DUPHALAC syr 200ml
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after a few days you do not feel better or your condition worsens, you should seek medical attention. See point 2.
Package contents and additional information
1. What Dufalac is and what it is used for
Dufalac contains a laxative called lactulose. It makes stools softer and easier to pass through the intestines by drawing water into them. It is not absorbed into your body.
Dufalac is used to treat constipation (difficulty passing stools, dry and hard stools) and to form soft stools. For example:
if you have hemorrhoids
if you have had operations on the anus or colon
Dufalac is used to treat hepatic encephalopathy (liver disease leading to confusion, tremors, changes in consciousness, including coma).
2. What you need to know before you take Dufalac
Do not take Dufalac:
if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6)
if you suffer from galactosemia (a rare genetic condition where you cannot digest galactose)
in cases of gastrointestinal obstruction (other than normal constipation)
perforation or risk of perforation of the digestive tract
Warnings and precautions
Talk to your doctor or pharmacist before taking Dufalac if:
you suffer from abdominal pain
you cannot digest milk sugar (lactose)
you have diabetes
You should not take Dufalac if you suffer from:
intolerance to galactose or fructose
lactose insufficiency
glucose-galactose malabsorption
If you have diabetes and are being treated for hepatic encephalopathy, your dose of Dufalac will be higher. This high dose contains a large amount of sugar. Therefore, the dose of your antidiabetic medicine should be changed.
Continued intake of an unadapted dose (resulting in more than 2-3 soft stools per day) or improper use can lead to diarrhea and electrolyte imbalance.
Please do not take Dufalac without a doctor's recommendation for more than 2 weeks.
During treatment with laxatives, you should drink enough fluids (approximately 2 liters per day, equal to 6-8 glasses).
If your condition does not improve after several days of treatment or your symptoms worsen, consult a doctor.
Children
In special circumstances, your doctor may prescribe Dufalac for your child, infant or baby. In these cases, the doctor will carefully monitor the treatment. Dufalac should be given to newborns and young children only if indicated because it may interfere with normal defecation reflexes.
Other medicines and Dufalac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Dufalac with food, drink and alcohol
Dufalac can be taken with or without food. There are no restrictions on what food and drinks you can consume.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice.
Dufalac can be used during pregnancy and breastfeeding. No effects on fertility are expected.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Dufalac has no or negligible influence on your ability to drive and use machines.
Important information about some of the ingredients of Dufalac.
Dufalac may contain milk sugar (lactose), galactose or fructose.
If your doctor has informed you that you have an intolerance to some sugars, please consult a doctor before taking this medicine.
3. How to take Dufalac
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Take the dose at the same time each day.
Swallow the medicine quickly, do not hold it in the mouth.
You can take Dufalac undiluted or diluted with liquid.
For Dufalac in a bottle, use the measuring cup.
For Dufalac 15 ml single dose sachet, break the end of the sachet and take the contents immediately.
Dosage for constipation and medical necessity of loose stools
The dose can be taken once daily, for example at breakfast, or divided into two daily doses. For Dufalac in a bottle, use the measuring cup.
After a few days, the starting dose may be changed to a maintenance dose based on your response. It takes several days (2-3 days) before an effect occurs.
Initial dosage per day Maintenance dosage per day
Adults and adolescents
15-45 ml,
which corresponds to 1-3 sachets
15-30 ml,
which corresponds to 1-2 sachets
Children 7-14 years
15ml,
which corresponds to 1 sachet
10-15 ml,
which corresponds to 1 sachet*
Children 1-6 years 5-10 ml 5-10 ml
Infants under 1 year Up to 5 ml Up to 5 ml
If the maintenance dose is less than 15 ml, use a Dufalac bottle.
For accurate dosing in infants and children up to 7 years of age, Dufalac in a bottle should be used.
Use in children
The use of laxatives in children, infants and newborns should be done exceptionally and under medical supervision, as it can affect the normal excretion of feces.
Please do not give Dufalac to children under 14 years of age before consulting your doctor for prescription and medical supervision.
Dosage in Hepatic Encephalopathy (Adults Only)
The starting dose is 30-45 ml of oral solution (2-3 sachets of the solution for oral administration) 3 to 4 times a day.
This dose can be changed to maintenance to ensure soft stools 2-3 times a day.
Use in children
No data are available for the treatment of children (newborns and up to 18 years of age) with hepatic encephalopathy.
Use in elderly patients and patients with renal or hepatic insufficiency
There are no specific recommended dosages.
If you have taken more than the required dose of Dufalac
If you have taken more than the required dose of Dufalac you may have diarrhoea, abdominal pain and loss of electrolytes.
Contact your doctor or pharmacist if you have taken a higher dose of Dufalac.
If you forget to take Dufalac
Do not take a double dose to make up for a missed dose.
If you have stopped taking Dufalac
Do not stop or change your treatment without consulting your doctor or pharmacist.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible adverse drug reactions when taking Dufalac.
Very common side effects (between 1 and 10 patients, in every 10 treated)
diarrhea
Common side effects (between 1 and 10 patients in every 100 treated):
flatulence (swelling of the abdomen)
nausea
vomiting
stomach ache
Uncommon side effects between 1 and 10 patients in every 1,000 treated):
electrolyte imbalance that is due to diarrhea
Abdominal swelling occurs during the first few days of treatment. As a rule, it disappears after a few days. When doses are higher than recommended, abdominal pain and diarrhea may occur. In these cases, the dose should be reduced.
If you use high doses (which is common only in hepatic encephalopathy) for a longer period of time, you may get electrolyte imbalance due to diarrhea.
Adverse reaction reporting
If you experience any side effects, tell your doctor. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Phone: +35 928903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Dufalac
Keep out of the reach of children.
To be stored at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the pack. The expiration date corresponds to the last day of the specified month.
Shelf life - 3 years
Expiry date after opening
Bottle:
Shelf life after first opening - 148 days.
Sachet:
Unused sachets should be discarded.
Do not dispose of medicines down the drain or household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Dufalac contains
The active substance is lactulose. 1 ml of Dufalac solution for oral administration contains 667 mg of lactulose.
Dufalac does not contain excipients. May contain other sugars such as lactose, galactose and fructose.
What Dufalac looks like and contents of the pack
Dufalac is a brownish-yellow solution for oral administration.
Sachets of 15 ml - made of polyester / aluminum / polyethylene laminate.
High-density polyethylene (HDPE) bottles with polypropylene caps - 200 ml, 300 ml and 500 ml; with polypropylene measuring cups.
