NUROFEN EXPRESS 400MG ORAL POWDER
Active substance: IBUPROFEN LYSINATE
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170 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER Nurofen Express 400mg Oral Powder Ibuprofen
Read all of this leaet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Nurofen Express carefully to get the best results from it. Keep this leaet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 5 days when treating pain or 3 days when treating fever. If any of the side eects gets serious, or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist.
Other warnings Medicines such as Nurofen Express may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. If you have heart problems, have had a stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist. Taking a painkiller for headaches for too long can make them worse. Fertility, pregnancy and breast-feeding Do not take in the last 3 months of pregnancy. Speak to your doctor or pharmacist before taking this product if you are in the rst 6 months of pregnancy or are breast-feeding. This medicine passes into breast milk but may be used during breast-feeding if it is used at the recommended dose and for the shortest possible time. Nurofen Express belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Nurofen Express, used occasionally will aect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant. Driving and using machines For short-term use and at normal dosage this medicine has no or negligible inuence on the ability to drive and use machines. If side-eects such as tiredness or dizziness occur do not drive or operate machines. Alcohol consumption increases the risk of these side-eect. Important information about some of the ingredients of Nurofen Express. Nurofen Express contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Nurofen Express contains tartrazine (E102). This may cause allergic reactions. 3. HOW TO TAKE NUROFEN EXPRESS This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Always take Nurofen Express exactly as stated in this package leaet. You should check with your doctor or pharmacist if you are not sure. The standard dose is: Adults and children aged 12 years and older: For oral use after dissolving in water. Dissolve the content of one sachet in a glass of water, stir, then drink immediately. You can take one sachet up to three times a day as required. Leave at least six hours between doses. Do not take more than three sachets in any 24 hour period. Not to be given to children under 12 years of age You should not take Nurofen Express for longer than 5 days when treating pain and 3 days when treating fever unless your doctor tells you to. If symptoms persist or worsen consult your doctor. Please speak to the doctor or pharmacist if you feel that the eect of this medicine is greater or less than you expected. If you take more Nurofen Express than you should Consult a doctor immediately. The following signs may occur: nausea, vomiting, stomach pain, headache, dizziness, drowsiness, nystagmus, blurred vision, ringing in the ear. Rarely: low blood pressure and loss of consciousness. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nurofen Express can cause side eects, although not everybody gets them. Side eects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. Although side eects are uncommon, you may suer one of the known side eects of NSAIDs. If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side eects. The following frequencies are taken as a basis when evaluating side eects: very common: common: uncommon: rare: very rare: not known: aects more than 1 user in 10 aects 1 to 10 users in 100 aects 1 to 10 users in 1,000 aects 1 to 10 users in 10,000 aects less than 1 user in 10,000 frequency cannot be estimated from the available data
In general, the habitual use of (several sorts of ) analgesics can lead in rare cases to lasting severe kidney problems. blood disorders resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, u-like symptoms and severe exhaustion psychotic reactions and depression worsening of inammation due to infection high blood pressure, arterial hypertension, palpitations, heart failure, heart attack liver problems or inammation of the liver. Liver failure or damage, particularly in long-term term use, shown by yellowing of the skin and eyes or pale stools and dark urine. the symptoms of aseptic meningitis with neck stiness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be aected. Contact a doctor at once, if these occur. swelling of skin tissue such as hands, feet or face.
