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Otc Direct Limited Lactulose Solution Bp (Select Health)

Document: label-leaflet MAH GENERIC_PL 04416-0218 change

ASANDOZ


Lactulose Solution BP

300 ml

Oral use. Read the package leaflet before use.

Store below 20°C. Do not freeze. Keep out of the reach and sight of children.

Each 5 ml spoonful contains 3.5 g of lactulose. Also contains lactose, fructose and D-galack See package leaflet for further information.

DOSAGE - Constripation:

Adults: Initially 15 ml (3 x 5 ml spoonfuls) daily.

Children: 1-5 years - 5 ml (1 x 5 ml spoonful) twice daily. 5-1 0 years - 10 ml (2 x 5 ml spoonfuls) twice daily. The above dosage serves as a guide. Dosage may vary depending on the condition. Eventually the dosage should be adjusted, usually reduced to meet the needs of the individual.

Hepatic encephalopathy:


Initially 30-50 ml (6-10 x 5 ml spoonfuls) three times daily. Adjust dose to produce 2 or 3 soft stools daily. Please Note: Due to the action of Lactulose Solution BP may take 2-3 days to show results. It is important to take the medicine regularly PL 04416/0218

Sandoz Ltd, Woolmer Way, Bordon, Hants, GU35 9QE. H ^ SANDOX    SZ00000LL000



A healthy decision Sandoz Ltd,

37 Woolmer Way, Bordon, Hampshire, GU35 9QE,

United Kingdom.

T: 01420 478301 F: 01420 474427 W: www.uk.sandoz.com

E: sandozartwork@btconnect.com


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Date approved

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Base Label


INFORMATION FOR THE USER Lactulose Solution BP (Lactulose)

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get 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 Solution BP is and what it is used for

2.    Before you take Lactulose Solution BP

3.    How to take Lactulose Solution BP

4.    Possible side effects

5.    How to store Lactulose Solution BP

6.    Further information


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

The active ingredient, lactulose, belongs to a group of therapeutic medicines known as osmotic laxatives which encourage regular bowel movements.

Lactulose Solution is useful as a treatment for constipation and hepatic encephalopathy where immediate bowel evacuation is desirable, which would have been diagnosed by your doctor (the symptoms of which may include drowsiness, confusion, difficulty in performing day-to-day tasks, and coma).


2. Before you take Lactulose Solution BP


DO NOT take this medicine before telling your doctor if:

•    you are, or might be, pregnant or you are breast-feeding

•    you are allergic or sensitive to lactulose, or any of the other ingredients in this medicine

•    you have any obstruction in your gut or intestines


Take special care if

•    you are sensitive or intolerant to lactose

•    you require a galactose-free diet


Taking other medicines

It is very important that you tell your doctor if you are taking any other medicines, including those you may have bought yourself, without a prescription.

3. How to take Lactulose Solution BP

Recommended doses follow. If the doctor prescribed this medicine for you, he or she may have prescribed different doses to these: if this applies to you, discuss it with the doctor, if you have not already done so. You should always follow your doctor's instructions as to how and when to take your medicine. Your pharmacist may be able to advise if you are not sure. Exactly how much medicine, and how often you must take it, will be written on the label. Please read it carefully.

Lactulose Solution should be swallowed by mouth. While you are taking lactulose, drink plenty of water and fluids.

Dosage

For the treatment of constipation


Adults:    Initially 3 x 5ml spoonfuls (15ml), twice a day.

Children aged 5 to 10 years:    2 x 5 ml spoonfuls (10ml), twice a day.

Children aged 1 to 5 years:    1 x 5ml spoonful (5ml), twice a day.

Please note that your dosage may vary, depending on the condition. Your dosage may be adjusted by your doctor to meet your individual needs.

For the treatment of hepatic encephalopathy

Initially 6 to 10 x 5ml spoonfuls (30ml to 50ml), three times a day. The dosage may be adjusted until you produce 2 or 3 soft stools a day. If you are unsure about how to go about this, see your doctor.

