Give your opinion on Lactulose Viatris - Mylan 10g / 15 ml 20 sachets is used for the symptomatic treatment of constipation and in cases of hepatic encephalopathy. Find out more about its composition and dosage in our online pharmacy.
For information on warnings, precautions for use and contraindications, please consult the instructions for use.
If the use of laxatives can be frightening, because it's more invasive than a simple change in eating habits, you should know that there are different, more or less aggressive forms:
Effective treatment of Constipation and Hepatic Encephalopathy with Viatris - Mylan Lactulose
A Versatile Solution for Two Medical Conditions
Viatris - Mylan Lactulose, presented in 10g / 15 ml sachets, is a medicine used both for the symptomatic treatment of constipation and in cases of hepatic encephalopathy. Its specific composition and mode of action make it remarkably effective in relieving the symptoms associated with these two medical conditions.
An Osmotic Laxative for Constipation
Lactulose, the main component of Lactulose Viatris - Mylan, is an osmotic laxative which acts by increasing the volume and frequency of stools, thus promoting intestinal transit and relieving constipation. Its gentle, well-tolerated action makes it a preferred choice for the short-term treatment of constipation in adults and children.
An ammonia-removing agent for hepatic encephalopathy
In cases of hepatic encephalopathy, Viatris - Mylan Lactulose also acts as an eliminator of ammonia, a toxin produced by the liver that can accumulate in the blood in cases of hepatic dysfunction. Lactulose promotes the excretion of ammonia through the stool, helping to reduce the neurological symptoms associated with this liver complication.
Lactulose Viatris - Mylan 10g / 15 ml is an osmotic laxative. It draws water into the intestine and increases stool volume.
It is used in the symptomatic treatment of constipation. Its laxative action can also be useful in the treatment of hepatic encephalopathy (brain disorder linked to liver disease).
For oral use.
Lactulose Viatris - Mylan 10g / 15 ml can be taken neat or diluted in a drink.
Rectal use.
This medicine must be diluted in water.
Constipation:
Dosage must be adapted to each individual according to the results obtained.
On average:
Adults:
Children aged 7 to 14:
If diarrhea occurs, reduce dosage.
Hepatic encephalopathy :
In all cases, the ideal dose is that which leads to two loose stools per day. Duration of treatment varies according to symptomatology:
initial treatment with gastric tube or enema in case of coma or pre-coma
relay treatment
per c to c per sachet or p c to s
Lactulose (fructose + galactose) 3.33 g 10 g
This medicine must not be used in the following cases:
Warning:
Box of 20 sachets.
Warning: this medicine is not 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.
Viatris - Mylan Lactulose FAQ:
Q: How should I take Lactulose Viatris - Mylan to treat constipation?
A: The dosage of Lactulose Viatris - Mylan varies according to age and the severity of constipation. It is generally recommended to start with a low dose and gradually adjust according to clinical response. Always consult the package leaflet or ask your doctor for advice.
Q: What are the possible side effects of Lactulose Viatris - Mylan?
A: The most common side effects of Lactulose Viatris - Mylan include abdominal cramps, bloating and diarrhea. However, these effects are generally mild and temporary. If you experience severe or persistent side effects, consult a health care professional.
Q: How long does it take to see improvements with Viatris - Mylan Lactulose in cases of hepatic encephalopathy?
A: Improvements in the symptoms of hepatic encephalopathy can be seen within days of starting treatment with Viatris Lactulose - Mylan. However, long-term treatment may be required to keep symptoms under control.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 16/09/2016
LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet
lactulose
You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor, pharmacist or nurse. 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.
Do not use this medication for children.
1. What is LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachets and in which cases it is used?
2. What should I know before taking LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachets?
3. How to take LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet?
4. What are the possible side effects?
5. How to store LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachets?
6. Package contents and other information.
1. WHAT IS LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachets AND WHAT IS IT?
Pharmacotherapeutic group - ATC code: A06AD11.
LACTULOSE BIOGARAN contains a laxative called lactulose. It makes the stools soft and easier to remove, attracting water into the intestine. It is not absorbed into your body.
This medication is used:
· to treat constipation (uncommon, hard and dry stools) by making the stool soft,
· in the treatment of systemic hepatic encephalopathy (a liver disease causing difficulty in thinking, confusion, tremors, decreased level of consciousness that can lead to coma).
2. BEFORE YOU TAKE LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet?
Do not take LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet:
· if you are allergic (hypersensitive) to lactulose or 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.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Special warnings
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:
· 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 LACTULOSE BIOGARAN should be exceptional because it may interfere with the normal functioning of the exemption reflex.
