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Lactulose Solution

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Document: label-leaflet ALMUS PHARMACEUTICALS_PL 04416-0218 change

Lactulose Solution BP

3

ml

ALMUS*!*

V|l

Almus Pharmaceuticals Almus is a registered trademark ®

Lactulose Solution BP 300ml

(^) Also includes lactose, fructose and D-galactose.


©Dosage - CONSTIPATION

Adults: Initially 15ml (3x5ml spoonfuls) twice daily.

Children: 1-5 years - 5ml (1x5ml spoonful) twice daily. 5-10 years - 10ml (2x5ml 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 30-50ml (6-10x5ml 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.

(T) KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN. For oral administration. iEach 5ml spoonful contains 3.4g of lactulose.

o Store below 25 °C. Do not freeze. Please read the attached leaflet.    I I

1 PL Holder: Sandoz Ltd, Bordon, Hants, GU35 9QE PL 4416/0218 I P I

PATIENT INFORMATION LEAFLET

WHAT YOU SHOULD KNOW ABOUT LACTULOSE

Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The name of your medicine is Lactulose Solution BP.

WHAT IS IN YOUR MEDICINE?

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

The product licence holder is:

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

The manufacturer is:

Canlac Corporation (ACIC Canada Inc.), Victoriaville, Quebec, Canada.


USES

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).

BEFORE TAKING YOUR MEDICINE

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.

•    You are sensitive or intolerant to lactose.

•    You require a galactose-free diet.

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.


TAKING YOUR MEDICINE

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.

For the treatment of CONSTIPATION Adults:

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

Children aged 5 to 10 years:

Two x 5ml spoonfuls (10ml), twice a day.

Children aged 1 to 5 years:

One 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 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.

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.

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.

STORING YOUR MEDICINE

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 25°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.

Date of revision: December 2007

Keep all medicines out of the sight and reach of children.

Your medicines can harm them.

REMEMBER this medicine is for you. Never give it to others it may harm them even if their symptoms are the same as yours.

This leaflet applies to Lactulose Solution BP only.

Lactulose Solution BP

3

ml

ALMUS**

tal

Almus Pharmaceuticals Almus is a registered trademark ®

Lactulose Solution BP 300ml

Also includes lactose, fructose and D-galactose.


— z:—c Oi

E:

CO ;

g:


©Dosage - CONSTIPATION

Adults: Initially 15ml (3x5ml spoonfuls) twice daily.

Children: 1-5 years - 5ml (1x5ml spoonful) twice daily. 5-10 years - 10ml (2x5ml 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 30-50ml (6-10x5ml 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.

(?) KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN. For oral administration.

VsS'/ Each 5ml spoonful of Lactulose Solution contains 3.4g of lactulose.

Store below 25 °C. Do not freeze. Please read the attached leaflet.    I I

Lactulose Solution BP

5

ml

ALMUS*!*

V|l

Almus Pharmaceuticals Almus is a registered trademark ®

Lactulose Solution BP 500ml

(^) Also includes lactose, fructose and D-galactose.


©Dosage - CONSTIPATION

Adults: Initially 15ml (3x5ml spoonfuls) twice daily.

Children: 1-5 years - 5ml (1x5ml spoonful) twice daily. 5-10 years - 10ml (2x5ml 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 30-50ml (6-10x5ml 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.

(T) KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN. For oral administration.

S.Each 5ml spoonful contains 3.4g of lactulose.

o Store below 25 °C. Do not freeze. Please read the attached leaflet.    I I

1 PL Holder: Sandoz Ltd, Bordon, Hants, GU35 9QE PL 4416/0218 I P I

PATIENT INFORMATION LEAFLET

WHAT YOU SHOULD KNOW ABOUT LACTULOSE

Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The name of your medicine is Lactulose Solution BP.

WHAT IS IN YOUR MEDICINE?

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

The product licence holder is:

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

The manufacturer is:

Canlac Corporation (ACIC Canada Inc.), Victoriaville, Quebec, Canada.


USES

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).

BEFORE TAKING YOUR MEDICINE

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.

•    You are sensitive or intolerant to lactose.

•    You require a galactose-free diet.

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.


TAKING YOUR MEDICINE

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.

For the treatment of CONSTIPATION Adults:

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

Children aged 5 to 10 years:

Two x 5ml spoonfuls (10ml), twice a day.

Children aged 1 to 5 years:

One 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 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.

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.

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.

STORING YOUR MEDICINE

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 25°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.

Date of revision: December 2007

Keep all medicines out of the sight and reach of children.

Your medicines can harm them.

REMEMBER this medicine is for you. Never give it to others it may harm them even if their symptoms are the same as yours.

This leaflet applies to Lactulose Solution BP only.

Lactulose Solution BP

5

ml

ALMUS**

tal

Almus Pharmaceuticals Almus is a registered trademark ®

Lactulose Solution BP 300ml

Also includes lactose, fructose and D-galactose.


— z:—c Oi

E:

CO ;

g:


©Dosage - CONSTIPATION

Adults: Initially 15ml (3x5ml spoonfuls) twice daily.

Children: 1-5 years - 5ml (1x5ml spoonful) twice daily. 5-10 years - 10ml (2x5ml 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 30-50ml (6-10x5ml 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.

(T) KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN. For oral administration.

VsS'/ Each 5ml spoonful contains 3.4g of lactulose.

Store below 25 °C. Do not freeze. Please read the attached leaflet.    I I

PL Holder: Sandoz Ltd, Bordon, Hants, GU35 9QE PL 4416/0218 I P I