Name of The Medicinal Product

1.
NAME OF THE MEDICINAL PRODUCT

PICO - SALAX Orange
PICO - SALAX Cranberry
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains the following active ingredients:
Sodium picosulfate 10.0mg

Magnesium oxide 3.5g
Citric acid, anhydrous 12.0g
Each sachet also contains:

Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg) potassium]
Lactose (as a component of the orange flavour)
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for oral solution in sachet.
White crystalline powder.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications

To clean the bowel prior to X-ray examination or endoscopy or surgery.
9.2 Posology and method of administration
Route of administration: Oral
Directions for reconstitution:
The contents of one sachet should be reconstituted in a cup of water (approximately
150ml) and stirred for 2-3 minutes until the solution becomes an off-white, cloudy
liquid with a faint odour of orange.
Adults (including the elderly):
One sachet reconstituted in water as directed, taken before 8 am on the day before the
procedure. Second sachet 6 to 8 hours later.
Children:
1 – 2 years: one measuring spoon full (equivalent to ¼ sachet ) in the morning,
one measuring spoon full (equivalent ¼ sachet) in the afternoon
2 – 4 years: two measuring spoons full (equivalent ½ sachet in the morning,
two measuring spoons full (equivalent ½ sachet) in the afternoon
4 – 9 years: 1 sachet morning, ½ sachet afternoon
9 and above: adult dose
A low residue diet is recommended on the day prior to the procedure. A clear liquid diet
is recommended on the day of the procedure. To avoid dehydration it is important to
follow the liquid intake recommendation as advocated together with the PICOLAX
dosing whilst the effects of PICOLAX persist (see section 4.2, Posology). Apart from
the liquid intake together with the treatment regimen (PICOLAX + additional liquids), a
normal, thirst driven intake of clear liquids is recommended.
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.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
- Congestive cardiac failure
- Gastric retention
- Gastro-intestinal ulceration
- Toxic colitis
- Toxic megacolon
- Ileus
- Nausea and vomiting
- Acute surgical abdominal conditions such as acute appendicitis
- Known or suspected gastro-intestinal obstruction or perforation.
- Severe dehydration
- Rhabdomyolysis
- Hypermagnesemia
- Active inflammatory bowel disease
- In patients with severely reduced renal function, accumulation of magnesium in
plasma may occur. Another preparation should be used in such cases.
-
4.4 Special warnings and special precautions for use

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.
An insufficient or excessive oral intake of water and electrolytes could create
clinically significant, deficiencies, particularly in less fit patients. In this
regard patients with low body weight, children, the elderly, debilitated
individuals and patients at risk of hypokalaemia or hyponatremia may need
particular attention. Prompt corrective action should be taken to restore
fluid/electrolyte balance in patients with signs or symptoms of hypokalaemia
or hyponatremia.
Drinking only water to replace the fluid losses may lead to electrolyte imbalance.
Care should also be taken in patients with recent gastro-intestinal surgery, renal
impairment, heart disease or inflammatory bowel disease.
Use with caution in patients on drugs that might affect water and/or electrolyte balance
e.g. diuretics, corticosteroids, lithium (see 4.5).
PICO SALAX may modify the absorption of regularly prescribed oral medication and
should be used with caution e.g. there have been isolated reports of seizures in patients
on antiepileptics, with previously controlled epilepsy (see 4.5 and 4.8).
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.
PICO SALAX should not be used as a routine laxative.
4.5 Interaction with other medicinal products and other forms of interaction
As a purgative, PICO SALAX increases the gastrointestinal transit rate. The
absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives,
anti-diabetics, antibiotics) may therefore be modified during the treatment period (see
4.4). Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and
penicillamine, should be taken at least 2 hours before and not less than 6 hours after
administration of PICO SALAX to avoid chelation with magnesium.
The efficacy of PICO SALAX is lowered by bulk-forming laxatives.
Care should be taken with patients already receiving drugs which may be associated
with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is
a particular risk i.e. cardiac glycosides). Caution is also advised when PICO SALAX is
used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic
antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and
carbamazepine as these drugs may increase the risk of water retention and/or electrolyte
imbalance.
4.6 Pregnancy and lactation

Pregnancy.
For PICO SALAX no clinical data on exposed pregnancy are available. Studies in
animals have shown reproductive toxicity (see section 5.3). As picosulfate is a stimulant
laxative, for safety measure, it is preferable to avoid the use of PICO SALAX during
pregnancy.
Fertility
There are no data on the effect of PICOSALAX on fertility in humans.
Male and female rat fertility was not affected by oral doses of sodium
picosulfate up to 100 mg/kg (see section 5.3).Breastfeeding.
There is no experience with the use of PICO SALAX in nursing mothers. However, due
to the pharmacokinetic properties of the active ingredients, treatment with PICO
SALAX may be considered for females who are breastfeeding.
4.7 Effects on ability to drive and use machines

