LACTULOSE AIWA 670 mg/mL oral solution, 1000 mL

Instructions for use for LACTULOSE AIWA 670 mg/mL oral solution, 1000 mL

Application Notes

Baby	5 ml	1 time per day	regardless of the meal
Children from 1-6 years	5-10 ml	1 time per day	regardless of the meal
Children from 7-14 years	15 ml	1 time per day	regardless of the meal
Adolescents from 14 years and adults	15-45 ml	1 time per day	regardless of the meal

Baby	5 ml	1 time per day	for the first meal
Children from 1-6 years	5-10 ml	1 time per day	for the first meal
Children from 7-14 years	10-15 ml	1 time per day	for the first meal
Adolescents from 14 years and adults	15-30 ml	1 time per day	for the first meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient is broken down by the naturally occurring bacteria in the large intestine and changes the acid-base balance there, which stimulates the intestinal wall to move more. Thus, the intestinal contents are transported away more easily. The high concentration of the broken down components (sugars and fatty acids) also draws water into the intestines. The intestinal contents are softened and increase in volume. The increased intestinal content causes a stretching stimulus on the intestinal wall and thus triggers the reflex to empty the intestines.
The active substance reduces the concentration of ammonia in the blood by approx. 25-50% by preventing the reabsorption of ammonia from the intestine into the bloodstream. The ammonia can no longer get into the brain, where it has a toxic effect.

Composition

Contraindications

What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Intestinal obstruction
- Bowel perforation or risk of bowel perforation

Under certain circumstances - talk to your doctor or pharmacist about this:
- Inflammatory gastrointestinal diseases that are acute
- Disorders of fluid and salt balance
- Disorder of sugar absorption

What age group do you need to consider?
- Children and adolescents under the age of 18: In this age group, the drug should only be used in certain areas of application. Please ask your doctor or pharmacist, if you have questions regarding this topic.

What about pregnancy and lactation?
- Pregnancy: According to current knowledge, the medicine has no harmful effects on the development of your child or the birth.
- Breast-feeding: According to current knowledge, there are no indications that the drug should not be used during breast-feeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

- Gastrointestinal problems such as:
- Nausea
- Vomiting
- Diarrhea
- Stomach pain
- Bloating
- Disorders of the salt balance

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Hints

What should you consider?
- Only use laxative medicines for short periods without medical advice. Long-term use may lead to chronic constipation and/or other problems. If you are unsuccessful after a short period of use, contact your doctor or pharmacist.
- Caution: Laxatives are not suitable for weight loss.
- Be careful if you have an intolerance to fructose (fruit sugar). If you have to follow a diabetic diet, you should consider the sugar content.
- Beware of intolerance to galactose. If you have to follow a diabetic diet, you should consider the sugar content.
- Beware of intolerance to lactose. If you have to follow a diabetic diet, you should consider the sugar content.
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

Detailed instructions for LACTULOSE AIWA 670 mg/mL oral solution, 1000 mL

Field of use

• The medicine contains a laxative (laxative) called lactulose. It draws water into the intestines, softening the stool so that it can pass through the intestines more easily. It is not absorbed into your body.
• The preparation is used:
  • to treat the symptoms of constipation
  • to treat a specific liver disease (portocaval encephalopathy)
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

Active substances / ingredients / ingredients

Lactulose syrup
670 mg lactulose
0.014 BE Total carbohydrate excipient (+)

Contraindications

• The drug must not be taken,
  • if you are allergic to lactulose or any of the other ingredients of this medicine.
  • if you under
    • Suffer from galactosemia (a severe genetic defect in which galactose cannot be digested)
    • acute inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis), obstructions in your gut (apart from normal constipation), perforation or risk of perforation in the gastrointestinal tract, or unexplained abdominal pain.

dosage

• 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 your doses at the same time each day. The dose can be given once a day, for example at breakfast, or divided into up to three doses per day.
• The recommended dose is:
  • For constipation:
    • Initial dose
      • Adults: 15 - 45 ml
        • corresponding to 10 - 30 g lactulose
    • Maintenance dose
      • Adults: 15 - 30 ml
        • corresponding to 10 - 20 g lactulose
  • Use in children and adolescents
    • Adolescents over 14 years of age
      • Initial dose: 15 - 45 ml
        • corresponding to 10 - 30 g lactulose
      • Maintenance dose: 15 - 30 ml
        • corresponding to 10 - 20 g lactulose
    • Children (7 - 14 years)
      • Initial dose: 15 ml
        • equivalent to 10 g lactulose
      • Maintenance dose: 10 - 15 ml
        • corresponding to 7 - 10 g lactulose
    • Children (1 - 6 years)
      • Initial dose: 5 - 10 ml
        • corresponding to 3 - 7 g lactulose
    • Newborn
      • Initial dose: up to 5 ml
        • corresponding to up to 3 g lactulose
• After that, the dose can be reduced individually.
• The daily dose should be taken in one serving at breakfast. It can take 2-3 days for the desired effect to set in, as lactulose is only broken down in the large intestine.
• In portacaval encephalopathy (disorder of brain function due to liver disease)
  • At the beginning of treatment 30 - 50 ml 3 times a day (equivalent to 60 - 100 g lactulose).
  • The dose should be adjusted to achieve 2-3 loose stools per day. The pH of the stools should be between 5.0 and 5.5.
  • There are no special dosage recommendations for elderly patients or patients with renal or hepatic insufficiency.
• Use in children and adolescents
  • The safety and efficacy in children aged 0 to 18 years have not been established.

 

• If you take more than you should
  • In the event of an overdose, diarrhea and abdominal pain may occur. Contact your doctor or pharmacist if you have taken more than the prescribed dose of lactulose.
    

 

• If you forget to take a dose
  • If you miss a dose of Lactulose, 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 it
  • The desired effect of the drug cannot then be achieved.

 

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Revenue

• Swallow the medicine quickly. Don't keep it in your mouth.
• You can take the medicine undiluted or diluted in liquid. Use the dosing aid provided.
• You should drink enough fluids (about 2 liters / day, equivalent to 6 - 8 glasses) during treatment with laxatives.

Patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking Lactulose.
  • If you suffer from gastrocardial syndrome (Roemheld syndrome), tell your doctor before taking lactulose.
  • If you experience symptoms such as meteorism or bloating after use, discontinue use and consult your doctor. The doctor will carefully monitor the treatment in these cases.
  • Long-term use of inappropriate doses (resulting in more than 2-3 loose stools per day) or abuse can lead to diarrhea and electrolyte imbalance. If you are elderly or in poor general condition and have been taking lactulose for more than 6 months, your doctor will check your blood electrolytes regularly.
  • Patients with portocaval encephalopathy should avoid the concomitant use of other laxatives because the drug dose cannot be individually adjusted in this way. Please do not use Lactulose for more than two weeks without medical advice.
  • Lactulose may contain traces of sugars through the synthetic pathway. If you have been told by your doctor that you have an intolerance to some sugars, then you should seek medical advice before taking this medicine.
  • You should drink enough fluids (about 2 liters / day, equivalent to 6 - 8 glasses) during treatment with laxatives.
  • Children
    • The medicine should not normally be given to infants and newborns, as it may interfere with normal bowel reflexes.
    • The doctor can prescribe lactulose for a child, toddler or newborn under special conditions. The doctor will carefully monitor the treatment in these cases.

 

• Ability to drive and use machines
  • Lactulose has no influence on the ability to drive and use machines.

Pregnancy

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Hints

Manufacturer:  T & D Pharma GmbH, Kleine Knopheide 4, 32657 Lemgo