1. NAME OF DRUG LANSOYL RASPBERRY, oral gel in a pot.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Liquid paraffin: 78.230 g Per 100g of gel. List of dilutants: saccharose, red cochineal A (E124). To see a complete list of dilutants, see section 6.1.
3. PHARMACEUTICAL FORM Oral gel.
4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment for constipation. 4.2. Dosage and how to use Orally. 1 tablespoon = 15ml 1 teaspoon = 5ml - For adults: 1-3 tablespoons per day. - Children between 2-15 years of age: 1-3 teaspoons per day. · For a newborn (under 24 months): 1/2 teaspoon per day, 1-2 times per day. Do not exceed the recommended doses. Do not increase the dosage if it does not work; consult your doctor. Take it outside of mealtimes. Avoid lying down in the 2 hours after taking this medication. Duration is capped at 15 days. 4.3. Contraindications - Over-sensitivity to the active ingredient or one of its dilutants. - Do not use if you have abdominal pain or intestine obstruction. - Patients who ahve swallowing difficulties due to the lipid pneumopathy. 4.4. Special warnings and side effects Special warnings: Do not use for a prolonged period of time as it reduces the absorption of vitamins (A, D, E, K). This treatment must also include: - increasing your vegetable fibre and drinks. - increasing your physical activity. - helping the exoneration. · In children the administration of laxatives must be exceptional: it must take into account the risk of impeding the normal functioning of the exoneration reflex. Specific precautions for use · Administration of liquid paraffin in young children, debilitated, elongated or having difficulty in swallowing should be prudent because of the risk of bronchial inhalation and lipoid pneumonitis. · This drug contains sucrose. This medication is not recommended for patients with a fructose intolerance, glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency. · This drug contains 2.12 g of saccharose per tablespoon. Be aware of the daily dose in the event of a low sugar diet or diabetes. This drug contains a azoic dye agent (E124) and can cause allergic reactions. 4.5. Interactions with other drugs The current data available does not suggest any clinical interactions. 4.6. Pregnancy and breast feeding There is no clear evidence of malformations detected in animals. There is not sufficient data to evaluate the malformation and foetal-toxic effect of liquid paraffin when taking during pregnancy. Paraffin oil is not absorbed but interferes with the absorption of vitamins which can can cause neonatal problems (potential bleeding...). For precaution measures, it is advisable not to take this drug during pregnancy. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects High doses of liquid paraffin can lead to: - anal seepage - perianal irritation - risk of bronchial inhalation and lipoid pneumopathy. 4.9. Overdose No case of an overdose has been reported. It can also lead to: - steatorrhoea - anal seepage - perianal irritation. In case of an overdose, stop treatment and apply a local treatment.
5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Pharmaco-therapeutic class: LAXATIVE LUBRICANT (A: digestive and metabolism) The liquid paraffin acts by mechanical action by lubricating the colic contents and by softening the stools. 5.2. Pharmacokinetics properties Taken orally, works for 6-8 hours. 5.3. Preclinical safety data Not known.
6. PHARMACEUTICAL DATA 6.1. List of dilutants Saccharose, citric acid monohydrate, red cochnieal A (E124), flavouring (1), drinking water. (1) Composition of flavouring: raspberry alcoholate, blackcurrant and iris buds, vanilla tincture, alcohol and plum alcohol, ethanol, amyl esters (formates, acetates, valerianates), ethylprotocatechic aldehyde, pelargonic aldehyde. Calorie count: 9 lkcal/tablespoon (15ml). 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging Pot (glass) of 90, 180, 225, 375 or 600 g. Not all pack sizes will be available. 6.6. Precautions for handling and disposal No specific requirements.
7. THE MARKETING AUTHORISATION HOLDER JOHNSON & JOHNSON SANTE BEAUTE FRANCE 1, RUE CAMILLE DESMOULINS 92130 ISSY LES MOULINEAUX
8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 305 703-5: 225 g pot (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.
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