iMedi.co.uk

Lactulose 3.3g/5ml Oral Solution

Informations for option: Lactulose 3.3g/5ml Oral Solution, show other option
Document: label-leaflet ALMUS PHARMACEUTICALS_PL 10321-0001 change

Braille text reads as follows:


Braille text reads as follows:

EXP:

IN:


For oral use. Read the package leaflet before use.

Keep out of the sight and reach of children.

Dosage for constipation:-Adults: 15 ml twice daily. pi Children 5to 10years: 10mltwice daily.

Children under 5 years: 5 ml twice daily, si- Babies under 1 year: 2.5 ml twice daily ^ or as directed by your doctor.

O Dosage for other conditions- as directed by your doctor 52 Take with water or fruit juice if required.

P Storage:

Do not store above 25°C. Do not refrigerate or freeze. Use within 6 months of first opening then discard.


o
o

Lactulose Oral Solution


3.3 g / 5 ml


300 ml Oral use

5ml of Lactulose Solution contains 3.3g of Lactulose.

Lactulose also contains lactose, galactose and small amounts of fructose (all are types of sugar).

MA Holder: Resolution Chemicals Ltd.,

Wedgwood Way, Stevenage, Hertfordshire, SG1 4QT, UK

Distributed by: Almus Pharmaceuticals Limited, 2 The Heights, pl 10321/0001 [P


Brooklands, Weybridge, Surrey, KT13 0NY

Almus ® is a registered trademark


A0288/8


lactulose

• • • •

• •• • •

#3.3 [ls]g

• ••

• • ••

• • •

• •• •


/#5ml    •    •

• • • •


solution

# denotes number symbol Note: dies comply with

• •


• • • • • •


Marburg Medium cell dimensions:

• •



6.0

fel

12.0

1 1 • •

• •

• •

• •

• •

• •

• •

• •

• •


(Figures are in mm)



PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution

{Lactulose}

Read all of this leaflet carefully before you start using 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 doctor or 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 your doctor if you do not feel better or if you feel worse

after several days._


What is in this leaflet

1.    What Lactulose Solution is and what it is used for

2.    What you need to know before you take Lactulose Solution

3.    Howto take Lactulose Solution

4.    Possible side effects

5.    Howto store Lactulose Solution

6.    Contents of the pack and other information

1. WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR

Lactulose Solution belongs to a group of medicines called laxatives. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body.

It is used in the treatment of constipation (infrequent bowel movements, hard and dry stools) and to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness including coma). This is also known as a 'hepatic coma’._


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IACTULOSE SOLUTION Do not take Lactulose Solution:

-    if you are allergic (hypersensitive) to lactulose or any of the other ingredients of this medicine (listed in Section 6);

-    if you are suffering from a blockage caused by anything else but normal constipation, digestive perforation or risk of digestive perforation;

-    if you suffer from a rare problem called 'galactosaemia'

Do not take Lactulose Solution if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lactulose Solution. Warnings and precautions

Talk to your doctor or pharmacist before taking Lactulose Solution if you suffer from any medical conditions or illnesses, in particular:

-    if you suffer from unexplained tummy ache

-    if you are unable to digest milk sugar (lactose intolerant)

-if you have diabetes


You should not take Lactulose Solution it you suffer from:

-    glucose-galactose malabsorption syndrome

-    Lapp lactase deficiency

-    galactose or fructose intolerance.

If you take lactulose solution for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Prolonged use of the same dose, or misuse, can lead to diarrhoea and disturbance of the electrolyte balance.

If you have diabetes and are treated for hepatic encephalopathy, your dose of lactulose will be higher. This high dose contains a large amount of sugar. Therefore, you may need to adjust the dose of your anti-diabetic medicine.


Children

In special circumstances your doctor may prescribe Lactulose Solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Lactulose Solution should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

Other medicines and Lnctulose Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Lactulose Solution with food ond drink

Lactulose Solution may betaken with or without food. There are no restrictions on what you can eat or drink.


Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking this medicine if you are pregnant might become pregnant or are breast-feeding. Lactulose Solution can be used in pregnancy and when breast-feeding if necessary. No effects on fertility are to be expected.

Driving and using machines

There should be no problems when taking Lactulose Solution.

Important information about some of the ingredients of Lactulose Solution

Lactulose Solution may contain small amounts of lactose, galactose, epilactose or fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


3. HOWTO TAKE IACTULOSE SOLUTION

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 Lactulose Solution from a spoon or measuring cup.

