Lactulose Biogaran 10g/15ml, drinkable solution sachet - Box of 20

Information Read all the information before taking this medication. It contains important information concerning your treatment. If you have any other questions or queries, consult your doctor or pharmacist. Keep this information as you may need to re-read it. If you have any other questions or queries, consult your doctor or pharmacist. If symptoms persist consult your doctor. If you notice side effects that are not mentioned here, or if certain side effects become more severe, please consult your doctor or pharmacist. Summary In this information: 1. WHAT IS LACTULOSE BIOGARAN 10g/15ml drinkable solution AND WHEN IS IT USED? 2. WHAT DO I NEED TO KNOW BEFORE TAKING LACTULOSE BIOGARAN drinkable solution? 3. HOW DO YOU TAKE LACTULOSE BIOGARAN drinkable solution? 4. WHAT ARE THE SIDE EFFECTS? 5. HOW TO STORE LACTULOSE BIOGARAN drinkable solution? 6. EXTRA INFORMATION. 1. WHAT IS LACTULOSE BIOGARAN 10g/15ml drinkable solution AND WHEN IS IT USED? Pharmaco-therapeutic class OSMOTIC LAXATIVE. HYPO AMMONIA. (A: digestive and metabolism) Therapeutic Indications This is symptomatic treatment for constipation. It is also treatment for hepatic encephalopathy 2. WHAT DO I NEED TO KNOW BEFORE TAKING LACTULOSE BIOGARAN drinkable solution? List of the necessary information before taking this medication. Not applicable. Contraindications Do not take LACTULOSE BIOGARAN 10g/15ml drinkable solution in the case of: · Allergy to lactulose or to one of its components, - Certain intestine or colon illnesses such as rectocolitis, Crohn’s disease or intestinal occlusion, - Abdominal pain (stomach pain), - Digestive perforation, - Intolerance to galactose. IF IN DOUBT IT IS ADVISABLE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Precautions of use and warning Be careful when taking LACTULOSE BIOGARAN: Occasional constipation This can be linked to a change in lifestyle (travelling). This is short-term help. Inform of your doctor if constipation from an unexplained change in lifestyle with pain, fever, swelling of the face appears. Chronic constipation (long-term) Can be linked to two causes: - intestine illness - an imbalance in the function of the intestine due to food habits and lifestyle. Treatment should also be alongside: - an increase in vegetable foods (green vegetables, crudities, bread, fruit...). - an increase in water and fruit juice consumption. - an increase in physical activity (sport, walking...). - defecation reflex. - addition to food. For children: Treatment on children is also based on certain hygiene factors: using good quality water for milk powders, foods rich in vegetables and fruit juice. Regular doses of laxatives can upset the functioning of the defecation reflex. Precautions for use If you have kidney or liver disease, be careful when taking this medication. IF IN DOUBT DO NOT HESITATE TO CONSULT YOUR DOCTOR OR PHARMACIST FOR ADVICE. Interactions with other drugs Taking other medication Talk to your doctor or pharmacist if you take or have recently taken any other drug, including any non-prescription drugs. Interaction with food and drinks Not applicable. Interaction with food and drinks Not applicable. Interactions with phytotherapy or other therapy products Not applicable. Use during pregnancy and breast feeding Pregnancy and breast feeding This drug can only be used during pregnancy following advice from your doctor. If you discover that you’re pregnant during the treatment, consult your doctor who is the only person who can judge whether the drug should be continued. Consult your doctor or pharmacist before taking any drugs. Sport players Not applicable. Effects on the ability to drive and operate machinery Not applicable. List of dilutants with effect Not applicable. 3. HOW DO YOU TAKE LACTULOSE BIOGARAN drinkable solution? Instruction for correct use. Not applicable. Dosage, How to use, Frequency & Length of treatment Dosage Constipation: Dosage must be adapted depending on each individual. On average: Adults: Attack treatment: 1-3 sachets per day. Maintenance treatment: 1-2 sachets per day. Children 7-14 years old: Attack treatment: 1 sachet per day. If diarrhoea appears, reduce the dosage. Hepatic encephalopathy: The ideal dose is one that makes you get two soft faeces per day. Adults: the daily dose is 1-2 sachets 3 times a day. How to use Orally. It can be taken in its pure state or diluted in a drink. Length of treatment The length of treatment depends on the symptoms. Symptoms and instructions in case of overdose If you have taken more of LACTULOSE BIOGARAN drinkable solution than told: Consult your doctor or pharmacist immediately. Instruction in case of omission of one or several doses Not applicable. Risks of withdrawal symptoms Not applicable. 4. WHAT ARE THE SIDE EFFECTS? Description of side effects Like all drugs LACTULOSE BIOGARAN 10g/15ml drinkable solution can cause side effects (this will not affect everyone). - Bloating, semi-liquid faeces. These can occur at beginning of treatment and they stop once the dosage has been adapted. - Rare cases of itching, anal pain and moderate weight loss. If you notice side effects that are not mentioned here, or if certain side effects become more severe, please consult your doctor or pharmacist. 5. HOW TO STORE LACTULOSE BIOGARAN drinkable solution? Keep out of reach and view from children. Expiry Date Do not use LACTULOSE BIOGARAN drinkable solution after the expiry date noted on the box. Storage conditions Store in a place below 25°C. Do not put in the fridge. Keep an eye out of signs of deterioration. Medication should not be thrown away with normal household waste. Ask your pharmacist what to do. These measures help protect the environment. 6. EXTRA INFORMATION. List of active ingredients Que contient LACTULOSE BIOGARAN 10 g/15 ml, solution buvable en sachet ? What is in LACTULOSE BIOGARAN drinkable solution? Active Ingredient: Liquid lactulose: 20.00 g Quantity of lactulose: 10.00 g Per sachet. Other ingredients: Prune flavouring. Pharmaceutical form and packaging What is the packaging of LACTULOSE BIOGARAN drinkable solution? This drug is in the form of an oral solution in a single-dose sachet. Box of 20. Drinkable solution. Name and Address of the Market Authorisation Holder Title BIOGARAN 15, BOULEVARD CHARLES DE GAULLE 92700 COLOMBES Owner BIOGARAN 15, BOULEVARD CHARLES DE GAULLE 92707 COLOMBES CEDEX Manufacturer DELPHARM USINE DU PETIT PARIS 91731 BRETIGNY-SUR-ORGE CEDEX or PHARMATIS SITE D’ESTREES SAINT-DENIS LIEU-DIT «LE FOSSE DE L’E TANG» B.P. 20 60190 ESTREES-SAINT-DENIS or H2 PHARMA ZAC LA CROIX BONNET 21 RUE JACQUES TATI 78390 BOIS D’ARCY Name of medication in EU Not applicable. REVIEW DATE OF INSTRUCTIONS The last f=review date was (date). AMM. Not applicable. Internet Information For more information about this medication please visit the Afssaps website (France). Information for Health Professionals Not applicable. Others Not applicable.