If you suffer with diarrhoea whilst taking lactulose, your dosage will need to be reduced.

Discuss this with your doctor or pharmacist.

If you take more Lactulose Solution BP than you should

If you take an unintentional extra dose, this should not cause problems. If you or someone else has taken too much lactulose or a large overdose has been taken, contact your doctor or hospital accident and emergency department immediately.


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Page 5


Lactulose Solution BP A 300 ml

Oral use. Read the package leaflet before use.

Store below 20°C. Do not freeze. Keep out of the reach and sight of children.

Each 5 ml spoonful contains 3.5 g of lactulose. Also contains lactose, fructose and D-galactose.

See package leaflet for further information.,

™J£Ao..oo oo o o oo DOSAGE - Conslr|pa"on: na n n n n

Adultshnitially 15 ml (3 x 5ml spoonfuls) dailt ^ ^ ^

ChildrO 1-5 years - 5 ml (1 x 5 mPspoonfuf) MceQbily. 5-^ year^^0 ml (2 x 5 ml

spoonfuls) twice daily. The above dosage serves as a guide. Dosage may vary

dependin^n t^ condi(0n. Eve@ally the dosage sh^d be adjusted, ©^lly O O O

reducedjto meet th^e^d^ of the individual O O 0 O Q

^p^tc^ncepKqfcp^hQ OO O O O

Initially 30-50 ml (6-10 x 5 ml spoonfuls) three times daily. Adjust dose to produce 2 or 3 soft stools daily. Please Note: Due to the action of Lactulose Solution BP it may take 2-3 days to show results. It is important to take the medicine regularly.

PL 04416/0218

Sandoz Ud, Woolmer Way, Bordon, Hants, GU35 9QE. Lu

^ SANDOX SZ00000LL000 ^

If you forget to take Lactulose Solution BP

If you forget to take a dose, take the missed dose as soon as you remember. If your next dose is due within 3 hours, take a single dose straight away and skip the next.

| 4. Possible side effects

As with all medicines, Lactulose Solution may cause unwanted effects in some people.

Common effects include wind and stomach pains or cramps.

If you have any of these effects and they become worse, inconvenient or upsetting, see your doctor or pharmacist. If you experience any other unpleasant effects which you think could be caused by this medicine you should contact your doctor or pharmacist for advice.

| 5. How to store Lactulose Solution BP

Do not take Lactulose Solution after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist for disposal.

Lactulose Solution should be stored below 20°C. Do not allow it to freeze.

If you notice any defects in the solution, take it to your pharmacist for advice before using it.

Keep all medicines out of the reach of children. Your medicines can harm them.

| 6. Further information

What Lactulose Solution BP contains:

Each 5ml spoonful of Lactulose Solution contains 3.4g of lactulose, the active ingredient.

It also contains lactose, D-galactose, fructose, D-tagatose and epilactose.

Lactulose Solution contains less than 0.03g of fructose per 5ml. When taken according to the dosage recommendations, each dose supplies up to 0.3g of fructose (based on a dose of 10 x 5ml spoonfuls). Unsuitable in hereditary fructose intolerance, should only be given to babies and young children after consultation with a doctor. This product also contains less than 0.4g of D-galactose and less than 0.4g of lactose (per 5ml). When taken according to the dosage

recommendations, each dose supplies up to 4g of D-galactose and up to 4g of lactose (based on a dose of 10 x 5ml spoonfuls). Unsuitable for people with lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.

Lactulose Solution is supplied in the following pack types and sizes: Opaque, strong plastic bottles. Pack sizes: 300ml and 500ml.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, 37 Woolmer Way, Bordon, Hampshire, GU35 9QE.

This leaflet was last approved in 01/2009


Top Label


Page 6


Page 7


Page 8


Lactulose Solution BP

500 ml

Oral use. Read the package leaflet before use.

