Lactulose 66.5% Biogaran, 200ml - Lactulose, Treatment for Constipation

1. NAME OF DRUG LACTULOSE BIOGARAN 66.5%, drinkable solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lactulose: 66.5 g 50% lactulose solution. Per 100ml of solution. 3. PHARMACEUTICAL FORM Drinkable solution. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment for constipation. Hepatic encephalopathy. 4.2. Dosage and how to use Orally. This medication can be taken in its pure state or diluted in a drink. One tablespoon (15ml) of this medication = 10g of lactulose. Constipation The dosage must be adapted to each individual. The daily dose is: Newborns from 0-12 months: 1 teaspoon (5ml) every day. Children 1-6 years old: 1-2 teaspoons per day. Children 7-14 years old: - Attack treatment: 1 tablespoon per day. - Maintenance treatment: 2 teaspoons per day. Adults: - Attack treatment: 1-3 tablespoons per day. - Maintenance treatment: 1-2 tablespoons per day. If you get diarrhoea, decrease the dosage. Hepatic encephalopathy The ideal dose is one that gives you two soft faeces per day. Treatment varies on the symptoms. - Treatment of attack by gastric tube or enema in case of coma or pre-coma: 6-10 tablespoons (15ml) pure or diluted in water. - Relay processing 1-2 tablespoons per day, 3 times per day. 4.3. Contraindications Inflammatory organic colopathies (ulcerative colitis, Crohn's disease ...), occlusive or subocclusive syndrome, digestive perforation or suspicion of perforation, indeterminate abdominal pain syndromes. Galactose-free diet due to the sugar content in this solution. 4.4. Special warnings and side effects Prolonged use of this treatment is not recommended. Treatment for constipation should also be combined with: - food rich in fibre and drinks, - physical activity and exoneration. In infants and children, the prescription of laxatives must be exceptional: it must take into account the risk of impairing the normal functioning of the exoneration reflex. 4.5. Interactions with other drugs Not applicable. 4.6. Pregnancy and breast feeding Studies in animals have not shown a teratogen effect. In the absence of a teratogenic effect in animals, a malformative effect on the human species is not expected. To date the substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies on two species. In clinical studies there are no particular malformative or fetotoxic effects appeared to date. However monitoring pregnancies exposed to lactulose is not enough to rule out any risk. Given the data, the use of lactulose is not recommended during pregnancy unless necessary. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects - Bloating, semi-liquid faeces. These can appear at the beginning of treatment. They stop once treatment has been changed. - rare cases of pruritis, anal pain and weight loss. 4.9. Overdose Symptom: diarrhoea. Treatment -stop with therapeutic. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties OSMOTIC LAXATIVE. HYPO AMMONIA. (A: digestive and metabolism). 1. Lactulose increases hydration and the the volume of colic. 2. In the colon, the transformation of lactulose into organic acids lowers the pH of the colon content, thus reducing the absorption of ammonia. 5.2. Pharmacokinetics properties Lactulose, a synthetic disaccharide, passes through the upper parts of the digestive tract without modification and without resorption. In the colon, under the effect of the local saccharolytic flora, it is transformed into organic acids (lactic and acetic), which are eliminated in the stool. 5.3. Preclinical safety data Not applicable. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Not applicable. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions Store in a place below 25°C. Do not put in the fridge. 6.5. Nature and contents of outside packaging 1000 or 200 ml bottle (glass). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER BIOGARAN 15, BOULEVARD CHARLES DE GAULLE 92700 COLOMBES 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 328 380-8: 200 ml bottle (glass). · 555 238-8: 1000 ml bottle (glass). 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.