Laevolac 3.3g/5ml Oral Solution

Document: label-leaflet ALMUS_PL 05061-0001 change

Lactulose #3,3 g/#5 ml

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Base label

Lactulose

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3.3 g / 5 ml

Oral Solution

5 ml contains 3.3 g lactulose

300 ml

A0288/3

Oral use

Oral use. Lift flap for further information about your medicine. Read the package leaflet before use. Lactulose oral solution is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).

Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose) Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose)

Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose)

Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose)

Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3-7 g lactulose)

Babies: Starting dose: up to 5 ml (corresponding to up to 3 g lactulose)

Portal systemic encephalopathy (Liver disease that affects the brain)

Adults: Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose).

The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5. Children: The safety and efficacy in children aged 0 - 18 years has not been established.

In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist. Do not store above 25°C. Keep out of the sight and reach of children. Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose).

Marketing Authorisation Holder: Fresenius Kabi Austria GmbH, HafnerstraBe 36, 8055 Graz, Austria.

Almus® is a registered trademark PL 05061/0001 ^P

Cover label


Lactulose	Oral use. Lift flap for further information about your medicine. Read the package leaflet before use. Lactulose oral solution is used to treat the symptoms of constipation and to treat a special liver disease (portal systemic encephalopathy).
3.3 g / 5 ml	Constipation: Adults and adolescents over 14 years: Starting dose: 15-45 ml (corresponding to 10-30 g lactulose) Maintenance dose: 15-30 ml (corresponding to 10-20 g lactulose) Children (7-14 years): Starting dose: 15 ml (corresponding to 10 g lactulose) Maintenance dose: 10-15 ml (corresponding to 7-10 g lactulose) Children (1-6 years): Starting dose: 5-10 ml (corresponding to 3-7 g lactulose) Babies: Starting dose: up to 5 ml (corresponding to up to 3 g lactulose) Portal systemic encephalopathy (Liver disease that affects the brain) Adults: Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose). The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5. Children: The safety and efficacy in children aged 0 - 18 tyears ha not been established. In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist. Do nc^J store above 25°C. Keep out of the sight and reach lo,_:of children. Contains traces of sugars (e.g. lactose, galactose, epilactose, tagatose, fructose). • • • _{PL 05061/0001} [7] ^ Marketing Authorisation Holder: Fresenius Kabi Austria GmbH, HaineistraBe 36, 8055 Graz, Austria. Almus® is a registered trademark
Oral Solution 5 ml contains 3.3 g lactulose 300 ml . A1.M1IS. • Oral use

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution

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 oral solution 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 after 3 days.

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

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In this leaflet	• treat the symptoms of constipation
1. What Lactulose oral solution is and what it is used for	• treat a special liver disease (portal systemic encephalopathy)
2. Before you take Lactulose oral solution 3. How to take Lactulose oral solution	2. BEFORE YOU TAKE LACTULOSE ORAL SOLUTION
4. Possible side effects	Do not take Lactulose oral solution
5. How to store Lactulose oral solution	• if you are allergic (hypersensitive) to any of the components of Lactulose oral solution.
6. Further Information	• if you suffer from galactosaemia (a severe genetic disorder where you cannot digest galactose)
1. WHAT LACTULOSE ORAL SOLUTION IS AND WHAT IT IS USED FOR	• acute inflammatory bowel disease (like Crohn's disease or ulcerative colitis), blockage in your bowel (apart from normal constipation), digestive perforation or risk of digestive perforation,
Lactulose oral solution contains a laxative called lactulose. It makes the stool softer and easier to	abdominal pain of undetermined cause.
pass, by drawing water into the bowel. It is not absorbed into your body.	Take special care with Lactulose oral solution
Lactulose oral solution is used to:	Please tell your doctor before taking Lactulose oral solution if you suffer from gastro-cardiac syndrome

(Roemheld syndrome). If you have symptoms like meteorism 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 oral solution for more than a 6 month period, your doctor will regularly check your blood electrolytes.

Patients with portal systemic encephalopathy should avoid concomitant administration of other laxatives, because it hinders the individualisation of drug dose.

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

Lactulose oral solution 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 oral solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully.

From the route of synthesis Lactulose oral solution may contain traces of sugars.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 1/day, equal to 6-8 glasses).

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.

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Lactulose oral solution may increase the loss of potassium induced by other drugs (e.g. thiazides, steroids and amphothericin B). Concomitant use of cardiac glycosides can increase the effect of the glycosides through potassium deficiency.

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 oral solution with food and drink

Lactulose oral solution 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 or pharmacist before you use Lactulose oral solution if you are pregnant or breastfeeding.

