PHENERGAN ELIXIR 5MG/5ML ORAL SOLUTION
Active substance: PROMETHAZINE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Phenergan Elixir 5mg/5ml Oral Solution
promethazine hydrochloride
Phenergan Elixir may be provided directly by a pharmacist for use in the following situations: To treat allergic conditions such as hay fever or rashes (like nettle rash or hives) To stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness Phenergan Elixir may also be given to you by a doctor. This can be for use in any of the above situations or for use in the following additional situations: To help you feel more relaxed before an operation As a sedative for both adults and children. This is a medicine given to reduce awareness or make you feel relaxed and at ease 2. Before you take Phenergan Elixir Do not take this medicine and tell your doctor if: The person taking the medicine is under 2 years of age You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Phenergan Elixir (listed in Section 6 below) The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Phenergan Elixir if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure ask your doctor or pharmacist (see Taking other medicines section below) from severe dizziness, drowsiness or headache Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Phenergan Elixir. Take special care with Phenergan Elixir Check with your doctor or pharmacist before taking your medicine if: tightness in the chest (asthma) or an infection in your lungs (bronchitis) You have epilepsy You have any serious heart problems You have liver or kidney problems passing water You have increased pressure in the eye (narrow angle glaucoma) 1
see or read? Phone 01483 505515 for help
contains important information for you. This medicine is available without prescription. However, you still need to take Phenergan Elixir carefully to get the best results from it. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 7 days. please tell your doctor or pharmacist. 1. What Phenergan Elixir is and what it is used for 2. Before you take Phenergan Elixir 3. How to take Phenergan Elixir 5. How to store Phenergan Elixir 6. Further Information 1. What Phenergan Elixir is and what it is used for Phenergan Elixir contains a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed. What Phenergan Elixir is used for Phenergan Elixir can be given to you either by a doctor or directly by a pharmacist depending on the condition you are being treated for.
weak or too strong, do not change the dose yourself, but ask your doctor How much to take The usual dose is: For allergies (such as hay fever, rashes and hives) Children 2-5 years: Either a single dose of one to three 5ml spoonfuls OR one 5ml spoonful twice a day DO NOT give more than three 5ml spoonfuls a day Children 5-10 years: spoonfuls OR one or two 5ml spoonfuls twice a day day Children over 10 years and adults (including the elderly): Start with two 5ml spoonfuls twice a day This may be increased to a maximum of four 5ml spoonfuls three times a day For children over 10 years and adults, Phenergan Tablets may be more convenient For travel sickness Children 2-5 years: One 5ml spoonful the night before the journey This may be repeated after 6-8 hours if necessary Children 5-10 years: Two 5ml spoonfuls the night before the journey This may be repeated after 6-8 hours if necessary Children over 10 years and adults (including the elderly): Five 5ml spoonfuls the night before the journey This may be repeated after 6-8 hours if necessary For children over 10 years and adults, Phenergan Tablets may be more convenient As a sedative Phenergan Elixir may also be used as a short term sedative. This will normally have been prescribed by a doctor. The information below is a guide to the doses recommended
Children 2-5 years: Three or four 5ml spoonfuls as a single dose at night time Children 5-10 years: night time Children over 10 years and adults (including the elderly): Use of Phenergan Tablets is recommended Exposure to sunlight Phenergan Elixir can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine. If you take more Phenergan Elixir than you should If you take more Phenergan Elixir than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Also do this if a child under 2 years of age swallows some of this medicine. In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements (seizures) loss of consciousness, uneven heart beat and breathing problems. In adults: uneven or forceful heartbeat (palpitations), loss of consciousness, breathing problems. If you forget to take Phenergan Elixir Do not take a double dose to make up for a forgotten dose If you are taking Phenergan Elixir for an allergic condition - take your medicine as soon as you remember, then carry on as before If you are taking Phenergan Elixir for sedation or sleeping problems - miss that dose and take the next evenings dose as usual If you have any further questions on the use of this product, ask your doctor or pharmacist. Tests certain tests. These include some pregnancy tests and skin tests. Phenergan Elixir should not be taken at least 3 days before the start of a skin test.
