iMedi.co.uk

Laevolac 10g/15ml Oral Solution

Document: leaflet INTRAPHARM LABORATORIES_PL 05061-0008 change

3203275 • Fresenius Linz • BP Intrapharm • V0056218/03 Kundencode: Lt.Daten • Eberle Druck, Wien • Dub Format: 148 x 520 mm Druck: Schwarz

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 10g/15 ml Oral Solution Sachets Lactulose

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Lactulose carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve within 3 days.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Lactulose is and what it is used for

2.    Before you take Lactulose

3.    How to take Lactulose

4.    Possible side effects

5.    How to store Lactulose

6.    Further Information

1. WHAT LACTULOSE IS AND WHAT IT IS USED FOR

Lactulose 10 g/15 ml oral solution sachets contains a laxative called lactulose. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body.

Lactulose is used to treat the symptoms of constipation.

2. BEFORE YOU TAKE LACTULOSE

Do not take Lactulose if you:

-    are allergic (hypersensitive) to any of the components of Lactulose

-    suffer from galactosaemia (a severe genetic disorder where you cannot digest galactose), acute inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), blockage in your bowel (apart from normal constipation), digestive perforation or risk of such perforation or unexplained abdominal pain

Take special care with Lactulose

Please tell your doctor before taking Lactulose 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 who take lactulose for a more than 6 months period, your doctor will regularly check your blood electrolytes.

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

During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres per day, equal to 6-8 glasses).

Children up to 6 years:

Lactulose should not normally be given to infants and smaller children as it can disturb the normal reflexes for passing stools.

In special circumstances your doctor may prescribe Lactulose for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.

Lactulose may increase the loss of potassium caused by other drugs (e.g. thiazides, steroids and amphothericin B). Use of cardiac glycosides (e.g. digoxin) 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) can be inactivated.

Taking Lactulose with food and drink

Lactulose can be taken with or without food. There are no restrictions on what you can eat or drink.

Pregnancy and breast-feeding

Talk to your doctor before you use Lactulose if you are pregnant or breast-feeding.

Driving and using machines

Lactulose will not affect your ability to drive safely or use machines.

Important information about some of the ingredients of Lactulose

Lactulose may contain small amounts of sugars (lactose, galactose 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.

May contain more than 5 g lactose/galactose/epilactose depending upon the dose taken. This should be taken into account in patients with diabetes mellitus.

15 ml of Lactulose contain 42.7 KJ (10.2 kcals) = 0.21 BU.

3. HOW TO TAKE LACTULOSE

Always take Lactulose exactly as described in this leaflet .You should check with your doctor or pharmacist if you are not sure.

Take your doses at the same time each day. The dose may be given 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 oral solution undiluted or diluted in some liquid.

During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2

litres per day, equal to 6-8 glasses).


For a precise dosing for babies, toddlers and children up to 6 years, it should be noted that not all included dose recommendations can be carried out with Lactulose and that other authorised products are available.

Constipation:

Starting dose

Maintenance dose

Adults and adolescents over 14 years

15-45ml

daily

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

15-30ml

daily

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

Children (7-14 years)

15ml daily

1 sachet, corresponding to 10 g lactulose

15ml daily

1 sachet, corresponding to 10 g lactulose

Thereafter the dose can be reduced individually.

The daily dose should be taken at once during breakfast. It can be taken 2-3 days until the desired effect will be achieved since Lactulose is not degraded until it reaches the colon.

Children:

Please do not give Lactulose to children before consulting your doctor for prescription and careful supervision.

In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist.

If you take more Lactulose 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 than you should.

If you forget to take Lactulose

If you forget to take a dose of Lactulose, 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 have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop taking Lactulose

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lactulose can cause side effects, although not everybody gets them. The frequencies are defined as follows:

very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data_

The following side effects have been reported with Lactulose:

Very common:

-    Flatulence (wind), especially during the first few days of treatment. This usually disappears after a couple of days.

-    When a higher dose than recommended is used, you may experience abdominal pain.

Common:

-    Nausea (feeling sick)


-    Vomiting

-    When a higher dose than recommended is used, you may experience diarrhoea.

Reporting of side effects

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

For patients in the United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For patients in Ireland

You can also report side effects directly via e-mail to imbpharmacovigilance@imb.ie. Alternatively you can call +353 1 6764971.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE LACTULOSE

Do not store above 25°C.

Keep out of the sight and reach of children.

Do not use Lactulose after the expiry date which is stated on the outer carton and sachets after “exp”. The expiry date refers to the last day of that month.

Partially used sachets have to be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Lactulose contains

-    The active substance is Lactulose (as lactulose liquid)

-    One sachet (15 ml) of Lactulose oral solution contains 10 g lactulose.

-    There are no other ingredients

What Lactulose looks like and contents of the pack

Lactulose 10 g/15 ml oral solution is a clear, viscous liquid, colourless or pale brownish-yellow solution and is available in following pack sizes:

10, 20, 30, 50 and 100 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder UK and Ireland

Fresenius Kabi Austria GmbH HafnerstralJe 36 8055 Graz, Austria

Manufacturer

Fresenius Kabi Austria GmbH Estermannstralie 17 4020 Linz, Austria

Distributor in the United Kingdom and Ireland:

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:

Czech Republic: Estonia:

Ireland:

Latvia:

Lithuania:

Germany:

Netherlands:

Norway:

Romania:

Spain:

Sweden:

United Kingdom:


Laevolac 10g/15ml - Losung zum Einnehmen Laktulosa Sandoz sacky 10g/15ml Franirose

Lactulose 10g/15ml Oral Solution Sachets

Franirose 10g/15ml skTdums iekskTgai lietosanaii

Lactulose Sandoz 10g/15ml geriamasis tirpalas

Lactulose unterwegs -1 A Pharma 66,7g/100ml Losung zum Einnehmen

Laevolac 10g/15ml - stroop

Lactulose Fresenius Kabi

Lactuloza Sandoz 10g/15ml solutie orala

Lactulosa Sandoz 10g solucion oral eb sobres EFG

Lactulose Fresenius 10g oral losning, dospase

Lactulose 10g/15ml oral solution sachets; Laevolac 10g/15ml - Oral solution


This leaflet was last revised in September 2013.

V0056218/03