LAXIDO ORANGE POWDER FOR ORAL SOLUTION

Active substance: SODIUM HYDROGEN CARBONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Laxido Orange
Powder for oral solution
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Laxido Orange carefully to get the best results from it. - Keep this leaflet. 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 14 days for chronic constipation, or after 3 days for faecal impaction. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Laxido Orange is and what it is used for 2. Before you take Laxido Orange 3. How to take Laxido Orange 4. Possible side effects 5. How to store Laxido Orange 6. Further information 1. WHAT LAXIDO ORANGE IS AND WHAT IT IS USED FOR Macrogol 3350 is a laxative used for the treatment of constipation, especially if you have been constipated for a long time. It is also used to treat a build up of hard faeces in your bowel which may be a result of long-term constipation (this is known as faecal impaction). Macrogol 3350 makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes help to maintain your bodys normal levels of sodium, potassium and water while you are being treated for constipation. 2. BEFORE YOU TAKE LAXIDO ORANGE Do not take Laxido Orange - if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in Laxido Orange - if you have a perforation in the wall of your intestine - if you have a blockage in your intestine - if you have paralysis of the intestine (for example, your intestines may stop working due to intestinal surgery or severe infection) - if you have ulcerative colitis, Crohns disease or toxic megacolon If any of these applies to you, please talk to your doctor or pharmacist for further advice. Take special care with Laxido Orange Before taking Laxido Orange to treat faecal impaction, you should have this condition confirmed by your doctor.

Taking other medicines Some medicines, e.g. anti-epileptics, may not work as effectively if they are taken at the same time as Laxido Orange. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. You should not take any other medicines by mouth for one hour before and for one hour after taking Laxido Orange. Taking Laxido Orange with food and drink Food and drink have no influence on the effect of Laxido Orange. Pregnancy and breast-feeding If you are pregnant or breast-feeding, talk to your doctor before taking Laxido Orange. Driving and using machines Laxido Orange has no effect on the ability to drive or use machinery. Important information about some of the ingredients of Laxido Orange Laxido Orange contains 0.68mmol (26mg) of potassium per sachet. This should be taken into consideration if you take more than one sachet daily and you have reduced kidney function, or if you are on a controlled potassium diet. Laxido Orange contains 8.13mmol (187mg) of sodium per sachet. This should be taken into consideration if you are on a controlled sodium diet. 3. HOW TO TAKE LAXIDO ORANGE Always take Laxido Orange exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Laxido Orange should be taken orally. Adults, children (aged 12 years and above) and the elderly: The usual dose for constipation is one sachet taken one to three times daily. This course of treatment for constipation does not normally last longer than 2 weeks. The usual dose for faecal impaction is eight sachets daily. All eight sachets must be taken within a six hour period. This course of treatment for faecal impaction does not normally last longer than 3 days. If you have a heart condition, do not take more than two sachets (in 250ml of water) in any one hour. Laxido Orange should be made up by dissolving the contents of one sachet in a glass of water (125ml or a quarter pint). If you are being treated for faecal impaction, you can dissolve the contents of all eight sachets together in a large container (in one litre of water). Your treatment may last for longer than two weeks if you have ongoing constipation, or a disease that causes constipation (such as Parkinsons disease or multiple sclerosis), or if you are taking other regular medicines that can cause constipation. In these cases, your doctor may reduce your dose to one sachet taken one or two times daily. If you take more Laxido Orange than you should You may experience severe pains and swelling in your abdomen, or vomiting or diarrhoea. If this happens, contact your doctor or pharmacist. If you forget to take Laxido Orange If you forget to take a dose, take it as soon as you remember and then continue on as before. Do not take a double dose to make up for a forgotten dose.
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If you stop taking Laxido Orange To get the most benefit from Laxido Orange, always finish the course of treatment recommended by your doctor or pharmacist. This will make sure that your constipation is cleared, otherwise the symptoms you are suffering from may persist. You must contact a doctor if your symptoms worsen or do not improve after 14 days for chronic constipation, or after 3 days for faecal impaction. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Laxido Orange can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking Laxido Orange and see your doctor immediately: - signs of a serious allergic reaction, such as difficulty in breathing, or swelling of the face, lips, tongue or throat - signs of an allergy, such as a rash, reddening of the skin, nettle rash, itching or shortness of breath - signs of a change in your bodys fluid or electrolyte levels, such as swelling (mainly in the ankles), feeling fatigued, dehydration or increased thirst with headache. These symptoms may be a sign that the potassium levels in your blood are higher or lower than normal. The following side effects are also possible: abdominal pain feeling bloated suffering from wind indigestion soreness of the anus (bottom) mild diarrhoea nausea vomiting swelling of your abdomen stomach rumbling