301467 467 3
You have had something called Reyes Syndrome or possible Reyes Syndrome signs include being sick and confused following a viral illness You have diabetes. This medicine contains hydrogenated glucose syrup (see Important information about some of the ingredients of Phenergan Elixir below) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Phenergan Elixir. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is
You should not take Phenergan Elixir if you are breast-feeding. This is because small amounts may pass into mothers milk. This can be harmful to your baby. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine. Driving and using machines You may feel drowsy or sleepy while taking this medicine or in the morning after taking this medicine. If this happens, do not drive or use any tools or machines. Important information about some of the ingredients of Phenergan Elixir This medicine contains: Hydrogenated glucose syrup (maltitol liquid). This is a type of carbohydrate which the body will convert into small amounts of sugar. The maximum 25ml single dose of Phenergan Elixir is equivalent to approximately 5 grams of sugar, or one teaspoon of sugar/ sugar lump. Taking this amount of your diabetes or require you to increase your diabetes medication. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. Hydrogenated glucose syrup may have a mild glucose syrup is 2.3kcal/g. A 5ml dose (one teaspoon) contains approximately 10kcal. Sodium sulphite and sodium metabisulphite. These may rarely cause severe allergic breathing, wheezing and tightness in the chest (bronchospasm) Sodium. It contains 37mg sodium per dose (5ml). Take this into account if you are on a controlled sodium diet 3. How to take Phenergan Elixir The amount you need to take depends on the reason you are taking Phenergan Elixir. The following information will help you to decide how much you need to take. You should check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth Do not take for longer than 7 days. If your symptoms worsen or do not improve after 7 days talk to your doctor or pharmacist After use, wipe the neck of the bottle with a clean damp cloth. This will remove any liquid that is left, before putting the cap back on
the way Phenergan Elixir works. Do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks: Some medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are not sure ask your doctor or pharmacist Tell your doctor or pharmacist if you are taking any of the following: Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or weak bladder. These can increase the risk of dizziness, dry mouth and blurred eyesight Medicines for depression (such as amitriptyline) Medicines to help you to sleep or feel more relaxed (such as diazepam or zolpidem) Medicines such as aspirin (for arthritis and pain in your joints). Phenergan Elixir may hide the Taking Phenergan Elixir with food and drink Do not drink alcohol while you are taking way the medicine works. Pregnancy and breast-feeding Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Phenergan Elixir should not be taken in the 2 weeks before birth.
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Like all medicines, Phenergan Elixir can cause side Stop taking Phenergan Elixir and see a doctor or go to a hospital straight away if you notice An allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Liver problems that may cause the eyes or skin to go yellow (jaundice) Being unable to control some muscles in your head or face You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling Very fast, uneven heartbeat or forceful heartbeat (palpitations) Irregular heartbeat Tiredness which lasts for a long time. This may be due to a blood problem called anaemia Over-active behaviour in children Tell your doctor or pharmacist if any of the than a few days. Also tell them if you notice Dry mouth, blurred vision or you can not pass water (urine) Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless Loss of appetite (anorexia), indigestion Feeling dizzy, lightheaded, faint (hypotension) Feeling confused, especially in elderly people Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps 5. How to store Phenergan Elixir Keep out of the reach and sight of children Do not use Phenergan Elixir after the expiry date which is stated on the carton and bottle label. The expiry date refers to the last day of that month Do not use Phenergan Elixir after the bottle has been opened for more than a month Store below 25C Keep the bottle in the outer carton in order to protect from light
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further Information What Phenergan Elixir contains. Each 5ml of solution contains 5mg of the active substance, promethazine hydrochloride. The other ingredients are hydrogenated glucose caramel (E150), sodium benzoate (E211), sodium sulphite anhydrous (E221), sodium metabisulphite (E223), ascorbic acid (E300), citric acid anhydrous (E330), sodium citrate (E331), acesulphame potassium (E950) and water. What Phenergan Elixir looks like and contents of the pack A clear, golden, syrupy liquid contained in an amber glass bottle. Your elixir is available in glass bottles of 100ml. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder One Onslow Street Guildford Surrey GU1 4YS UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Unither Liquid Manufacturing 1-3 Allee de la Neste Z.I. den Signal 31770 Colomiers France about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in November 2012 Sanofi, 1973 - 2012 301467 467 4
