What Picolax is used for and how to use it
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Picolax - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: Germany
Condition: Bowel Preparation
Class: Laxatives
Form: Powder
Ingredients: sodium picosulfate, magnesium citrate, anhydrous citric acid, potassium hydrogen carbonate, saccharin sodium and natural, spray-dried orange flavour which includes acacia gum, lactose, ascorbic acid, butylated hydroxyanisole

Powder for oral solution

Sodium Picosulfate / Magnesium Oxide / Citric Acid

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 in adults, adolescents and children from the age of 1 year

to clear the bowel before an x-ray examination, endoscopy or surgery when judged clinical necessary.

What You Need to Know 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 acute 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 damaged muscles that are leaking their contents to your blood
  • have a condition called:
  • ileus (intestinal blockage or failure of normal bowel movements),
  • 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 a sufficient amount of

fluid and electrolytes during the course of the treatment.

  • are taking Picolax prior to surgery involving the bowel.

If any of these apply to you, or if you are not sure, contact your doctor before taking Picolax

Other Medicines and Picolax

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, Breast-Feeding and Fertility

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.

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 150ml). 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 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 8 am, followed by at least five 250 ml drinks of clear liquids spread over several hours and the second sachet 6-8 hours later, followed by at least three 250 ml drinks of clear liquids spread over several hours.

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 spoonfuls 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 (4g of powder).
  • Pour the powder from the spoon into a cup of water. The cup should contain:
    • 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

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 liquids throughout the treatment with Picolax until the bowel movements have ceased. In general, you should try to drink clear liquids when you are thirsty.

Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream) and water. Do not drink only water.

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.

Possible Side Effects

Like all medicines, Picolax can cause side effects, although not everybody gets them.

There have been isolated reports of severe prolonged abdominal pain in some patients which may indicate a serious condition and require 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of Side Effects

If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme,

website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Picolax

Keep out of the 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 which 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.

Contents of the Pack and Other 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).

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.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ferring Pharmaceuticals Limited,

Drayton Hall, Church Road,

West Drayton, UB7 7PS, UK.

Manufacturers

Pharmaserve Ltd, Clifton Technology

Park, Wynne Avenue, Swinton,

Manchester M27 8FF (UK).

Ferring GmbH, Wittland 11,

D-24109 Kiel, Germany

 

This medicinal product is authorised in the Member States of EEA under the following names:

PICOLAX

United Kingdom

PICOPREP

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Netherlands. Norway, Portugal, Romania, Slovak Republic, Spain, Sweden