Lactulose which is not broken down in the stomach and small intestine, begins its action in the large intestine where it is broken down primarily by intestinal bacteria. In this degradation process, lactic acid is produced, this in turn supports the growth of intestinal bacteria important for humans and hinders the growth of putrefactive bacteria. Thus normalization of intestinal flora (eubiosis) results. In addition, the increase in metabolic degradation products in the blood which cannot be sufficiently detoxified by the liver is reduced.

1. Constipation (chronic constipation): In every case of chronic constipation, initial treatment should consist of a diet rich in fiber (vegetables, salads, fruits, supplements of linseeds, wheat germ, etc.) a generous amount of liquids and much physical exercise. Sinalac is only to be taken when these measures prove insufficient. 2. Intestinal flora disturbances: In -damage to intestinal flora, following therapy with broad spectrum antibiotics infants -gall bladder diseases -intestinal diseases (colitis, diverticulosis, megacolon) 3. Increased blood ammonia levels (hyperammoniemia in hepatopathy, portal systemic encephtopathy, precoma,coma) 4. Diseases of the gums and the parodontic apparatus (paradontosis, bleeding from the gums, inflammation, dystrophy)

Dosage should be followed accurately unless otherwise specified. 1. In constipation (chronic constipation): Due to the fact that every organism responds differently to Sinalac, each patient must determine his/her own optimal dose in the course of time. Adults 3-6 tea-spoons daily Initially Adults 3-6 tea-spoons daily 1-5-6 tea-spoons daily in long-term therapy Children upto 14 years 3 tea-spoons daily initialy & 1-2 tea spoons daily in long-term therapy. Infants and toddlers 1-2 tea-spoons daily Initially & 1 tea spoons daily Initially. With Sinalac a prompt laxative effect may be achieved by drinking a mixture of 3-9 tea-spoons in l/8-1/4 liter water, coffee, tea, fruit juice, or milk on an empty stomach after getting up in the morning. Normally, defecation takes place approximately 2 hours later in the form of a fluid pulpy mass (increased defecation reflex). 2. In damaged intestinal flora (e.g. following long-term antibiotic treatment): Adults: 1-2 tea-spoon daily Children: 1 tea-spoon daily 3. For reduction of blood ammonia level (In hepatopathy): A maximum of 60-100g Lactulose daily, that is, 18-30 tea-spoons 4. In precoma: A maximum of 100 g Lactulose daily, that is 30 tea-spoons Sinalac spread over the course of the day. 5. Diseases of the gums and the parodontic apparatus (paradontopathy): Adults: 3-6 tea-spoons Sinalac daily.

Hypersensitivity to either galactose and or lactose, galactose-free diet. Gastro-cardial symptom complex (heart problems stemming from the gastro-intestinal tract), suspected intestinal obstruction.

Do not take Enulose, Kristalose, Constulose or Generlac, if you are allergic to lactulose or any ingredients contained in this drug.

Occasionally flatulence can occur at the beginning of treatment, this is rapidly eliminated by reducing the dose and or taking the daily dose in several smaller individual portions spread over the course of the day. Overdosage can result in diarrhoea. In abuse: loss of electrolytes (primarilly Potassium).

Pregnancy category B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by a registered physician.

The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse. Habit forming effects : None known.

Overdose may cause nausea, vomiting, diarrhea, and stomach cramps, or symptoms of low blood potassium or low blood sodium

Keep in a cool (below 30°C) and dry place, protect from light.

Each bottle contains Solution 60 ml, 100 ml, 200 ml & 450 ml