Phenergan Elixir 5mg/5ml Oral Solution
promethazine hydrochloride
Phenergan Elixir may be provided directly by a pharmacist for use in the following situations: To treat allergic conditions such as hay fever or rashes (like nettle rash or hives) To stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness Phenergan Elixir may also be given to you by a doctor. This can be for use in any of the above situations or for use in the following additional situations: To help you feel more relaxed before an operation As a sedative for both adults and children. This is a medicine given to reduce awareness or make you feel relaxed and at ease 2. Before you take Phenergan Elixir Do not take this medicine and tell your doctor if: The person taking the medicine is under 2 years of age You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Phenergan Elixir (listed in Section 6 below) The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Phenergan Elixir if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure ask your doctor or pharmacist (see Taking other medicines section below) from severe dizziness, drowsiness or headache Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Phenergan Elixir. Take special care with Phenergan Elixir Check with your doctor or pharmacist before taking your medicine if: tightness in the chest (asthma) or an infection in your lungs (bronchitis) You have epilepsy You have any serious heart problems You have liver or kidney problems passing water You have increased pressure in the eye (narrow angle glaucoma) 1
see or read? Phone 01483 505515 for help
contains important information for you. This medicine is available without prescription. However, you still need to take Phenergan Elixir carefully to get the best results from it. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 7 days. please tell your doctor or pharmacist. 1. What Phenergan Elixir is and what it is used for 2. Before you take Phenergan Elixir 3. How to take Phenergan Elixir 5. How to store Phenergan Elixir 6. Further Information 1. What Phenergan Elixir is and what it is used for Phenergan Elixir contains a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed. What Phenergan Elixir is used for Phenergan Elixir can be given to you either by a doctor or directly by a pharmacist depending on the condition you are being treated for.
weak or too strong, do not change the dose yourself, but ask your doctor How much to take The usual dose is: For allergies (such as hay fever, rashes and hives) Children 2-5 years: Either a single dose of one to three 5ml spoonfuls OR one 5ml spoonful twice a day DO NOT give more than three 5ml spoonfuls a day Children 5-10 years: spoonfuls OR one or two 5ml spoonfuls twice a day day Children over 10 years and adults (including the elderly): Start with two 5ml spoonfuls twice a day This may be increased to a maximum of four 5ml spoonfuls three times a day For children over 10 years and adults, Phenergan Tablets may be more convenient For travel sickness Children 2-5 years: One 5ml spoonful the night before the journey This may be repeated after 6-8 hours if necessary Children 5-10 years: Two 5ml spoonfuls the night before the journey This may be repeated after 6-8 hours if necessary Children over 10 years and adults (including the elderly): Five 5ml spoonfuls the night before the journey This may be repeated after 6-8 hours if necessary For children over 10 years and adults, Phenergan Tablets may be more convenient As a sedative Phenergan Elixir may also be used as a short term sedative. This will normally have been prescribed by a doctor. The information below is a guide to the doses recommended
Children 2-5 years: Three or four 5ml spoonfuls as a single dose at night time Children 5-10 years: night time Children over 10 years and adults (including the elderly): Use of Phenergan Tablets is recommended Exposure to sunlight Phenergan Elixir can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine. If you take more Phenergan Elixir than you should If you take more Phenergan Elixir than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Also do this if a child under 2 years of age swallows some of this medicine. In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements (seizures) loss of consciousness, uneven heart beat and breathing problems. In adults: uneven or forceful heartbeat (palpitations), loss of consciousness, breathing problems. If you forget to take Phenergan Elixir Do not take a double dose to make up for a forgotten dose If you are taking Phenergan Elixir for an allergic condition - take your medicine as soon as you remember, then carry on as before If you are taking Phenergan Elixir for sedation or sleeping problems - miss that dose and take the next evenings dose as usual If you have any further questions on the use of this product, ask your doctor or pharmacist. Tests certain tests. These include some pregnancy tests and skin tests. Phenergan Elixir should not be taken at least 3 days before the start of a skin test.