•    Lactulose may be taken with water or fruit juice. It is recommended that you drink plenty of fluids (1.5-2 l/day, equal to 6-8 glasses throughout the day).

•    Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if this medicine is taken for long periods.

•    Lactulose takes 2 to 3 days to start working. After this time you may be able to reduce the dose you take according to your needs.

PTO
_

page 3


5

pages


pages


Constipation

Adults:    15ml twice daily (3 x 5ml spoonful)

Children 5 to 10 years:    10ml twice daily (2 x 5ml spoonful)

Children under 5 years:    5ml twice daily (I x 5ml spoonful)

Babies under 1 year:    2.5ml twice daily i'A x 5ml spoonful)

Use in children: Use of laxatives in children, infants and babies should be exceptional and under medical supervision because it can influence the normal reflexes for passing stools. Please do not give Lactulose Solution to children before consulting yourdoctorfor prescription and careful supervision.

To treat hepatic encephalopathy (adults only)

Higher doses of Lactulose Solution are required


Adults: 30-50ml three times daily.

Children: No information is available for treatment of children (newborn to 18 years) with hepatic encephalopathy.

Elderly and patients with renal or hepatic insufficiency: No special dosage recommendations exist.

If you take more Lactulose Solution than you should

If you take more Lactulose Solution than you should stop taking lactulose and talk to a doctor or pharmacist.

You may have diarrhoea and abdominal pain.

If you forget to take Lactulose Solution

If you forget to take a dose of Lactulose 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.


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 Solution:

Very common (may affect more than 1 in 10 people)

•    diarrhoea

Common (may affect up to 1 in 10 people)

•    flatulence (wind)

•    nausea (feeling sick)

•    vomiting

•    abdominal pain

Uncommon (may affect up to 1 in 100 people)

•    electrolyte imbalance due to diarrhoea

Flatulence may occur during the first few days of treatment. Generally it disappears after a few days. When dosages higher than instructed are


used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.

If you use high doses (normally only associated with hepatic encephalopathy) for an extended period of time, you may experience electrolyte imbalance due to diarrhoea.

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.

S. HOWTO STORE IACTULOSE SOLUTION

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Do not refrigerate or freeze.


Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month. Use within 6 months of first opening and discard any remaining solution.

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

B. CONTENTS OF THE PACK AND OTHER INFORMATION What Lactulose Solution contains

•    The active substance is lactulose. Each 5ml of Lactulose Solution contains 3.3g of lactulose.

•    Lactulose Solution does not contain any other ingredients. However it may contain small amounts of other sugars, such as lactose, galactose, epilactose and fructose.


What Lactulose Solution looks like and contents of the pack

Lactulose Solution is a clear, colourless to brownish yellow viscous liquid. Lactulose Solution is available in plastic bottles containing 200,300,500, 1000 and 5000 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Resolution Chemicals Limited

Wedgwood Way, Stevenage, Hertfordshire, SG1 4QT, UK.

Manufacturers

Central Pharma Limited, Caxton Road, Bedford, MK41 0XZ.

Thorpe Laboratories Limited, Enterprise Road, Mablethorpe, LN121NB This leaflet was last revised in October 2016


Lactulose Oral Solution


3.3 g / 5 ml


300 ml Oral use

5ml of Lactulose Solution contains 3.3g of Lactulose.

Lactulose also contains lactose, galactose and small amounts of fructose (all are types of sugar).

MA Holder: Resolution Chemicals Ltd.,

Wedgwood Way, Stevenage, Hertfordshire, SG1 4QT, UK

Distributed by: Almus Pharmaceuticals Limited, 2 The Heights, pl 10321/0001 [P]

A0288/8


Brooklands, Weybridge, Surrey, KT13 0NY

Almus ® is a registered trademark


DIMENSIONS 180 x 55mm


REVISED ARTWORK FOR MHRA APPROVAL


VERSION: 8 (ResoChem)


DRAFT ISSUE: 4


REASON FOR CHANGE: Safety text updates


Client:    Almus UK

Project:    10665 / UK

Lactulose 3.3g/5ml x 300ml

Item(s):    Label Leaflet


Colours used:

PMS    PMS    PMS

424    8401    2945



SUPPLIER ISSUE DATE: 2.11.2016


pmdc

design


BARCODE 5060034830047 PHARMA CODE TBA ALMUS CODE A0288/8 SUPPLIER CODE TBA


CUTTER BRAILLE


This scale measures 100mm when artwork is 100%

0    10    20    30    40    50


Checked by: Paul Adams

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

Date: 2.11.2016


pmdc design

Lower Test Studios Sheardley Lane, Droxford Hampshire SO32 3QY +44 (0)1489 878780 www.pmdc.co.uk



EXP:

IN:


For oral use. Read the package leaflet before use.

