Package Leaflet: Information for the User

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose-MIP, 650 mg/ml, oral solution

Active substance: Lactulose

[Text to be used in Austria, where the product is subjected to prescription: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.]

[Text to be used in countries where product is available over-the-counter: [Read all of this leaflet carefully because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must talk to a doctor if you do not feel better or if you feel worse. - If you get any side effectstalk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.]

What is in this leaflet 1. What Lactulose-MIP is and what it is used for 2. What you need to know before you take Lactulose-MIP 3. How to take Lactulose-MIP 4. Possible side effects 5. How to store Lactulose-MIP 6. Contents of the pack and other information

1. WHAT LACTULOSE-MIP IS AND WHAT IT IS USED FOR

Lactulose-MIP is a laxative and is used to treat constipation. It cannot be digested in the small intestine and hence it is transported to the colon unmodified. There it is degraded by enteric bacteria to acids which retain water in the colon. This causes an extension of the intestinal volume in the colon and indirectly stimulates bowel movement. Furthermore Lactulose-MIP is used at high doses to prevent and treat cerebral dysfunction due to liver diseases.

Therapeutic indications:

- Constipation which cannot be influenced sufficiently by high-roughage diet or other general measures, as well as diseases requiring easy defecation

- Prevention and treatment of portal systemic encephalopathy (i.e. cerebral dysfunction due to chronic liver diseases, in particular liver cirrhosis)

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE-MIP

1 Do not take Lactulose-MIP - if you suffer from obstruction of the bowels - if you suffer from galactose intolerance - if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor or pharmacist before taking Lactulose-MIP.

Take special care with Lactulose-MIP - if you suffer from inflammatory gastrointestinal diseases - if you suffer from disturbances of water and salt balance

If you already suffer from constipation for a longer time, you should first consult your doctor before you start treatment with Lactulose-MIP because chronic dysfunction or derogation of bowel movement can be an indication for a more severe disease!

Children Since in newborns, infants and toddlers a hereditary fructose intolerance may not be discovered yet, they should not get Lactulose-MIP without consulting a doctor.

Other medicines and Lactulose-MIP Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Lactulose can increase the loss of potassium induced by other, concomitantly taken medicinal products such as diuretics, corticosteroids and amphotericin B. In case of a deficiency of potassium, sensitivity to cardiac glycosids (e.g. Digitoxin) can be enhanced.

Lactulose-MIP with food and drink Lactulose-MIP can be taken undiluted or mixed with water as well as warm drinks, e.g. coffee or tea, or stirred in yoghurt, cereal or porridge.

Pregnancy and breast-feeding Lactulose-MIP can be taken during pregnancy and breast-feeding. 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.

Driving and using machines Lactulose-MIP has no or negligible influence on the ability to drive and use machines.

Important information about some of the ingredients of Lactulose-MIP Information for diabetics and patients with other dysfunctions of carbohydrate metabolism: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicinal product contains small amounts of digestible carbohydrates, e.g. fructose, galactose and lactose. Only a small amount thereof is absorbed from the intestine into the body and thus has only minor nutritive value. Nevertheless notice that one measuring cup of Lactulose-MIP, corresponding to 30 ml solution, contains a maximum of 7.8 g of digestible carbohydrates, which is equivalent to 0.65 bread units. For this reason caution should be exercised for diabetics when the maximum dose of Lactulose-MIP is taken for treating cerebral dysfunction caused by chronic liver disease (portal systemic encephalopathy).

3. HOW TO TAKE LACTULOSE-MIP

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

2 Dosage: Lactulose-MIP has to be taken in different dosages depending on the indication. The dosage recommendations given below are meant as orientation only, and hence are to be adjusted in order to take effect. The quantities indicated can be measured with the enclosed measuring cup.

In case of constipation: Adults and adolescents (14-17 years): The initial dose is 15-30 ml daily, taken either in a single dose (preferably in the morning) or in two divided doses. When bowel movement begins, the dose should be reduced by half. If no effect can be recognised after 3 days, the dosage may be raised to twice the initial dose. If then there is still no effect, you must consult a physician.