301467 467 3
You have had something called Reyes Syndrome or possible Reyes Syndrome signs include being sick and confused following a viral illness You have diabetes. This medicine contains hydrogenated glucose syrup (see Important information about some of the ingredients of Phenergan Elixir below) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Phenergan Elixir. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is
You should not take Phenergan Elixir if you are breast-feeding. This is because small amounts may pass into mothers milk. This can be harmful to your baby. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine. Driving and using machines You may feel drowsy or sleepy while taking this medicine or in the morning after taking this medicine. If this happens, do not drive or use any tools or machines. Important information about some of the ingredients of Phenergan Elixir This medicine contains: Hydrogenated glucose syrup (maltitol liquid). This is a type of carbohydrate which the body will convert into small amounts of sugar. The maximum 25ml single dose of Phenergan Elixir is equivalent to approximately 5 grams of sugar, or one teaspoon of sugar/ sugar lump. Taking this amount of your diabetes or require you to increase your diabetes medication. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. Hydrogenated glucose syrup may have a mild glucose syrup is 2.3kcal/g. A 5ml dose (one teaspoon) contains approximately 10kcal. Sodium sulphite and sodium metabisulphite. These may rarely cause severe allergic breathing, wheezing and tightness in the chest (bronchospasm) Sodium. It contains 37mg sodium per dose (5ml). Take this into account if you are on a controlled sodium diet 3. How to take Phenergan Elixir The amount you need to take depends on the reason you are taking Phenergan Elixir. The following information will help you to decide how much you need to take. You should check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth Do not take for longer than 7 days. If your symptoms worsen or do not improve after 7 days talk to your doctor or pharmacist After use, wipe the neck of the bottle with a clean damp cloth. This will remove any liquid that is left, before putting the cap back on
the way Phenergan Elixir works. Do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks: Some medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are not sure ask your doctor or pharmacist Tell your doctor or pharmacist if you are taking any of the following: Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or weak bladder. These can increase the risk of dizziness, dry mouth and blurred eyesight Medicines for depression (such as amitriptyline) Medicines to help you to sleep or feel more relaxed (such as diazepam or zolpidem) Medicines such as aspirin (for arthritis and pain in your joints). Phenergan Elixir may hide the Taking Phenergan Elixir with food and drink Do not drink alcohol while you are taking way the medicine works. Pregnancy and breast-feeding Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Phenergan Elixir should not be taken in the 2 weeks before birth.
2
Like all medicines, Phenergan Elixir can cause side Stop taking Phenergan Elixir and see a doctor or go to a hospital straight away if you notice An allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Liver problems that may cause the eyes or skin to go yellow (jaundice) Being unable to control some muscles in your head or face You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling Very fast, uneven heartbeat or forceful heartbeat (palpitations) Irregular heartbeat Tiredness which lasts for a long time. This may be due to a blood problem called anaemia Over-active behaviour in children Tell your doctor or pharmacist if any of the than a few days. Also tell them if you notice Dry mouth, blurred vision or you can not pass water (urine) Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless Loss of appetite (anorexia), indigestion Feeling dizzy, lightheaded, faint (hypotension) Feeling confused, especially in elderly people Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps 5. How to store Phenergan Elixir Keep out of the reach and sight of children Do not use Phenergan Elixir after the expiry date which is stated on the carton and bottle label. The expiry date refers to the last day of that month Do not use Phenergan Elixir after the bottle has been opened for more than a month Store below 25C Keep the bottle in the outer carton in order to protect from light
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further Information What Phenergan Elixir contains. Each 5ml of solution contains 5mg of the active substance, promethazine hydrochloride. The other ingredients are hydrogenated glucose caramel (E150), sodium benzoate (E211), sodium sulphite anhydrous (E221), sodium metabisulphite (E223), ascorbic acid (E300), citric acid anhydrous (E330), sodium citrate (E331), acesulphame potassium (E950) and water. What Phenergan Elixir looks like and contents of the pack A clear, golden, syrupy liquid contained in an amber glass bottle. Your elixir is available in glass bottles of 100ml. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder One Onslow Street Guildford Surrey GU1 4YS UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer Unither Liquid Manufacturing 1-3 Allee de la Neste Z.I. den Signal 31770 Colomiers France about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in November 2012 Sanofi, 1973 - 2012 301467 467 4
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
