Laevolac Plum Flavour 10g/15ml Oral Solution
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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 |
PACKAGE LEAFLET: INFORMATION FOR THE USER
Laevolac plum flavour 10 g/15 ml oral solution Lactulose
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.
What is in this leaflet
1. What Laevolac plum flavour is and what it is used for
2. What you need to know before you take Laevolac plum flavour
3. How to take Laevolac plum flavour
4. Possible side effects
5. How to store Laevolac plum flavour
6. Contents of the pack and other information
1. What Laevolac plum flavour is and what it is used for
Laevolac 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.
Laevolac 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 Laevolac plum flavour Do not take Laevolac 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 Laevolac plum flavour.
Please tell your doctor before taking Laevolac 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 Laevolac 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. Laevolac 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 Laevolac plum flavour for a child, infant or newborn infants. In these cases your doctor will supervise the treatment carefully.
Other medicines and Laevolac 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 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.
Laevolac plum flavour with food and drink
Laevolac 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
Laevolac 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
Laevolac plum flavour has no or negligible influence on your ability to drive and use machines. Laevolac plum flavour may contain small amounts of sugars.
Laevolac Plum 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 Laevolac 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 Laevolac 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).
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 Laevolac 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 Laevolac plum flavour than you should.
If you forget to take Laevolac plum flavour
If you forget to take a dose of Laevolac 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 Laevolac 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 Laevolac 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 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 Laevolac 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 Laevolac plum flavour contains
- The active substance is lactulose.
One sachet (15 ml) of Laevolac 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 Laevolac plum flavour looks like and contents of the pack
Laevolac plum flavour is a clear, viscous liquid, colourless or pale brownish-yellow oral solution with plum odour and taste and is available in the following packsizes: 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
Manufacturer
Fresenius Kabi Austria GmbH EstermannstraUe 17 4020 Linz, Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Laevolac Pflaumenaroma 10 g/15 ml Losung zum Einnehmen
Germany: Laevolac Pflaumenaroma 10 g/15 ml Losung zum Einnehmen
Ireland: Laevolac Plum 10 g/15 ml oral solution
Italy: Lattulosio Fresenius
This leaflet was last revised in June 2014
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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.
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 |
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 Laevolac plum flavour to children and adolescents < 14 years before consulting your doctor for prescription and careful supervision.
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