Properties
- Form
- sirofi
- Dosage mg
- 667მგ/
- Pack
- 1
What is it?
DUFALAC ®, Syrup 667 mg/ml Active substance: Lactulose Read this leaflet carefully before you start taking this medicine, as it contains important information for you. • Keep the leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you experience any side effects, talk to your doctor. This applies to any possible side effects, including those not listed in section 4 of this leaflet. Contents of the leaflet What DUFALAC ® is and what it is used for What you need to know before taking DUFALAC ® How to take DUFALAC ® Possible side effects How to store DUFALAC ® Contents of the pack and other information. 1. What DUFALAC ® is DUFALAC ® syrup contains the active ingredient lactulose, which is an osmotic laxative. It increases the volume of intestinal contents by osmotic action. This stimulates peristalsis of the colon and normalizes the consistency of the stool, which helps to eliminate constipation and restore the physiological rhythm of the colon. DUFALAC ® syrup is used to treat constipation (infrequent, hard or dry stools) and to soften stools, e.g. • if you have hemorrhoids • if you have had surgery on the colon or anal area. DUFALAC ® syrup is used to treat hepatic encephalopathy (HE) (a liver disease that can cause confusion, tremors, pre-coma or coma). If you do not feel better or feel worse, you should consult a doctor. See blog: Constipation and its treatment — all about DUFALAC 2. What you need to know before taking DUFALAC ® Do not take DUFALAC ® : • if you are allergic (hypersensitive) to lactulose or any of the other ingredients of this medicine (listed in paragraphs 2 and 6); • if you have galactosemia (a rare genetic disorder that prevents the body from processing galactose); • if you have intestinal obstruction (other than ordinary constipation); • intestinal perforation or risk of perforation (e.g. acute inflammatory bowel disease such as Crohn's disease or severe recurrent inflammation of the colon (ulcerative colitis)) Do not take DUFALAC ® if any of the above apply to you. If you are unsure, talk to your doctor or pharmacist before taking DUFALAC ® . Special warnings and precautions Before taking DUFALAC ® , talk to your doctor or pharmacist if: • you have abdominal pain of unknown origin; • you suffer from recurrent pain in the chest area and bloating or Roemheld's syndrome (a syndrome where gas accumulates in the gastrointestinal tract (flatulence) or stomach distension causes heart problems); • you have lactose intolerance; • you have diabetes. If you have been taking DUFALAC ® for several days and your condition does not improve or your symptoms worsen, consult your doctor. DUFALAC ® should not be used if you suffer from: • galactose or fructose intolerance; • general lactase deficiency; • glucose-galactose malabsorption. If you have diabetes and are being treated for hepatic encephalopathy, the dose of DUFALAC ® syrup you use will be higher. This higher dose contains an increased amount of sugar. Therefore, a dose adjustment of the preparation may be necessary for diabetes mellitus. For patients with Roemheld's syndrome: If you experience symptoms such as bloating (flatulence) or swelling after use, stop treatment and consult your doctor. Careful medical supervision is required in these cases. Continuous use of unadjusted doses (soft stools 2-3 times a day) and misuse can lead to diarrhea and electrolyte imbalance. Do not use DUFALAC ® for more than 2 weeks without consulting your doctor. When used as an enema for the treatment of acute cases of hepatic encephalopathy, fecal incontinence may develop due to the strong cleansing effect, as well as perianal irritation (around the anus). During treatment with laxatives, it is recommended to drink enough fluids throughout the day. Drink up to 2 liters of fluid per day, which corresponds to 6-8 glasses. Other medicines and DUFALAC ® Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. DUFALAC ® may increase potassium loss caused by other medicines (e.g., thiazides, corticosteroids, and amphotericin B). The simultaneous use of DUFALAC ® and cardiac glycosides (e.g., digoxin) may enhance the effect of glycosides due to reduced potassium levels in the blood. Consult your doctor or pharmacist before using DUFALAC ® if any of the above applies to you or if you have any doubts. Interactions of DUFALAC ® with food and drinks DUFALAC ® syrup can be taken regardless of meals. There are no restrictions regarding food and drinks. Use in pregnant and breastfeeding women, information on fertility If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. DUFALAC ® syrup can be used during pregnancy and breastfeeding. The preparation does not affect fertility. Children In special cases, a doctor may prescribe DUFALAC ® for a child, infant, or newborn. Intensive medical supervision is required in these cases. Children, infants, and newborns should only be given DUFALAC ® if indicated, as it may interfere with normal bowel evacuation reflexes. Driving and operating machinery The use of DUFALAC ® has no effect or a negligible effect on the ability to drive and operate machinery. Special instructions regarding excipients DUFALAC ® syrup contains small amounts of milk sugar (lactose), galactose, epilactose or fructose, and sulfite formed during the production process. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. Allergic reactions (hypersensitivity reactions), including bronchospasm (sudden narrowing of the bronchi), may occur with sulfites. In this case, you should seek medical attention immediately. 