Keep out of the sight and reach of children.

Dosage for constipation:-Adults: 15 ml twice daily. pi Children 5to 10years: 10mltwice daily.

Children under 5 years: 5 ml twice daily, si- Babies under 1 year: 2.5 ml twice daily ^ or as directed by your doctor.

O Dosage for other conditions- as directed by your doctor 52 Take with water or fruit juice if required.

P Storage:

Do not store above 25°C. Do not refrigerate or freeze. Use within 6 months of first opening then discard.


o
o

Lactulose Oral Solution


3.3 g / 5 ml


500 ml Oral use

5ml of Lactulose Solution contains 3.3g of Lactulose.

Lactulose also contains lactose, galactose and small amounts of fructose (all are types of sugar).

MA Holder: Resolution Chemicals Ltd.,

Wedgwood Way, Stevenage, Hertfordshire, SG1 4QT, UK

Distributed by: Almus Pharmaceuticals Limited, 2 The Heights, pl 10321/0001 [P


Brooklands, Weybridge, Surrey, KT13 0NY

Almus ® is a registered trademark


A0289/8


lactulose

• • • •

• •• • •

#3.3 [ls]g

• ••

• • ••

• • •

• •• •


/#5ml    •    •

• • • •


solution

# denotes number symbol Note: dies comply with

• •


• • • • • •


Marburg Medium cell dimensions:

• •



6.0

fel

12.0

1 1 • •

• •

• •

• •

• •

• •

• •

• •

• •


(Figures are in mm)



PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution

{Lactulose}

Read all of this leaflet carefully before you start using 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 doctor or 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 your doctor if you do not feel better or if you feel worse

after several days._


What is in this leaflet

1.    What Lactulose Solution is and what it is used for

2.    What you need to know before you take Lactulose Solution

3.    Howto take Lactulose Solution

4.    Possible side effects

5.    Howto store Lactulose Solution

6.    Contents of the pack and other information

1. WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR

Lactulose Solution belongs to a group of medicines called laxatives. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body.

It is used in the treatment of constipation (infrequent bowel movements, hard and dry stools) and to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness including coma). This is also known as a 'hepatic coma’._


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IACTULOSE SOLUTION Do not take Lactulose Solution:

-    if you are allergic (hypersensitive) to lactulose or any of the other ingredients of this medicine (listed in Section 6);

-    if you are suffering from a blockage caused by anything else but normal constipation, digestive perforation or risk of digestive perforation;

-    if you suffer from a rare problem called 'galactosaemia'

Do not take Lactulose Solution if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lactulose Solution. Warnings and precautions

Talk to your doctor or pharmacist before taking Lactulose Solution if you suffer from any medical conditions or illnesses, in particular:

-    if you suffer from unexplained tummy ache

-    if you are unable to digest milk sugar (lactose intolerant)

-if you have diabetes


You should not take Lactulose Solution it you suffer from:

-    glucose-galactose malabsorption syndrome

-    Lapp lactase deficiency

-    galactose or fructose intolerance.

If you take lactulose solution for several days and there is no improvement in your condition or if your symptoms worsen, please contact your doctor.

Prolonged use of the same dose, or misuse, can lead to diarrhoea and disturbance of the electrolyte balance.

If you have diabetes and are treated for hepatic encephalopathy, your dose of lactulose will be higher. This high dose contains a large amount of sugar. Therefore, you may need to adjust the dose of your anti-diabetic medicine.


Children

In special circumstances your doctor may prescribe Lactulose Solution for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Lactulose Solution should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

Other medicines and Lnctulose Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Lactulose Solution with food ond drink

Lactulose Solution may betaken with or without food. There are no restrictions on what you can eat or drink.


Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking this medicine if you are pregnant might become pregnant or are breast-feeding. Lactulose Solution can be used in pregnancy and when breast-feeding if necessary. No effects on fertility are to be expected.

Driving and using machines

There should be no problems when taking Lactulose Solution.

Important information about some of the ingredients of Lactulose Solution

Lactulose Solution may contain small amounts of lactose, galactose, epilactose or fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


3. HOWTO TAKE IACTULOSE SOLUTION

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 Lactulose Solution from a spoon or measuring cup.

•    Lactulose may be taken with water or fruit juice. It is recommended that you drink plenty of fluids (1.5-2 l/day, equal to 6-8 glasses throughout the day).

•    Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if this medicine is taken for long periods.

