LACTULOSE AL

LACTULOSE AL syrup

Important notes (mandatory information)

Lactulose AL Syrup Areas of application: for constipation that cannot be sufficiently influenced by a diet rich in fibre and other general measures, as well as for conditions that require easier bowel movements and for the prevention and treatment of portocaval encephalopathy (i.e. disorders of brain function due to chronic liver diseases, especially in the case of liver cirrhosis).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


Patient information: Information for the user
Lactulose AL Syrup
Active ingredients: Lactulose 66.7 g in 100 ml syrup

Read all of the patient information carefully because it contains important information for you. This medicine is available without a prescription. However, Lactulose AL Syrup must be used as directed in order to be effective.
o Keep the patient information. You may need to read it again later.
o Ask your pharmacist if you need more information or advice.
o If your symptoms worsen or do not improve, you must see a doctor.
o If any of the side effects gets serious, or if you notice any side effects not listed in this patient information, please tell your doctor or pharmacist.

This patient information includes

1. WHAT IS LACTULOSE AL SYRUP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING LACTULOSE AL SYRUP?
3. HOW SHOULD LACTULOSE AL SYRUP BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LACTULOSE AL SYRUP BE STORED?
6. FURTHER INFORMATION

1. WHAT IS LACTULOSE AL SYRUP AND WHAT IS IT USED FOR?
Lactulose AL Syrup is a laxative; liver and intestinal therapeutic.

Lactulose AL Syrup is used

o for constipation that cannot be sufficiently influenced by a diet rich in fibre and other general measures, as well as for conditions that require easier bowel movements.
o for the prevention and treatment of portocaval encephalopathy (i.e. disorders of brain function due to chronic liver diseases, especially in the case of liver cirrhosis).

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING LACTULOSE AL SYRUP?
Lactulose AL Syrup must not be taken
Complaints such as abdominal pain, vomiting and fever can be signs of a serious condition, such as intestinal obstruction (ileus) or inflammation in the gastrointestinal tract. If you experience such symptoms, you should not take Lactulose AL Syrup and seek medical advice immediately. Lactulose AL Syrup should also not be taken in the event of disorders of the water and electrolyte balance (loss of salt).

Special care must be taken when taking Lactulose AL Syrup
If you have been suffering from constipation for a long time, you should consult your doctor for advice and examination before starting therapy with Lactulose AL Syrup, because chronic disorders or impairments of bowel movements can be signs of a more serious condition!

Children
Since an inherited fructose intolerance may not yet have been detected in infants and toddlers, they should only receive Lactulose AL Syrup after consulting a doctor.

When taking Lactulose AL Syrup with other medicines
Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Lactulose AL Syrup can increase the loss of potassium caused by other medicines used at the same time. These include certain diuretics and adrenal hormones (corticosteroids) and amphotericin B, which is used against fungi. In the event of potassium deficiency, the sensitivity to cardiac glycosides (e.g. digitoxin) is increased.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking/using any medicine. No harmful effects of lactulose have been reported when taken during pregnancy and breast-feeding. Lactulose can also be taken during pregnancy and breast-feeding.

Driving and operating machinery
Lactulose AL Syrup has no adverse effects on perception, judgement and reaction time.

Important information about certain other ingredients of Lactulose AL Syrup
This medicine contains small amounts of digestible carbohydrates due to the manufacturing process, but only a relatively small amount is absorbed from the intestine into the body and therefore has almost no nutritional value. Please only take Lactulose AL Syrup after consulting your doctor if you know that you suffer from an intolerance to certain sugars.
100 ml Lactulose AL Syrup contains a maximum of 17 g digestible carbohydrates, e.g. fructose (fruit sugar), galactose, lactose (milk sugar), corresponding to a maximum of 1.4 BE (bread units). If you are on a diabetic diet, you should take this into account.

3. HOW SHOULD LACTULOSE AL SYRUP BE TAKEN?
Always take Lactulose AL Syrup exactly as described in this patient information. Please ask your doctor or pharmacist if you are not sure. Please follow the instructions for use, otherwise Lactulose AL Syrup will not work properly! Also bear in mind that it takes a considerable amount of time, which often varies from patient to patient, after taking the specified doses of Lactulose AL Syrup for the desired effect to appear. For example, the laxative effect of Lactulose AL Syrup can occur after just 2-10 hours; however, it can also take 1-2 days until the first bowel movement, especially if the dosage is still insufficient.

Unless otherwise prescribed by your doctor, the usual dose is

Lactulose AL Syrup must be dosed differently depending on the area of application. The dosages given here can only serve as a guide and may need to be changed in order to achieve the desired effect. Lactulose AL Syrup is dosed using a measuring cup.

For constipation

o Adults: 1 to 2 times a day 7.5-15 ml Lactulose AL Syrup (corresponding to 1 to 2 times 5-10 g lactulose/day).
o Children: 1 to 2 times a day 4.5-9 ml Lactulose AL Syrup (corresponding to 1 to 2 times 3-6 g lactulose/day).
Larger doses of Lactulose AL Syrup are often required, especially at the beginning of treatment for constipation. In general, this slightly higher initial dose can be reduced after 3-4 days.
In the case of portocaval encephalopathy, i.e. in the case of impaired brain function in the context of a liver disease
o Adults: At the beginning of treatment for portocaval encephalopathy, adults should take 3 to 4 times a day 7.5-15 ml Lactulose AL Syrup (corresponding to 3 to 4 times 5-10 g lactulose/day). The dose should then be slowly and carefully increased to 3 to 4 times a day 30-45 ml Lactulose AL Syrup (corresponding to 3 to 4 times 20-30 g lactulose/day). The aim should be to empty 2-3 soft stools per day.
o Children: No information is available on the use in children.

Method of administration
Please measure the dose of Lactulose AL Syrup you need using the measuring cup. This amount of Lactulose AL Syrup is then mixed with water or with warm drinks, e.g. coffee or tea, or stirred into yoghurt, muesli or porridge and taken together with these foods. To prevent the dosing dispenser from sticking, the dosing dispenser should be closed after each removal (see illustration on the dosing dispenser). Lactulose can be taken independently of meals. If a single dose of Lactulose AL Syrup is sufficient for the successful treatment of constipation, it has proven to be particularly well-tolerated when taken in the morning after breakfast.

Duration of use
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 Lactulose AL Syrup is too strong or too weak.

If you have taken more Lactulose AL Syrup than you should
If Lactulose AL Syrup has been taken in too large quantities, nausea, vomiting, diarrhoea and loss of water and electrolytes (especially potassium and sodium) can occur, which may need to be compensated for with drug therapy. Inform your doctor if such symptoms have occurred in the event of an overdose. He or she will then also decide on any treatment measures to be initiated.

If you forget to take Lactulose AL Syrup
Even if the recommended dose of Lactulose AL Syrup is taken correctly, it can take some time for the desired effect to occur (see also above). If you have taken too little, the time until the effect occurs may be longer; however, the treatment may also be completely unsuccessful. If you have forgotten to take a dose of Lactulose AL Syrup, please continue the therapy as recommended without increasing the dose yourself! In case of doubt, please ask your doctor for advice!

If you stop taking Lactulose AL Syrup
If you interrupt treatment with Lactulose AL Syrup or stop taking it prematurely, you must expect that the desired effect will not occur or that the clinical picture will worsen again. Therefore, please consult your doctor if you want to end or interrupt treatment.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Lactulose AL Syrup can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects
Metabolism and nutrition disorders
In rare cases, an increased sodium concentration in the blood (hypernatremia) has been reported during the treatment of portocaval encephalopathy. In the case of long-term use of Lactulose AL Syrup in a dosage that leads to persistently thin stools, the usual disorders in the water and electrolyte balance (increased excretion of potassium, sodium and water) and their consequences must be expected.

Gastrointestinal disorders
Mild abdominal pain and flatulence occur very frequently at the beginning of treatment with Lactulose AL Syrup at a medium dosage. Nausea, vomiting and diarrhoea with disorders in the electrolyte balance are also possible with high dosages.

Countermeasures
The possible adverse drug reactions that may occur at the beginning of treatment with Lactulose AL Syrup, which manifest themselves in mild abdominal pain and flatulence, usually disappear on their own in the further course of treatment. If diarrhoea and subsequent disorders in the water and electrolyte balance occur during a - usually high-dose - intake of Lactulose AL Syrup, these must be treated with medication if necessary and any deficiency of water, potassium or sodium salts must be compensated for. A reduction in the amount of Lactulose AL Syrup to be taken is often also necessary. If you notice these side effects, please inform your doctor. He or she will then also decide whether a reduction or, in rare cases, discontinuation of Lactulose AL Syrup is necessary.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this patient information. You can also report side effects directly

Federal Institute for Drugs and Medical Devices
Department of Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD LACTULOSE AL SYRUP BE STORED?
Keep out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after "Use by". The expiry date refers to the last day of the month. Do not store above + 30°C. Even after opening the pack, Lactulose AL Syrup can be stored for a maximum of up to the printed expiry date if stored and kept properly!
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION
What Lactulose AL Syrup contains
The active ingredient is lactulose. 100 ml syrup contains 66.7 g lactulose. The other ingredient is purified water.

Note

The syrup contains fructose, galactose and lactose due to the manufacturing process.

What Lactulose AL Syrup looks like and contents of the pack
Clear, colourless to slightly brownish-yellow syrup.
Lactulose AL Syrup is available in packs of 200 ml, 500 ml and 1000 ml (with practical dosing dispenser) syrup.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad V ilb e l

This patient information was last revised in March 2014.

Source: Information from the package leaflet
Status: 12/2014
Areas of application: for constipation that cannot be sufficiently influenced by a diet rich in fibre and other general measures, as well as for conditions that require easier bowel movements and for the prevention and treatment of portocaval encephalopathy (i.e. disorders of brain function due to chronic liver diseases, especially in the case of liver cirrhosis).