3. How to take DUFALAC ® Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. Always take the medicine at the same time of day. Swallow the medicine quickly. Do not hold it in your mouth. DUFALAC ® can be taken diluted or undiluted. You can use the enclosed measuring cup to take DUFALAC ® from the bottles. To take DUFALAC ® syrup from single-dose sachets (sticks) of 15 ml, tear open the corner of the sachet (stick) and take the contents immediately. Dosage For constipation or for medical purposes to soften stools DUFALAC ® can be taken once a day or divided into two doses; you can use the measuring cup in the bottle to take lactulose. Depending on your response to this medicine, the initial dose may be adjusted after a few days to a maintenance dose. It may take a few days (2-3) for the therapeutic effect to appear. Lactulose syrup in bottles or sachets (sticks) with a single dose of 15 ml: Age Initial daily dose (ml) Maintenance daily dose (ml) Adults and adolescents 15-45 ml (10-30 g lactulose), equivalent to 1-3 sachets (sticks) 15-30 ml (10-20 g lactulose), equivalent to 1-2 sachets (sticks) Children (7-14 years) 15 ml (10 g lactulose), equivalent to 1 sachet (stick) 10-15 ml (7-10 g lactulose), equivalent to 1 sachet (stick)* Children (1-6 years) 5-10 ml (3-7 g lactulose) 5-10 ml (3-7 g lactulose) Infants under 1 year 5 ml (up to 3 g lactulose) 5 ml (up to 3 g lactulose) * If the maintenance dose is less than 15 ml, DUFALAC ® syrup in bottles should be used. Use lactulose syrup in bottles with precise dosing for infants and children up to 7 years of age. Use in children Laxatives should be used in children, infants, and newborns only in exceptional cases and under medical supervision, as DUFALAC ® may interfere with normal bowel movement reflexes. Do not give DUFALAC ® syrup to children under 14 years of age until you have consulted your doctor for further advice and careful monitoring. Dosage for hepatic encephalopathy (adults only) Oral administration: The initial dose for hepatic encephalopathy is 30-50 ml of syrup 3 times a day. This dose can be adjusted to a maintenance dose so that soft stools occur no more than 2-3 times a day. Rectal administration: In acute cases of hepatic encephalopathy (pre-coma or coma), DUFALAC ® diluted in water may be administered as an enema (300 ml DUFALAC ® /700 ml water) until oral administration is possible. Use in children with hepatic encephalopathy There is no data on the use of the preparation in children under 18 years of age with hepatic encephalopathy. Use in elderly patients and patients with kidney or liver failure. There are no specific dosage recommendations. If you take more DUFALAC ® than you should: If you take more of the medicine than you should, you may experience diarrhea and abdominal pain. If you have taken too much DUFALAC ®, consult your doctor or pharmacist. If you forget to take DUFALAC ® : If you forget to take DUFALAC ®, wait until the next dose is due. Do not take a double dose to make up for a missed dose. If you stop taking DUFALAC ® : Do not stop or change treatment without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, DUFALAC ® can cause side effects, although not everybody gets them. The following side effects have been reported with DUFALAC ® : Very common (may affect more than 1 in 10 people): • Diarrhea Common (may affect up to 1 in 10 people): • Flatulence (bloating), • Abdominal pain, • Nausea, • Vomiting. Uncommon (may affect up to 1 in 100 people): • Electrolyte imbalance due to diarrhea Unknown (frequency cannot be estimated from the available data): • Hypersensitivity (hypersensitivity); skin reactions such as rash, itching, hives, redness (erythema). In the first few days of taking DUFALAC ® , flatulence may occur. This usually disappears after a few days. Abdominal pain and diarrhea may occur with doses higher than prescribed. In this case, the dose should be reduced. If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately. If you are taking high doses of the preparation (usually only for hepatic encephalopathy (HE)) for a long time, electrolyte imbalance may occur due to diarrhea. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This applies to any possible side effects, including any that are not listed in this leaflet. You can also report side effects directly through the reporting system of the Eurasian Economic Union member states. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store DUFALAC ® Keep this medicine out of the sight and reach of children. Store at a temperature not exceeding 25°C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. This date also applies to the bottles after opening the packaging (bottle). Discard any partially used sachet (stick) of DUFALAC ® . Do not throw away medicines in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information The active ingredient of DUFALAC ® is lactulose. One sachet (stick) of DUFALAC ® syrup contains 15 ml, which is equivalent to 10 g of lactulose. One ml of DUFALAC ® syrup contains 667 mg of lactulose. DUFALAC ® syrup contains purified water as an excipient. Syrup DUFALAC ® contains small amounts of other substances formed during the production process, see paragraph 2. Dosage form, nature and contents of primary packaging Syrup, 667 mg/ml. In white, high-density polyethylene bottles of 200 ml, 500 ml or 1000 ml with a polypropylene screw cap with a first-opening control. The top of the cap (made of polypropylene) sits on the cap and acts as a measuring cup. A label with instructions for use is attached to the bottle. In single-dose sachets (sticks) made of PET/aluminum/PET/PE multilayer material, 15 ml. 10 sachets (sticks) in a cardboard box with instructions for use. Not all pack sizes may be marketed. Description of DUFALAC ® preparation A clear, viscous liquid from colorless to light yellow with a brownish tint. Conditions of dispensing Over-the-counter.