In this leaet: 1. What Nurofen Express is and what it is used for 2. Before you take Nurofen Express 3. How to take Nurofen Express 4. Possible side eects 5. How to store Nurofen Express 6. Further information 1. WHAT NUROFEN EXPRESS IS AND WHAT IT IS USED FOR Nurofen Express contains ibuprofen 400mg as ibuprofen lysinate. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inammatory Drugs (NSAIDs). These medicines provide relief by changing the bodys response to pain, swelling and high temperature. Nurofen Express is used to relieve: symptoms of mild to moderate pain such as headache, toothache, period pains, rheumatic and muscular pain and migraine. cold and u symptoms such as sore throat and fever. 2. BEFORE YOU TAKE NUROFEN EXPRESS Do not take Nurofen Express if you: have (or have had two or more episodes of ) a stomach ulcer, perforation or bleeding of the stomach are allergic to ibuprofen, tartrazine (E102) or any of the other ingredients (see section 6) of Nurofen Express or to acetylsalicylic acid (aspirin) or other anti-inammatory painkillers suer from severe kidney, liver or heart problems have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-Steroidal Anti-inammatory drugs) have ever suered from shortness of breath, have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, acetylsalicylic acid (aspirin) or other similar painkillers (NSAIDs) are suering from severe dehydration (caused by vomiting, diarrhoea or insucient uid intake) are suering from cerebrovascular or other active bleeding are suering from blood cell production or clotting disorders are in the last three months of pregnancy (see below). Please do not give to children under 12 years of age. Speak to a pharmacist or your doctor before taking this product if you: have or have had asthma have kidney, heart, liver or bowel problems have high blood pressure, diabetes, high cholesterol or are a smoker have been told by your doctor that you have an intolerance to some sugars have systemic lupus erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders) have had a heart attack or stroke have a history of gastrointestinal disease (such as ulcerative colitis or Crohns disease) are in the rst 6 months of pregnancy have chicken pox (varicella). Consult a doctor before using Nurofen Express if any above mentioned conditions concerns you. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking: blood thinning or anti-clotting medicines (anticoagulants) such as acetylsalicylic acid (aspirin), warfarin, triciopine, glucocorticoids (medicinal products containing cortisone or cortisone-like substances), aspirin, or other NSAIDs (anti-inammatories and analgesics): since these may increase the risk of gastrointestinal ulcers or bleeding lithium (a medicine for manic depressive illness and depression) since the eect of lithium may be enhanced selective serotonin reuptake inhibitors (a medicine used for depression) as these may increase the risk of gastrointestinal side eects. methotrexate (a medicine for cancer or rheumatism) since the eect of methotrexate may be enhanced zidovudine: (a medicine for treating HIV infection) since the use of Nurofen Express may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling. ciclosporin and tacrolimus (to prevent transplant rejection) as there could be an increased risk for the kidney. medicines for high blood pressure (ACE-inhibitors e.g.captopril, betareceptor blocking medicines, angiotensin II antagonists) and water tablets (diuretics), as NSAIDs may reduce the eects of these medicines and there could be a possible increased risk for the kidney (using potassium sparing diuretics with ibuprofen can lead to high blood levels of potassium) sulfonylureas (antidiabetic medicine) as interactions may be possible phenytoin (for epilepsy) as the eect may be enhanced quinolone antibiotics as the risk of convulsions may be increased. cardiac glycosides such as digoxin mifepristone (used to terminate pregnancies) as the eect may be reduced probenecid and sulnpyrazones (medicines for gout): it may take longer for ibuprofen to be broken down by the body.
Medicines such as Nurofen Express may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. If any of the side eects get serious, or if you notice any side eects not listed in the leaet, please tell your doctor or pharmacist. 5. HOW TO STORE NUROFEN EXPRESS Keep out of the reach and sight of children. This medicinal product does not require any special temperature storage conditions. Do not use Nurofen Express after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Nurofen Express contains: Each sachet contains 400mg of the active substance ibuprofen (as ibuprofen lysinate). The other ingredients are: Betadex Lemon essence (containing natural avouring substances and preparations, maltodextrin, modied maize starch and tartrazine E102) Saccharin sodium (E954) Sodium cyclamate (E952) Sodium citrate (E331) Sucrose What Nurofen Express looks like and contents of the pack: This medicine is a white, lemon avoured powder supplied in sachets. Single-dose sachet made of a heat-sealable paper/aluminium sheet /polythene complex. Outer carton containing 1, 2, 3, 4, 5, 6, 7 and 8 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS. PL 00063/0616 Manufacturer Laboratorio de aplicaciones farmacodinmicas, s.a. (fardi) Grassot, 16 08025 BARCELONA (SPAIN) This medicinal product is authorised in the Member States of the EEA under the following names: Poland Nurofen Ultra Forte do rozpuszczania United kingdom Nurofen Express 400mg oral powder This leaet was last approved in November 2011.
480 mm
STOP TAKING this medicine and seek immediate medical help if you develop: signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools, blood in your faeces (stools/motions), vomiting blood or dark particles that look like coee grounds. signs of rare but serious allergic reaction such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, diculty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on rst use of this medicine. severe skin reactions such as rashes covering the whole body, peeling, blistering or aking skin. Tell your doctor if you have any of the following side eects, they become worse or you notice any eects not listed. Common heart burn, abdominal pain, feeling sick and indigestion Uncommon inammation of the stomach, worsening of colitis and Crohn's disease headache, dizziness, sleeplessness, agitation, irritability or tiredness visual disturbances atulence (wind), diarrhoea, constipation and vomiting allergic reactions , such as skin rashes, itching and asthma attacks Rare tinnitus (ringing in the ears) kidney damage and the development of gout Very rare inammation of the oesophagus or pancreas, blockages in the gut serious infections of the skin have occurred during chicken pox kidney disorders that may be shown by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs).