6. FURTHER INFORMATION What Laxido Orange contains The active substances are macrogol 3350 (13.125g), sodium chloride (350.7mg), sodium hydrogen carbonate (178.5mg) and potassium chloride (46.6mg). The other ingredients are acesulfame potassium (E950) and orange flavour (containing maltodextrin and propylene glycol (E1520)). What Laxido Orange looks like and contents of the pack Laxido Orange is a white powder that is packed in sachets. It has an orange taste and smell. Each sachet contains 13.8g of powder and is packed in cartons containing 2, 8, 10, 20, 30, 50 and 100 sachets. Not all of these pack sizes are marketed. Marketing Authorisation Holder Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK Manufacturer Co-Pharma Limited Unit 4 Metro Centre Tolpits Lane Watford Hertfordshire WD18 9SS United Kingdom This leaflet was last approved in 06/2012 Laxido is a trade mark

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE LAXIDO ORANGE Keep out of the reach and sight of children. Do not use Laxido Orange after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month. You should store unopened sachets below 25C. Do not use Laxido Orange if you notice that any of the sachets is damaged.
1017625

Reconstituted Laxido Orange solution can be covered and stored in the refrigerator (2C to 8C), and should be used within six hours. After six hours, any unused solution should be discarded. Unused sachets of Laxido Orange should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused sachets, which you no longer require. These measures will help to protect the environment.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Laxido Orange
Powder for oral solution
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Laxido Orange carefully to get the best results from it. - Keep this leaflet. 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 14 days for chronic constipation, or after 3 days for faecal impaction. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Laxido Orange is and what it is used for 2. Before you take Laxido Orange 3. How to take Laxido Orange 4. Possible side effects 5. How to store Laxido Orange 6. Further information 1. WHAT LAXIDO ORANGE IS AND WHAT IT IS USED FOR Macrogol 3350 is a laxative used for the treatment of constipation, especially if you have been constipated for a long time. It is also used to treat a build up of hard faeces in your bowel which may be a result of long-term constipation (this is known as faecal impaction). Macrogol 3350 makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes help to maintain your bodys normal levels of sodium, potassium and water while you are being treated for constipation.

Taking other medicines Some medicines, e.g. anti-epileptics, may not work as effectively if they are taken at the same time as Laxido Orange. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. You should not take any other medicines by mouth for one hour before and for one hour after taking Laxido Orange. Taking Laxido Orange with food and drink Food and drink have no influence on the effect of Laxido Orange. Pregnancy and breast-feeding If you are pregnant or breast-feeding, talk to your doctor before taking Laxido Orange. Driving and using machines Laxido Orange has no effect on the ability to drive or use machinery. Important information about some of the ingredients of Laxido Orange Laxido Orange contains 0.68mmol (26mg) of potassium per sachet. This should be taken into consideration if you take more than one sachet daily and you have reduced kidney function, or if you are on a controlled potassium diet. Laxido Orange contains 8.13mmol (187mg) of sodium per sachet. This should be taken into consideration if you are on a controlled sodium diet. 3. HOW TO TAKE LAXIDO ORANGE Always take Laxido Orange exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Laxido Orange should be taken orally. Adults, children (aged 12 years and above) and the elderly: The usual dose for constipation is one sachet taken one to three times daily. This course of treatment for constipation does not normally last longer than 2 weeks. The usual dose for faecal impaction is eight sachets daily. All eight sachets must be taken within a six hour period. This course of treatment for faecal impaction does not normally last longer than 3 days. If you have a heart condition, do not take more than two sachets (in 250ml of water) in any one hour. Laxido Orange should be made up by dissolving the contents of one sachet in a glass of water (125ml or a quarter pint). If you are being treated for faecal impaction, you can dissolve the contents of all eight sachets together in a large container (in one litre of water). Your treatment may last for longer than two weeks if you have ongoing constipation, or a disease that causes constipation (such as Parkinsons disease or multiple sclerosis), or if you are taking other regular medicines that can cause constipation. In these cases, your doctor may reduce your dose to one sachet taken one or two times daily. If you take more Laxido Orange than you should You may experience severe pains and swelling in your abdomen, or vomiting or diarrhoea. If this happens, contact your doctor or pharmacist. If you forget to take Laxido Orange If you forget to take a dose, take it as soon as you remember and then continue on as before. Do not take a double dose to make up for a forgotten dose. PX2046/2