Precautions for use
Talk to your doctor, pharmacist or nurse before taking LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachets, if you suffer from medical conditions or diseases, in particular:
· if you suffer:
o galactose intolerance, galactosemia;
o malabsorption syndrome of glucose or galactose (rare hereditary diseases);
o Lapp lactase deficiency;
· 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 liver encephalopathy, the dose of LACTULOSE BIOGARAN 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 disturbances (eg in patients with renal or hepatic impairment, concomitant use of diuretics), talk to your doctor or pharmacist before taking LACTULOSE BIOGARAN.
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 take LACTULOSE BIOGARAN for several days without improving your condition or if the symptoms worsen, consult your doctor.
children
Not applicable.
Other medicines and LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachets with food and beverages
Pregnancy and breast feeding
LACTULOSE BIOGARAN 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 or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Driving and using machines
LACTULOSE BIOGARAN has no or negligible influence on the ability to drive or use machines.
LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet contains {name the excipient (s)}
Not applicable.
3. HOW TO TAKE LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet?
Dosage
Constipation:
This medication can be given once a day, for example at breakfast or two times a day.
Depending on your response to treatment, the initial dose can be adjusted to reach the maintenance dose. Several days (2 to 3) may be necessary before the treatment takes effect.
It is on average:
Adults and adolescents:
· Attack treatment: 1 to 3 sachets per day.
· Maintenance treatment: 1 to 2 sachets per day.
Children from 7 to 14 years:
· Attack treatment: 1 sachet per day.
If diarrhea occurs, decrease dosage.
For appropriate dosage in infants and children up to 7 years of age, LACTULOSE BIOGARAN bottle should be used.
Use in children and adolescents
In infants and children, the prescription of LACTULOSE BIOGARAN should be exceptional because it may interfere with the normal functioning of the exemption reflex.
Do not give LACTULOSE BIOGARAN 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 1 to 2 sachets 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.
The corner of the sachet of LACTULOSE BIOGARAN must be torn and the contents taken immediately.
Swallow the drug quickly, without keeping it in your mouth.
LACTULOSE BIOGARAN can be taken pure or diluted in a drink.
Duration of treatment
The duration of treatment varies according to the symptomatology.
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
If you take more LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet you should:
Immediately consult your doctor or pharmacist.
In case of overdose, diarrhea or abdominal pain may occur.
If you forget to take LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet:
If you forget to take a dose of LACTULOSE BIOGARAN, do not worry. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet:
Not applicable.
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):
· Diarrhea.
Common (affects up to 1 in 10 people using this drug):
· Flatulence (bloating).
· Nausea.
· Vomiting.
· Abdominal pain.
Uncommon (affecting up to 1 in 100 people using this drug):
· Electrolytic 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, pharmacist or nurse. 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 LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet?
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 .
Do not refrigerate (to avoid 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 LACTULOSE BIOGARAN contains 10 g / 15 ml, oral solution in sachet
· The active substance is:
Liquid Lactulose ................................................ .................................................. .......... 20.00 g
Quantity corresponding to lactulose .............................................. .................................. 10.00 g
· The other excipients are:
Prune aroma *.
* Prune aroma composition: benzaldehyde, benzyl alcohol, ethyl butyrate, isobutyric acid, butyl acetate, dihydrocoumarin, ethyl acetate, hexyl acetate, geraniol, cyclotene, furfural, gamma octalactone, gamma dodecalactone, oil essential orange, linalool, phenyl acetaldehyde, ethyl vanillin, ethyl maltol, propylene glycol.
What is LACTULOSE BIOGARAN 10 g / 15 ml, oral solution in sachet and contents of the pack
This medication is in the form of a drinkable solution in a sachet. Box of 20.
Oral solution in sachet.
Not all pack sizes may be marketed.
Marketing Authorization Holder
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing Authorization Operator
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
USINE OF PETIT PARIS
91731 BRETIGNY-SUR-ORGE CEDEX
or
Pharmatis
SITE OF ESTREES SAINT-DENIS
PLACE "THE POND OF THE POND"
BP 20
60190 ESTREES-SAINT-DENIS
or
H2 PHARMA
ZAC LA CROIX BONNET
21 RUE JACQUES TATI
78390 BOIS D'ARCY
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]
Detailed information on this medicine is available on the ANSM website (France).
Osmotic laxative
This medication is a generic of DUPHALAC
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
LACTULOSE BIOGARAN 50%: oral solution (orange flavoring); bottle of 200 ml.
Refunded at 30%. - price: 1,52 euro (s).
LACTULOSE BIOGARAN 10 g / 15 ml: oral solution; box of 20 sachets of 15 ml.
Refunded at 30%. - price: 2,33 euro (s).
Biogaran Laboratory
| pc to c | p sachetou pc to s | |
| Lactulose (fructose + galactose) | 3.33 g | 10 g |
Usual dosage:
Constipation:
