Picolax 10mg/ 3.5g/ 12g powder for Oral Solution

Summary of Product Characteristics last updated on medicines.ie: 23/7/2019

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Ferring Ireland Limited

Ferring Ireland Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23 July 2019

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.2 -  Update to the definition of clear fluids and improvement of the instructions on fluid intake when treated with Picolax

Section 4.4 - Addition of information on consequences of not adhering to the instructions on fluid intake

Section 4.9 -  Rephrased to be aligned with updates in sections 4.2 and 4.4

Section 10 - Update date of revision of the text

 

Updated on 25 May 2015

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 May 2015 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to include new HPRA contact information

Updated on 25 May 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Update to include new HPRA contact information

Updated on 26 August 2013 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Section 2:

Inserted “Lactose (60 mg flavour contains 7.5% lactose which equals 4.5 mg per dosage form)”

 

 

Section 4.2:

Posology included for children. Section text also updated. Full, updated text is:

 

 

“Route of administration: Oral.

 

A low residue diet is recommended on the day prior to the hospital procedure. To avoid dehydration it is recommended to drink a sufficient amount of clear liquids while the effects of Picolax persist.  Clear liquids may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or even coffee without milk.

 

Directions for reconstitution:

Reconstitute the contents of one sachet in a cup of water (approximately 150ml).  Stir for 2-3 minutes. The solution should now become an off-white, cloudy liquid with a faint odour of orange.  Drink the solution. If it becomes warm wait until it cools sufficiently to drink.

 

Adults (including the elderly):

One sachet reconstituted in water as directed, taken before 8am on the day before the procedure. Second sachet 6 to 8 hours later.

 

Children:

The first dose reconstituted in water as directed, taken before 8 am on the day before the procedure. Second dose 6 to 8 hours later.

1-2 years: ¼ sachet morning, ¼ sachet afternoon

2-4 years: ½ sachet morning, ½ sachet afternoon

4-9 years: 1 sachet morning, ½ sachet afternoon

9 and above: adult dose”

 

 

Section 4.3:

Additional contraindications added:

-          Severe nausea and vomiting

-          Severe dehydration

-          Rhabdomyolysis

-          Hypermagnesemia

-          Active inflammatory bowel disease

 

Section 4.4:

New text added:

-          Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery if clearly needed. The risks of the treatment should be carefully weighed against possible benefits and needs depending on surgical procedures performed.”

-          Care should be taken in patients with recent gastro-intestinal surgery, renal impairment, heart disease or inflammatory bowel disease.

-          “An insufficient or excessive oral intake of water and electrolytes could create clinically significant deficiencies, particularly in less fit patients.  In this regard, children, the elderly, debilitated individuals and patients at risk of hypokalaemia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hyponatraemia.  The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.

 

This medicine contains 5 mmol (or 195 mg) potassium per sachet.  This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

 

This medicine contains lactose as a component of the flavour.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Picolax should not be used as a routine laxative.”

 

Section 4.5

New text inserted:

“Medicines with the potential to chelate with magnesium (e.g. tetracycline and fluroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine) should be taken at least 2 hours before and not less than 6 hours after administration of Picolax.”

 

Section 4.6

Section updated to:

For Picolax no clinical data on exposed pregnancy are available.  Studies with Picolax in animals have shown no impairment of fertility or embry-fetal toxicity.  In studies with sodium picosulfate alone, embryofetal toxicity has been observed in rats and rabbits at very high doses (see section 5.3).  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

There is no experience with the use of Picolax in nursing mothers, so the drug should only be used in nursing mothers if clearly needed.”

 

 

Section 4.8

Section fully updated and reformatted – see SPC for full information.

 

Section 5.1, 5.2 and 5.3

Sections fully updated – see SPC for further information

 

Section 6.1

“Orange flavour” updated to “Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic acid, butylated hydroxyanisole”

 

Section 6.3

“Use immediately after reconstitution” updated to “Once the sachet has been opened, use immediately and discard any unused powder or solution.”

 

Section 6.4

New sentence inserted: “Store in the original package in order to protect from moisture.”

Updated on 26 August 2013 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

 

Section 2:

Inserted “Lactose (60 mg flavour contains 7.5% lactose which equals 4.5 mg per dosage form)”

 

 

Section 4.2:

Posology included for children. Section text also updated. Full, updated text is:

 

 

“Route of administration: Oral.

 

A low residue diet is recommended on the day prior to the hospital procedure. To avoid dehydration it is recommended to drink a sufficient amount of clear liquids while the effects of Picolax persist.  Clear liquids may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or even coffee without milk.

 

Directions for reconstitution:

Reconstitute the contents of one sachet in a cup of water (approximately 150ml).  Stir for 2-3 minutes. The solution should now become an off-white, cloudy liquid with a faint odour of orange.  Drink the solution. If it becomes warm wait until it cools sufficiently to drink.

