This information is intended for use by health professionals

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

1 to 2 sachets per day, preferably taken as a single dose in the morning. Each sachet should be dissolved in a glass of water just before use.

The effect of PEGLAX becomes apparent within 24 to 48 hours after its administration.

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.

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.

4.3 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.

4.4 Special warnings and precautions for use

Warnings

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.

Patients with hereditary problems of fructose intolerance should not take this medicinal product.

In case of diarrhoea, caution should be exercised in patients who are prone to a disturbance of water electrolyte balance (e.g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.

Precautions for use

Hypersensitivity reactions (rash, urticaria, and oedema) have been reported with drugs containing macrogol (polyethylene glycol) Exceptional cases of anaphylactic shock have been reported.

PEGLAX does not contain a significant quantity of sugar or polyol and can be prescribed to diabetic patients or patients on a galactose-free diet

4.5 Interaction with other medicinal products and other forms of interaction

Not applicable

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); unknown (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

Adverse reactions

Gastrointestinal disorders

Common

Abdominal pain and/ or distension

Diarrhoea

Nausea

Uncommon

Vomiting

Urgency to defecate

Fecal incontinence

Metabolism and Nutrition Disorders

Unknown

Electrolytes disorders (Hyponatremia, Hypokalaemia) and or dehydration, especially in elderly patients

Immune system disorders

Very rare

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

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

Gastrointestinal disorders

Common

Abdominal pain

Diarrhoea*

Uncommon

Vomiting

Bloating

Nausea

Immune system disorders

Unknown

Hypersensitivity reactions

* Diarrhoea may cause perianal soreness

4.9 Overdose

Overdose could lead to diarrhoea 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. Pharmacological properties
5.1 Pharmacodynamic properties

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.

The volume of unabsorbed intestinal fluid accounts for the laxative properties of the solution.

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, mutagenic, or carcinogenic effect.

Potential drug interaction studies performed in rats on some NSAIDs, anticoagulants, gastric antisecretory agents, or on a hypoglycaemic sulfamide showed that PEGLAX did not interfere with gastrointestinal absorption of these compounds.

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, 50 and 100 sachets

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

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

11/06/2013

10. Date of revision of the text

01/09/2015