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DUPHALAC (LACTULOSE) MIKSTŪRA 200ML

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-29
DUPHALAC-LACTULOSE-drug/medicine aproximate price on "DUPHALAC (LACTULOSE) MIKSTŪRA 200ML" in Riga city, Latvia is:
  • 5.90€  6.38$  5.05£  681Rub  68SEK  25PLN  23.48₪ 

DUPHALAC, 667 mg/ml, geriamasis tirpalas, 200 ml


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine  DUPHALAC (LACTULOSE) MIKSTŪRA 200ML     Recheck

Reģ. Nr.: 09-0375

ATC codeA06AD11 

Active substances: Lactulosum

 


Vendor, principal: Solvay Pharmaceut.
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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DUPHALAC 667 mg/ml geriamasis tirpalas 200 ml

 .

DUPHALAC 667MG/1ML 200ML

Package information leaflet: Information for the user

Duphalac 667 mg/ml oral solution

Lactulosum

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you develop any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days.

What is in this leaflet:

1.   What Duphalac is and what it is used for
2.   Before you take Duphalac
3.   How to take Duphalac
4.   Possible side effects
5.   How to store Duphalac
6.   Contents of the pack and other information

1. What Duphalac is and what it is used for What Duphalac is

Duphalac contains a laxative called lactulose. Lactulose works by drawing water into the bowel, which makes the stools softer and easier to pass. Lactulose does not absorb.

What Duphalac is used for

Duphalac is used in case constipation (emptying of the bowel occurs rarely, the stools are dry and hard) to soften the stools. For example:
-   if you have haemorrhoids;
-   if you have had surgery in rectal or descending bowel region.
Duphalac is used for treatment of encephalopathy due to hepatic failure (hepatic encephalophaty). Hepatic encephalophaty is a liver disease causing confusion, tremors, decreased level of conciousness, including coma.
You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days.

2. What you need to know before you use Duphalac Do not take Duphalac:

-   if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
-   if you have:
-   galactosemia (severe genetic disorder that affects your organism’s ability to metabolise galactose),
-   digestive tract blockage (unlike the regular constipation),
-   digestive tract perforation or risk of digestive tract perforation.
Check with your doctor or pharmacist before taking Duphalac if you are not sure.

Warnings and precautions

Before taking Duphalac please ask your doctor or your pharmacist, if you have some condition or disease, especially:
-   if you have abdominal pain with an unknown cause;
-   if you are lactose intolerant;
-   if you have diabetes.
Do not take Duphalac, if you have:
-   galactose or fructose intolerance;
-   lactase deficiency;
-   glucose-galactose malabsorption.
If you have diabetes and you are treated for hepatic encephalophaty, your Duphalac dosage will be higher. This high dose contains a lot of sugar. Therefore you may have to adjust the dosage of your diabetes medication.
Long-term use of unadjusted doses (more than 2-3 soft stools per day) or misuse may cause diarrhoea and electrolyte imbalance.
During treatment with Duphalac, the reflexes of your emptying of the gut, such as the frequency of bowel movements and the need to defecate, may be different from the usual ones.
In the course laxative treatment you need to drink sufficient amounts of liquid (approximately 2 litres daily, equals to 6 to 8 glasses)
Please contact your doctor if you have taken Duphalac for more than 3 days, but your condition has not improved or the symptoms have worsened.

Children

On certain conditions, the doctor may prescribe Duphalac to children or infants. In this case the doctor will carefully observe the treatment.

Other medicines and Duphalac

Tell your pharmacist if you are taking, have recently taken or might take any other medicines.

Duphalac with food and drink

Duphalac may be taken with or without food. There are no limitations concerning food or liquids.

Pregnancy, breast-feeding and fertility

Duphalac may be used during pregnancy and breast-feeding.
There is no known effect on fertility.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Duphalac has no or negligible influence on the ability to drive and use machines.

Duphalac may contain sugars, such as lactose, galactose, epilactose or fructose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Duphalac

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take the medicine every day at the same time.
Swallow the medication at once. Do not hold it in your mouth.
You may take Duphalac oral solution undiluted or diluted with a small amount of liquid.
For bottled Duphalac oral solution you can use the measuring cap included in the package.

Dosing in case of constipation or in case softening of the stool is indicated for medicinal reasons

Daily dose may be administered once daily, e.g. with breakfast, or in two separate doses.
It may take 2 to 3 days for the treatment to take effect. After that, the initial dose will be adjusted to individually suited maintenance dose.

Daily initial dose
Daily maintenance dose
Adults and adolescents
15...45 mL
15...30 mL
Children (7 to 14 years of age)
15 mL
10...15 mL
Children (1 to 6 years of age)
5...10 mL
5...10 mL
Infants under 1 year of age
up to 5 mL
up to 5 mL
Use in children
Use of the laxatives in children, infants and newborns is exceptional and is allowed only under medical supervision.
Do not give Duphalac to children (under 14 years of age) before you have consulted your doctor about prescription and careful observation.

Dosing in case of encephalopathy due to hepatic failure (only for adults):

In case of hepatic encephalopathy the initial dose is 30...45 mL 3...4 times daily.
This dosage may be adjusted to maintenance dose to achieve 2 to 3 soft stools per day.

Use in the elderly patients and patients with renal and hepatic insufficiency

No dosing recommendations can be given.

If you take more Duphalac than you should

In case of overdose you may develop diarrhoea, loss of electrolytes and abdominal pain. If you took more Duphalac than you should have, contact your doctor or pharmacist.

If you forget to take Duphalac

If you forget to take Duphalac, do not worry. Just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Duphalac

Do not change or discontinue the treatment before 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, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions have been reported:
Very common (may affect more than 1 in 10 people)
-   diarrhoea
Common (may affect up to 1 in 10 people)
-   bloated stomach
-   nausea
-   vomiting
-   abdominal pain
Uncommon (may affect up to 1 in 100 people)
-   electrolyte balance disorders due to diarrhoea.
Flatulence may occur during first days of treatment. As a rule it disappears after a couple of days. When higher than recommended doses are used, abdominal pain and diarrhoea may develop. In such case the dose should be reduced.
If you use high doses (which is usually only associated with hepatic encephalopathy) for a longer period, you may develop electrolyte balance disorders due to diarrhoea.

Reporting of side effects

If you develop any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Duphalac

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the bottle label after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Duphalac contains:

The active substance is lactulose.
One ml of Duphalac oral solution contains 667 mg of lactulose.
Duphalac does not contain any other ingredients. It may still contain other sugars from synthesis (e.g. lactose, galactose or fructose) and sulphite.

What Duphalac looks like and contents of the pack

Duphalac oral solution is clear viscous liquid, colourless to brownish-yellow.
Duphalac oral solution is available in 200 mL, 300 ml, 500 mL or 1,000 mL plastic bottles together with a plastic measuring cup. The measuring cup has following measuring lines: 2.5 mL, 5 mL,
10 mL, 15 mL, 20 mL, 25 mL and 30 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

BGP Products SIA
Mūkusalas 101
Rīga, LV 1004
Latvia

Manufacturer

Abbott Biologicals B.V.
Veerweg 12 8121 AA Olst Netherlands
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
BGP Products Switzerland GmbH Estonian branch Liivalaia 13/15 10118 Tallinn Tel: + 372 6363 052

This leaflet was last revised in August 2018.

5





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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