PACKAGE LEAFLET: INFORMATION FOR THE USER

What is in this leaflet

1.    What Lactuflave is and what it is used for

2.    What you need to know before you take/use Lactuflave

3.    How to take/use Lactuflave

4.    Possible side effects

5.    How to store Lactuflave

6.    Contents of the pack and other information

1. What Lactuflave is and what it is used for

Lactuflave contains a substance called lactulose which increases defecation (laxative). It makes the stool softer and easier to pass by drawing water into the bowel. It is not absorbed into your body.

Lactuflave is used to:

- treat the symptoms of constipation

2. What you need to know before you take/use Lactuflave

Do NOT take/use Lactuflave

-    if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6)

-    if you suffer from galactose intolerance (a serious genetic disorder in which your body cannot break down galactose)

-    if you suffer from blockage in your bowel (apart from normal constipation)

-    if you suffer from organic inflammatory bowel disorders (ulcerative proctocolitis, Crohn‘s disease)

-    if you suffer from abdominal pain of unknown cause

Warnings and precautions

Talk to your doctor or pharmacist before taking/using Lactuflave

-    if you suffer from disturbances in water and salt (electrolyte) balance

Please tell your doctor before taking Lactuflave if you suffer from a gastro cardiac syndrome (Ro-emheld syndrome). If you do and you have symptoms like meteorism or bloating after using Lactuflave, stop the treatment and consult your doctor. Your doctor will supervise the treatment carefully.

Length of treatment

Please do not take/use Lactuflave without medical advice for more than two weeks.

Long-term use of Lactuflave with unadjusted dosages (exceeding 2 - 3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the salt (electrolyte) balance.

If you are an elderly patient or a patient in generally poor health and take lactulose for longer than 6 months, your doctor will regularly check your blood electrolytes.

Children

Lactuflave should not normally be given to infants and smaller children since it can disturb the normal reflexes for passing stools. In special circumstances your doctor may prescribe Lactuflave for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.

General remark

From its route of synthesis Lactuflave may contain traces of sugars, e.g. fructose, lactose and galactose (see below "Further information for diabetics and patients with other disorders of carbohydrate metabolism").

During the treatment with substances that increase defecation (laxatives) like Lactuflave you should drink sufficient amounts of fluids (approx. 2 l/day, equal to 6 - 8 glasses).

Other medicines and Lactuflave

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

Lactulose may increase the loss of potassium induced by other drugs (e.g. water pills (thiazides), steroids (corticosteroids) and amphothericin B). If in addition, you take cardiac glycosides (used to treat heart failure, e.g. digoxin), the effect of the glycosides can be increased by the low levels of potassium.

The pH in the bowel decreases with increasing dose of Lactuflave. The lower pH can cause the inactivation of drugs that are released in the bowel in a pH dependent manner (e.g. 5-amino salicylic acid).

Lactuflave with food and drink

Lactuflave can be taken with or without food. There are no restrictions on what you can eat or drink.

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

Lactuflave will not affect your ability to drive safely or use machines.

Lactuflave contains fructose, galactose and lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Further information for diabetics and patients with other disorders of carbohydrate metabolism:

This medicinal product contains small amounts of digestible carbohydrates, e.g. fructose, lactose and galactose. Only a small amount of these is absorbed from the bowel into the body and thus has only minor nutritive value. Nevertheless, one measuring spoon of Lactuflave, corresponding to 5 ml (about 6.7 g) oral gel, contains a maximum of 0.98 g of digestible carbohydrates, which is equivalent to about 0.08 bread units.

3. How to take/use Lactuflave

Always take/use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

How and how long should you take Lactuflave?

Lactuflave is taken orally. Lactuflave can be taken independently from meals. The quantities indicated below can be measured with the enclosed measuring spoon, which holds 5 ml. For example, for a quantity of 30 ml of the gel, 6 full measuring spoons should be taken. For the precise dosing and to avoid overfilling, the excess gel should be scraped off the filled measuring spoon e.g. with the back of a knife.

Take your doses at the same time each day. The dose may be given once daily, for example during breakfast or divided into two doses a day.

The length of treatment depends on how you respond to the treatment.

During the treatment with substances that increase defecation (laxatives) like Lactuflave you should drink sufficient amounts of fluids (approx. 2 l/day, equal to 6 - 8 glasses).

Dosage

Lactuflave has to be taken in different doses depending on the respective disease. The dosage recommendations given below are meant for orientation only, and hence need to be adjusted for the best effect.

Please keep in mind that after taking the indicated dosage of Lactuflave, it may take 2 - 3 days until the desired effect is achieved. This varies from patient to patient.

Constipation

Total dose per day:

Starting dose			Maintenance dose
Adults and adolescents over 14 years	15 - 45 ml	corresponding to about 10 - 30 g lactulose	15 - 30 ml	corresponding to about 10 - 20 g lactulose
Children (7 - 14 years)	15 ml	corresponding to about 10 g lactulose	10 - 15 ml	corresponding to about 7 - 10 g lactulose
Children (1 - 6 years)	5 - 10 ml	corresponding to about 3 - 7 g lactulose	—	—
Babies	up to 5 ml	corresponding to about up to 3 g lactulose	—	—

Thereafter the dose can be reduced individually so that a soft stool is produced.

If you take/use more Lactuflave than you should

If you take/use too much Lactuflave, you may experience feeling sick to your stomach (nausea), vomiting, diarrhoea, abdominal pain and loss of water and electrolytes (in particular potassium and sodium). Contact your doctor or pharmacist if you have taken more Lactuflave than you should.

If you forget to take/use Lactuflave

If you forget to take/use a dose of Lactuflave, do not worry. Just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking/using Lactuflave

The desired effect of the treatment may not be achieved or the symptoms may worsen again. Thus please speak with your doctor or pharmacist if you want to stop 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 (affects more than 1 user in 10):

-    Flatulence (wind), especially during the first few days of treatment. This usually disappears after a couple of days.

-    When a higher dose than recommended is used, you may experience abdominal pain.

Common (affects 1 to 10 users in 100):

-    Feeling sick (nausea)

-    Vomiting

-    When a higher dose than recommended is used, you may experience diarrhoea.

If you have diarrhoea followed by a disturbance in your electrolyte and water balance during a high-dosed lactulose treatment, please inform your doctor. The doctor will decide if a reduction of the dosage of Lactuflave and/or additional measures in order to compensate loss of water, potassium and sodium will be necessary.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Lactuflave

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

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

After first opening the jar the medicinal product may be stored for a maximum of 6 weeks.

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

6. Contents of the pack and other information

What Lactuflave contains

-    The active substance is lactulose.

1 ml oral gel contains 650 mg lactulose as lactulose liquid 66 % (w/v).

1 measuring spoon with 5 ml oral gel contains 3.25 g lactulose.

- The other ingredients are agar, cola flavour, sulphite ammonia caramel (E150d), purified water, citric acid, anhydrous

-    Remark: Contains fructose, galactose and lactose due to production process.

What Lactuflave looks like and contents of the pack

This medicinal product is a brownish to dark brown oral gel.

It is available in package sizes of 1 jar of 100 ml, 200 ml and 500 ml.

Each package contains a measuring spoon with a volume of 5 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MIP Pharma GmbH Kirkeler Strafle 41 66440 Blieskastel Germany

This leaflet was last revised in 05/2012.