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COLOCLEAR 1500 MG TABLETS

Active substance(s): SODIUM PHOSPHATE DIBASIC / SODIUM PHOSPHATE MONOBASIC MONOHYDRATE / SODIUM PHOSPHATE DIBASIC ANHYDROUS / SODIUM PHOSPHATE MONOBASIC / SODIUM PHOSPHATE DIBASIC ANHYDROUS / SODIUM PHOSPHATE MONOBASIC

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Coloclear 1500 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1102 mg of sodium phosphate monobasic monohydrate and 398
mg of disodium phosphate anhydrous.
For excipients, see 6.1.

3

PHARMACEUTICAL FORM

Tablet
White to off-white oval compressed 18.7 mm x 10 mm tablets. The upper half bisected with a
monogram “SLX” on the left and “102” on the right, and the lower half plain. The score line
is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

This medicine is indicated for cleansing of the bowel when required as a preparation for
certain diagnostic procedures such as colonoscopy.
Coloclear is indicated in adults over 18 years of age.

4.2

Posology and method of administration

Posology
Adults (over 18 years of age):
The usual adult dosage of this medicine is 32 tablets. The total dose of phosphate is 32.79 g.
The intake of this medicine should begin the day before the colonoscopy. The day before the
colonoscopy, patients may have a light, low-fibre breakfast (coffee or tea with or without
sugar, toast, butter or equivalent, fruit jelly or honey). After noon, taking only “clear liquids”
is permitted. “Clear liquid” may be water, light soup, diluted fruit juice without pulp, weak
tea or black coffee, light soda with or without bicarbonate.

Recommended administration regimen:
The evening before the colonoscopy procedure:

Take 4 tablets with 250 ml of water (or another clear liquid)


Then repeat 4 times in the same conditions, every 15 minutes, for a total of 20 tablets
to swallow.

The day of the colonoscopy procedure, (starting 3-5 hours before the procedure):

Take 4 tablets with 250 ml of water (or another clear liquid)


Then repeat 2 times in the same conditions, every 15 minutes for a total of 12 tablets
to swallow.

Alternative administration regimen in case of morning colonoscopy:
For early morning colonoscopy, it is possible to adapt the dosing schedule by taking all the
tablets in the evening before the procedure, and with an interval of at least 4 hours between
the beginning of the intake of the first 20 tablets (to be absorbed at the rate of 4 tablets with
250 ml of water or another clear liquid every 15 minutes) and the intake of the last 12 tablets
(to be absorbed at the rate of 4 tablets with 250 ml of water or another clear liquid every 15
minutes).
Patients should be advised of the importance of following the recommended fluid regimen
and of drinking as much liquid as possible to replace lost fluids by increased intestinal
peristalsis.
Drinking large amounts of clear liquid also helps ensure the cleanliness of the colon during
colonoscopy. See Section 4.4 Special warnings and precautions for use.
Patients should not repeat this dosage for at least seven days. No additional laxatives are
necessary when taking this medicine, particularly those agents containing sodium phosphate.
Elderly:
In the elderly, the dosage is identical to that of adults. It may be useful to assess renal function
before use in the elderly. This product is contraindicated in patients over 75 years of age (See
section 4.3).
Paediatric population
Do not administer to children and adolescents under 18 years of age.
Method of administration

Adults (over 18 years of age):
This medicine should be administered orally in the following manner according to the
recommended administration regimen or to the alternative administration regimen in case of
morning colonoscopy as described above.
Each intake of 4 tablets must be done with 250 ml of water or another clear liquid.
No solid food should be taken from the start of the course of treatment until after the clinical
procedure.

