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STRIGOL 13.72G 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
STRIGOL 13.72 g powder for oral solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of STRIGOL 13.72 g powder for oral solution contains the
following active ingredients:
Macrogol 3350
Sodium chloride
Sodium bicarbonate
Potassium chloride

13.125 g
350.7 mg
178.5 mg
46.6 mg

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
Excipient(s) with known effect
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 in adults and children above 12
years. STRIGOL is also effective in resolving faecal impaction, defined as

refractory constipation with faecal loading of the rectum and/or colon in adults
and children above 12 years.

4.2

Posology and method of administration
Posology
Chronic constipation
A course of treatment for constipation with STRIGOL 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.
Paediatric population
Children (below 12 years old): Not recommended. Alternative STRIGOL
Paediatric powder for oral solution 6.86 g product is available for children.
Faecal impaction
A course of treatment for faecal impaction with Macrogol 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.
Paediatric population
Children (below 12 years old): Not recommended. Alternative STRIGOL
Paediatric powder for oral solution 6.86 g product is available for children.
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 substance(s) or to any of the excipients listed in
section 6.1.

4.4

Special warnings and precautions for use
The fluid content of STRIGOL 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) STRIGOL
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 STRIGOL (see section
4.5).
STRIGOL contains 0.6213 mmol (24.230) of potassium per sachet. This
should be taken into consideration if the patient takes more than one sachet
daily and has reduced kidney function or is on a controlled potassium diet.
Paediatric population
There is no clinical data on the use of STRIGOL 13.72 g, powder for oral
solution in children, therefore it should not be used in children below 12 years
of age.

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 STRIGOL (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 STRIGOL 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.
STRIGOL 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.
STRIGOL can be used during breast-feeding.
Fertility
There are no data on the effects of STRIGOL 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
STRIGOL has no or negligible 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 STRIGOL. 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 Order Class
Adverse Event
Immune system disorders

Metabolism and nutrition
disorders
Nervous system disorders
Gastrointestinal
disorders

General disorders and
administration site
conditions

Allergic reactions, including
anaphylaxis, angioedema, dyspnoea,
rash, erythema, urticaria, and pruritus.
Electrolyte disturbances, particularly
hyperkalaemia and hypokalaemia.
Headache
Abdominal pain, diarrhoea, vomiting,
nausea, dyspepsia, abdominal
distension, borborygmi, flatulence, 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 Website:
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

Mechanism of action
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
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 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, STRIGOL 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 efficacy and safety
Clinical studies in the use of STRIGOL 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
STRIGOL 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
Lemon Flavour

6.2

Incompatibilities
None are known.

6.3

Shelf life
4 years
Reconstituted solution: 24 hours

6.4

Special precautions for storage
Reconstituted solution: Store in a refrigerator (2°C - 8°C) and covered

6.5

Nature and contents of container
Sachet: Laminate consisting of four layers: low density polyethylene (LDPE),
Aluminium, LDPE and paper. Pack sizes: Boxes of 6, 8, 10, 20, 30, 40, 50, 60
or 100 sachets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Throw away any solution not used within a 24 hour period.

7

MARKETING AUTHORISATION HOLDER
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS,
United Kingdom.

8

MARKETING AUTHORISATION NUMBER(S)
PL 28176/0176

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/09/2016

10

DATE OF REVISION OF THE TEXT
22/09/2016

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Further information

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