DUPHALAC 10 g/15 ml S buv en sachet 20Sach/15ml

Oral solution (colorless to brownish-yellow liquid, clear and viscous).
Sachet of 15 ml. Box of 20 (large size) or of 400.

For one sachet of 15 ml:

Lactulose: 10,00 g
In the form of liquid lactulose.

DUPHALAC contains residues with a notable effect arising from the synthesis route, see section Warnings and precautions.

Excipients:

• Symptomatic treatment of constipation.
• Hepatic encephalopathy.

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

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 liters, i.e. 6 to 8 glasses) during the day.

Constipation

DUPHALAC may be administered in one or two intakes per day.

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

The dosage is on average:

Adults and adolescents

• initial treatment: 1 to 3 sachets per day.
• maintenance treatment: 1 to 2 sachets per day.

Children from 7 to 14 years

• initial treatment: 1 sachet per day.

If diarrhoea occurs, reduce the dosage.

For an appropriate dosage in infants and children up to 7 years, DUPHALAC 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 by gastric tube or enema in case of coma or pre-coma:
  • enema with gastric tube: 6 to 10 sachets diluted in water,
  • retention enema with balloon catheter: 20 sachets in 700 ml of lukewarm water to be kept for 30 minutes to 1 hour. The procedure should be repeated if necessary 12 hours later.
• maintenance treatment by oral route: 1 to 2 sachets, 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 are 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 dissolved in water.

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

• 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 painful syndromes of undetermined cause.

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

The dose 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 fibres and fluids,
• Advice on physical activity and rehabilitation of evacuation.

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 lactose, galactose and fructose arising from the synthesis route. Therefore, patients with galactose or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) must not take this medicine.

DUPHALAC should be administered with caution in patients intolerant to lactose.

This product contains sulfites from the synthesis route.

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.

DUPHALAC may 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.

DUPHALAC may be used during breastfeeding.

Fertility

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

DUPHALAC has no 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.

Undesirable effects are classified in the table below according to the different parts of the body affected and their frequency, using the following convention: 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); frequency not known (cannot be estimated from the available data).

MedDRA SOC	Frequency category
	Very common	Common	Uncommon	Frequency not known
Gastrointestinal disorders	Diarrhoea	Flatulence, abdominal pain, nausea, vomiting
Investigations			Electrolyte imbalance due to diarrhoea
Immune system disorders				Hypersensitivity reactions*
Skin and subcutaneous tissue disorders				Rash*, pruritus*, urticaria*

* 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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - 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: OSMOTIC LAXATIVE, HYPOAMMONAEMIC AGENT, 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 of up to 40-75 ml; for higher doses, part of the lactulose may be excreted unchanged.

The results of acute, sub-acute and chronic toxicity studies in different species show that the active substance is very weakly toxic. The effects observed appear to be related more 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.

Marketing authorisation (AMM)

CIP 3400955566823 (400 sachets/15 ml). CIP 3400927693199 (20 sachets/15 ml).

Price:

2,58 euros (20 sachets/15 ml).

Box of 20 : Reimbursed by Social Security at 30 %. Collect.

Box of 400 : Collection.

 

Marketing Authorisation Holder : Cooper Consumer Health B.V., Verrijn Stuartweg 60, 1112 AX Diemen, Netherlands.