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MOLAXOLE POWDER FOR ORAL SOLUTION

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Molaxole powder for oral solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains following active substances
Macrogol 3350
13.125 g
Sodium chloride
350.7 mg
Potassium chloride
46.6 mg
Sodium hydrogen carbonate 178.5 mg
The content of electrolyte ions per sachet when made up to 125 ml of solution.
Sodium
65 mmol/l
Potassium
5.4 mmol/l
Chloride
53 mmol/l
Hydrogen carbonate
17 mmol/l
For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
Powder for oral solution
A white crystalline powder.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of chronic constipation. Resolving faecal impaction, defined as
refractory constipation with faecal loading of the rectum and/or colon confirmed by
physical examination of the abdomen and rectum.

4.2

Posology and method of administration
Posology
Chronic constipation:
Adults: 1-3 sachets daily in divided doses. Normal dose for most patients is 12 sachets per day. Depending on the individual response 3 sachets per day
might be needed.

A course of treatment for constipation does not normally exceed two weeks,
although this can be repeated if required.
For extended use, the lowest effective dose should be used.
Faecal impaction:
Adults: 8 sachets daily, all of which should be consumed within a 6 hour
period.
A course of treatment for faecal impaction does not normally exceed 3 days.
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.
Paediatric population:
Not recommended for children below 12 years old.
Method of administration
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 tracts, 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.

The cause of constipation should be investigated if daily use of laxatives is
necessary.
Patients using this preparation should seek medical advice if there is no
improvement after two weeks.
Long term use can be necessary in serious chronical or refractory
constipation due to i.e multiple sclerosis (MS) or Parkinsons disease, or
constipation induced by drugs, especially opioides or antimuscarine products.
If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g.
oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure)
Molaxole should be stopped immediately and electrolytes measured, and any
abnormality should be treated appropriately.
There is no clinical data on the use of Molaxole in children, therefore it is not
recommended.
The absorption of other medicinal products could transiently be reduced due
to an increase in gastro-intestinal transit rate induced by Molaxole (see
section 4.5).
Paediatric population
Not recommended for children below 12 years old.

4. 5

Interaction with other medicinal products and other forms of interaction
There is a possibility that the absorption of other medicinal products could be
transiently reduced during use with Molaxole (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 is no experience of the use of Molaxole during pregnancy and it should
only be used if considered essential by the physician.
Breast-feeding
There is no experience of the use of Molaxole during breast-feeding. The risk
of undesirable effects in nursing infants is considered to be negligible since the
systemic exposure of the breast-feeding woman of Macrogol 3350 is
negligible.
Fertility

There are no or limited amount of data on the effect of Molaxole on fertility.

4.7

Effects on ability to drive and use machines

Molaxole has no effect on the ability to drive and use machines.
4.8

Undesirable effects

The most common undesirable effects are gastrointestinal effects. 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 Molaxole. Mild
diarrhoea usually responds to dose reduction.
Adverse events are listed below by system organ class and frequency. Frequencies are
defined as: 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), not
known (cannot be estimated from the available data).
System Organ Class
Immune system disorders

Frequency
Common
Uncommon
Very rare

Metabolism and nutrition
disorders

Very rare

Nervous system disorders
Gastrointestinal disorders

Common
Very common

Uncommon

General disorders and
administration site
conditions

Very rare
Common

Adverse Event
Pruritus
Rash
Allergic reactions,
including anaphylaxis,
angioedema, dyspnoea,
erythema, urticaria and
rhinitis
Electrolyte disturbances,
particularly hyperkalaemia
and hypokalaemia.
Headache
Stomach ache and cramp,
diarrhoea, vomiting,
nausea, borborygmi,
flatulence
Dyspepsia, abdominal
distension
Anal discomfort
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: Drugs for constipation, 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 consequences are an
improved propulsive colonic transportation of the softened stools and a facilitation of
the defecation. 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 or 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, macrogol, sodium chloride, potassium chloride and sodium hydrogen
carbonate cleared the faecal impaction in 12/27 (44%) after 1 days´ treatment; 23/27
(85%) after 2 days´ treatment and 24/27 (89%) at the end of 3 days.
Clinical studies in the use of macrogol, sodium chloride, potassium chloride and
sodium hydrogen carbonate 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 is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract and has no known pharmacological activity. 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, although no tests of its effects on reproduction or genotoxicity have
been conducted.
There are no long term animal toxicity or carcinogenicity studies involving macrogol
3350, although there are toxicity studies using high levels of orally administered high
molecular weight macrogols that provide evidence of safety at the recommended
therapeutic dose.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Acesulfam potassium (E950), lemon flavour.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.
Store the reconstituted solution in refrigerator (2ºC-8ºC) and discard any
solution not used within 6 hours.

6.4

Special precautions for storage

This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5

Nature and content of container

Sachets of Paper/LDPE/Aluminium/LDPE alternatively

Sachets of Paper/PE/Aluminium/ Ethylene Methacrylic Acid Copolymer e.g. Surlyn
Package of: 2, 6, 8, 10, 20, 30, 40, 50, 60 and 100 sachets.
Not all pack sizes may be marketed.
6.6

Special precautions for disposal

No special requirements for disposal.

7. MARKETING AUTHORISATION HOLDER
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road

Takeley
Bishop’s Stortford
CM22 6PU

8

MARKETING AUTHORISATION NUMBER(S)
PL 15142/0108

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/04/2013

10

DATE OF REVISION OF THE TEXT
27/02/2015

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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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