Order DUPHALAC 66,5 % oral suspension 200ml without prescription and give your opinion. This medicine is recommended for the symptomatic treatment of constipation.
Find the composition and dosage of DUPHALAC 66.5% Oral Suspension 200ml in our online organic pharmacy: lactulose solution.
For warnings, precautions and contraindications, please refer to the DUPHALAC 66.5% Oral Suspension 200ml non-prescription leaflet.
When should I seek medical advice for constipation?
In the event of worsening of symptoms or changes in the usual symptoms, it is imperative to consult a specialist. If the period of constipation becomes too long, if there is a reduction in stool size, the appearance of intense pain, blood in the stools or vomiting, a medical check-up should be carried out to ensure that there is no more serious associated disease.
Hepatic encephalopathy is initially characterized by changes in the nycthemeral rhythm, i.e. the rhythm of wakefulness and sleep during the day, and asterixis, manifested by abnormal wrist movements. The disease then progresses to consciousness and behavior disorders, confusion and even coma.
Take by mouth.
Take doses at the same time each day.
Swallow promptly, without holding it in the mouth.
Duphalac comes in a 200ml bottle.
DUPHALAC 66.5% Oral Suspension 200ml is not a product like any other. Read the package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 20/04/2017
DUPHALAC 66.5 PERCENT, oral solution in vial
lactulose
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well after several days.
1. What is DUPHALAC 66.5 PERCENT, oral solution in vial and in which cases it is used?
2. What should I know before taking DUPHALAC 66.5 PER CENT, oral solution in a vial?
3. How to take DUPHALAC 66.5 PERCENT, oral solution in vial?
4. What are the possible side effects?
5. How to store DUPHALAC 66.5 PER CENT, oral solution in a vial?
6. Package contents and other information.
1. WHAT IS DUPHALAC 66.5 PERCENT, oral solution in a vial AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code:
· DUPHALAC is used to treat constipation (uncommon, hard and dry stools) by making loose stools.
· DUPHALAC is used in the treatment of systemic hepatic encephalopathy (a liver disease causing difficulty in thinking, confusion, tremors, decreased level of consciousness that can go as far as coma).
2. BEFORE YOU TAKE DUPHALAC 66.5 PER CENT, oral solution in a vial?
Do not take DUPHALAC 66.5 PERCENT, oral solution in vial:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6;
· in the case of progressive or inflammatory bowel disease or bowel disease such as ulcerative colitis, Crohn's disease;
· in the case of intestinal occlusion;
· in case of digestive perforation or suspicion of perforation;
· in case of abdominal pain (stomach pain) of undetermined cause.
Warnings and Precautions
Talk to your doctor or pharmacist before taking DUPHALAC 66.5 PERCENT, oral solution in a vial .
IN THE CONTEXT OF CONSTIPATION NO LONGER USE (OVER 8 DAYS) WITHOUT MEDICAL ADVICE.
Occasional constipation
It may be related to a recent change in lifestyle (eg travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation)
It can be linked to two causes:
· or a bowel disease that requires a physician to take care of;
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);
· increased consumption of water and fruit juices;
· an increase in physical activities (sports, walking, etc.);
· rehabilitation of the defecation reflex;
· sometimes, adding sound to the diet.
Special cases of the child
In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right amount of water with infant milk powders, a diet rich in vegetable products, addition of Juice.
In infants and children, the prescription of DUPHALAC should be exceptional because it can impede the normal functioning of the exemption reflex.
Precautions for use
Please consult your doctor before taking DUPHALAC if you are suffering from medical conditions or diseases, in particular:
· if you suffer:
o galactose intolerance, galactosemia,
o of a syndrome of malabsorption of glucose or galactose (rare hereditary diseases),
o of a lactase deficiency of Lapp,
o fructose intolerance (rare hereditary disease),
· if you are diabetic.
The dosage usually used in the treatment of constipation is not likely to affect diabetic patients.
If you are diabetic and you are being treated for hepatic encephalopathy, the dose of DUPHALAC will be higher. This high dose contains a greater amount of sugar. Therefore, it may be necessary to adjust the dose of your antidiabetic medication.
Chronic use at an unsuitable dose (resulting in more than 2 to 3 loose stools per day) or misuse can result in diarrhea and electrolyte balance disorders.
If you have a tendency to develop electrolyte disorders (eg in patients with renal or hepatic impairment, simultaneous use of diuretics), talk to your doctor or pharmacist before taking DUPHALAC.
You should drink a sufficient amount of fluid (about 1.5 to 2 liters per day, or 6 to 8 glasses) during treatment with laxatives.
If you are taking DUPHALAC for several days without improving your condition or if the symptoms worsen, consult your doctor.
children
Not applicable.
Other drugs and DUPHALAC 66.5 PERCENT, oral solution in vial
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DUPHALAC 66.5 PERCENT, oral solution in food and beverage bottle
DUPHALAC may be taken with or without food. There is no restriction on what you can eat or drink.
Pregnancy and breast feeding
DUPHALAC can be used during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Driving and using machines
DUPHALAC has no or negligible influence on the ability to drive or use machines.
DUPHALAC 66.5 PERCENT, oral solution in vial contains some sugars.
DUPHALAC may contain small amounts of milk sugar (lactose), galactose, epilactose or fructose (see section Precautions for use).
3. HOW TO USE DUPHALAC 66.5 PERCENT, oral solution in vial?
Dosage
Constipation:
This medication can be given once a day, for example at breakfast or two times a day.
After a few days, depending on your response to the treatment, the attack dose can be adjusted to reach the maintenance dose. Several days (2 to 3) may be required before treatment takes place.
The average dosage:
Children and Infants
Infants from 0 to 12 months: up to 5 ml per day
Children from 1 to 6 years: 5 to 10 ml or 1 graduation of 5 ml to 1 graduation of 10 ml per day
Children from 7 to 14 years:
· Treatment of attack: 15 ml or graduation of 15 ml per day.
· Maintenance treatment: 10 ml or 1 graduation of 10 ml per day.
Adults and adolescents
· Treatment of attack: 15 to 45 ml or 1 graduation of 15 ml to 3 graduations of 15 ml per day.
· Maintenance treatment: 10 to 25 ml or 1 graduation of 10 ml to 1 graduation of 25 ml per day.
If diarrhea occurs, decrease dosage.
Use in children and adolescents
In infants and children, the prescription of DUPHALAC should be exceptional because it can impede the normal functioning of the exemption reflex.
Do not give DUPHALAC to children (<14 years of age) without consulting a doctor for a prescription and without close supervision.
In the elderly patient and patient with renal or hepatic impairment, no dosage adjustment is necessary as exposure to lactulose is negligible.
Hepatic encephalopathy
In all cases, the ideal dose is that which leads to two loose stools per day.
Use in adults: the average dosage is 15 to 30 ml or 1 graduation of 15 ml to 1 graduation of 30 ml, 3 times a day.
Use in children and adolescents: No data are available for the treatment of children (newborns up to 18 years of age) with hepatic encephalopathy.
Administration mode
Oral use.
Take the doses every day at the same time.
Swallow the drug quickly, without keeping it in your mouth.
DUPHALAC 66.5 PERCENT can be taken pure or diluted in a drink.
On the cup, the dosage per dose is indicated in ml (2.5 to 30 ml).
Rinse the bucket thoroughly with clean water after each use and replace it on the bottle cap.
Duration of the treatment
The duration of treatment varies according to the symptomatology.
If you take more DUPHALAC 66.5 PERCENT oral solution in a vial than you should:
In case of overdose, diarrhea or abdominal pain may occur.
If you take more DUPHALAC than you should, consult your doctor or pharmacist.
If you forget to take DUPHALAC 66.5 PER CENT, oral solution in vial:
If you stop taking DUPHALAC 66.5 PERCENT, oral solution in vial:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following adverse reactions have been reported:
· Very common (affect more than 1 in 10 people using this drug)
o diarrhea.
· Common (affects up to 1 in 10 people using this drug)
o flatulence (bloating),
o nausea,
o vomiting,
o abdominal pain.
· Uncommon (affecting up to 1 in 100 people using this medication)
o electrolyte imbalance caused by diarrhea.
Bloating may occur at the beginning of treatment, usually they stop after a few days.
When doses above the recommended dosage are used, abdominal pain and diarrhea may occur.
If high doses are given for a prolonged period (usually in case of liver encephalopathy), an electrolyte imbalance may occur due to diarrhea.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE DUPHALAC 66.5 PER CENT, oral solution in vial?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C. Do not refrigerate (risk of crystallization).
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What DUPHALAC contains 66.5 PERCENT, oral solution in vial
· The active substance is:
Lactulose ................................................. .................................................. 66.5 g
In the form of liquid lactulose.
For 100 ml of solution
· The other excipients components are:
No.
What is DUPHALAC 66.5 PERCENT, oral solution in bottle and contents of the pack
This medication is in the form of a colorless to yellowish-brownish, viscous and clear solution.
This medicine is available as a 200 ml, 300 ml, 500 ml or 1000 ml bottle.
Not all pack sizes may be marketed.
Marketing Authorization Holder
42, RUE ROUGET DE LISLE
92150 SURESNES
Marketing Authorization Operator
42, RUE ROUGET DE LISLE
92150 SURESNES
VEERWEG 12
8121 AA OLST
NETHERLANDS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Osmotic laxative
lactulose
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
DUPHALAC: oral solution; 200 ml bottle with measuring cup graduated from 2.5 ml to 30 ml.
Refunded at 30%. - price: 1,52 euro (s).
DUPHALAC: oral solution; box of 20 sachets of 15 ml.
Refunded at 30%. - price: 2.53 euro (s).
Laboratory
| p 15 ml | p sachet | |
| Lactulose (fructose + galactose) | 10 g | 10 g |
Usual dosage:
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