Suitable for

Adults and children

Age Restriction You must be at least 16 years old to purchase this product

How to use

Please read the enclosed leaflet carefully before use.
Patient Information Leaflets are updated periodically by the manufacturer.
For oral use only.
Constipation:
Adult and adolescents over 14 years

• • Starting dose: 15-45 ml corresponding to 10-30g lactulose

• Maintenance dose: 15-30 ml corresponding to 10-20 g lactulose

Children (7-14 years)

• • Starting dose: 15 ml corresponding to 10 g lactulose

• Maintenance dose: 10-15 ml corresponding to 7-10 g lactulose

Children (1-6 years)

• Starting dose: 5-10 ml corresponding to 3-7 g lactulose

Babies

• Starting dose: up to 5 ml corresponding to up to 3 g lactulose

Thereafter the dose can be reduced individually.
The daily dose should be taken once during breakfast. It can be taken for 2-3 until the desired effect is achieved since Lactulose oral solution is not degraded until it reaches the colon.
Portal systemic encephalopathy (Liver disease that affects the brain)
Adults:
Beginning with 30 – 50 ml 3 times daily (corresponding to 60 – 100 g lactulose). The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5.
Children:
The safety and efficacy in children aged 0-18 years has not been established.
In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist.

Hazards and Cautions

Before you take Lactulose Oral Solution
Do not take Lactulose oral solution:

• • if you are allergic (hypersensitive) to any of the components of Lactulose oral solution.

• • if you suffer from galactosaemia (a severe genetic disorder where you cannot digest galactose).

• acute inflammatory bowel disease (like Crohn’s disease or ulcerative colitis), blockage in your bowel (apart from normal constipation), digestive perforation or risk of digestive perforation, abdominal pain or undetermined cause.

Take special care with Lactulose oral solution
Please tell your doctor before taking Lactulose oral solution:

• • if you suffer from gastro-cardiac syndrome (Roemheld syndrome)

• if you have symptoms like meterorism or bloating after using it, stop the treatment and consult your doctor.

In these cases your doctor will supervise the treatment carefully.
Longterm use of unadjusted dosages (exceeding 2-3 soft stools per day) or misuse can lead to diarrhoea and siturbance of the electrolytes balance.
If you are an elderly patient or a patient in bad general condition and who take Lactulose oral solution for more than a 6 month period, your doctor will regularly check your blood electrolytes.
Patients with portal systemic encephalopathy should avoid concmitant administration of other laxatives, beacuse it hinders the individualisation of drug dose.
Please do not use Lactulose oral solution without medical advice for more than two weeks.
Children
Lactulose oral solution should not normally be given to infants and smaller children as it can disturb the normal reflexes for passing stools. In special circumstances your doctor may prescrive Lactulose oral solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.
Storage
Do not store above 25°C.
Keep out of the sight and reach of children.
Do no use Lactulose oral solution after the expiry date which is stated on the label of the bottle (EXP: mm yyyy). The expiry date refers to the last day of that month.
Contains traces of sugar (e.g. Lactose, Galactose, Epilactose, Tagatose, Fructose).

Active ingredients

Lactulose

Ingredients

Acitve Ingredients: Lactulose (as Lactulose liquid). 5 ml of Lactulose oral solution contains 3.3 g Lactulose.
There are no other ingredients.