•    Lactulose takes 2 to 3 days to start working. After this time you may be able to reduce the dose you take according to your needs.

PTO
_

page 3


5

pages


pages


Constipation

Adults:    15ml twice daily (3 x 5ml spoonful)

Children 5 to 10 years:    10ml twice daily (2 x 5ml spoonful)

Children under 5 years:    5ml twice daily (I x 5ml spoonful)

Babies under 1 year:    2.5ml twice daily i'A x 5ml spoonful)

Use in children: Use of laxatives in children, infants and babies should be exceptional and under medical supervision because it can influence the normal reflexes for passing stools. Please do not give Lactulose Solution to children before consulting yourdoctorfor prescription and careful supervision.

To treat hepatic encephalopathy (adults only)

Higher doses of Lactulose Solution are required


Adults: 30-50ml three times daily.

Children: No information is available for treatment of children (newborn to 18 years) with hepatic encephalopathy.

Elderly and patients with renal or hepatic insufficiency: No special dosage recommendations exist.

If you take more Lactulose Solution than you should

If you take more Lactulose Solution than you should stop taking lactulose and talk to a doctor or pharmacist.

You may have diarrhoea and abdominal pain.

If you forget to take Lactulose Solution

If you forget to take a dose of Lactulose 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.


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 Solution:

Very common (may affect more than 1 in 10 people)

•    diarrhoea

Common (may affect up to 1 in 10 people)

•    flatulence (wind)

•    nausea (feeling sick)

•    vomiting

•    abdominal pain

Uncommon (may affect up to 1 in 100 people)

•    electrolyte imbalance due to diarrhoea

Flatulence may occur during the first few days of treatment. Generally it disappears after a few days. When dosages higher than instructed are


used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.

If you use high doses (normally only associated with hepatic encephalopathy) for an extended period of time, you may experience electrolyte imbalance due to diarrhoea.

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.

S. HOWTO STORE IACTULOSE SOLUTION

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Do not refrigerate or freeze.


Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month. Use within 6 months of first opening and discard any remaining solution.

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

B. CONTENTS OF THE PACK AND OTHER INFORMATION What Lactulose Solution contains

•    The active substance is lactulose. Each 5ml of Lactulose Solution contains 3.3g of lactulose.

•    Lactulose Solution does not contain any other ingredients. However it may contain small amounts of other sugars, such as lactose, galactose, epilactose and fructose.


What Lactulose Solution looks like and contents of the pack

Lactulose Solution is a clear, colourless to brownish yellow viscous liquid. Lactulose Solution is available in plastic bottles containing 200,300,500, 1000 and 5000 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Resolution Chemicals Limited

Wedgwood Way, Stevenage, Hertfordshire, SG1 4QT, UK.

Manufacturers

Central Pharma Limited, Caxton Road, Bedford, MK41 0XZ.

Thorpe Laboratories Limited, Enterprise Road, Mablethorpe, LN121NB This leaflet was last revised in October 2016


Lactulose Oral Solution

3.3 g / 5 ml

AUV1US0

ml Oral use 5ml of Lactulose Solution contains 3.3g of Lactulose.

Lactulose also contains lactose, galactose and small amounts of fructose (all are types of sugar).

MA Holder: Resolution Chemicals Ltd.,

Wedgwood Way, Stevenage, Hertfordshire, SG1 4QT, UK

Distributed by: Almus Pharmaceuticals Limited, 2 The Heights, pl 10321/0001 Brooklands, Weybridge, Surrey, KT13 0NY

Almus ® is a registered trademark    A028


500


0

9/8


DIMENSIONS 180 x 55mm


REVISED ARTWORK FOR MHRA APPROVAL


VERSION: 8 (ResoChem)


DRAFT ISSUE: 4


REASON FOR CHANGE: Safety text updates


Client:    Almus UK

Project:    10666 / UK

Lactulose 3.3g/5ml x 500ml

Item(s):    Label Leaflet


Colours used:

PMS    PMS    PMS

424    8401    2945



SUPPLIER ISSUE DATE: 2.11.2016


pmdc

design


BARCODE 5060034830047 PHARMA CODE TBA ALMUS CODE A0289/8 SUPPLIER CODE TBA


CUTTER BRAILLE


This scale measures 100mm when artwork is 100%

0    10    20    30    40    50


Checked by: Paul Adams

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

Date: 2.11.2016


pmdc design

Lower Test Studios Sheardley Lane, Droxford Hampshire SO32 3QY +44 (0)1489 878780 www.pmdc.co.uk


60    70    80    90    100