Active ingredients

Auxiliary materials

Indication / application

• The preparation is a laxative; Liver and intestinal therapeutic
• The medicine is used
  • in the case of constipation, which cannot be sufficiently influenced by a high-fiber diet and other general measures
  • for diseases that require easier bowel movements
  • for the prevention and treatment of portocaval encephalopathy (ie disorders of the brain function as a result of chronic liver diseases, especially in cirrhosis of the liver).

dosage

• Always take the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• Also keep in mind that after taking the specified doses of the preparation, it may take a long time, often different from patient to patient, for the desired effect to be seen. The laxative effect of the drug can occur after 2 to 10 hours, but it can also pass 1 to 2 days before the first bowel movement, especially if the dosage is still inadequate.
• The preparation must be dosed differently depending on the area of ​​application. The dosages given here are only intended as a guide and may have to be changed in order to achieve the desired effect.
• Unless otherwise prescribed by your doctor, the usual dose is:
  • With constipation
    • adult
      • 1 to 2 times a day 5 - 10 g (corresponding to 7.5 - 15 ml)
    • children
      • 1 to 2 times a day 3 - 6 g (corresponding to 4.5 - 9 ml)
    • Larger doses of the drug are often required, especially at the beginning of treatment for constipation. In general, this slightly higher starting dose can be reduced after 3-4 days.
  • With portocaval encephalopathy, ie with impairment of the brain function in the context of a liver disease
    • adult
      • When starting treatment for portocaval encephalopathy, adults should take 5 to 10 g (corresponding to 7.5 to 15 ml) 3 to 4 times daily.
      • The dose should then be increased slowly and carefully to 20 - 30 g (corresponding to 30 - 45 ml) 3 to 4 times a day. The goal should be to defecate two to three soft stools a day.
    • children
      • No information is available for use in children.

• Duration of application
  • The duration of treatment depends on the development of the respective clinical picture.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of the drug is too strong or too weak.

• If you take more than you should
  • If the drug has been taken in too large quantities, nausea, vomiting, diarrhea and loss of water and electrolytes (especially potassium and sodium) may occur, which may have to be compensated for by drug therapy.
  • Inform your doctor if such symptoms occur in the event of an overdose. This will then also decide on any treatment measures that may be initiated.

• If you forget to take a dose
  • Even if the recommended dose is taken correctly, it can take some time before the desired effect is achieved.
  • If you have taken too little, the time until it takes effect can be longer; however, the treatment may not be successful at all.
  • If you have forgotten to take a dose of the drug, please continue with the therapy as recommended without increasing the dose yourself! If in doubt, please ask your doctor for advice!

• If you stop taking it
  • If you interrupt treatment with the preparation or stop taking it prematurely, you must expect that the desired effect will not be achieved or that the clinical picture will worsen again. Therefore, please consult your doctor if you want to stop or interrupt treatment.

• If you have any further questions on the use of the medicinal product, ask your doctor and pharmacist.

way

• Please measure the dose you need. This amount of syrup is then mixed with water or with warm drinks, e.g. coffee or tea, or stirred into yogurt, muesli or porridge and taken with these foods.
• It can be taken independently of meals. If a single dose is sufficient to successfully treat constipation, taking it in the morning after breakfast has proven to be particularly tolerable.

Side effects

• Like all medicines, the preparation can cause side effects, although not everybody gets them. When evaluating side effects, the following frequencies are usually used as a basis:
  • Very common: affects more than 1 in 10 people
  • Common: affects 1 to 10 users in 100
  • Uncommon: affects 1 to 10 users in 1,000
  • Rare: affects 1 to 10 users in 10,000
  • Very rare: less than 1 user in 10,000
  • Not known: frequency cannot be estimated from the available data
• Gastrointestinal disorders
  • Very common: With moderate doses, mild abdominal pain or gas and flatulence occurs at the beginning of treatment. At high doses, nausea, vomiting and diarrhea with disturbances in the electrolyte balance can occur.
• Metabolism and nutrition disorders
  • Not known: Long-term use in a dose that leads to persistently thin stools, the usual laxative-related disorders in the area of ​​the water and electrolyte balance (increased excretion of potassium, sodium and water) and their consequential effects must be expected.
  • Rare: Increased sodium levels in the blood (hypernatremia) have been reported in the treatment of disorders of brain function due to chronic liver disease (portocaval encephalopathy).
• Significant side effects or signs to look out for and what to do if they're affected:
  • The possible adverse drug effects at the beginning of treatment with the drug, which can manifest themselves in mild abdominal pain and flatulence, usually disappear on their own in the further course of treatment.
  • Should diarrhea and subsequent disturbances in the water and electrolyte balance occur while taking the preparation, usually in high doses, these may need to be treated with medication and any deficiency in water, potassium or sodium salts compensated for. In this case, it is often necessary to reduce the amount of the drug to be taken.
  • If you notice these undesirable effects, please inform your doctor. This will then also decide whether a reduction or, in rare cases, discontinuation of the preparation is necessary.
• Please inform your doctor or pharmacist if you get seriously affected by any of the side effects listed, or if you notice side effects that are not listed.

Interactions

• When using the preparation with other drugs
  • Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
  • The preparation can increase the loss of potassium from other medicines taken at the same time. These include certain water tablets (diuretics) and adrenal cortical hormones (corticoids) and amphotericin B.
  • In the case of a potassium deficiency, the sensitivity to cardiac glycosides (e.g. digitoxin) is increased.

Contraindications

• The medicine must NOT be taken
  • if you are hypersensitive (allergic) to lactulose or any of the other ingredients of the preparation
  • if you have symptoms such as stomach pain, vomiting and fever These could be signs of a serious illness such as bowel obstruction (ileus) or inflammation of the gastrointestinal area In the event of such complaints, you should seek medical advice immediately.

pregnancy and breast feeding period

• There are no known harmful effects of lactulose when taken during pregnancy and breastfeeding. Lactulose can also be taken during pregnancy and breastfeeding.

Patient information

• Take special care when taking the drug
  • If the water and electrolyte balance is disturbed (salt loss), the preparation should not be taken.
  • If you have been constipated for a long time, you should consult and examine your doctor before starting therapy with the drug, because chronic disorders or impaired bowel movements can be signs of a more serious illness!
• children
  • Since an inherited fructose intolerance may not yet have been recognized in infants and young children, they should only receive the preparation after consulting a doctor.

• Driving and using machines
  • The drug has no adverse effects on cognition, judgment or the ability to react.