LACTULOSE-

LACTULOSE-ratiopharm syrup

Important notes (mandatory information)

Lactulose-ratiopharm Syrup 66.7 g/100 ml. 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). Warning: Contains lactose, fructose and galactose due to the manufacturing process.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose-ratiopharm Syrup 66.7 g/100 ml
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-RATIOPHARM SYRUP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LACTULOSE-RATIOPHARM SYRUP?
3. HOW SHOULD LACTULOSE-RATIOPHARM SYRUP BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LACTULOSE-RATIOPHARM SYRUP BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LACTULOSE-RATIOPHARM SYRUP AND WHAT IS IT USED FOR?

Lactulose-ratiopharm Syrup contains a laxative called lactulose. It softens your stools by drawing water into your bowel; this makes it easier to pass stools. Lactulose-ratiopharm Syrup is not absorbed by your body. Lactulose-ratiopharm Syrup 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, 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). If you do not feel better or even worse after a few days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LACTULOSE-RATIOPHARM SYRUP?

Lactulose-ratiopharm Syrup 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-ratiopharm Syrup:

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

You should not take Lactulose-ratiopharm Syrup in the following cases:

• Disturbances of 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-ratiopharm Syrup, because chronic disorders or impairments of bowel movements can be signs of a more serious illness! Continuous use of inappropriate doses (exceeding 2 to 3 soft stools per day) or improper use can lead to diarrhoea and electrolyte imbalances. 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-ratiopharm Syrup for your child. In these cases, your doctor will monitor the treatment carefully. Lactulose-ratiopharm Syrup should not normally be given to newborns or infants, as it can interfere with normal bowel reflexes.

Diabetics and patients with other carbohydrate metabolism disorders

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 note, however, that Lactulose-ratiopharm Syrup 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. Higher amounts of Lactulose-ratiopharm Syrup are required, especially for the treatment of portosystemic encephalopathy; 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-ratiopharm Syrup after consulting a doctor.

Taking Lactulose-ratiopharm Syrup 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-ratiopharm Syrup 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. Potassium deficiency increases the sensitivity to cardiac glycosides (e.g. digitoxin).

Taking Lactulose-ratiopharm Syrup with food and drink

Lactulose-ratiopharm Syrup 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 reported 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-ratiopharm Syrup has no or negligible influence on your ability to drive safely or operate machines.

Lactulose-ratiopharm Syrup contains lactose, fructose and galactose

Therefore, please only take Lactulose-ratiopharm Syrup after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD LACTULOSE-RATIOPHARM SYRUP 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-ratiopharm Syrup differently. Please follow the instructions for use, otherwise Lactulose-ratiopharm Syrup will not work properly! Also bear in mind that it takes a considerable time, which often varies from patient to patient, after taking the specified doses of Lactulose-ratiopharm Syrup for the desired effect to occur. For example, the laxative effect of Lactulose-ratiopharm Syrup 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-ratiopharm 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 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-ratiopharm Syrup (corresponding to 5 to 10 g lactulose).
• Children: 1– to 2–times daily 4.5 — 9 ml Lactulose-ratiopharm Syrup (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 normal bowel movements. Please do not give Lactulose-ratiopharm Syrup to children (under 14 years of age) without first contacting a doctor. Larger doses of Lactulose-ratiopharm Syrup are often required, especially at the beginning of treatment for constipation. In general, this slightly higher initial dose can be reduced after 3 to 4 days.

For portosystemic encephalopathy, i.e. impaired 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-ratiopharm Syrup (corresponding to 5 to 10 g lactulose). The dose should then be slowly and carefully increased to 3– to 4–times daily 30 — 45 ml Lactulose-ratiopharm Syrup (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-ratiopharm Syrup at the same time of day. Please measure out the dose of Lactulose-ratiopharm Syrup you need. This amount of Lactulose-ratiopharm 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. Lactulose can be taken independently of meals. If a single dose of Lactulose-ratiopharm 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. If there is no improvement or a worsening of the symptoms after taking Lactulose-ratiopharm Syrup 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-ratiopharm Syrup in the recommended dose is too strong or too weak.

If you have taken more Lactulose-ratiopharm Syrup than you should

If Lactulose-ratiopharm Syrup 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 with medication. 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-ratiopharm Syrup

If you have forgotten to take a dose of Lactulose-ratiopharm Syrup, please continue the therapy as recommended without increasing the dose yourself! Do not take twice the amount of Lactulose-ratiopharm Syrup, but take the next dose at the usual time.

If you stop taking Lactulose-ratiopharm Syrup

If you interrupt treatment with Lactulose-ratiopharm 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, 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 imbalances due to diarrhoea

Flatulence may occur at the beginning of treatment with Lactulose-ratiopharm Syrup. This usually disappears after a few days. Abdominal pain and diarrhoea may occur when taking higher doses than prescribed. In these cases, the dosage should be reduced. With long-term use of Lactulose-ratiopharm Syrup 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 adverse drug reactions that may occur at the beginning of treatment with Lactulose-ratiopharm Syrup, which may manifest themselves as 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-ratiopharm Syrup, these may have 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-ratiopharm 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-ratiopharm 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 package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. 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-RATIOPHARM SYRUP BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Any discolouration that may occur after prolonged storage does not affect the quality of the product. Shelf life after opening the container: Lactulose-ratiopharm Syrup can be stored for 12 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lactulose-ratiopharm Syrup contains

The active ingredient is lactulose. 100 ml syrup contain 66.7 g lactulose. The other ingredient is: Purified water. Note: Contains fructose, galactose and lactose due to the manufacturing process.

What Lactulose-ratiopharm Syrup looks like and contents of the pack

Clear, colourless to slightly brownish-yellow, viscous liquid. Lactulose-ratiopharm Syrup is available in packs of: 200 ml syrup, 500 ml syrup and 1,000 ml syrup with a pump dispenser.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 09/2017
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