Normalax

/ Taro

Oral use. Adults and Children over 8 years: 17g dissolved in about 230ml (1 cup) of any chosen beverage, once daily, preferably taken as a single dose in the morning. The effect of Normalax  ecomes apparent within 24-48 hours after its administration. Children: 6 months- 1 year: 4 grams per day. 1 year- 4 years 4-8 grams per day. 4 years -8 years 8-16 grams per day. Each 4 gram dose should be dissolved in approximately 50 ml of any chosen beverage (including baby formula) just before use. When more than 4 grams are required the dose can be divided and taken twice daily– morning and evening. Treatment-induced restoration of bowel movements will be maintained by lifestyle and dietary measures. The daily dose for children should be adapted according to the clinical response and may range from 4 grams to 16 grams a day. The effect of Normalax becomes apparent within 24-48 hours after its administration.

For the treatment of constipation.

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).

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 fiber. Appropriate physical activity and rehabilitation of the bowel reflex. In case of diarrhea, 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. Normalax does not contain sugar or polyol and can be prescribed to diabetic patients or patients on a galactose-free diet.

Abdominal pain and/ or distension, diarrhoea nausea.

Not applicable.

Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to this drug is negligible and it can be used during pregnancy.
Lactation: No effects on the breast feeding newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to polyethylene glycol 3350 is negligible; polyethylene glycol 3350 can be used during breast feeding.

Overdose could lead to diarrhea which disappears when treatment is temporarily interrupted or the dosage is reduced. Excessive fluid loss by diarrhea 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.

Storage: Store below 25°C.