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Laevolac Plum Flavour 10g/15ml Oral Solution

Document: leaflet INTRAPHARM LABORATORIES_PL 05061-0009 change

1st sheet


2nd sheet


The recommended dose is:

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

Starting dose

Maintenance dose

Adolescents over 14 years

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

Children and adolescents (7-14 years)

15 ml daily

1 sachets, corresponding to 10 g lactulose

15 ml daily

1 sachets, corresponding to 10 g lactulose



Laevolac Pflaumenaroma 10 g/15 ml Losung zum Einnehmen Laevolac Pflaumenaroma 10 g/15 ml Losung zum Einnehmen

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose plum flavour 10 g/15 ml oral solution sachets

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.

-

-    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.

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

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

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.

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 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.

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 I / 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 infant. In these cases your doctor will supervise the treatment carefully.

Other medicines and Lactulose plum flavour

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 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.

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 I / day, equal to 6 - 8 glasses).

If diarrhoea occurs, the dose should be reduced.

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

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.

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.

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.

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/vellowcard. 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).

-

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

HafnerstraUe 36

8055 Graz, Austria

Tel.: +43 316 249 0

Fax: +43 316 249 1470

info-atgr@fresenius-kabi.com

Manufacturer

Fresenius Kabi Austria GmbH EstermannstraUe 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:

UK:


The recommended dose is:

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

Starting dose

Maintenance dose

Adults

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


This leaflet was last revised in September 2014

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.

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