Lactulose Sandoz 670 mg/ml, stroop

Lactulose Sandoz belongs to a group of medicines known as laxatives. Lactulose, the active substance, makes the stool softer and easier to pass by drawing water into the bowel. It is not absorbed into your body.

Lactulose Sandoz is used to treat

• Symptoms of constipation

Do not take Lactulose Sandoz

• if you are allergic to Lactulose Sandoz or any of the other ingredients of this medicine (listed in section 6)
• if you have any blockage in your bowel that is not due to constipation
• if you have a stomach or bowel perforation or a risk of this
• if you have abdominal pain of undetermined cause
• if you cannot digest galactose due a genetic disorder called galactosaemia

Warnings and precautions

Talk to your doctor before taking Lactulose Sandoz if you have heart problems caused by much gas in bowel or stomach, called Roemheld syndrome. Your doctor will supervise the treatment carefully in this case. Stop treatment and consult your doctor if you have symptoms like wind or bloating after using Lactulose Sandoz.

Drink at least 1.5 to 2 litres of liquid per day during treatment with laxatives.

Longterm use of unadjusted dosages - exceeding 2-3 soft stools per day - or misuse, can lead to diarrhoea and disturbance of the mineral balance.

Elderly patients, or those in bad general condition taking Lactulose Sandoz longer than 6 months, require regular blood checks of their mineral levels.

Children and adolescents

Lactulose Sandoz should only be given to children under doctor’s supervision.

Other medicines and Lactulose Sandoz

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

The following medicines can affect or be affected by Lactulose Sandoz:

• medicines to increase urine output with active substance names mostly ending with “thiazide” or “tizide”
• medicines to treat inflammation or prevent organ transplant rejection, such as cortisone
• amphotericin B: a medicine to treat fungal infections
• medicines to treat heart weakness, such as digitoxin, digoxin
• mesalazine, a medicine to treat disease with long-lasting bowel inflammation

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.

Lactulose Sandoz may be used during pregnancy and breast-feeding.

Driving and using machines

Lactulose Sandoz has no influence on the ability to drive and use machines.

Lactulose Sandoz contains certain sugars

Lactulose Sandoz may contain milk sugar (lactose), galactose or fructose. 15 ml of Lactulose Sandoz contains 42.7 KJ (10.2 kcals) = 0.21 bu. This should be taken into account in patients with diabetes mellitus.

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

The recommended dose is:

Constipation

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

The daily dose should be taken all at once in the morning, or divided into two doses per day. It can be taken for 2-3 days until the desired effect has been achieved.

In elderly patients and patients with reduced kidney or liver function no special dosage recommendations exist.

Method of use

You can take Lactulose Sandoz undiluted or diluted in some liquid, with or without food. Use the measuring cup provided.

Swallow the medicine quickly. Do not keep it in your mouth.

Duration of use

Please do not use Lactulose Sandoz without medical advice for more than two weeks.

If you take more Lactulose Sandoz than you should

Please contact your doctor or pharmacist.

When you have taken too much Lactulose Sandoz, diarrhoea and abdominal pain may occur.

If you forget to take Lactulose Sandoz

If you have forgotten to take a dose, then 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 Lactulose Sandoz

The desired effect of the medicine may not be achieved.

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

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

Side effects can occur with the following frequencies:

Very common, may affect more than 1 per 10 users

• wind, especially during the first few days of treatment This usually disappears after a couple of days
• abdominal pain

Common, may affect up to 1 in 10 users

• nausea
• vomiting
• diarrhoea, if the dose is too high

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

Do not store above 25°C.

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 of the bottle as well on the

outer carton after "exp". The expiry date refers to the last day of that month.

After first opening Lactulose Sandoz can be used for 1 year.

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.

What Lactulose Sandoz contains

The active substance is lactulose as lactulose liquid.

One ml of Lactulose Sandoz solution contains 670 mg lactulose.

There are no other ingredients.

What Lactulose Sandoz looks like and contents of the pack

Lactulose Sandoz is a clear, viscous liquid, colourless or pale brownish-yellow solution and is available in following packsizes:

Brown PET bottles with polyethylene screw cap or polypropylene closure containing 180ml and 200ml.

As measuring device a measuring cup (polypropylene) with filling marks at 5, 10, 15, 20, 25 and 30 ml is added

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz B.V., Veluwezoom 22, Almere, Nederland

Correspondentie: Postbus 10332, 1301 AH Almere

Manufacturers

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana Slovenië

LEK S.A.

ul. Domaniewska 50 C 02-672 Warschau Polen

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Duitsland

MA-number:

RVG 109595

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

Nederland	Lactulose Sandoz 670 mg/ml, stroop
Italië	Lattulosio Sandoz GmbH

Deze bijsluiter is voor het laatst goedgekeurd in september 2012