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PEGLAX 10 G POWDER FOR ORAL SOLUTION IN SACHET

Active substance(s): MACROGOL 4000 / MACROGOL 4000 / MACROGOL 4000

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
PEGLAX 10 g powder for oral solution in sachet

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 10 g of macrogol 4000.
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Powder for oral solution in sachet.
Almost white powder

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Symptomatic treatment of constipation in adults and children aged 8 years and above.
An organic disorder should have been ruled out before initiation of treatment
PEGLAX 10 g should remain a temporary adjuvant treatment to appropriate lifestyle
and dietary management of constipation, with a maximum 3-months treatment course
in children. If symptoms persist despite associated dietary measures, an underlying
cause should be suspected and treated

4.2

Posology and method of administration

Oral use
Posology
1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to
drink 125 ml of liquids (e.g. water) after each dose.
The effect of Peglax becomes apparent within 24 to 48 hours after its administration.

The daily dose should be adapted according to the clinical effects and may range from one
sachet every other day (especially in children) up to 2 sachets a day.
Treatment should be stopped gradually and resumed if constipation recurs.
Paedriatic population
1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to
drink 125 ml of liquids (e.g. water) after each dose.
In children, treatment should not exceed 3 months due to a lack of clinical data for treatment
lasting longer than 3 months. Treatment-induced restoration of bowel movements will be
maintained by lifestyle and dietary measures.
Method of administration
Each sachet should be dissolved in a glass of water (125 ml approximately) just before use.
The resultant solution will be clear and transparent like water.

4.3

4.4

Contraindications
-

Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease)
or toxic megacolon, associated with symptomatic stenosis,

-

Digestive perforation or risk of digestive perforation,

-

Ileus or suspicion of intestinal obstruction,

-

Painful abdominal syndromes of indeterminate cause,

-

Hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients.

Special warnings and precautions for use

The treatment of constipation with any medicinal product is only an adjuvant to a healthy
lifestyle and diet, for example:
- Increased intake of liquids and dietary fibre,
- Appropriate physical activity and rehabilitation of the bowel reflex.
Due to the presence of sulphur dioxide, Peglax may rarely cause severe hypersensitivity
reactions and bronchospasm.
In case of diarrhoea, caution should be exercised in patients who are prone to a disturbance of
water and/or electrolyte balance (e.g. the elderly, patients with impaired hepatic or renal
function or patients taking diuretics) and electrolyte control should be considered.
Hypersensitivity reactions (rash, urticaria, and oedema) have been reported with drugs
containing macrogol (polyethylene glycol) Exceptional cases of anaphylactic shock have been
reported.
Peglax contains a non-significant amount of sugar or polyol and thus may be prescribed to
diabetic patients or patients on a galactose-free diet.

According to the way of action of macrogol, it is recommended to intake liquids during the
treatment with this medicine (please see section 5.1).
The absorption of other medicinal products could transiently be reduced due to an increase in
gastro-intestinal transit rate induced by macrogol (see section 4.5).
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 Peglax. The therapeutic effect of medicinal products with a narrow
therapeutic index may be particularly affected (e.g antiepileptics, digoxin and
immunosuppressive agents).

4.6

Fertility, Pregnancy and lactation
Pregnancy
Macrogol 4000 was not teratogenic in rats or rabbits.
No effects during pregnancy are anticipated, since systemic exposure to PEGLAX is
negligible. PEGLAX can be used during pregnancy.
Breastfeeding
No effects on the breast feeding newborn/infant are anticipated since the systemic
exposure of the breast-feeding woman to macrogol 4000 is negligible; PEGLAX can
be used during breast feeding.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects

Undesirable effects are listed under headings of frequency using the following categories:
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).
Adult population:
The undesirable effects listed in the table below have been reported during clinical trials
(including 600 adult patients) and post-marketing use. Generally, adverse reactions have been
minor and transitory and have mainly concerned the gastrointestinal system:

System Organ Class
Immune system disorders
Very rare

Adverse reactions
Hypersensitivity reactions (Pruritus, Rash,
Face oedema, Quincke oedema, Urticaria,
Anaphylactic shock)

Not known
Metabolism and Nutrition Disorders
Not known

Gastrointestinal disorders
Common

Uncommon

Erythema
Electrolytes
disorders
(Hyponatremia,
Hypokalaemia)
and or dehydration, especially in elderly
patients
Abdominal pain and/ or distension
Diarrhoea
Nausea
Vomiting
Urgency to defecate
Fecal incontinence

Paediatric population:
The undesirable effects listed in the table below have been reported during clinical trials
including 147 children aged from 6 months to 15 years and post-marketing use. As in adult
population, adverse reactions have generally been minor and transitory and have mainly
concerned the gastrointestinal system:
System Organ Class

Adverse reactions

Immune system disorders
Not known

Hypersensitivity reactions (Anaphylactic shock, Angioedema,
Urticaria, Rash, Pruritus)

Gastrointestinal disorders
Common

Uncommon

Abdominal pain
Diarrhoea*
Vomiting
Bloating
Nausea
* Diarrhoea may cause perianal soreness

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 national
reporting system listed in www.mhra.gov.uk/yellowcard.
4.9

Overdose

Overdose could lead to diarrhoea, abdominal pain and vomiting which disappears when
treatment is temporarily interrupted or the dosage is reduced.
Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte
disturbances
Cases of aspiration have been reported when extensive volumes of macrogol (polyethylene
glycol) and electrolytes were administered with nasogastric tube. Neurologically impaired
children who have oromotor dysfunction are particularly at risk of aspiration.

5.

5.1

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for constipation. Osmotically acting laxatives, ATC code:
A06AD15
High molecular weight (4000) macrogols are long linear polymers which retain water
molecules by means of hydrogen bonds. When administered by the oral route, they lead to an
increase in volume of intestinal fluids. This is why an adequate hydration is important during
the treatment.

5.2

Pharmacokinetic properties
The pharmacokinetic data confirm that macrogol 4000 undergoes neither
gastrointestinal resorption nor biotransformation following oral ingestion.

5.3

Preclinical safety data

Toxicological studies conducted in different animal species did not reveal any sign of
systemic or local gastrointestinal toxicity. Macrogol 4000 had no teratogenic or
mutagenic effect.
No carcinogenicity studies have been performed.
Macrogol 4000 was not teratogenic in rats or rabbits.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Saccharin sodium (E954), apple flavour*
*Composition of the apple flavour:
Natural flavour, maltodextrine, gum arabic E414, sulfurous anhydride E220, alpha
tocopherol E307

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years

6.4

Special precautions for storage
This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container

Sachet (complex with an external polyester layer, intermediate of aluminium and an
internal of polyethylene)
Single dose sachets presented in pack sizes of 10, 20, 30, 50 and 100 sachets
Not all pack sizes may be marketed
6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Casen Recordati, S.L.
Autovía de Logroño, Km. 13,300
50180 UTEBO. Zaragoza (Spain)

8

MARKETING AUTHORISATION NUMBER(S)
PL 43885/0006

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/01/2016

10

DATE OF REVISION OF THE TEXT
17/01/2016

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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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