 

Adults (including the elderly):

One sachet reconstituted in water as directed, taken before 8am on the day before the procedure. Second sachet 6 to 8 hours later.

 

Children:

The first dose reconstituted in water as directed, taken before 8 am on the day before the procedure. Second dose 6 to 8 hours later.

1-2 years: ¼ sachet morning, ¼ sachet afternoon

2-4 years: ½ sachet morning, ½ sachet afternoon

4-9 years: 1 sachet morning, ½ sachet afternoon

9 and above: adult dose”

 

 

Section 4.3:

Additional contraindications added:

-          Severe nausea and vomiting

-          Severe dehydration

-          Rhabdomyolysis

-          Hypermagnesemia

-          Active inflammatory bowel disease

 

Section 4.4:

New text added:

-          Because a clinically relevant benefit of bowel cleansing prior to elective, open colorectal surgery could not be proven, bowel cleansers should only be administered before bowel surgery if clearly needed. The risks of the treatment should be carefully weighed against possible benefits and needs depending on surgical procedures performed.”

-          Care should be taken in patients with recent gastro-intestinal surgery, renal impairment, heart disease or inflammatory bowel disease.

-          “An insufficient or excessive oral intake of water and electrolytes could create clinically significant deficiencies, particularly in less fit patients.  In this regard, children, the elderly, debilitated individuals and patients at risk of hypokalaemia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hyponatraemia.  The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.

 

This medicine contains 5 mmol (or 195 mg) potassium per sachet.  This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

 

This medicine contains lactose as a component of the flavour.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Picolax should not be used as a routine laxative.”

 

Section 4.5

New text inserted:

“Medicines with the potential to chelate with magnesium (e.g. tetracycline and fluroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine) should be taken at least 2 hours before and not less than 6 hours after administration of Picolax.”

 

Section 4.6

Section updated to:

For Picolax no clinical data on exposed pregnancy are available.  Studies with Picolax in animals have shown no impairment of fertility or embry-fetal toxicity.  In studies with sodium picosulfate alone, embryofetal toxicity has been observed in rats and rabbits at very high doses (see section 5.3).  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

There is no experience with the use of Picolax in nursing mothers, so the drug should only be used in nursing mothers if clearly needed.”

 

 

Section 4.8

Section fully updated and reformatted – see SPC for full information.

 

Section 5.1, 5.2 and 5.3

Sections fully updated – see SPC for further information

 

Section 6.1

“Orange flavour” updated to “Natural, spray dried orange flavour which contains acacia gum, lactose, ascorbic acid, butylated hydroxyanisole”

 

Section 6.3

“Use immediately after reconstitution” updated to “Once the sachet has been opened, use immediately and discard any unused powder or solution.”

 

Section 6.4

New sentence inserted: “Store in the original package in order to protect from moisture.”

Updated on 24 April 2013 PIL

Reasons for updating

  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 6.1: 'Orange flavour' updated to 'Orange flavour (containing acacia gum, lactose, ascorbic acid and butylated hydroxyanisole)'

Updated on 24 April 2013 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.1: 'Orange flavour' updated to 'Orange flavour (containing acacia gum, lactose, ascorbic acid and butylated hydroxyanisole)'

Updated on 3 April 2009 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 2 and Section 6.1:  Change in excipient name to potassium hydrogen carbonate

Updated on 3 April 2009 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 and Section 6.1:  Change in excipient name to potassium hydrogen carbonate

Updated on 23 December 2008 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 1:  Change of trade name to 'Picolax 10mg / 3.5g / 12g Powder for Oral Solution
Section 2: Inclusion of 'Each sachet also contains: Potassium Bicarbonate 0.5g [equivalent to 5 mmol (195 mg) potassium]'
Section 4.8:  Addition of 'Isolated cases of mild reversible aphthoid ileal ulcers have been reported.'

Updated on 23 December 2008 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1:  Change of trade name to 'Picolax 10mg / 3.5g / 12g Powder for Oral Solution
Section 2: Inclusion of 'Each sachet also contains: Potassium Bicarbonate 0.5g [equivalent to 5 mmol (195 mg) potassium]'
Section 4.8:  Addition of 'Isolated cases of mild reversible aphthoid ileal ulcers have been reported.'

Updated on 27 August 2008 PIL

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Section 6.6 was embedded in the text. Updated to improve readability.

Updated on 27 August 2008 SPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.6 was embedded in the text. Updated to improve readability.

Updated on 8 March 2007 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Changes in section 4.2, 4.3, 4.4, 4.5 and 4.8 of the SPC

Updated on 8 March 2007 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes in section 4.2, 4.3, 4.4, 4.5 and 4.8 of the SPC

Updated on 13 February 2007 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change due to variation to update section 4.2, 4.3, 4.4, 4.5, 4.8 of the SPC

Updated on 13 February 2007 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Change due to variation to update section 4.2, 4.3, 4.4, 4.5, 4.8 of the SPC

Updated on 27 June 2005 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Updated on 27 June 2005 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie