LACTULOSE-

LACTULOSE AbZ 66.7 g/100 ml syrup

Important notes (mandatory information)

Lactulose AbZ 66.7 g/100 ml Syrup. Areas of application: for constipation (irregular bowel movements, hard and dry stools) that cannot be sufficiently influenced by a diet rich in fibre and other general measures; for conditions that require easier bowel movements (e.g. haemorrhoids or operations on the rectum or anal area) and for the prevention and treatment of portosystemic encephalopathy (i.e. disorders of brain function as a result of chronic liver diseases that can lead to confusion, tremors and impaired consciousness, even to a coma).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose AbZ 66.7 g/100 ml Syrup
Active ingredient: Lactulose

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after a few days, contact your doctor.

What this package leaflet contains

1. WHAT IS LACTULOSE ABZ 66.7 G/100 ML AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LACTULOSE ABZ 66.7 G/100 ML?
3. HOW SHOULD LACTULOSE ABZ 66.7 G/100 ML BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LACTULOSE ABZ 66.7 G/100 ML BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LACTULOSE ABZ 66.7 G/100 ML AND WHAT IS IT USED FOR?

Lactulose AbZ 66.7 g/100 ml contains a laxative called lactulose. It softens your stools by drawing water into your bowel; this makes it easier to pass stools. Lactulose AbZ 66.7 g/100 ml is not absorbed by your body.

Lactulose AbZ 66.7 g/100 ml is used for:

• Constipation (irregular bowel movements, hard and dry stools) that cannot be sufficiently influenced by a diet rich in fibre and other general measures.
• Conditions that require easier bowel movements (e.g. haemorrhoids or operations on the rectum or anal area).
• Prevention and treatment of portosystemic encephalopathy (i.e. disorders of brain function as a result of chronic liver diseases that can lead to confusion, tremors and impaired consciousness, even to a coma).

If you do not feel better or even worse after a few days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LACTULOSE ABZ 66.7 G/100 ML?

Lactulose AbZ 66.7 g/100 ml must not be taken:

• if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from an intestinal obstruction (ileus) or a perforation of the intestine.
• if you are at risk of a perforation of the intestine.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Lactulose AbZ 66.7 g/100 ml:

• if you suffer from abdominal pain of unknown cause.
• if you have diabetes.

You should not take Lactulose AbZ 66.7 g/100 ml in the case of:

• Disturbances in the water and electrolyte balance (loss of salts).
• Inflammation in the gastrointestinal tract. In particular, if you suffer from symptoms such as abdominal pain, vomiting and fever, you should seek medical advice immediately.

If you have been suffering from constipation for a long time, you should consult your doctor for advice and examination before starting treatment with Lactulose AbZ 66.7 g/100 ml, because chronic disorders or impairments of bowel movements can be signs of a more serious illness! Continuous use of inappropriate dosages (exceeding 2 to 3 soft stools per day) or improper use can lead to diarrhoea and disturbances in the electrolyte balance. During treatment with laxatives, you should drink sufficient amounts of fluid (1.5 to 2 litres per day, corresponding to 6 to 8 glasses).

Children and adolescents

In special circumstances, your doctor may prescribe Lactulose AbZ 66.7 g/100 ml for your child. In these cases, your doctor will monitor the treatment carefully. Lactulose AbZ 66.7 g/100 ml should normally not be given to newborns or infants, as it can interfere with the normal reflexes for bowel movements.

Diabetics and patients with other carbohydrate metabolism disorders

This medicine contains small amounts of digestible carbohydrates due to the manufacturing process, but these are only absorbed from the intestine into the body to a relatively small extent and therefore have almost no nutritional value. Nevertheless, please note that Lactulose AbZ 66.7 g/100 ml contains a maximum of 17 g of digestible carbohydrates per 100 ml of syrup, e.g. fructose (fruit sugar), galactose, lactose (milk sugar), which corresponds to a maximum of 1.4 BE. Particularly when treating portosystemic encephalopathy, higher amounts of Lactulose AbZ 66.7 g/100 ml are required; in this case, an adjustment of your antidiabetic medication may be necessary.

Infants and toddlers

Since an inherited fructose intolerance may not yet have been detected in infants and toddlers, they should only receive Lactulose AbZ 66.7 g/100 ml after consulting a doctor.

Taking Lactulose AbZ 66.7 g/100 ml with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Lactulose AbZ 66.7 g/100 ml can increase the loss of potassium caused by other medicines taken at the same time. These include certain diuretics and adrenal hormones (corticosteroids) and the antifungal agent amphotericin B. In the case of potassium deficiency, the sensitivity to cardiac glycosides (e.g. digitoxin) is increased.

Taking Lactulose AbZ 66.7 g/100 ml with food and drink

Lactulose AbZ 66.7 g/100 ml can be taken independently of meals. There are no restrictions on what you can eat or drink.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. No harmful effects of lactulose have been observed when taken during pregnancy and breast-feeding. Lactulose can also be taken during pregnancy and breast-feeding. No effects on fertility are to be expected.

Driving and using machines

Lactulose AbZ 66.7 g/100 ml has no or negligible influence on your ability to drive safely or operate machines.

Lactulose AbZ 66.7 g/100 ml contains lactose, fructose and galactose

Therefore, please only take Lactulose AbZ 66.7 g/100 ml after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD LACTULOSE ABZ 66.7 G/100 ML BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The following information applies unless your doctor has prescribed Lactulose AbZ 66.7 g/100 ml differently. Please adhere to the instructions for use, otherwise Lactulose AbZ 66.7 g/100 ml cannot 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 AbZ 66.7 g/100 ml for the desired effect to become apparent. For example, the laxative effect of Lactulose AbZ 66.7 g/100 ml can occur after just 2 to 10 hours, but it can also take 1 to 2 days until the first bowel movement, especially if the dosage is still insufficient. Lactulose AbZ 66.7 g/100 ml 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 to achieve the desired effect.

The recommended dose is

For constipation and when soft stools are of medical benefit:

• Adults: 1– to 2–times daily 7.5 – 15 ml Lactulose AbZ 66.7 g/100 ml (corresponding to 5 to 10 g lactulose).
• Children: 1– to 2–times daily 4.5 – 9 ml Lactulose AbZ 66.7 g/100 ml (corresponding to 3 to 6 g lactulose).

The use of laxatives in children, newborns and babies should only be used in exceptional cases and under medical supervision, as this can interfere with the normal bowel emptying reflexes. Please do not give Lactulose AbZ 66.7 g/100 ml to children (under 14 years of age) without first contacting a doctor. Especially at the beginning of treatment for constipation, larger doses of Lactulose AbZ 66.7 g/100 ml are often required. In general, this slightly higher initial dose can be reduced after 3 to 4 days.

For portosystemic encephalopathy, i.e. impairment of brain function in the context of liver disease (only in adults):

• Adults: At the beginning of treatment for portosystemic encephalopathy, adults should take 3– to 4–times daily 7.5 – 15 ml Lactulose AbZ 66.7 g/100 ml (corresponding to 5 to 10 g lactulose). The dose should then be increased slowly and carefully to 3– to 4–times daily 30 – 45 ml Lactulose AbZ 66.7 g/100 ml (corresponding to 20 to 30 g). The dosage should be adjusted so that 2 to 3 soft stools are passed daily.

• Children and adolescents

  There are no data on the treatment of children (up to 18 years of age) with portosystemic encephalopathy.

Elderly patients and patients with impaired liver or kidney function

There are no special dosage recommendations.

Method of administration

Always take Lactulose AbZ 66.7 g/100 ml at the same time of day. Please measure the dose of Lactulose AbZ 66.7 g/100 ml you require. This amount of Lactulose AbZ 66.7 g/100 ml 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. Lactulose can be taken independently of meals. If a single dose of Lactulose AbZ 66.7 g/100 ml is sufficient for the successful treatment of constipation, taking it in the morning after breakfast has proven to be particularly well-tolerated.

Duration of use

The duration of treatment depends on the development of the respective clinical picture. If there is no improvement or a worsening of the symptoms after taking Lactulose AbZ 66.7 g/100 ml in the recommended dose, even after a few days, please inform your doctor.

Please talk to your doctor or pharmacist if you have the impression that the effect of Lactulose AbZ 66.7 g/100 ml in the recommended dose is too strong or too weak.

If you have taken more Lactulose AbZ 66.7 g/100 ml than you should

If Lactulose AbZ 66.7 g/100 ml has been taken in too large amounts, nausea, abdominal pain, vomiting, diarrhoea and loss of water and electrolytes (especially potassium and sodium) may occur, which may need to be balanced out by drug therapy. Inform your doctor if such symptoms occur 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 AbZ 66.7 g/100 ml

If you have forgotten to take a dose of Lactulose AbZ 66.7 g/100 ml, please continue the therapy as recommended without increasing the dose yourself! Do not take twice the amount of Lactulose AbZ 66.7 g/100 ml, but take the next dose at the usual time.

If you stop taking Lactulose AbZ 66.7 g/100 ml

If you interrupt treatment with Lactulose AbZ 66.7 g/100 ml 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, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• Diarrhoea

Common (may affect up to 1 in 10 people):

• Flatulence
• Nausea
• Vomiting
• Abdominal pain

Uncommon (may affect up to 1 in 100 people):

• Electrolyte disturbances due to diarrhoea At the beginning of treatment with Lactulose AbZ 66.7 g/100 ml, flatulence may occur. This usually disappears after a few days.

If higher doses than prescribed are taken, abdominal pain and diarrhoea may occur. In these cases, the dosage should be reduced. With long-term use of Lactulose AbZ 66.7 g/100 ml in a dosage that leads to persistently thin stools, the usual disturbances in the water and electrolyte balance (increased excretion of potassium, sodium and water) and their consequences must be expected. In rare cases, hypernatremia (increased serum sodium concentration) has been reported in the treatment of portosystemic encephalopathy.

Countermeasures to be taken in the event of side effects

The possible undesirable effects of Lactulose AbZ 66.7 g/100 ml that may occur at the beginning of treatment, which can manifest themselves in mild abdominal pain and flatulence, usually disappear on their own in the further course of treatment. If diarrhoea and subsequent disturbances in the water and electrolyte balance occur when taking a – usually high-dose – of Lactulose AbZ 66.7 g/100 ml, these may need to be treated with medication and any deficiency of water, potassium or sodium salts must be balanced out. A reduction in the amount of Lactulose AbZ 66.7 g/100 ml to be taken is often also necessary. If you notice these undesirable effects, please inform your doctor. He or she will then also decide whether a reduction or, in rare cases, discontinuation of Lactulose AbZ 66.7 g/100 ml 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 package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting