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MACROLYTE 13.8G SACHET POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Macrolyte 13.8g sachet, powder for oral solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MACROLYTE contains the following active substances
Macrogol 3350 (Polyethylene Glycol) 3350
Sodium chloride

350.7 mg

Sodium bicarbonate

178.5 mg

Potassium chloride

46.6 mg

13.125 g

The content of electrolyte ions per sachet when made up to 125 ml of solution is as
follows:
Sodium

65 mmol/l

Chloride

53 mmol/l

Potassium

5.4 mmol/l

Bicarbonate

17 mmol/l

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Powder for oral solution. Free flowing white powder.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of chronic constipation. Macrolyte is also effective in resolving
faecal impaction, defined as refractory constipation with faecal loading of the rectum
and/or colon.

4.2

Posology and method of administration
Posology
Chronic constipation
A course of treatment for constipation with MACROLYTE does not normally exceed
2 weeks, although this can be repeated if required.
As for all laxatives, prolonged use is not usually recommended. Extended use may be
necessary in the care of patients with severe chronic or resistant constipation,
secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular
constipating medication in particular opioids and antimuscarinics.
Adults, adolescents and older people: 1 –3 sachets daily in divided doses, according
to individual response.
For extended use, the dose can be adjusted down to 1 or 2 sachets daily.
Children below 12 years old: Not recommended.

Faecal impaction
A course of treatment for faecal impaction with MACROLYTE does not normally
exceed 3 days.
Adults, adolescents and older people: 8 sachets daily, all of which should be
consumed within a 6 hour period.
Children below 12 years old: Not recommended.
Patients with impaired cardiovascular function: For the treatment of faecal
impaction the dose should be divided so that no more than 2 sachets are taken in any
one hour.
Patients with renal insufficiency: No dosage change is necessary for the treatment
of constipation or faecal impaction.

Method of administration
Each sachet should be dissolved in 125 ml water. For use in faecal impaction 8
sachets may be dissolved in 1 litre of water.

4.3

Contra-indications
Intestinal perforation or obstruction due to structural or functional disorder of the gut
wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s
disease and ulcerative colitis and toxic megacolon.
Hypersensitivity to the active substances or to any of the excipients listed in section
6.1.

4.4

Special warnings and precautions for use
The fluid content of MACROLYTE when re-constituted with water does not replace
regular fluid intake and adequate fluid intake must be maintained.
Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical
or radiological examination of the abdomen and rectum.
Mild adverse drug reactions are possible as indicated in Section 4.8. If patients
develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness
of breath, increasing fatigue, dehydration, cardiac failure) MACROLYTE should be
stopped immediately and electrolytes measured and any abnormality should be
treated appropriately.
The absorption of other medicinal products could transiently be reduced due to an
increase in gastro-intestinal transit rate induced by MACROLYTE (see section 4.5).

4.5

Interaction with other medicinal products and other forms of interaction
Macrogol raises the solubility of medicinal products that are soluble in alcohol and
relatively insoluble in water. There is a possibility that the absorption of other
medicinal products could be transiently reduced during use with MACROLYTE (see
section 4.4).There have been isolated reports of decreased efficacy with some
concomitantly administered medicinal products, e.g. anti-epileptics.

4.6

Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data from the use of MACROLYTE in pregnant women.
Studies in animals have shown indirect reproductive toxicity (see section 5.3).
Clinically, no effects during pregnancy are anticipated, since systemic exposure to
macrogol 3350 is negligible.
MACROLYTE can be used during pregnancy.
Breastfeeding
No effects on the breastfed newborn/infant are anticipated since the systemic
exposure of the breast-feeding woman to Macrogol 3350 is negligible.
MACROLYTE can be used during breast-feeding.
Fertility
There are no data on the effects of MACROLYTE on fertility in humans. There were
no effects on fertility in studies in male and female rats (see section 5.3).

4.7

Effects on ability to drive and use machines
There is no effect on the ability to drive and use machines.

