Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
LACTULOSE
Olinka (UK) Limited
3350 MG/5ml
Oral Solution
1991-10-11
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lactolax 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of solution contains 3.35 g of lactulose. 3 PHARMACEUTICAL FORM Oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. In the treatment of hepatic encephalopathy. 2. In the treatment of constipation. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION _Hepatic encephalopathy_ Adults including the elderly: Initially 30 - 50 ml (6 - 10 x 5 ml spoonfuls) 3 to 4 times daily; dosage should be subsequently adjusted to produce 2 to 3 soft stools daily and an acidic faecal pH. _Constipation_: Adults including the elderly: Initially 15 ml (3 x 5ml spoonfuls) twice daily. Dosage can often be gradually reduced to 10-20 ml a day or every other day. Children 5 to 10 years 10 ml (2 x 5ml spoonfuls) twice daily Children under 5 years 5 ml (1 x 5ml spoonful) twice daily Each dose may, if necessary be taken with water, milk or fruit juices to increase palatability. 4.3 CONTRAINDICATIONS 1. Use in patients who require a galactose-free diet 2. Use in patients with evidence of gastrointestinal obstruction. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 1. In the event of diarrhoea adequate fluid intake should be maintained during treatment, and the dosage reduced to avoid loss of fluid and potassium and exacerbation of encephalopathy. 2. Long term use of this product is inadvisable except under medical supervision. 3. A dose of 30ml provides 116 KJ (28 Kcals), and is unlikely to adversely affect diabetics. 4. Lactolax should be administered with care to patients who are intolerant to lactose. (It contains 0.3g Lactose per 5ml). IRISH MEDICINES BOARD ___________________________________________________________________________________________________________ Soma hati kamili