4.3

Contraindications















4.4

Hypersensitivity to the active substances or to any of the excipients listed in
section 6.1
Children under 18 years
Patients over 75 years of age
Use with other laxatives containing sodium phosphate.
Clinically significant renal insufficiency and/or biopsy-proven acute phosphate
nephropathy
Primary hyperparathyroidism associated with hypercalcemia
Congestive heart failure and/or uncontrolled heart failure
Unstable angina pectoris
Ascites
Ileus or acute bowel obstruction or pseudo-obstruction, severe chronic
constipation
Hypomotility syndrome (such as hypothyroidism, scleroderma)
Megacolon (congenital or acquired) or patients who have undergone gastric
bypass surgery
Bowel perforation
Active inflammatory bowel disease (IBD).
Special warnings and precautions for use

In rare cases, this medicine was associated with severe and potentially fatal electrolyte
disorders, in elderly patients. The benefit / risk ratio of this medicine must be carefully
assessed before use in this population at risk.
Before initiating the treatment, it is necessary to ensure the absence of known
contraindications and to stress on the importance of appropriate hydration. For at risk
populations, it is important to check serum electrolyte concentrations before and after
treatment (see below and section 4.2 and 4.3).
This medicine should be used with caution in patients with:
a history of renal insufficiency, history of acute phosphate nephropathy, known or
suspected electrolyte disorders, arrhythmias, cardiomyopathy, in patients within three
months of an acute myocardial infarction or cardiac surgery, including coronary
artery bypass graft surgery, patients using diuretics, angiotensin converting enzyme
(ACE) inhibitors, angiotensin receptor blockers (ARBs) or NSAIDs.
risk factors for electrolyte disorders (e.g., dehydration, gastric retention, inability to
drink sufficient quantities of liquids, hypertension or other diseases treated by
medicines that can induce dehydration, see below), hypotension with clinical
consequences or associated with hypovolemia, or in the elderly or weakened patients.

In these patients at risk, serum electrolyte including sodium, potassium, calcium,
chloride, bicarbonate, phosphate, urea and creatinine assessment should be performed
before and after treatment.
risk factors for hyponatremia, e.g. SIADH, inadequately treated hypothyroidism,
adrenal insufficiency or with risk factors for development of tonic-clonic seizures,
e.g. a history of seizures, use of drugs that lower the seizure threshold such as
tricyclic antidepressants or withdrawal from alcohol or benzodiazepines.
intestinal hypomotility, history of gastrointestinal surgery or who have other diseases
predisposing to intestinal hypomotility. In patient with colostomy or ileostomy or
being on a low salt diet, the medicine must be used with caution because dehydration,
electrolytes or acid-base imbalance may occur.
in diabetic patients as the recommended liquid diet during the period of
administration prior to the procedure may affect blood glucose levels, requiring
adjustment of antidiabetic medication or insulin.
Electrolyte disorders
Serum sodium and phosphate may increase and serum calcium and potassium may decrease,
therefore, hypernatraemia, hyperphosphataemia, hypocalcaemia, hypokalaemia and acidosis
may occur.
Patients should be advised to drink sufficient quantities of clear liquids or water when taking
this medicine. Inadequate fluid intake, as with any effective purgative, may lead to
dehydration and hypovolemia, which may be exacerbated by vomiting, loss of appetite or the
use of diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor
blockers (ARBs) and nonsteroidal anti-inflammatory drugs (NSAIDs).
However it is recommended not to drink too much liquid in order to avoid overhydration
(water intoxication). If a patient experiences one or more of any of the following symptoms,
they must be advised not drink any further liquid and contact a doctor immediately. Signs
and/symptoms which might indicate water intoxication in particular are nausea and vomiting,
headache, blurred vision, twitching, slowed breathing, change in personality or bizarre
behaviour, (hallucinations, and confusion or disorientation). If left untreated, overhydration
can lead to dangerously low levels of sodium in the blood (hyponatremia). This can cause
more severe symptoms, such as, muscle weakness, spasms or cramps, seizures and
unconsciousness.
Renal disease and acute phosphate nephropathy
There have been very rare, but serious reports of acute phosphate nephropathy associated with
transient renal failure in patients who received oral sodium phosphate products for colon
cleansing prior to colonoscopy. The time of onset is typically within days; however, in some
cases, the diagnosis of these events has been delayed up to several months after ingestion of
these products. The majority of cases occurred in elderly women taking anti-hypertensive
agents and other drugs such as diuretics or NSAIDs which can cause dehydration. Patient
hydration should first be assessed by identifying those who are predisposed to dehydration or
those taking drugs that may decrease the glomerular filtration rate, such as angiotensin
converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), before using
laxative preparations. Patients should be monitored appropriately. When prescribing this
medicine, special attention must be paid to the contraindications and adequate hydration of
the patient.
Prolonged QT and cardiac arrhytmia
A mild prolongation of the QT interval may rarely occur because of electrolyte imbalance
such as hypocalcaemia or hypokalaemia. This medicine should be used with caution in