Driving and using machines

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

Important information about some of the ingredients of Lactulose oral solution

Lactulose oral solution may contain milk sugar (lactose), galactose, epilactose, tagatose or frustose. Please refer to section "Take special care with Lactulose oral solution".

15 ml of Lactulose oral solution contain 42.7 KJ (10.2 kcals) = 0.21 bu. The dose used for treatment may need to be taken into considerations for diabetics.

3. HOW TO TAKE LACTULOSE ORAL SOLUTION

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

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Take your doses at the same time each day. The dose may be given once daily, for example during breakfast, or divided up to 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. Use the measuring cup provided.

During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 21/day, equal to 6-8 glasses).

Constipation:

	Starting dose		Maintenance dose
Adults and adolescents over 14 years	15-45 ml	corresponding to 10-30 g lactulose	15-30 ml	corresponding to 10-20 g lactulose
Children (7-14 years)	15 ml	corresponding to 10 g lactulose	10-15 ml	corresponding to 7-10 g lactulose
Children (1-6 years)	5-10 ml	corresponding to 3-7 g lactulose
Babies	up to 5 ml	corresponding to up to 3 g lactulose

IQ It can be taken 2-3 days until the desired

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Thereafter the dose can be reduced individually.

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

If you take more Lactulose oral solution 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 oral solution than you should.

Portal systemic encephalopathy (Liver disease that affects the brain)

Adults:

Beginning with 30 - 50 ml 3 times daily (corresponding to 60 - 100 g lactulose). The dosage has to be adopted to get 2-3 soft stools daily, pH of the stools should be between 5.0 to 5.5.

Children:

The safety and efficacy in children aged 0-18 years has not been established.

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

If you forget to take Lactulose oral solution

If you forget to take a dose of Lactulose oral solution, 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 oral solution

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.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Lactulose oral solution can cause side effects, although not everybody gets them. The following side effects have been reported with Lactulose oral solution 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 and diarrhoea.

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.

5. HOW TO STORE LACTULOSE ORAL SOLUTION

Do not store above 25°C. Keep container tightly closed.

Keep out of the sight and reach of children.

Do not use Lactulose oral solution after the expiry date which is stated on the label of the bottle (EXP: mm yyyy). The expiry date refers to the last day of that month.

Common:

• Nausea (feeling sick)

• Vomiting

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.

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6. FURTHER INFORMATION

What Lactulose oral solution contains

• The active substance is Lactulose (as lactulose liquid)

5 ml of Lactulose oral solution contains 3.3 g lactulose.

• There are no other ingredients

What Lactulose oral solution looks like and contents of the pack

Lactulose oral solution is a clear, viscous liquid, colourless or pale brownish-yellow solution and is available in glass, PET bottles or HDPE bottles containing 200 ml, 300 ml, 500 ml and 1000 ml.

Marketing Authorisation Holder

Fresenius Kabi Austria GmbH, HafnerstraBe 36, 8055 Graz, Austria.

Tel.:+43 316 249 0 Fax:+43 316 249 1470 Tnfo-atBr(®.fresenius-kabi.com

Manufacturer

Fresenius Kabi Austria GmbH, EstermannstraBe 17, 4020 Linz, Austria.

Tel.:+43 732 7651 0 Fax:+43 732 7651 2429 office(3).fresenius-kabi.com

A measuring cup (polypropylene) with filling marks is added as a measuring device. Not all pack sizes may he marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last approved in May 2012 (to be amended after approval).

REVISED ARTWORK FOR MHRA APPROVAL

LASER COPIES SUPPLIED AS VISUAL REFERENCE ONLY. DO NOT MATCH FOR COLOUR

VERSION: 3 (SANDOZ)

DRAFT ISSUES: 7 + 3

REASON FOR CHANGE: LABEL LEAFLET UPDATE

SUPPLIER ISSUE DATE: 29.11.2012

Client:	Almus UK	Special
		Colours:
Project:	8369 / A / UK
Project:	Lactulose 3.3g/5ml	BLACK
Item(s):	Label Leaflet

Checked by: Paul Adams. Queries regarding this artwork, please contact: Paul Adams or Steve Hobbs

Date: 29.11.2012

Lactulose #3,3 g/#5 ml

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• • • •

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• • • •

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L A C

U L O

> •

* •

• •

• • •

•

• • •

•

• •

•

• •

•

• •

•

• •

•

Base label

Lactulose

-Nj

-P>

o

-p^

3.3 g / 5 ml

Oral Solution

5 ml contains 3.3 g lactulose

500 ml

A0289/3