RB004517 RB004517
PACKAGE LEAFLET: INFORMATION FOR THE USER Nurofen Express 400mg Oral Powder Ibuprofen
Read all of this leaet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Nurofen Express carefully to get the best results from it. Keep this leaet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 5 days when treating pain or 3 days when treating fever. If any of the side eects gets serious, or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist.
Other warnings Medicines such as Nurofen Express may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. If you have heart problems, have had a stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist. Taking a painkiller for headaches for too long can make them worse. Fertility, pregnancy and breast-feeding Do not take in the last 3 months of pregnancy. Speak to your doctor or pharmacist before taking this product if you are in the rst 6 months of pregnancy or are breast-feeding. This medicine passes into breast milk but may be used during breast-feeding if it is used at the recommended dose and for the shortest possible time. Nurofen Express belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Nurofen Express, used occasionally will aect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant. Driving and using machines For short-term use and at normal dosage this medicine has no or negligible inuence on the ability to drive and use machines. If side-eects such as tiredness or dizziness occur do not drive or operate machines. Alcohol consumption increases the risk of these side-eect. Important information about some of the ingredients of Nurofen Express. Nurofen Express contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Nurofen Express contains tartrazine (E102). This may cause allergic reactions. 3. HOW TO TAKE NUROFEN EXPRESS This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Always take Nurofen Express exactly as stated in this package leaet. You should check with your doctor or pharmacist if you are not sure. The standard dose is: Adults and children aged 12 years and older: For oral use after dissolving in water. Dissolve the content of one sachet in a glass of water, stir, then drink immediately. You can take one sachet up to three times a day as required. Leave at least six hours between doses. Do not take more than three sachets in any 24 hour period. Not to be given to children under 12 years of age You should not take Nurofen Express for longer than 5 days when treating pain and 3 days when treating fever unless your doctor tells you to. If symptoms persist or worsen consult your doctor. Please speak to the doctor or pharmacist if you feel that the eect of this medicine is greater or less than you expected. If you take more Nurofen Express than you should Consult a doctor immediately. The following signs may occur: nausea, vomiting, stomach pain, headache, dizziness, drowsiness, nystagmus, blurred vision, ringing in the ear. Rarely: low blood pressure and loss of consciousness. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nurofen Express can cause side eects, although not everybody gets them. Side eects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. Although side eects are uncommon, you may suer one of the known side eects of NSAIDs. If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side eects. The following frequencies are taken as a basis when evaluating side eects: very common: common: uncommon: rare: very rare: not known: aects more than 1 user in 10 aects 1 to 10 users in 100 aects 1 to 10 users in 1,000 aects 1 to 10 users in 10,000 aects less than 1 user in 10,000 frequency cannot be estimated from the available data
In general, the habitual use of (several sorts of ) analgesics can lead in rare cases to lasting severe kidney problems. blood disorders resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, u-like symptoms and severe exhaustion psychotic reactions and depression worsening of inammation due to infection high blood pressure, arterial hypertension, palpitations, heart failure, heart attack liver problems or inammation of the liver. Liver failure or damage, particularly in long-term term use, shown by yellowing of the skin and eyes or pale stools and dark urine. the symptoms of aseptic meningitis with neck stiness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be aected. Contact a doctor at once, if these occur. swelling of skin tissue such as hands, feet or face.