Not applicable.
4.8 Undesirable effects

MedDRA Organ Common (≥1/100 to Uncommon Not known
Class ≤1/10) ((≥1/1000 to ≤1/100) (cannot be
estimated from
the available
data)
Immune system Anaphylactic reaction,
disorder hypersensitivity
Metabolism and Hyponatraemia and
nutrition disorders hypokalaemia
Nervous system Headache Epilepsy, grand mal
disorders convulsion,
convulsions,
confusional state
Gastrointestinal Nausea and Vomiting, abdominal Diarrhoea, faecal
disorders proctalgia pain, aphthoid ileal incontinence
ulcers*
Skin and Rash (including
subcutaneous tissue erythematous and
disorders maculo-papular rash,
rticarial, purpura)
*Isolated cases of mild reversible aphthoid ileal ulcers have been reported.
¤ The frequencies of the side effects are based on post-marketing experience.
Diarrhoea and faecal incontinence are the primary clinical effect of PICOSALAX. Isolated
cases of severe diarrhoea have been reported post-marketing.
Hyponatraemia has been reported with or without associated convulsions. In epileptic

patients, there have been isolated reports of seizure/grand mal convulsion without associated
hyponatraemia. There have been isolated reports of anaphylactoid reaction.
Reporting suspected adverse reactions after authorization of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the
National Regulation by using an online form
http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic
@moh.gov.il
4.9 Overdose
Overdosage would lead to profuse diarrhoea. Treatment is by general supportive
measures and correction of fluid and electrolyte balance.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Contact Laxatives
ATC code: A06A B58
The active components of PICO SALAX are sodium picosulfate and magnesium citrate.
S odium picosulfate is a locally acting stimulant cathartic, which after bacterial cleavage
in the colon forms the active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-
methane (BHPM), which has a dual-action with stimulation of the mucosa of both the
large intestine and of the rectum. Magnesium citrate acts as an osmotic laxative by
retaining moisture in the colon. The combined action of the two substances is of a
'washing out' effect combined with peristaltic stimulation to clear the bowel.
The product is not intended for use as a routine laxative.
5.2 Pharmacokinetic properties

Both active components are locally active in the colon, and neither are absorbed in any
detectable amounts.
5.3 Preclinical safety data

Prenatal developmental studies in rats and rabbits did not reveal any teratogenic
potential after oral dosing of sodium picosulfate, but embryotoxicity has been observed
in rats at 1000 and 10000 mg/kg/day and in rabbits at 1000 mg/kg/day. The
corresponding safety margins were 3000 to 30000 times the anticipated human dose. In
rats, daily doses of 10 mg/kg during late gestation (fetal development) and lactation
reduced body weights and survival of the offspring. Male and female rat fertility was
not affected by oral doses of sodium picosulfate up to 100 mg/kg.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients:
Pico Salax Orange:

Potassium hydrogen carbonate
Sodium saccharin
Natural spray dried orange flavour which contains acacia gum, lactose, ascorbic acid,
butylated hydroxyanisole.
Pico Salax Cranberry:

Potassium hydrogen carbonate
Sodium saccharin
Cranberry flavor S/D
6.2 Incompatibilities
Not applicable
6.3 Shelf life

The expiry date of the product is indicated on the packaging materials
Once the sachet has been opened, use immediately and discard any unused powder or
solution.
6.4 Special precautions for storage

Do not store above 25ºc. Store in the original package in order to protect from moisture.
6.5 Nature and contents of container

Sachet:
4 layers: paper-low density polyethylene-aluminium-thermofusible resin
Each pack contains a pair of sachets that can be separated by tearing apart the perforated strip.
In addition each pack contains measuring spoon. A full measuring spoon contains 4gr
powder.
Weight of sachet contents: 16.1g
6.6 Instructions for use, handling and disposal

None
7. MANUFACTURER
Ferring GmbH, Germany
8. LICENSE HOLDER
Ferring Pharmaceuticals Ltd
8, Hashita Street, Industrial Park Caesarea 3088900
ISRAEL
9. Marketing authorization number: Pico Salax Orange: 144-04-32928-

Pico Salax Cranberry: 157-91-35155-
The format of this leaflet was determined by the Ministry of Health and its content was
checked and approved on 04/2018

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1.

NAME OF THE MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium picosulfate 10.0mg

Each sachet also contains:

For full list of excipients, see section 6.1.

4.1 Therapeutic indications

4.4 Special warnings and special precautions for use

PICO SALAX should not be used as a routine laxative.

4.6 Pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

¤ The frequencies of the side effects are based on post-marketing experience.

Hyponatraemia has been reported with or without associated convulsions. In epileptic

Reporting suspected adverse reactions after authorization of the medicinal product is

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6.1 List of excipients:

Pico Salax Orange:

Pico Salax Cranberry:

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Instructions for use, handling and disposal

9. Marketing authorization number: Pico Salax Orange: 144-04-32928-

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