Lactulose Solution
DLQA 016, ISS.10
) select|health
• Constipation • Hepatic encephalopathy
''N
s
) select|health
For Oral Use: Each 5ml spoonful of Lactulose Solution contains 3.4g of lactulose, the active ingredient. Also contains lactose, fructose and D-galactose.
Due to the action of Lactulose solution BP it may take 2-3 days to show results.
It is important that the medicine is taken regularly.
Constipation: ADULTS: Initially 15ml (3 x 5ml spoonfuls) twice daily.
CHILDREN: 1-5 years - 5ml (I x 5ml spoonful) twice daily. 5-10 years - 10ml (2 x 5ml 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 (6-10 x 5ml spoonfuls) three times daily: adjust dose to produce 2 or 3 soft stools daily.
Please read the attached leaflet carefully before use.
MM KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Store below 20°C. Do not freeze I P I PL Holder: Sandoz Ltd., Bordon, Hants, GU35 9QE PL 4416/0218
8 81 mm leaflet fits here
A
SZ40288LL0IC SH00I/I
36
• Constipation • Hepatic encephalopathy
For Oral Use: Each 5ml spoonful of Lactulose Solution contains 3.4g of lactulose the active ingredient. Also contains lactose, fructose and D-galactose.
your doctor or hospital accident and emergency department immediately.
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.
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.
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
constipation relief
Due to the action of Lactulose solution BP it mavtake 2-3 days to show results.
• ^ltJimjfhant thgthe medfflne is taken ^
Const’^a^on* ADULTS: Tally IH (3x 5ml spoonfuls) twice daily.
CHILDREN: 1-5 years - 5ml (Tx 5ml spoonful) twice daily. 5-10 years - 10ml (2 x 5ml spoonfuls) tv're d?:iy. The a^v^sage serves ^ guide, T^e may vary de^pip; on fhe condition Eventual1'1 the dosage sfpld be a^sted, usully Ced i itho&°n invidual. p
Hepatic encephalopathy: Initially 30-50ml (6-10 x 5ml spoonfuls) three times daily: adjust dose to produce 2 or 3 soft stools daily.
Please read the attached leaflet carefully before use.
MM KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Store below 20°C. Do not freeze I P I PL Holder: Sandoz Ltd., Bordon, Hanti, GU35 9QE PL 4416/0218
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.
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.
The product licence holder is: Sandoz Ltd,Woolmer Way, Bordon, Hampshire, GU35 9QE.
The manufacturer is: Canlac Corporation (ACIC Canada Inc.),Victoriaville, Quebec, Canada.
This leaflet was last approved in {07/2007}
Page 1 81 mm Page 6 80 mm Page 7 80 mm Page 8 79 mm
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
• 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 5ml 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
Page 2 79 mm
Page 3 80 mm
Page 4 80 mm
Page 5 81 mm
) select|health
• Constipation • Hepatic encephalopathy
''N
constipation relief
For Oral Use: Each 5ml spoonful of Lactulose Solution contains 3.4g of lactulose, the active ingredient. Also contains lactose, fructose and D-galactose.
A
V.
Due to the action of Lactulose solution BP it may take 2-3 days to show results.
It is important that the medicine is taken regularly.
Constipation: ADULTS: Initially 15ml (3 x 5ml spoonfuls) twice daily.
CHILDREN: 1-5 years - 5ml (I x 5ml spoonful) twice daily. 5-10 years - 10ml (2 x 5ml 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 (6-10 x 5ml spoonfuls) three times daily: adjust dose to produce 2 or 3 soft stools daily.
Please read the attached leaflet carefully before use.
MM KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Store below 20°C. Do not freeze I P I PL Holder: Sandoz Ltd., Bordon, Hants, GU35 9QE PL 4416/0218
8 81 mm leaflet fits here
36
• Constipation • Hepatic encephalopathy
For Oral Use: Each 5ml spoonful of Lactulose Solution contains 3.4g of lactulose, the active ingredient. Also contains lactose, fructose and D-galactose.
your doctor or hospital accident and emergency department immediately.
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.
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.
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
Due to the action of Lactulose solution BP it mavtake 2-3 days to show results.
• ^ltJimjfhant thgthe medfflne is taken ^
Const’^a^on* ADULTS: Tally IH (3x 5ml spoonfuls) twice daily.
CHILDREN: 1-5 years - 5ml (Tx 5ml spoonful) twice daily. 5-10 years - 10ml (2 x 5ml spoonfuls) tv're d?:iy. The a^v^sage serves ^ guide, T^e may vary de^pip; on fhe condition Eventual1'1 the dosage sfpld be a^sted, usully Cced to meetthe needsof t^n individual. p
Hepatic encephalopathy: Initially 30-50ml (6-10 x 5ml spoonfuls) three times daily: adjust dose to produce 2 or 3 soft stools daily.
Please read the attached leaflet carefully before use.
MM KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Store below 20°C. Do not freeze I P I PL Holder: Sandoz Ltd., Bordon, Hants, GU35 9QE PL 4416/0211
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.
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.
The product licence holder is: Sandoz Ltd,Woolmer Way, Bordon, Hampshire, GU35 9QE.
The manufacturer is: Canlac Corporation (ACIC Canada Inc.),Victoriaville, Quebec, Canada.
This leaflet was last approved in {07/2007}
Page 1 81 mm Page 6 80 mm Page 7 80 mm Page 8 79 mm
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
• 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 5ml 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
Page 2 79 mm
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Page 5 81 mm