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

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

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.”

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.”

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

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