Store below 20°C. Do not freeze. Keep out of the reach and sight of children.

Each 5 ml spoonful contains 3.5 g of lactulose. Also contains lactose, fructose and D-galact< See package leaflet for further information.

DOSAGE - Constripation:

Adults: Initially 15 ml (3 x 5 ml spoonfuls) daily.

Children: 1-5 years - 5 ml (1 x 5 ml spoonful) twice daily. 5-10 years - 10 ml (2 x 5 ml spoonfuls) twice daily. The above dosage serves as a guide. Dosage may vary depending on the condition. Eventually the dosage should be adjusted, usually reduced to meet the needs of the individual.

Hepatic encephalopathy:


Initially 30-50 ml (6-10 x 5 ml spoonfuls) three times daily. Adjust dose to produce 2 or 3 soft stools daily. Please Note: Due to the action of Lactulose Solution BP it may take 2-3 days to show results. It is important to take the medicine regularly.

PL 04416/0218

Sandoz Ltd, Woolmer Way, Bordon, Hants, GU35 9QE. H ^ SANDOZ    SZ00000LL000



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ASANDOZ

A healthy decision Sandoz Ltd,

37 Woolmer Way, Bordon, Hampshire, GU35 9QE,

United Kingdom.

T: 01420 478301 F: 01420 474427 W: www.uk.sandoz.com

E: sandozartwork@btconnect.com sandozartwork2@btconnect.com

Artwork Proof Box

Ref:

Proof No

Date prepared

Prepared by

RA Approved?

Date approved

Approved by

Colours

■ □ ■

Fonts

Dimensions


Base Label


INFORMATION FOR THE USER Lactulose Solution BP (Lactulose)

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get 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 Solution BP is and what it is used for

2.    Before you take Lactulose Solution BP

3.    How to take Lactulose Solution BP

4.    Possible side effects

5.    How to store Lactulose Solution BP

6.    Further information


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

The active ingredient, lactulose, belongs to a group of therapeutic medicines known as osmotic laxatives which encourage regular bowel movements.

Lactulose Solution is useful as a treatment for constipation and hepatic encephalopathy where immediate bowel evacuation is desirable, which would have been diagnosed by your doctor (the symptoms of which may include drowsiness, confusion, difficulty in performing day-to-day tasks, and coma).


2. Before you take Lactulose Solution BP


DO NOT take this medicine before telling your doctor if:

•    you are, or might be, pregnant or you are breast-feeding

•    you are allergic or sensitive to lactulose, or any of the other ingredients in this medicine

•    you have any obstruction in your gut or intestines


Take special care if

•    you are sensitive or intolerant to lactose

•    you require a galactose-free diet


Taking other medicines

It is very important that you tell your doctor if you are taking any other medicines, including those you may have bought yourself, without a prescription.

3. How to take Lactulose Solution BP

Recommended doses follow. If the doctor prescribed this medicine for you, he or she may have prescribed different doses to these: if this applies to you, discuss it with the doctor, if you have not already done so. You should always follow your doctor's instructions as to how and when to take your medicine. Your pharmacist may be able to advise if you are not sure. Exactly how much medicine, and how often you must take it, will be written on the label. Please read it carefully.

Lactulose Solution should be swallowed by mouth. While you are taking lactulose, drink plenty of water and fluids.

Dosage

For the treatment of constipation


Adults:    Initially 3 x 5ml spoonfuls (15ml), twice a day.

Children aged 5 to 10 years:    2 x 5 ml spoonfuls (10ml), twice a day.

Children aged 1 to 5 years:    1 x 5ml spoonful (5ml), twice a day.

Please note that your dosage may vary, depending on the condition. Your dosage may be adjusted by your doctor to meet your individual needs.

