines used to treat a break bar on one side, each tablet or think you may be. depression containing 25 mg of Doxylamine • See a doctor if you are breast- • Medicines used to treat anxiety Succinate. feeding. • Medicines used to treat high The tablets also contain the blood pressure following inactive ingredients: When you must not use it • Barbiturates calcium hydrogen phosphate, • Do not use Dozile tablets if you • Atropine povidone, starch pregelatinised have an allergy to Doxylamine • Strong pain killers maize, microcrystalline cellulose, Succinate or to any other croscarmellose sodium, magnesium • Medicines used to treat ingredient in the tablet (see stearate and talc. Parkinson’s disease section 1 entitled Product There are many other medicines or Free from fragrance, colour, Description). foodstuffs which may make you preservatives, lactose, yeast, dairy • If you have narrow angle drowsy such as alcohol, sleeping products, gluten, and PABA (p- glaucoma. tablets, medicines to treat mental aminobenzoic acid). • If you have epilepsy. disorders, tablets to calm your • Do not use this product after the nerves and some antihistamines. expiry date printed on the pack. These medicines may be affected by 2. WHAT IS DOZILE • Do not use Dozile tablets if the Dozile, or may affect how well it USED FOR? packaging is torn or shows signs works. You may need different of tampering. amounts of your medicine, or you Dozile provides effective temporary may need to take different relief of insomnia or sleeplessness. Taking other medicines medicines. It contains an active ingredient Some medicines should not be Your doctor or pharmacist will called Doxylamine Succinate. taken with Dozile tablets. advise you. Doxylamine Succinate is an Dozile® Published by MIMS/myDr April 2017 1 Taking a skin test 6. IF YOU TAKE TOO Do not leave Dozile tablets in the car on hot days. Stop taking Dozile tablets 48 hours MUCH (OVERDOSE) before you have any skin tests. Keep out of reach of children. Immediately telephone the Skin tests are used to determine the Poisons Information Centre (Tel Disposal reaction of the body to a substance 131 126), or your doctor, or go to by observing the results of injecting casualty at your nearest hospital, Return any unused medicine to your the substance within the tissue of if you think that you or anyone pharmacist. the skin or applying it topically to else may have taken an overdose the skin. Antihistamine in Dozile of Dozile tablets even if there are may interfere with the skin test no signs of discomfort or results. poisoning. 9. WHERE TO GO You may need urgent medical FOR FURTHER attention. INFORMATION Symptoms of overdose of Dozile 4. HOW TO USE tablets (and antihistamines in If you have any questions about this DOZILE TABLETS general) include excessive or any other medication, discuss drowsiness, dizziness, impaired with your doctor or pharmacist. Directions for use: consciousness, nervousness, Adults and children over 12 years: irrational behaviour, convulsions, Take 1 to 2 tablets with water 20 dilated pupils, excitation, fast or minutes before retiring. irregular heartbeat or pulse rate, 10. SUPPLIER Do not exceed the recommended tremor and nausea or vomiting. Dozile tablets are supplied by: dose. These are not the only possible Key Pharmaceuticals Pty Ltd Not recommended for children symptoms of overdose. 12 Lyonpark Road under 12 years of age. Macquarie Park NSW 2113 Please read this information Telephone: (02) 8113 6200 carefully before you start to take 7. UNWANTED SIDE E-mail: [email protected] your medicine. EFFECTS The Australian Registration If you are unsure of how to take this Number for Dozile tablets is AUST medication ask your pharmacist or Dozile tablets provide relief of R 143861 doctor. insomnia or sleeplessness but you ®Registered trademark may experience some of the following symptoms: dizziness, Principles of good sleep hygiene: stomach pain, vomiting, excessive • Go to bed and arise at the same 5. WHILE YOU ARE drowsiness, dry mouth or inability time daily; USING DOZILE to pass urine. You may experience • Engage in relaxing activities TABLETS other symptoms – these are not the before bedtime; only possible adverse effects. • Exercise regularly but not in the Precautions while using this If you are concerned by any of these late evening; medicine: reactions, discontinue use and • Avoid eating meals or large • This medication is for the relief consult your doctor. snacks just before bedtime; of minor and temporary ailments • Eliminate daytime naps; and should be used as directed. • Avoid caffeine-containing • Prolonged use without medical drinks after midday; supervision may be harmful. 8. AFTER USING • Avoid alcohol or the use of • If symptoms persist consult your DOZILE TABLETS nicotine late in the evening; doctor. • Minimise external disruption • This preparation is to aid sleep. Storage (e.g. light and noise); This medication may cause Dozile tablets should be stored • If you are unable to sleep, do not drowsiness, which may continue below 30°C until the expiry date become anxious; leave the the following day. If affected do shown on the carton and blister bedroom and participate in not drive or operate machinery. pack. Keep your tablets in the relaxing activities such as • Avoid alcohol. blister pack until immediately before use. Dozile® Published by MIMS/myDr April 2017 2 reading or listening to music until you are tired. This leaflet was prepared 5 December 2007. LF0000KDT/1 Dozile® Published by MIMS/myDr April 2017 3.