LACTULOSE SANDOZ 10 g Oral solution in sachet-dose 20 sachet/15mL

Liquid lactulose ........................................................................................................................................ 20,00 g

Quantity corresponding to lactulose ..................................................................................................... 10,00 g

For one sachet-dose.

• Symptomatic treatment of constipation.

• Hepatic encephalopathy.

Dosage

The dosage must be adapted according to the needs of each patient.

In the case of a single daily intake, it must be taken at the same time, for example during breakfast.

During treatment with laxatives, it is recommended to drink sufficient liquid (1,5 to 2 litres, i.e. 6 to 8 glasses) during the day.

Constipation

LACTULOSE SANDOZ may be administered in one or two doses per day.

After a few days, depending on response to treatment, the loading dose must be adjusted to reach the maintenance dose. Several days (2 to 3 days) may be required before the treatment takes effect.

The dosage is on average:

Adults and adolescents:

• loading treatment: 1 to 3 sachets-doses per day;

• maintenance treatment: 1 to 2 sachets-doses per day.

Children aged 7 to 14 years :

• loading treatment: 1 sachet-dose per day.

If diarrhoea occurs, reduce the dosage.

For an appropriate dosage in infants and children up to 7 years, LACTULOSE SANDOZ bottle must be used.

Hepatic encephalopathy

In all cases, the ideal dose is the one that leads to two or three soft stools per day.

The duration of treatment varies depending on the symptoms:

• initial treatment via nasogastric tube or enema in case of coma or pre-coma:

• enema with gastric tube: 6 to 10 sachets-doses diluted in water,
• retention enema with balloon tube: 20 sachets-doses in 700 ml of lukewarm water to be retained for 30 minutes to 1 hour; the procedure must be repeated if necessary 12 hours later;

• Relay treatment by oral route: 1 to 2 sachet-doses, 3 times per day.

Paediatric population

The safety and efficacy in children (from newborns up to 18 years) with hepatic encephalopathy have not been established. No data is available.

Elderly patients and patients with renal or hepatic impairment

In elderly patients and patients with renal or hepatic impairment, no dose adjustment is necessary because exposure to lactulose is negligible.

Method of administration

Oral use.

This medicine may be taken neat or diluted in a drink.

Rectal route.

This medicine must be diluted in water.

The corner of the LACTULOSE SANDOZ sachet must be torn off and the contents taken immediately.

The dose of lactulose must be swallowed in one go and must not be kept in the mouth for a prolonged period.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

• Obstructive or subobstructive syndrome.

• Gastrointestinal perforation or suspicion of gastrointestinal perforation.

• Active inflammatory bowel disease (for example: Crohn's disease, ulcerative colitis).

• Abdominal pain syndromes of undetermined cause.

Prolonged use of this medicine without medical supervision is not recommended.

The dosage usually used in the treatment of constipation is not likely to affect diabetic patients: 30 ml of solution provides 116 kJ (28 kcal). The calories are of carbohydrate origin.

The dose used in patients suffering from hepatic encephalopathy is usually much higher and may need to be taken into consideration in diabetic patients.

Drug treatment of constipation is only an adjunct to dietary and lifestyle measures:

• enrichment of the diet with vegetable fibers and fluids,

• advice on physical activity and re-education of defecation.

Chronic use at inappropriate doses or misuse may cause diarrhoea and disturb the fluid and electrolyte balance.

This medicine should therefore be used with caution in patients prone to fluid and electrolyte disorders (such as patients with impaired renal or hepatic function, or those receiving a diuretic).

When administered as a retention enema, due to the strong cathartic effect, faecal incontinence, soiling of the bed and perianal irritation due to acidic stools can be expected. The hydration status of the patient should be carefully monitored.

It should be taken into account that the normal functioning of the defecation reflex may be hindered during treatment.

Information on excipients with known effect arising from the synthesis route:

This medicine contains galactose, lactose and fructose from the synthesis pathway. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) must not take this medicine.

Patients with hereditary fructose intolerance (HFI) must not take/receive this medicine.

The additive effect of concomitantly administered products containing fructose (or sorbitol) and the dietary intake of fructose (or sorbitol) must be taken into account.

Paediatric population

In infants and children, the prescription of laxatives should be exceptional.

No interaction studies have been performed.

Pregnancy

As systemic exposure to lactulose is negligible, no effect is expected in pregnant women.

The Lactulose can be used during pregnancy.

Breast-feeding

As systemic exposure to lactulose in breastfeeding women is negligible, no effect is expected in breastfed newborns or infants.

Lactulose can be used during breastfeeding.

Fertility

No effect is expected because systemic exposure to lactulose is low.

Lactulose has no effect or negligible effect on the ability to drive vehicles and use machines.

Bloating may occur at the start of treatment. In general, it disappears after a few days.

When the medicine is administered at doses higher than the recommended dosage, abdominal pain and diarrhoea may occur. In this case, the dosage should be reduced (see section Overdose).

If high doses are administered over a prolonged period (usually only in cases of hepatic encephalopathy), an electrolyte imbalance may occur due to diarrhoea.

Adverse effects are classified in the table below according to the different body systems affected and their frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000), very rare (<1/10 000); frequency not known (cannot be estimated from the available data).

* reported after marketing

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Symptoms :

Diarrhoea, loss of electrolytes and abdominal pain.

Treatment :

Discontinuation of treatment or reduction of the dosage. Correction of any fluid and electrolyte disturbances in the event of significant fluid loss secondary to diarrhoea and vomiting.

Pharmacotherapeutic class: HYPOAMMONAEMIC OSMOTIC LAXATIVES, ATC code: A06AD11.

In the colon, the conversion of lactulose by colonic bacteria into low molecular weight organic acids lowers the pH of the colonic contents and, through an osmotic effect, increases the volume of the colonic contents.

These effects stimulate colonic peristalsis and normalise stool consistency. Constipation disappears and the physiological rhythm of the colon is restored.

In hepatic encephalopathy (HE), the effect has been attributed to the suppression of proteolytic bacteria through an increase in acidophilic bacteria (for example lactobacillus), and to the retention of ammonia in ionic form through acidification of the colonic contents.

Lactulose is poorly absorbed after oral administration and reaches the colon unchanged, where it is metabolised by the bacterial flora. Metabolism is complete for intakes up to 40 - 75 ml; for higher doses, part of the lactulose may be excreted unchanged.

The results of acute, subacute and chronic toxicity studies in different species show that the active substance is very weakly toxic. The effects observed appear to be more related to the bulk effect in the gastrointestinal tract than to a more specific toxic activity.

No adverse effects were observed in reproduction and teratogenicity studies in rabbits, rats and mice.

3 years.

Store at a temperature not exceeding 25°C.

Any partially used sachet must be discarded.