Children, daily dosage: Under 1 year: 5 ml 1-6 years: 10-15 ml 7-14 years: 15 ml

Dosage should be individually adjusted so that a soft stool is produced.

In case of portal systemic encephalopathy (PSE): Acute PSE (precoma and coma hepaticum, i.e. cerebral dysfunction caused by liver disease): Initially 50 ml solution every 2 hours until 2 bowel movements producing stools. In the following dosage should be adjusted so that 2-3 soft stools are produced daily. Chronic PSE: Initially 30-45 ml 3 to 4 times a day. After that, dosage should be adjusted to produce 2-3 soft stools daily.

Please keep in mind that after taking the indicated dosage of Lactulose-MIP, varying from patient to patient, it may take a while until the desired effect is seen. The laxative effect of Lactulose-MIP may already occur within 2-10 hours, but it may also take up to 2 days till bowel movement begins, especially if dosage is still insufficient.

How and how long should you take Lactulose-MIP? Lactulose-MIP is taken orally. Please measure the required dose of Lactulose-MIP with the enclosed measuring cup. The measured dose can be taken undiluted or mixed with water as well as warm drinks, e.g. coffee or tea, or stirred in yoghurt, cereal or porridge.

Lactulose-MIP can be taken independently from meals. If a single dose of Lactulose-MIP is sufficient for treatment of constipation, taking it in the morning is recommended.

The period of therapy depends on the development of the respective disease.

If you take more Lactulose-MIP than you should

If you have taken too much of lactulose, nausea, vomiting, diarrhoea and loss of water and electrolytes (in particular potassium and sodium) may occur. These symptoms may require to be compensated by medicinal therapy. Inform your doctor if you have taken too much lactulose. He will then decide about medical care to be taken potentially.

If you forget to take Lactulose-MIP

Do not take a double dose to make up for a forgotten dose. Carry on as normal with the next dose.

If you stop taking Lactulose-MIP

If you interrupt treatment with Lactulose-MIP or prematurely stop taking, you must consider that the desired effect will not occur or that the symptoms worsen again. Thus please speak with your doctor or pharmacist if you want to terminate or interrupt the treatment.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed: Very common (more than 1 of 10 patients): Mild abdominal pain, meteorism and flatulence at the beginning of the treatment. Common (less than 1 of 10, but more than 1 of 100 patients): Nausea, vomiting and diarrhoea at higher dosage levels. Rare (less than 1 of 1000, but more than 1 of 10000 patients): Raised levels of sodium in blood (Hypernatraemia).

Countermeasures Adverse drug reactions like mild abdominal pain and flatulence which you may feel during the first days of treatment with Lactulose-MIP, usually disappear spontaniously in the course of treatment.

In case of diarrhoea followed by disturbances of electrolytes and water in course of - most highly dosed - lactulose treatment, please inform your doctor. The doctor will decide if a reduction of the dosage of Lactulose-MIP and/or additional measures in order to compensate loss of water, potassium and sodium will be necessary.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE LACTULOSE-MIP

Keep this medicine out of the sight and reach of children.

Do not store above 30C.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

After opening the bottle for the first time and under appropriate storage conditions, Lactulose-MIP can be taken for 6 months.

4 Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lactulose-MIP contains

- The active substance is lactulose. 1 ml solution contains 650 mg lactulose. - The other ingredients are citric acid (anhydrous), cherry flavour and purified water. - Remark: Contains fructose, galactose and lactose due to production process.

What Lactulose-MIP looks like and contents of the pack

Lactulose-MIP is a clear colourless or yellowish, viscous liquid

Lactulose-MIP is available in package sizes of 100, 200, 500 and 1000 ml. Not all pack sizes may be marketed. Each pack contains a measuring cup with graduations from 5 to 30 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: [to be completed nationally]

Manufacturer: Chephasaar Chem.-pharm. Fabrik GmbH Mühlstraße 50 66386 St. Ingbert Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Lactulose-MIP Danmark: Lactulose “MIP“ Finland: Lactulose-MIP Germany: Lactuflor Norway: Laktulose MIP Pharma

This leaflet was last revised in {MM/YYYY}.

[To be completed nationally]