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

Oral solution in sachet-dose.

Lactulose......................................................................................................................................................10,00 g

As a lactulose solution at 50 percent (w/w)

For one sachet-dose.

Excipients with known effect: soybean oil, propylene glycol, benzyl alcohol.

LACTULOSE VIATRIS SANTE contains residues with known effect originating from the synthesis route (see section Warnings and precautions).

Excipients:

LACTULOSE VIATRIS SANTE is indicated in adults, adolescents and children aged 7 to 14 years for the symptomatic treatment of constipation.

LACTULOSE VIATRIS SANTE is indicated in adults for the treatment of 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 VIATRIS SANTE may be administered as one or two doses 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 single-dose sachets per day.
• maintenance treatment: 1 to 2 single-dose sachets per day.

Paediatric population

EChildren aged 7 to 14 years :

• initial treatment: 1 single-dose sachet per day.

If diarrhoea occurs, reduce the dosage.

For an appropriate dosage in infants and children up to 7 years, LACTULOSE BIPHAR 66,5 %, oral solution 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:

• Treatment of attack by gastric tube or enema in case of coma or pre-coma:
  • enema via gastric tube: 6 to 10 sachets diluted in water,
  • retention enema with balloon catheter: 20 sachets in 700 mL of lukewarm water to be retained for 30 minutes at 1 hour. The procedure should be repeated if necessary 12 hours later.
• oral relay treatment: 1 to 2 sachets, 3 times a 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.

The corner of the LACTULOSE VIATRIS SANTE 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.

Rectal route.

This medicine must be diluted in water.

• 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.
• Due to the presence of soybean oil, this medicine is contraindicated in cases of allergy to peanut or soy.

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

Chronic use at inappropriate doses or misuse may cause diarrhoea and disrupt 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 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.

LACTULOSE VIATRIS SANTE should be administered with caution in patients with lactose intolerance.

This product contains sulfites from the synthesis route.

Excipients

This medicine contains soybean oil. If the patient is allergic to peanut or soy, do not use this medicine.

This medicine contains benzyl alcohol, which may cause allergic reactions.

This medicine contains approximately 30 mg of propylene glycol per dose sachet.

Paediatric population

In infants and children, the prescription of laxatives should be exceptional: the risk of interfering with the normal functioning of the defecation reflex must be taken into account.

No interaction studies have been performed.

Pregnancy

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

LACTULOSE VIATRIS SANTE 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.

LACTULOSE VIATRIS SANTE may be used during breastfeeding.

Fertility

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

LACTULOSE VIATRIS SANTE has no or negligible influence on the ability to drive 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 affected body systems 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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals 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 Pharmacovigilance Centres – Website: www.signalement-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: HYPOAMMONEMIC OSMOTIC LAXATIVE, ATC code: A06AD11.

Mechanism of action

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.

Pharmacodynamic effects

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, 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.

2 years

Store at a temperature not exceeding 25°C.

No special requirements for disposal.

Marketing authorisation (AMM)

CIP 3400935838582 (20Sach/15ml).

Price:

2,48 euros (20 sachets/15 ml).

Social security reimbursement at 30%.
Collection.