2. BEFORE YOU TAKE LAXIDO ORANGE Do not take Laxido Orange - if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in Laxido Orange - if you have a perforation in the wall of your intestine - if you have a blockage in your intestine - if you have paralysis of the intestine (for example, your intestines may stop working due to intestinal surgery or severe infection) - if you have ulcerative colitis, Crohns disease or toxic megacolon If any of these applies to you, please talk to your doctor or pharmacist for further advice. Take special care with Laxido Orange Before taking Laxido Orange to treat faecal impaction, you should have this condition confirmed by your doctor.

If you stop taking Laxido Orange To get the most benefit from Laxido Orange, always finish the course of treatment recommended by your doctor or pharmacist. This will make sure that your constipation is cleared, otherwise the symptoms you are suffering from may persist. You must contact a doctor if your symptoms worsen or do not improve after 14 days for chronic constipation, or after 3 days for faecal impaction. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Laxido Orange can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking Laxido Orange and see your doctor immediately: - signs of a serious allergic reaction, such as difficulty in breathing, or swelling of the face, lips, tongue or throat - signs of an allergy, such as a rash, reddening of the skin, nettle rash, itching or shortness of breath - signs of a change in your bodys fluid or electrolyte levels, such as swelling (mainly in the ankles), feeling fatigued, dehydration or increased thirst with headache. These symptoms may be a sign that the potassium levels in your blood are higher or lower than normal. The following side effects are also possible: - abdominal pain - feeling bloated - suffering from wind - indigestion - soreness of the anus (bottom) - mild diarrhoea - nausea - vomiting - swelling of your abdomen - stomach rumbling If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE LAXIDO ORANGE Keep out of the reach and sight of children. Do not use Laxido Orange after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month. You should store unopened sachets below 25C. Do not use Laxido Orange if you notice that any of the sachets is damaged. Reconstituted Laxido Orange solution can be covered and stored in the refrigerator (2C to 8C), and should be used within six hours. After six hours, any unused solution should be discarded. Unused sachets of Laxido Orange should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused sachets, which you no longer require. These measures will help to protect the environment.

6. FURTHER INFORMATION What Laxido Orange contains The active substances are macrogol 3350 (13.125g), sodium chloride (350.7mg), sodium hydrogen carbonate (178.5mg) and potassium chloride (46.6mg). The other ingredients are acesulfame potassium (E950) and orange flavour (containing maltodextrin and propylene glycol (E1520)). What Laxido Orange looks like and contents of the pack Laxido Orange is a white powder that is packed in sachets. It has an orange taste and smell. Each sachet contains 13.8g of powder and is packed in cartons containing 2, 8, 10, 20, 30, 50 and 100 sachets. Not all of these pack sizes are marketed. Marketing Authorisation Holder Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK Manufacturer Almac Pharma Services Limited Almac House 20 Seagoe Industrial Estate Craigavon BT63 5QD UK This leaflet was last approved in 06/2012 Laxido is a trade mark

PX2046/2

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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.

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