patients who are taking medications known to prolong the QT interval. Electrolyte
abnormalities such as hypernatraemia, hyperphosphataemia, hypokalaemia or hypocalcaemia
should be corrected before treatment with this medicine.
Seizures
There have been rare reports of generalised tonic-clonic seizures and/or loss of consciousness
associated with use of sodium phosphate products in patients with no prior history of seizures.
The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia,
hypokaliemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The
neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Colon aphtous ulcerations
Single or multiple aphthous ulcerations, located in the sigmoid or rectum were observed by
endoscopy. They consist in either lymphoid follicle or discrete inflammatory infiltrates or
epithelial abnormalities observed following the use of the bowel preparation. These anomalies
have no clinical relevance and disappear spontaneously. These findings should be considered
in patients with known or suspected inflammatory bowel disease.
This medicine contains 313 mg of sodium per tablet. This should be taken into consideration
by patients on a controlled sodium diet.
Patients should be advised that they will have frequent and watery stools. This medicine
usually acts ½ hour to 6 hours after dosing. Undigested or partially digested medicine may be
seen in the watery stool or during colonoscopy. Undigested tablets of other medications may
also be seen. When there is no bowel movement increase within 6 hours after taking this
medicine, the patient should be aware of the necessity to discontinue the drug and contact a
doctor immediately because there is a risk of dehydration.
This medicine should not be used as a treatment for constipation.

4.5

Interaction with other medicinal products and other forms of interaction
No drug interaction studies have been conducted for this medicine.
As with other purgatives the absorption of other orally administered medicines (e.g.
oral contraceptives, antibiotics, antidiabetics, antiepileptic drugs) may be delayed or
completely prevented.
Phosphate absorption is reduced by concomitant aluminium, calcium or magnesium
salts. Phosphate absorption is increased by concomitant administration of vitamin D.
Care should be taken with patients taking calcium channel blockers, diuretics,
angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers
(ARBs), drugs known to prolong the QT interval, NSAIDs, drugs containing
parathyroid hormone, lithium treatment or other medications that might affect
electrolyte levels as hyperphosphataemia, hypocalcaemia, hypokalaemia,
hypernatraemic dehydration or acidosis may occur.
This medicine must not be used with other laxatives containing sodium phosphate.

4.6

Fertility, pregnancy and lactation

No clinical data on exposed pregnancies are available or even data from animal
studies on the embryonic / fetal development, childbirth and postnatal development.
The potential risk for humans is unknown. This medicine should not be used during
pregnancy unless clearly necessary.
Not knowing if this medicine is excreted in breast milk and also if the sodium
phosphate may pass into breast milk, it is advisable to draw the milk and not to use as
soon after the first intake of this medicine up to 24 hours after taking the second dose.
Therefore, women should not breastfeed their babies within 24 hours after taking the
second dose of this medicine.

4.7

Effects on ability to drive and use machines
This medicine may cause dizziness, probably due to dehydration, and this may have a
minor or moderate influence on the ability to drive and use machines.

4.8

Undesirable effects

The side effects listed below have been reported at frequencies corresponding to: very
common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare
(≥ 1/10,000 to <1/1,000), very rare (<1/10,000). Within each frequency grouping,
undesirable effects are presented in order of decreasing seriousness.
Cardiac disturbances
Very rare: myocardial infarction, arrhythmias
Rare: mild prolonged QT interval
Gastrointestinal disorders
Very common: abdominal bloating, abdominal pain and nausea
Common: vomiting, abnormalities in colonoscopy (single or multiple aphthous like
ulcerations located in the sigmoid and rectum without clinical relevance and
disappearing spontaneously without treatment), abnormalities in gastroscopy
(erythematous gastritis like lesions and/or superficial gastric ulcerations with
necrotizing base, most often asymptomatic and spontaneously regressive).
General disorders and administration site conditions
Very common: chills, asthenia
Common: chest pain
Immune system disorders
Rare: hypersensitivity reactions such as rash, pruritus, urticaria, throat tightness,
bronchospasm, dyspnea, pharyngeal oedema, dysphagia, paresthesia and swelling of
the lips and tongue and facial swelling, anaphylaxis
Very rare: allergic dermatitis
Metabolism and nutrition disorders
Uncommon: dehydration
Rare: hypomagnesaemia
Very rare: dysnatraemia, hypocalcaemia, hypokalaemia, hyperphosphataemia,
metabolic acidosis, tetany

