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LAEVOLAC PLUM FLAVOUR 10G/15ML ORAL SOLUTION

Active substance(s): LACTULOSE LIQUID / LACTULOSE LIQUID / LACTULOSE LIQUID

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2nd sheet

PACKAGE LEAFLET: INFORMATION FOR THE USER

The recommended dose is:
For constipation or where a soft stool is considered of medicinal benefit:

Lactulose plum flavour 10 g/15 ml oral solution sachets

Starting dose
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- 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
not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

Adolescents over
14 years
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Maintenance dose

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)

What is in this leaflet
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

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

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.

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.

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 (e.g. lactobacilli) present in the colon. This makes the stool softer and
easier to pass, by drawing water into the bowel.

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.

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.

4. Possible side effects

2. What you need to know before you take Lactulose plum flavour

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

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)
- acute inflammatory bowel disease (like Crohn‘s disease or ulcerative colitis) blockage in your
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.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Lactulose plum flavour.
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.
Longterm use of unadjusted dosages (exceeding 2 - 3 soft stools per day) or misuse can lead to
diarrhoea and disturbance of the electrolytes balance.
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.
Please do not use Lactulose plum flavour without medical advice for more than two weeks.
During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 1.5 - 2 l / day,
equal to 6 - 8 glasses).
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
infants. In these cases your doctor will supervise the treatment carefully.
Other medicines and Lactulose plum
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Lactulose may increase the loss of potassium caused by other drugs (e.g. thiazides, steroids and
amphotericin 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.
Lactulose plum flavour with food and drink
Lactulose plum flavour can be taken with or without food. There are no restrictions on what you can
eat or drink.
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.
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.
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.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
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.
During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 1.5 - 2 l / day,
equal to 6 - 8 glasses).
If diarrhoea occurs, the dose should be reduced.

The following side effects have been reported with Lactulose plum flavour:
- Flatulence (wind), especially during the first few days of treatment. This usually disappears after a
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 diarrhea.
The frequency of these side effects is not known, i.e. the frequency cannot be estimated from the
available data.
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Lactulose plum flavour
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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.
Partially used sachets have to be discarded.
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
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).
- The other ingredient is plum flavour. The plum flavour consists of plum extract, ethyl alcohol,
propylene glycol, aromatic substance and caramel colour.
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.
Marketing Authorisation Holder and Manufacturer
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
Manufacturer
Fresenius Kabi Austria GmbH
Estermannstraße 17
4020 Linz, Austria
Distributor in UK
Intrapharm Laboratories Limited
The Courtyard Barns
Choke Lane
Cookham Dean
Maidenhead
Berks. SL6 6PT
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria:
Germany:
Ireland:
Italy:
United Kingdom:

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

This leaflet was last revised in December 2016

The recommended dose is:
For constipation or where a soft stool is considered of medicinal benefit:

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

In elderly patients (≥ 65 years) and patients with renal or hepatic insufficiency no special dosage
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

LaevoGo Pflaumenaroma 10 g/15 ml Lösung zum Einnehmen
Lactulose Pflaumenaroma 10 g/15 ml Lösung zum Einnehmen
Lactulose Plum 10 g/15 ml oral solution
Lattulosio Fresenius 10 g/15 ml soluzione orale
Laevolac plum flavour 10 g/15 ml oral solution;
Lactulose plum flavour 10 g/15 ml oral solution sachets

V0000000/00

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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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