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MACROGOL COMPOUND ORAL POWDER 13.8 G 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
Macrogol Compound Oral Powder 13.8 g sachet, powder for oral solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following quantitative composition of active ingredients:
Macrogol 3350

13.125 g

Sodium Chloride

0.3507 g

Sodium Hydrogen Carbonate

0.1785 g

Potassium Chloride

0.0466 g

The content of electrolyte ions per sachet following reconstitution in 125 ml of water
is equivalent to:
Sodium

65 mmol/l

Chloride

53 mmol/l

Hydrogen Carbonate (Bicarbonate)

17 mmol/l

Potassium

5 mmol/l

Excipient: Sorbitol (E420) (0.78 mg per sachet).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Powder for oral solution
Single-dose sachet containing a free flowing white powder.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of chronic constipation. Macrogol Compound Oral Powder 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
Macrogol Compound Oral Powder is for oral use.
Chronic constipation
A course of treatment for chronic constipation with Macrogol Compound Oral
Powder 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 the elderly: 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 Macrogol Compound Oral Powder
does not normally exceed 3 days.
Adults, adolescents and the elderly: 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 two sachets are taken in any one
hour.
Patients with renal insufficiency: No dosage change is necessary for treatment of
either 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

Contraindications
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
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) Macrogol Compound Oral
Powder should be stopped immediately and electrolytes measured, and any
abnormality should be treated appropriately.
The lemon lime flavor in Macrogol Compound Oral Powder contains sorbitol (E420).
Patients with rare hereditary problems of fructose intolerance should not take this
medicine.
The absorption of other medicinal products could transiently be reduced due to an
increase in gastro-intestinal transit rate induced by Macrogol Compound Oral Powder
(see section 4.5).

4.5

Interaction with other medicinal products and other forms of interaction
Macrogol 3350 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 Macrogol Compound Oral Powder (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 amounts of data from the use of Macrogol Compound Oral Powder
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.
Macrogol Compound Oral Powder can be used during pregnancy.
Breasfeeding
No effects on the breastfed newborn/infant are anticipated since the systemic
exposure of the breast-feeding woman to Macrogol 3350 is negligible.

Macrogol Compound Oral Powder can be used during breast-feeding.
Fertility
There are no data on the effects of Macrogol Compound Oral Powder 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
Macrogol Compound Oral Powder has no influence on the ability to drive and
use machines.

4.8

Undesirable effects
Reactions related to the gastrointestinal tract occur 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 Macrogol Compound Oral Powder. 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.
Immune System Disorders:
Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash,
urticaria and pruritus.
Skin and subcutaneous tissue disorders:
Erythema.
Metabolism and nutrition disorders:
Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.
Nervous system disorders:
Headache.
Gastro-intestinal Disorders:
Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal
distension, borborygmi, flatulence, 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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Severe 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
Pharmacotherapeutic 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, the listed combination of active substances 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 using the listed active substances in chronic constipation have shown
that the dose needed to produce normal formed stools tends to reduce over time.
Many patients respond to between one and two 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 gastrointestinal 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
macrogol 3350 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
Colloidal anhydrous silica
Saccharin sodium
Orange flavour
(Orange flavour contains: flavouring substances and flavouring preparations,
maltodextrin, acacia gum, alpha-tocopherol)
Lemon lime flavour
(Lemon lime flavour contains: flavouring preparations, maltodextrin, mannitol,
gluconolactone, sorbitol (E420), acacia gum, colloidal anhydrous silica)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.

Reconstituted solution: 24 hours

6.4

Special precautions for storage
Sachet: Do not store above 25 °C.
Reconstituted solution: Store covered in a refrigerator (2 °C to 8 °C).

6.5

Nature and contents of container
The sachet is composed of paper, ethylene / methacrylic acid co-polymer and
aluminium.
Sachets are packed in cartons of 2, 6, 8, 10, 20, 30, 50, 60 (2x30) and 100
(2x50).
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
After 24 hours, any unused solution should be discarded.

7

MARKETING AUTHORISATION HOLDER
Neopharma Limited
57 High Street
Odiham
Hampshire
RG29 1LF

8

MARKETING AUTHORISATION NUMBER(S)
PL 33579/0001

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/05/2014

10

DATE OF REVISION OF THE TEXT

18/12/2015

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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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