Picolax Powder For Oral Solution
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Picolax® Powder for oral solution
(sodium picosulfate, magnesium oxide light, citric acid)
Patient Information Leaflet
Read all of this 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.
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): Timings as above
A measuring spoon is provided with the product.
From 1 and below 2 years: 1 spoonful morning, 1 spoonful afternoon From 2 and below 4 years: 2 spoonsfuls morning, 2 spoonfuls afternoon From 4 and below 9 years: 1 sachet morning (taken as described under ‘adults'), 2 spoonfuls afternoon 9 years and above: adult dose.
To measure the dose with the measuring spoon:
- Fill the spoon with a heap of powder from the sachet.
- Pass the flat back of a knife across the top of the measuring spoon.
- The powder left in the measuring spoon is one spoonful (4 g of powder).
- Pour the powder from the spoon into a cup of water. The cup should conain:
• Approximately 50 ml of water if you are measuring one spoonful of powder
• Approximately 100 ml of water if you are measuring two spoonfuls of powder
- Stir in the cup for 2-3 minutes.
- Drink the solution. Sometimes the solution becomes warm as Picolax® dissolves. If this happens, wait until it cools sufficiently before drinking it.
- Discard any remaining powder from the sachet.
This medicine is available using the above name but will be referred to as Picolax® throughout the Patient Information Leaflet.
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 Crohn's 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 Crohn's 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®.
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 taken 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 anti-psychotics
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 using 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.
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.
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® than you should:
If you have 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Picolax®
• Keep out of the sight and reach 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 which is stated on the sachet.
• If the powder becomes discoloured or shows signs of deterioration, you should seek advice of your pharmacist who will advise you what to do.
• 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. Furthur Information
What Picolax® contains:
The active substances are 10 mg sodium picosulfate, 3.5 g magnesium oxide light and 12 g citric acid anhydrous.
The other ingredients are: potassium bicarbonate, sodium saccharin and natural aroma spray dried orange containing acacia gum, lactose, ascorbic acid, butylated hydroxyanisole
What Picolax® looks like and contents of the pack:
Your medicine is called Picolax®. It is a white powder for oral solution. It is supplied in packs of 2 sachets.
A measuring spoon is included in the pack, in order to ensure correct dosing for children. The spoon is used to measure 4 g of powder (4.75 ml). You should only use the spoon if you are dosing a child under 9 years.
Manufacturer and Product Licence Holder
This product is manufactured by Pharmaserve Ltd, Clifton Technology Park, Wynne Avenue, Swinton, Manchester, M27 8FF (UK) and/or Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. It is procured from within the EU by the Product Licence Holder: Swinghope Limited, Brandon House, Marlowe Way, Croydon CR0 4XS UK.
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PL No: 10380/1586
Leaflet revision date: 04/05/2016
Picolax® is registered trademark of Ferring BV, Netherlands.
T05691