PICOLAX POWDER FOR ORAL SOLUTION
Active substance: SODIUM PICOSULFATE
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PICOPREP
1 (2)
Powder for oral solution
Taking other medicines: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines - including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking: bulk forming laxatives e.g. bran prescribed oral medication, especially if it is regularly prescribed as their effects may be modified e.g. contraceptives, antibiotics, anti-diabetics, iron, penicillamine, or anti-epileptics. These medicines should be take at least 2 hours before and not less than 6 hours after administration of Picolax prescribed medication that may affect water and/or electrolyte balance e.g. water tablets, steroids, lithium, digoxin, antidepressants, carbamazepine or antipsychotics Pregnancy and breast-feeding: If you are pregnant, trying to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking Picolax. Driving and usin machines: Picolax has no effect on the ability to drive and use machines. However, you should make sure that you have access to a toilet at all times following each dose, until the effect wears off. Important information about some of the ingredients of Picolax: Each sachet contains 5 mmol (or 195 mg) potassium. You should discuss this with your doctor if you have kidney problems or you have been put on a controlled potassium diet. This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Read all of ths leaflet carefully before you start using this medicine. Keep this leaflet, you may need to read it again If you have further questions, please ask your doctor or pharmacist This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What PICOLAX is and what it is used for 2. Before you take PICOLAX 3. How to take PICOLAX 4. Possible side effects 5. How to store PICOLAX 6. Further information
1. What Picolax is and what it is used for
Picolax is a powder that contains sodium picosulfate, a laxative that works by increasing the activity of the intestine. Picolax also contains magnesium citrate, another type of laxative that works by holding back fluid in the bowel to provide a wash-out effect. Picolax is used to clear your bowel before you have an x-ray examination, endoscopy or surgery.
2. Before you take Picolax
Do not take Picolax if you: are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients have reduced ability of the stomach to empty (gastric retention) have stomach or intestinal ulcers have severe problems with your kidneys have a blockage or perforation of your bowel are currently suffering from feeling or being sick have a condition requiring abdominal surgery such as appendicitis have been told by a doctor that you have congestive heart failure (the heart is unable to pump blood efficiently around the body) have active inflammatory bowel disease such as Crohns disease or ulcerative colitis have been told by your doctor that you have too much magnesium in your blood are very thirsty or may be severely dehydrated have been told by your doctor that you have damage muscles that are leaking their contents to your blood have a condition called: ileus (intestinal blockage or failure of normal bowel movement) toxic colitis (damage to the intestinal wall) toxic megacolon (expansion of the large bowel) In these conditions, the movement of the contents of the bowel may be impaired or prevented. Symptoms include nausea, vomiting, diarrhoea, abdominal pain, tenderness or swelling, colicky pain and fever. Take special care with Picolax if you: have recently had abdominal surgery have a heart disease or kidney problems have inflammatory bowel disease such as ulcerative colitis or Crohns disease are younger than 18 years, elderly or physically weak. You should make sure to drink sufficient amount of fluid and electrolytes during the course of the treatment are taking Picolax prior surgery involving the bowel If any of these apply to you, or if you are not sure, contact your doctor before taking Picolax.
3. How to take Picolax
Always take Picolax exactly as your doctor has told you. You should check with your doctor if you are not sure. Picolax powder should be dissolved in a cup of cold water (approximately 150 ml). Stir for 2-3 minutes and then drink the solution. Sometimes the solution becomes hot as Picolax dissolves. If this happens, wait until it cools sufficiently before drinking it. Adults (including the elderly) and children 9 and over: The usual dose is one sachet in the morning and one sachet in the afternoon on the day before your procedure. The first sachet taken before 8am, and the second sachet 6 to 8 hours later. Children (under 9 years): Timing as above From 1 and below 2 years: sachet morning, sachet afternoon From 2 and below 4 years: sachet morning, sachet afternoon From 4 and below 9 years: 1 sachet morning, sachet afternoon 9 years and above: adult dose You should expect frequent, loose bowel motions to start at any time after taking a dose of Picolax. Please ensure that you have access to a toilet at all times following each dose, until the effects wear off. In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with Picolax until the bowel movement have ceased. In general, you should try to drink a glass of water (about 250 ml) or other clear fluid every hour whilst the effects of Picolax persist. The success of your hospital procedure that you undergo depends on the bowel being as clear as possible. The procedure may need to be repeated if you do not achieve a clear bowel. You should always follow the dietary instructions given by your doctor. If you take more Picolax: If you should taken more Picolax than you should, contact your doctor immediately or go to the casualty department at your nearest hospital. If you forget to take Picolax: Please consult your doctor, nurse or pharmacist for advice. continued overleaf