4.8

Undesirable effects
Reactions related to the gastrointestinal tract occur the most commonly.
These reactions may occur as a consequence of expansion of the contents of the
gastrointestinal tract, and an increase in motility due to the pharmacologic effects of
MACROLYTE. Mild diarrhoea usually responds to dose reduction
The frequency of the adverse effects is not known as it cannot be estimated from the
available data.
System Organ Class

Adverse Event

Immune system
disorders

Allergic reactions, including
anaphylaxis, anaphylactic reactions,
dyspnoea and skin reactions (see below)

Skin and subcutaneous
tissue disorders

Allergic skin reactions including
angioedema, urticaria, pruritus, rash, erythema.

Metabolism and
nutrition disorders

Electrolyte disturbances, particularly
hyperkalaemia and hypokalaemia.

Nervous system
disorders

Headache.

Gastrointestinal
disorders

Abdominal pain, diarrhoea, vomiting,
nausea, dyspepsia, abdominal distension,
borborygmi, flatulence and anorectal
discomfort.

General disorders and
administration site
conditions

Peripheral oedema.

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 Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Severe abdominal pain or distension can be treated by nasogastric aspiration.
Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte
disturbances.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Phamacotherapeutic group: Osmotically acting laxatives
ATC code: A06A D65
Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a
laxative effect. Macrogol 3350 increases the stool volume, which triggers colon
motility via neuromuscular pathways. The physiological consequence is an improved
propulsive colonic transportation of the softened stools and a facilitation of the
defaecation. Electrolytes combined with Macrogol 3350 are exchanged across the
intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water
without net gain or loss of sodium, potassium and water.
For the indication of faecal impaction controlled comparative studies have not been
performed with other treatments (e.g. enemas). In a non-comparative study in 27
adult patients, Macrolyte cleared the faecal impaction in 12/27 (44%) after 1 day’s
treatment; 23/27 (85%) after 2 days’ treatment and 24/27 (89%) at the end of 3 days.
Clinical studies in the use of Macrolyte in chronic constipation have shown that the
dose needed to produce normal formed stools tends to reduce over time. Many
patients respond to between 1 and 2 sachets a day, but this dose should be adjusted
depending on individual response.

5.2

Pharmacokinetic properties
Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the
gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

5.3

Preclinical safety data
Preclinical studies provide evidence that macrogol 3350 has no significant systemic
toxicity potential, based on conventional studies of pharmacology, repeated dose
toxicity and genotoxicity.
There were no direct embryotoxic or teratogenic effects in rats even at maternally
toxic levels that are a multiple of 66 x the maximum recommended dose in humans
for chronic constipation and 25 x for faecal impaction. Indirect embryofetal effects,
including reduction in fetal and placental weights, reduced fetal viability, increased
limb and paw hyperflexion and abortions, were noted in the rabbit at a maternally
toxic dose that was 3.3 x the maximum recommended dose in humans for treatment
of chronic constipation and 1.3 x for faecal impaction. Rabbits are a sensitive animal

test species to the effects of GI-acting substances and the studies were conducted
under exaggerated conditions with high dose volumes administered, which are not
clinically relevant. The findings may have been a consequence of an indirect effect of
MACROLYTE related to poor maternal condition as the result of an exaggerated
pharmacodynamic response in the rabbit. There was no indication of a teratogenic
effect.
There are long-term animal toxicity and carcinogenicity studies involving macrogol
3350. Results from these and other toxicity studies using high levels of orally
administered high molecular weight macrogols provide evidence of safety at the
recommended therapeutic dose.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Acesulfame potassium (E950)
Lime and lemon flavour*
(*Lemon and lime flavour contains the following constituents: acacia solids,
maltodextrin, lime oil, citric acid and water.)

6.2

Incompatibilities
None are known.

6.3

Shelf life
3 years.
Reconstituted solution: 6 hours.

6.4

Special precautions for storage
Sachet: Do not store above 25°C.
Solution: Store at 2 - 8°C (in a refrigerator and covered).

6.5

Nature and contents of container
Sachets: laminate consisting of four layers: low density polyethylene, aluminium, low
density polyethylene and paper.
Pack sizes: boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.
Not all pack sizes may be marketed

6.6

Special precautions for disposal
Any unused solution should be discarded within 6 hours.

7

MARKETING AUTHORISATION HOLDER
Norgine BV
Hogehilweg 7
1101CA Amsterdam ZO
The Netherlands

8

MARKETING AUTHORISATION NUMBER(S)
PL 20142/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/05/2008

10

DATE OF REVISION OF THE TEXT
08/03/2016

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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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