Polyethylene Glycol 4000 oral laxative liquid
Each 25 ml contains
Polyethylene Glycol 4000 IP……………………10 mg
Excipients……………………………………….q.s.
Oral liquid 25 ml/10 mg
Symptomatic treatment of constipation in adults and children.
Adults
The recommended dose is 25 to 50 mL (10 mg to 20 mg) per day, preferably taken as a single dose in the morning. It is recommended to drink an adequate amount of liquids (e.g., water) after each dose.
The effect of Pegzor usually becomes apparent within 24 to 48 hours after administration. The daily dose should be adjusted according to the clinical response. Treatment should be discontinued gradually and may be resumed if constipation recurs.
Paediatric population
In constipation: For children aged 6 months to 15 years, the recommended dose is 0.5 g per kg body weight per day.
In faecal disimpaction: The recommended dose is 1.5 g per kg body weight per day for 6 days or until resolution of faecal impaction.
The dose should preferably be taken as a single dose in the morning. It is recommended to drink an adequate amount of liquids (e.g., water) after each dose.
In children, treatment duration should not exceed 3 months due to limited clinical data for longer use. Restoration of bowel movements achieved with treatment should be maintained through appropriate lifestyle and dietary measures.
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.
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 polyethylene glycol.
Exceptional cases of anaphylactic shock have been reported.
According to the way of action of Polyethylene Glycol, it is recommended to intake liquids during the treatment with this medicine.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by Polyethylene Glycol.
There is a possibility that the absorption of other medicinal products could be transiently reduced during use with Polyethylene Glycol 4000. 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. There are limited amount of data (less than 300 pregnancy outcomes) for the use of Polyethylene Glycol 4000 in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to Polyethylene Glycol 4000 is negligible. Polyethylene Glycol 4000 can be used during pregnancy.
Lactation
There are no data on the excretion of Polyethylene Glycol 4000 in breast milk. No effects on the breast fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Polyethylene Glycol 4000 is negligible. Polyethylene Glycol 4000 can be used during breast feeding.
Fertility
No fertility studies were conducted with Polyethylene Glycol 4000 however since Polyethylene Glycol 4000 is not significantly absorbed no effects are anticipated.
Polyethylene Glycol 4000 has no influence on ability to drive and use machines.
Adults
| System Organ Class | Frequency | Adverse Reactions |
|---|---|---|
| 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 |
Pediatric population
| System Organ Class | Frequency | Adverse Reactions |
|---|---|---|
| Immune system disorders | Not known | Hypersensitivity reactions (Anaphylactic shock, Angioedema, Urticaria, Rash, Pruritus) |
| Gastrointestinal disorders | Common | Abdominal pain; Diarrhoea |
| Uncommon | Vomiting; Bloating; Nausea |
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorization 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 email to: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
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 Polyethylene Glycol (polyethylene glycol) and electrolytes were administered with nasogastric tube. Neurologically impaired children who have oromotor dysfunction are particularly at risk of aspiration.
High molecular weight (4000) Polyethylene Glycol 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. The volume of unabsorbed intestinal fluid accounts for the laxative properties of the solution.
The pharmacokinetic data confirm that Polyethylene Glycol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.
Toxicological studies conducted in different animal species did not reveal any sign of systemic or local gastrointestinal toxicity. Polyethylene Glycol 4000 had no teratogenic or mutagenic effect. No carcinogenicity studies have been performed. Polyethylene Glycol 4000 was not teratogenic in rats or rabbits.
PEGZOR contains the active substance Polyethylene Glycol 4000 and belongs to a group of medicines called osmotic laxatives. Polyethylene Glycol carries water to your stool, which loosens and increases stool volume, helping to overcome sluggish bowels.
Not applicable
As per carton
As per carton
Store protected from moisture, at a temperature not exceeding 25°C.