For the treatment of hepatic encephalopathy

Initially 6 to 10 x 5ml spoonfuls (30ml to 50ml), three times a day. The dosage may be adjusted until you produce 2 or 3 soft stools a day. If you are unsure about how to go about this, see your doctor.

If you suffer with diarrhoea whilst taking lactulose, your dosage will need to be reduced.

Discuss this with your doctor or pharmacist.

If you take more Lactulose Solution BP than you should

If you take an unintentional extra dose, this should not cause problems. If you or someone else has taken too much lactulose or a large overdose has been taken, contact your doctor or hospital accident and emergency department immediately.


Page 2


Page 3


Page 4


Page 5


Lactulose Solution BP A 500 ml

Oral use. Read the package leaflet before use.

Store below 20°C. Do not freeze. Keep out of the reach and sight of children.

Each 5 ml spoonful contains 3.5 g of lactulose. Also contains lactose, fructose and D-galactose.

See package leaflet for further information.

.■ oo oo o o oo

DOijE - ConslriPaliori: o o o o o o Adults:Snitially 15 ml (3 x 5 ml spoonfuls) daily. ^ ^ L7 Children? 1-5 years - 5 ml (1 x 5 spoofl) Oc^bily. 5-^ year£^0 ml (2 x 5 ml spoonfuls) twice daily. The above dosage serves as a guide. Dosage may vary

depending^ the conditfoT. Eventually the d^ge shnuj^ ^^adjust^d usually O O O reduc^Jo meet th^ee^ of the individual O O O O ^ blepatiQ^ephtajap^h^Q OO O O O O Initially 30-50 ml (6-10 x 5 ml spoonfuls) three times daily. Adjust dose to produce 2 or 3 soft stools daily. Please Note: Due to the action of Lactulose Solution BP it may take 2-3 days to show results. It is important to take the medicine regularly.

PL 04416/0218

Sandoz Ud, Woolmer Way, Bordon, Hants, GU35 9QE. (.Li

^ AANDOZ SZ00000LL000 ^

If you forget to take Lactulose Solution BP

If you forget to take a dose, take the missed dose as soon as you remember. If your next dose is due within 3 hours, take a single dose straight away and skip the next.

| 4. Possible side effects

As with all medicines, Lactulose Solution may cause unwanted effects in some people.

Common effects include wind and stomach pains or cramps.

If you have any of these effects and they become worse, inconvenient or upsetting, see your doctor or pharmacist. If you experience any other unpleasant effects which you think could be caused by this medicine you should contact your doctor or pharmacist for advice.

| 5. How to store Lactulose Solution BP

Do not take Lactulose Solution after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist for disposal.

Lactulose Solution should be stored below 20°C. Do not allow it to freeze.

If you notice any defects in the solution, take it to your pharmacist for advice before using it.

Keep all medicines out of the reach of children. Your medicines can harm them.

| 6. Further information

What Lactulose Solution BP contains:

Each 5ml spoonful of Lactulose Solution contains 3.4g of lactulose, the active ingredient.

It also contains lactose, D-galactose, fructose, D-tagatose and epilactose.

Lactulose Solution contains less than 0.03g of fructose per 5ml. When taken according to the dosage recommendations, each dose supplies up to 0.3g of fructose (based on a dose of 10 x 5ml spoonfuls). Unsuitable in hereditary fructose intolerance, should only be given to babies and young children after consultation with a doctor. This product also contains less than 0.4g of D-galactose and less than 0.4g of lactose (per 5ml). When taken according to the dosage

recommendations, each dose supplies up to 4g of D-galactose and up to 4g of lactose (based on a dose of 10 x 5ml spoonfuls). Unsuitable for people with lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.

Lactulose Solution is supplied in the following pack types and sizes: Opaque, strong plastic bottles. Pack sizes: 300ml and 500ml.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, 37 Woolmer Way, Bordon, Hampshire, GU35 9QE.

This leaflet was last approved in 01/2009


Top Label


Page 6


Page 7


Page 8