Musculoskeletal and connective tissue disorders
Very rare: muscle cramps
Nervous system disorders
Common: headache and dizziness;
Very rare: generalised tonic-clonic seizures and/or loss of consciousness, paresthesia
Renal and urinary disorders
Very rare: Increased blood urea nitrogen (BUN), increased creatinine, acute renal
failure, chronic renal failure, nephrocalcinosis, acute phosphate nephropathy and renal
tubular necrosis.

Vascular disorders
Very rare: hypotension

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the MHRA Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

4.9

Overdose

In case of overdose, patients may experience the following symptoms: dehydration,
hypovolaemia, hypotension, cardiac arrhythmias, tachypnea, cardiac arrest, shock,
respiratory failure, dyspnea, convulsions, paralytic ileus, anxiety, pain. Overdoses can
lead to high sodium and phosphate serum concentrations and to a decrease in calcium
and potassium concentrations. In such cases, hypernatraemia, hyperphosphataemia,
hypocalcaemia, hypokalaemia and acidosis may occur.
When taking excessive doses of this medicine, fatal cases of hyperphosphataemia
with concomitant hypocalcaemia, hypernatraemia and acidosis have been reported in
children or patients with bowel obstruction.
Cases of complete recovery after overdose have also been documented both in
children after accidental ingestion of this medicine and in patients with bowel
obstruction, one having taken six times the recommended dose.
Treatment of overdose usually consists in rehydration; the administration of
intravenous 10% calcium gluconate may be needed.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: OSMOTICALLY ACTING LAXATIVE
ATC code: A06AD
This medicine is a saline laxative that acts by an osmotic process by increasing fluid
retention in the lumen of the small intestine. The fluid accumulation in ileum
produces distention and thus facilitates peristalsis and bowel evacuation.

5.2

Pharmacokinetic properties
Approximately 60-65% of ingested dietary phosphate is absorbed from the gastrointestinal tract via an active energy-dependent process.
Phosphate distributes into plasma and extracellular fluid, cell membranes and
intracellular fluids. More than 90% of plasma phosphate is filtered and 80% of the
filtered phosphate is actively reabsorbed in the steady state. The ionised, inorganic
form of phosphate in the circulating plasma is excreted almost entirely by the
kidneys. This medicine is not expected to be metabolised in the liver.
Clinical studies with a higher dose of a previous formulation of this medicine have
demonstrated that maximum peak plasma concentrations of serum inorganic
phosphorous are achieved at approximately three hours after the administration of the
first 30 g dose of this medicine, where serum inorganic phosphorous levels are
increased by a mean of 1.21 ± 0.53 mmol/L. Following a second 30 g dose of this
medicine a maximum peak plasma concentration of serum inorganic phosphorous is
obtained at approximately four hours and the serum inorganic phosphorous levels are
increased by a mean of 1.42 ± 0.60 mmol/L. The dosing instructions for this
medicine recommend a first dose of 30 g and a second dose of 18 g.

5.3

Preclinical safety data

Limited non-clinical data reveal no special hazard for humans.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol 8000
Magnesium Stearate

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months.

6.4

Special precautions for storage

Keep the bottle tightly closed in order to protect from moisture.

6.5

Nature and contents of container

High-density polyethylene (HDPE) bottles with child-resistant polyolefin screw cap
containing a multilayer sealing pad SP/Alu/PE, containing 2 silica gel desiccants.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Laboratoires MAYOLY SPINDLER
6 avenue de l’Europe – BP 51
78401 CHATOU CEDEX
FRANCE

8

MARKETING AUTHORISATION NUMBER(S)
PL 19549/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/04/2015

10

DATE OF REVISION OF THE TEXT
06/07/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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