PICOPREP
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4. Possible side effects
Like all medicines, Picolax can cause side effects, althought not everybody gets them. There have been isolated reports of severe prolonged abdominal pain in some patients which may indicate a serious condition and required urgent medical care, and isolated reports of severe allergic reactions which may lead to difficulty in breathing. Isolated cases of mild ulcers in the small bowel have also been reported. In the case of allergic reaction or severe prolonged abdominal pain, contact your doctor or nearest casualty department immediately. The known side effects of Picolax are described below: Common (affects less than 1 in 10 but more than 1 in 100 patients): Headache Nausea Proctalgia (anal pain) Uncommon (affects less than 1 in 100 but more than 1 in 1,000 patients): Rash and/or itching Vomiting and severe diarrhoea can lead to dehydration with headache and confusion without proper fluid and salt replacement Abdominal pain Vomiting Low levels of sodium or potassium in the blood (hyponatraemia or hypokalaemia) with or without associated fits. Fits have occasionally been reported in epileptic patients Other side effects for which the occurrence is not known: As the primary clinical effect, very regular, loose bowel movements, or diarrhoea may happen. However, if your bowel movements become troublesome or give you concern, you should contact your doctor. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Picolax
Keep out of reach and sight of children. Store in the original packaging in order to protect from moisture. Single use only. Discard any unused contents. Do not use Picolax after the expiry date wihch is stated on the sachet. 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 Picolax contains: The active substances are 10 mg sodium picosulfate, 3.5 g magnesium oxide light and 12 g anhydrous citric acid. The other ingredients are potassium hydrogen carbonate, saccharin sodium and natural spray-dried orange flavour which includes acacia gum, lactose, ascorbic acid, butylated hydroxyanisole. What Picolax looks like and contents of the pack: Your medicine is called Picolax. It is a powder for oral solution. It is supplied in packs of 2 sachets, 100 sachets (50 packs, each containing 2 sachets), or 300 sachets (150 packs, each containing 2 sachets). Not all pack sizes may be marketed. Marketing authorisation Holder: Ferring Pharmaceuticals Ltd. Drayton Hall, Church Road, West Drayton, UB7 7PS (UK). Picolax: PL 03194/0014 Manufacturers: Pharmaserve Ltd. Clifton Technology Park, Wynne Avene, Swinton, Manchester M27 8FF (UK). Ferring GmbH Wittland 11, D-24109 Kiel, Germany. This leaflet was last revised in July 2012.
1 (2)
Powder for oral solution
Taking other medicines: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines - including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking: bulk forming laxatives e.g. bran prescribed oral medication, especially if it is regularly prescribed as their effects may be modified e.g. contraceptives, antibiotics, anti-diabetics, iron, penicillamine, or anti-epileptics. These medicines should be take at least 2 hours before and not less than 6 hours after administration of Picolax prescribed medication that may affect water and/or electrolyte balance e.g. water tablets, steroids, lithium, digoxin, antidepressants, carbamazepine or antipsychotics Pregnancy and breast-feeding: If you are pregnant, trying to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking Picolax. Driving and usin machines: Picolax has no effect on the ability to drive and use machines. However, you should make sure that you have access to a toilet at all times following each dose, until the effect wears off. Important information about some of the ingredients of Picolax: Each sachet contains 5 mmol (or 195 mg) potassium. You should discuss this with your doctor if you have kidney problems or you have been put on a controlled potassium diet. This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Read all of ths leaflet carefully before you start using this medicine. Keep this leaflet, you may need to read it again If you have further questions, please ask your doctor or pharmacist This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What PICOLAX is and what it is used for 2. Before you take PICOLAX 3. How to take PICOLAX 4. Possible side effects 5. How to store PICOLAX 6. Further information
1. What Picolax is and what it is used for
Picolax is a powder that contains sodium picosulfate, a laxative that works by increasing the activity of the intestine. Picolax also contains magnesium citrate, another type of laxative that works by holding back fluid in the bowel to provide a wash-out effect. Picolax is used to clear your bowel before you have an x-ray examination, endoscopy or surgery.
