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LACTULOSE PLUM FLAVOUR 10 G / 15 ML ORAL SOLUTION SACHETS

Active substance(s): LACTULOSE LIQUID

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The recommended dose is:

PACKAGE LEAFLET: INFORMATION FOR THE USER
Lactulose plum flavour 10 g/15 ml oral solution sachets

Starting dose
Adolescents over
14 years

important information for you.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

15 - 45 ml
daily

1 - 3 sachets,
corresponding to
10 - 30 g
lactulose

15 - 30 ml
daily

1 - 2 sachets,
corresponding to
10 - 20 g
lactulose

15 ml
daily

1 sachets,
corresponding to
10 g lactulose

15 ml
daily

1 sachets,
corresponding to
10 g lactulose

Children and
adolescents
(7-14 years)

- You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

Maintenance dose

Treatment duration:
The duration of treatment has to be adopted according to the symptoms. It can take 2 - 3 days until the
desired effect will be achieved since lactulose is not degraded until it reaches the colon.

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

If you take more Lactulose plum flavour than you should
In case of overdosage, you may experience diarrhoea and abdominal pain. Contact your doctor or
pharmacist if you have taken more Lactulose plum flavour than you should.
If you forget to take Lactulose plum flavour
If you forget to take a dose of Lactulose plum flavour, 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.

1. What Lactulose plum flavour is and what it is used for

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Lactulose plum flavour is used to treat the symptoms of constipation.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know before you take Lactulose plum flavour

If you stop taking Lactulose plum flavour
The desired effect of the medicine may not be achieved.
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 reported with Lactulose plum flavour:
couple of days.
- Nausea (feeling sick)
- Vomiting
- Electrolyte imbalance due to diarrhoea can be found during investigations.
- When a higher dose than recommended is used, you may experience abdominal pain and diarrhoea.

Do not take Lactulose plum flavour:
- if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from
- galactosaemia (a severe genetic disorder where you cannot digest galactose)
bowel (apart from normal constipation), a hole in your stomach or bowel or risk of a hole in your
stomach or bowel, abdominal pain for which no cause has been found.

The frequency of these side effects is not known, i.e. the frequency cannot be estimated from the
available data.

Warnings and Precautions
Talk to your doctor or pharmacist before taking Lactulose plum flavour.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not

Please tell your doctor before taking Lactulose plum flavour if you suffer from gastro-cardiac syndrome
(Roemheld syndrome). If you have symptoms like excess gas in your bowels or bloating after using it,
stop the treatment and consult your doctor. In these cases your doctor will supervise the treatment
carefully.

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

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

5. How to store Lactulose plum flavour
Keep this medicine out of the sight and reach of children.

If you are an elderly patient or a patient in bad general condition and take lactulose for a more than 6
months period, your doctor will regularly check your blood electrolytes.

Do not store above 25°C.

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

Do not use this medicine after the expiry date which is stated on the outer carton/sachet after "EXP".
The expiry date refers to the last day of that month.

equal to 6 - 8 glasses).
Partially used sachets have to be discarded.
Children and adolescents:
Children and adolescents should use laxatives only under the supervision of a doctor. Lactulose plum
flavour should not normally be given to toddlers and infants as it can disturb the normal reflexes for
passing stools.
In special circumstances your doctor may prescribe Lactulose plum flavour for a child, infant or
newborn infant. In these cases your doctor will supervise the treatment carefully.

Do not throw away any medicines via waste water 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

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

What Lactulose plum flavour contains
- The active substance is lactulose.
One sachet (15 ml) of Lactulose plum flavour contains 10 g lactulose (as lactulose liquid).
propylene glycol, aromatic substance and caramel colour.

Lactulose may increase the loss of potassium caused by other drugs (e.g. thiazides, steroids and
amphothericin B). Use of cardiac glycosides along with lactulose can increase the effect of the
glycosides by decreasing potassium in the blood.
With increasing dosage a decrease of pH-value in the colon is found. Therefore drugs which are
released in the colon pH-dependently (e.g. 5-ASA (5-aminosalicylate)) can be inactivated.

What Lactulose plum flavour looks like and contents of the pack
Lactulose plum flavour is a clear, viscous liquid, colourless or pale brownish-yellow oral solution with
plum odour and taste and is available in following pack sizes: 10 and 20 sachets.
Not all pack sizes may be marketed.

Lactulose plum flavour with food and drink
eat or drink.

Marketing Authorisation Holder and Manufacturer

Pregnancy, breast-feeding and fertility
Lactulose plum flavour can be used 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.

Marketing Authorisation Holder
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz, Austria
Tel.: +43 316 249 0
Fax: +43 316 249 1470
info-atgr@fresenius-kabi.com

Driving and using machines
Lactulose plum flavour has no or negligible influence on your ability to drive and use machines.
Lactulose plum flavour may contain small amounts of sugars.
Lactulose plum flavour may contain small amounts of sugars (milk sugar (lactose), fruit sugar (fructose),
galactose, tagatose or epilactose). If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product.

Manufacturer
Fresenius Kabi Austria GmbH
Estermannstraße 17
4020 Linz, Austria

The dose normally used should not pose a problem for diabetics. 15 ml of lactulose contain 42.7 KJ
(10.2 kcals) = 0.21 BU.
3. How to take Lactulose plum flavour
For oral use.
you. Check with your doctor or pharmacist if you are not sure.
Take your doses at the same time each day. The dose may be taken once daily, for example during
breakfast, or divided into two or three doses a day.
Swallow the medicine quickly. Do not keep it in your mouth.
You can take Lactulose plum flavour oral solution undiluted or diluted in some liquid.
equal to 6 - 8 glasses).
If diarrhoea occurs, the dose should be reduced.

This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria:
Germany:
Ireland:
Italy:
UK:

For a precise dosing for infants, toddlers and children up to 6 years, lactulose is available in bottles.
The recommended dose is:

This leaflet was last revised in September 2014

Starting dose
Adults

15 - 45 ml
daily

1 - 3 sachets,
corresponding to
10 - 30 g
lactulose

Maintenance dose
15 - 30 ml
daily

1 - 2 sachets,
corresponding to
10 - 20 g
lactulose

recommendations exist.
Use in children and adolescents:
Please do not give Lactulose plum flavour to children and adolescents < 14 years before consulting
your doctor for prescription and careful supervision.

V0000000/00

Laevolac Plum 10 g/15 ml oral solution
Lattulosio Fresenius
Laevolac plum flavour 10 g/15 ml oral solution;
Lactulose plum flavour 10 g/15 ml oral solution sachets

V0000000/00

Laetus code:
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Distributor in UK:
Intrapharm Laboratories Limited
The Courtyard Barns
Choke Lane
Cookham Dean
Maidenhead
Berks. SL6 6PT
United Kingdom
Laetus code:
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Laetus code:
o :
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Lactulose plum flavour contains the active substance lactulose, it is not absorbed into your body and
reaches the colon unchanged. Lactulose is a laxative and a prebiotic substance that supports the
growth acidophilic bacteria (eg lactobacilli) present in the colon. This makes the stool softer and easier
to pass, by drawing water into the bowel.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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