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Lactuflave Cherry

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Lactufl.cherry - GB-6.Korr. 05.07.2010    10:29 Uhr Seite 1

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Lactuflave®cherry carefully to get the best results from it.

-Keep this leaflet.You may need to read it again.

-Ask your pharmacist if you need more information or advice.

-You must contact a doctor if your symptoms worsen or do not improve.

-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.


Lactuflave® cherry

Oral solution with 3.35 g Lactulose per 5 ml




In this leaflet:

1.    What Lactuflave® cherry is and what it is used for

2.    Before you take Lactuflave®cherry

3.    How to use Lactuflave® cherry

4.    Possible side effects

5.    How to store Lactuflave® cherry

6.    Further information

1.    WHAT LACTUFLAVE® CHERRY IS AND WHAT IT IS USED FOR?

Lactulose (an artificial sugar) belongs to the group of laxatives called osmotic laxatives, which work by drawing water into the bowel.



Lactuflave® cherry is for use in treating constipation.

It may also be used to help in the disease called hepatic encephalopathy (disorders of the brain caused by the liver).

2.    BEFORE YOU TAKE LACTUFLAVE® CHERRY

Do not take Lactuflave® cherry

-    if you are allergic (hypersensitive) to lactulose or any of the other ingredients of Lactuflave®cherry,

-    if you have a blockage of the gut (other than constipation),

-    if you have the inherited disorder of sugar metabolism called galactosaemia and should be on a galactose-free diet,

-    if you reacted badly to lactose (milk sugar).

Take special care with Lactuflave® cherry

You may use Lactuflave® cherry if you are diabetic, since it contains less than 5 kcal (21 KJ) of available calories per 5 ml. This does not normally affect control of diabetes, but if you are in any doubt see your doctor or pharmacist.

Taking/Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Lactulose may intensify the loss of potassium especially with simultaneous intake of thiazide diuretics, corticosteroids, carbenoxolone and amphotericin.

Taking Lactuflave® cherry with food and drink

If you wish, you can take Lactuflave® cherry in water, tea or fruit juice, etc.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You may use Lactuflave® cherry if you are pregnant or breast feeding, but check with your doctor first before starting treatment.

Driving and using machines

Lactuflave® cherry has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Lactuflave® cherry

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


Lactufl.cherry - GB-6.Korr. 05.07.2010    10:29 Uhr Seite 2



3. HOW TO USE LACTUFLAVE® CHERRY

Always use Lactuflave® cherry exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Why to use Lactuflave® cherry regularly

As it may take up to 48 hours before the full effect is obtained, this medicine should be taken regularly.


Constipation:

The amount of Lactuflave®cherry you should take depends on your own needs. The suggestions below should be followed when you first start taking the medicine, but the amount can be changed later if needed.


Use the measuring beaker supplied to measure out the correct dose.


Starting dose:

-    Adults:

-    Children 5-10 years:

-    Children under 5 years:

-    Babies under 1 year:


15 ml twice daily 10 ml twice daily 5 ml twice daily 2.5 ml twice daily


Hepatic encephalopathy:

Adults:

Use as instructed by your doctor. Use the measuring beaker supplied to measure out the correct amount of Lactuflave® cherry. As a guide, the amount to take when starting treatment is 30 to 50 ml three times a day. The dose should then be changed if necessary to produce two or three soft stools each day.

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



4.    POSSIBLE SIDE EFFECTS

Like all medicines, Lactuflave® cherry can cause side effects, although not everybody gets them.

Gas or cramps in the gut, or flatulence may occur occasionally (less than 1 in 1,000 people). These effects usually settle down after the first stage of treatment. Large quantities of Lactuflave® cherry may cause nausea in some people. Talk to your doctor or pharmacist if you feel the medicine is not suiting you.

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.

5.    HOW TO STORE LACTUFLAVE® CHERRY

Keep out of the reach and sight of children.

Do not freeze. Store below 25°C.

After the first opening, the solution can be stored for 6 months.

Do not use Lactuflave® cherry after the expiry date which is stated on the bottle label and carton. The expiry date refers to the last day of that month.



6. FURTHER INFORMATION

What Lactuflave® cherry contains

The active substance is Lactulose.

Each 5 ml of the oral solution contain 3.35 g lactulose.

The other ingredients are cherry flavour, citric acid and water.

What Lactuflave® cherry looks like and contents of the pack

Clear, colourless to yellow brownish solution

Lactuflave® cherry is available in bottles with 100 ml, 200 ml, 500 ml and 1000 ml of solution.


Marketing Authorisation Holder

MIP Pharma GmbH Kirkeler Stral3e 41 66440 Blieskastel Germany

Manufacturer

Chephasaar

Chem.-pharm. Fabrik GmbH Muhlstral3e 50 66386 St. Ingbert Germany.


This leaflet was last approved in June 2010.


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MIP Pharma GmbH, Kirkeler Strafie 41, 66440 Blieskastel