2. Before you take Picolax
Do not take Picolax if you: are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients have reduced ability of the stomach to empty (gastric retention) have stomach or intestinal ulcers have severe problems with your kidneys have a blockage or perforation of your bowel are currently suffering from feeling or being sick have a condition requiring abdominal surgery such as appendicitis have been told by a doctor that you have congestive heart failure (the heart is unable to pump blood efficiently around the body) have active inflammatory bowel disease such as Crohns disease or ulcerative colitis have been told by your doctor that you have too much magnesium in your blood are very thirsty or may be severely dehydrated have been told by your doctor that you have damage muscles that are leaking their contents to your blood have a condition called: ileus (intestinal blockage or failure of normal bowel movement) toxic colitis (damage to the intestinal wall) toxic megacolon (expansion of the large bowel) In these conditions, the movement of the contents of the bowel may be impaired or prevented. Symptoms include nausea, vomiting, diarrhoea, abdominal pain, tenderness or swelling, colicky pain and fever. Take special care with Picolax if you: have recently had abdominal surgery have a heart disease or kidney problems have inflammatory bowel disease such as ulcerative colitis or Crohns disease are younger than 18 years, elderly or physically weak. You should make sure to drink sufficient amount of fluid and electrolytes during the course of the treatment are taking Picolax prior surgery involving the bowel If any of these apply to you, or if you are not sure, contact your doctor before taking Picolax.
3. How to take Picolax
Always take Picolax exactly as your doctor has told you. You should check with your doctor if you are not sure. Picolax powder should be dissolved in a cup of cold water (approximately 150 ml). Stir for 2-3 minutes and then drink the solution. Sometimes the solution becomes hot as Picolax dissolves. If this happens, wait until it cools sufficiently before drinking it. Adults (including the elderly) and children 9 and over: The usual dose is one sachet in the morning and one sachet in the afternoon on the day before your procedure. The first sachet taken before 8am, and the second sachet 6 to 8 hours later. Children (under 9 years): Timing as above From 1 and below 2 years: sachet morning, sachet afternoon From 2 and below 4 years: sachet morning, sachet afternoon From 4 and below 9 years: 1 sachet morning, sachet afternoon 9 years and above: adult dose You should expect frequent, loose bowel motions to start at any time after taking a dose of Picolax. Please ensure that you have access to a toilet at all times following each dose, until the effects wear off. In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with Picolax until the bowel movement have ceased. In general, you should try to drink a glass of water (about 250 ml) or other clear fluid every hour whilst the effects of Picolax persist. The success of your hospital procedure that you undergo depends on the bowel being as clear as possible. The procedure may need to be repeated if you do not achieve a clear bowel. You should always follow the dietary instructions given by your doctor. If you take more Picolax: If you should taken more Picolax than you should, contact your doctor immediately or go to the casualty department at your nearest hospital. If you forget to take Picolax: Please consult your doctor, nurse or pharmacist for advice. continued overleaf
PICOPREP
2 (2)
4. Possible side effects
Like all medicines, Picolax can cause side effects, althought not everybody gets them. There have been isolated reports of severe prolonged abdominal pain in some patients which may indicate a serious condition and required urgent medical care, and isolated reports of severe allergic reactions which may lead to difficulty in breathing. Isolated cases of mild ulcers in the small bowel have also been reported. In the case of allergic reaction or severe prolonged abdominal pain, contact your doctor or nearest casualty department immediately. The known side effects of Picolax are described below: Common (affects less than 1 in 10 but more than 1 in 100 patients): Headache Nausea Proctalgia (anal pain) Uncommon (affects less than 1 in 100 but more than 1 in 1,000 patients): Rash and/or itching Vomiting and severe diarrhoea can lead to dehydration with headache and confusion without proper fluid and salt replacement Abdominal pain Vomiting Low levels of sodium or potassium in the blood (hyponatraemia or hypokalaemia) with or without associated fits. Fits have occasionally been reported in epileptic patients Other side effects for which the occurrence is not known: As the primary clinical effect, very regular, loose bowel movements, or diarrhoea may happen. However, if your bowel movements become troublesome or give you concern, you should contact your doctor. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Picolax
Keep out of reach and sight of children. Store in the original packaging in order to protect from moisture. Single use only. Discard any unused contents. Do not use Picolax after the expiry date wihch is stated on the sachet. 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 Picolax contains: The active substances are 10 mg sodium picosulfate, 3.5 g magnesium oxide light and 12 g anhydrous citric acid. The other ingredients are potassium hydrogen carbonate, saccharin sodium and natural spray-dried orange flavour which includes acacia gum, lactose, ascorbic acid, butylated hydroxyanisole. What Picolax looks like and contents of the pack: Your medicine is called Picolax. It is a powder for oral solution. It is supplied in packs of 2 sachets, 100 sachets (50 packs, each containing 2 sachets), or 300 sachets (150 packs, each containing 2 sachets). Not all pack sizes may be marketed. Marketing authorisation Holder: Ferring Pharmaceuticals Ltd. Drayton Hall, Church Road, West Drayton, UB7 7PS (UK). Picolax: PL 03194/0014 Manufacturers: Pharmaserve Ltd. Clifton Technology Park, Wynne Avene, Swinton, Manchester M27 8FF (UK). Ferring GmbH Wittland 11, D-24109 Kiel, Germany. This leaflet was last revised in July 2012.
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.
