Lactulose Solution Lactulose Solution

Do not take Lactulose Solution if: • You are allergic (hypersensitive) to lactulose or any of the other ingredients of Lactulose Solution . • You have a rare problem called 'galactosaemia'. • You have an intestinal blockage caused by anything else but normal constipation, digestive perforation or risk of digestive perforation. Do not take Lactulose Solution if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lactulose Solution.

Warnings and precautions: Talk to your doctor or pharmacist before taking Lactulose Solution if you suffer from any medical conditions or illnesses, in particular: • if you suffer from unexplained stomach pains • if you are unable to digest lactose (sugar found in milk) • if you have diabetes You should not take Lactulose Solution if you suffer from: • galactose or fructose intolerance • glucose-galactose malabsorption • Lapp lactase deficiency or if pregnant or breastfeeding.

If you have diabetes and are treated for hepatic encephalopathy, your dose of Lactulose Solution will be higher. This high dose contains a large amount of sugar. Therefore, your anti-diabetic medicine may need to be adjusted. Chronic use of unadjusted dosages (exceeding 2-3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the electrolytes balance. During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres/day, equal to 6-8 glasses). If you take Lactulose Solution for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Children In special circumstances your doctor may prescribe Lactulose for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Lactulose should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

Other medicines and Lactulose Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking Lactulose with food and drink Duphalac can be taken with or without food. There are no restrictions on what you can eat or drink.

 Pregnancy, breast-feeding and fertility Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Lactulose can be used during pregnancy and when breast-feeding if necessary. No effects on fertility are to be expected.

Driving and using machines Lactulose has no or negligible influence on your ability to drive safely or use machines. Important Information about some of the Ingredients of Lactulose.  Lactulose contains sugars, such as milk sugar (lactose), galactose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.Lactulose contains sulphite

Like all medicines, Lactulose Solution can cause side effects, although not everybody gets them The following side effects have been reported with Lactulose Solution: Very common (may affect more than 1 in 10 people) • diarrhoea Common (may affect up to 1 in 10 people) • flatulence (wind) • nausea (feeling sick) • vomiting • abdominal pain Uncommon (may affect up to 1 in 100 people) • electrolyte imbalance due to diarrhoea Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased. If you use high doses (normally only associated with hepatic encephalopathy, HE) for an extended period of time, you may experience an electrolyte imbalance due to diarrhoea.

Reporting of side effects If you get any side effects, talk to yourdoctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Taking this medicine • Take Lactulose from a spoon or measuring cup. • You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids (approximately 6-8 glasses throughout the day). • Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Lactolose is taken for long periods.

Lactolose takes 2 to 3 days to start working. • After this time you may be able to reduce the dose you take according to your needs.

Constipation Adults and adolescents: The starting dose is 15-45ml . After this the dose can be adjusted to 15-30ml daily.

Children 7 to 14 years: The starting dose is 15ml or  daily. After this the dose can be adjusted to 10-15ml  daily.

Children 1-6 years: The usual dose is 5-10ml daily. Infants under 1 year: The usual dose is up to 5ml daily.

Use in Children: Use of laxatives in children, infants, and babies should be exceptional and under medical supervision because it can influence the normal reflexes for passing stools.

Please do not give Lactolose to children (under 14 years) before consulting your doctor for prescription and careful supervision.

Hepatic encephalopathy Adults: The usual starting dose is 3 to 4 times a day of 30-45ml .

Use in Children: No information is available for treatment of children (newborn to 18 years of age) with hepatic encephalopathy.

 Use in elderly patients and patients with renal or hepatic insufficiency: No special dosage recommendations exist.

The active substance in Lactulose Solution is lactulose. Each 5ml of Lactulose Solution contains 3.35g of lactulose. • Lactulose Solution does not contain any other ingredients. However, it may contain small amounts of other sugars, such as lactose, galactose, epilactose and fructose.