PEGLAX Powder for oral solution Ref.[7756] Active ingredients: Macrogol

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.

This medicine contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially “sodium-free”.

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)

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).

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

There are limited amount of data (less than 300 pregnancy outcomes) for the use of Peglax in pregnant women.

No effects during pregnancy are anticipated, since systemic exposure to Peglax is negligible. Peglax can be used during pregnancy.

Lactation

There are no data on the excretion of Peglax in breast milk. No effects on the breast fed 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.

Fertility

No fertility studies were conducted with Peglax however since macrogol 4000 is not significantly absorbed no effects are anticipated.

Peglax has no influence on ability to drive and use machines.

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:

Immune system disorders

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

Not known: Erythema

Metabolism and Nutrition Disorders

Not known: Electrolytes disorders (Hyponatremia, Hypokalaemia) and or dehydration, especially in elderly patients

Gastrointestinal disorders

Common: Abdominal pain and/or distension, Diarrhoea, Nausea

Uncommon: 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:

Immune system disorders

Not known: Hypersensitivity reactions (Anaphylactic shock, Angioedema, Urticaria, Rash, Pruritus)

Gastrointestinal disorders

Common: Abdominal pain, Diarrhoea*

Uncommon: 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.

Not applicable.