In this leaet: 1. What Nurofen Express is and what it is used for 2. Before you take Nurofen Express 3. How to take Nurofen Express 4. Possible side eects 5. How to store Nurofen Express 6. Further information 1. WHAT NUROFEN EXPRESS IS AND WHAT IT IS USED FOR Nurofen Express contains ibuprofen 400mg as ibuprofen lysinate. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inammatory Drugs (NSAIDs). These medicines provide relief by changing the bodys response to pain, swelling and high temperature. Nurofen Express is used to relieve: symptoms of mild to moderate pain such as headache, toothache, period pains, rheumatic and muscular pain and migraine. cold and u symptoms such as sore throat and fever. 2. BEFORE YOU TAKE NUROFEN EXPRESS Do not take Nurofen Express if you: have (or have had two or more episodes of ) a stomach ulcer, perforation or bleeding of the stomach are allergic to ibuprofen, tartrazine (E102) or any of the other ingredients (see section 6) of Nurofen Express or to acetylsalicylic acid (aspirin) or other anti-inammatory painkillers suer from severe kidney, liver or heart problems have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-Steroidal Anti-inammatory drugs) have ever suered from shortness of breath, have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, acetylsalicylic acid (aspirin) or other similar painkillers (NSAIDs) are suering from severe dehydration (caused by vomiting, diarrhoea or insucient uid intake) are suering from cerebrovascular or other active bleeding are suering from blood cell production or clotting disorders are in the last three months of pregnancy (see below). Please do not give to children under 12 years of age. Speak to a pharmacist or your doctor before taking this product if you: have or have had asthma have kidney, heart, liver or bowel problems have high blood pressure, diabetes, high cholesterol or are a smoker have been told by your doctor that you have an intolerance to some sugars have systemic lupus erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders) have had a heart attack or stroke have a history of gastrointestinal disease (such as ulcerative colitis or Crohns disease) are in the rst 6 months of pregnancy have chicken pox (varicella). Consult a doctor before using Nurofen Express if any above mentioned conditions concerns you. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking: blood thinning or anti-clotting medicines (anticoagulants) such as acetylsalicylic acid (aspirin), warfarin, triciopine, glucocorticoids (medicinal products containing cortisone or cortisone-like substances), aspirin, or other NSAIDs (anti-inammatories and analgesics): since these may increase the risk of gastrointestinal ulcers or bleeding lithium (a medicine for manic depressive illness and depression) since the eect of lithium may be enhanced selective serotonin reuptake inhibitors (a medicine used for depression) as these may increase the risk of gastrointestinal side eects. methotrexate (a medicine for cancer or rheumatism) since the eect of methotrexate may be enhanced zidovudine: (a medicine for treating HIV infection) since the use of Nurofen Express may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling. ciclosporin and tacrolimus (to prevent transplant rejection) as there could be an increased risk for the kidney. medicines for high blood pressure (ACE-inhibitors e.g.captopril, betareceptor blocking medicines, angiotensin II antagonists) and water tablets (diuretics), as NSAIDs may reduce the eects of these medicines and there could be a possible increased risk for the kidney (using potassium sparing diuretics with ibuprofen can lead to high blood levels of potassium) sulfonylureas (antidiabetic medicine) as interactions may be possible phenytoin (for epilepsy) as the eect may be enhanced quinolone antibiotics as the risk of convulsions may be increased. cardiac glycosides such as digoxin mifepristone (used to terminate pregnancies) as the eect may be reduced probenecid and sulnpyrazones (medicines for gout): it may take longer for ibuprofen to be broken down by the body.
Medicines such as Nurofen Express may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. If any of the side eects get serious, or if you notice any side eects not listed in the leaet, please tell your doctor or pharmacist. 5. HOW TO STORE NUROFEN EXPRESS Keep out of the reach and sight of children. This medicinal product does not require any special temperature storage conditions. Do not use Nurofen Express after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Nurofen Express contains: Each sachet contains 400mg of the active substance ibuprofen (as ibuprofen lysinate). The other ingredients are: Betadex Lemon essence (containing natural avouring substances and preparations, maltodextrin, modied maize starch and tartrazine E102) Saccharin sodium (E954) Sodium cyclamate (E952) Sodium citrate (E331) Sucrose What Nurofen Express looks like and contents of the pack: This medicine is a white, lemon avoured powder supplied in sachets. Single-dose sachet made of a heat-sealable paper/aluminium sheet /polythene complex. Outer carton containing 1, 2, 3, 4, 5, 6, 7 and 8 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS. PL 00063/0616 Manufacturer Laboratorio de aplicaciones farmacodinmicas, s.a. (fardi) Grassot, 16 08025 BARCELONA (SPAIN) This medicinal product is authorised in the Member States of the EEA under the following names: Poland Nurofen Ultra Forte do rozpuszczania United kingdom Nurofen Express 400mg oral powder This leaet was last approved in November 2011.
480 mm
STOP TAKING this medicine and seek immediate medical help if you develop: signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools, blood in your faeces (stools/motions), vomiting blood or dark particles that look like coee grounds. signs of rare but serious allergic reaction such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, diculty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on rst use of this medicine. severe skin reactions such as rashes covering the whole body, peeling, blistering or aking skin. Tell your doctor if you have any of the following side eects, they become worse or you notice any eects not listed. Common heart burn, abdominal pain, feeling sick and indigestion Uncommon inammation of the stomach, worsening of colitis and Crohn's disease headache, dizziness, sleeplessness, agitation, irritability or tiredness visual disturbances atulence (wind), diarrhoea, constipation and vomiting allergic reactions , such as skin rashes, itching and asthma attacks Rare tinnitus (ringing in the ears) kidney damage and the development of gout Very rare inammation of the oesophagus or pancreas, blockages in the gut serious infections of the skin have occurred during chicken pox kidney disorders that may be shown by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs).
RB004517 RB004517
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.
