Lactulose Solution
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SE SOLN 300ML TUK <DAN Version: 2 12 May 2015
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Each 5 ml of Lactulose Solution contains 3.35 g of lactulose. Also includes lactose and galactose. Gentle relief of constipation for all ages.
TEVA UK Limited, Eastbourne, BN22 9AG.
DOSAGE: Use as directed by a doctor or pharmacist. Please read the leaflet.
CONSTIPATION:
Adults: 15 ml twice daily.
Children 5-10 years: 10 ml twice daily.
Children 1-5 years: 5 ml twice daily.
Babies (under 1 year): 2.5 ml twice daily
HEPATIC ENCEPHALOPATHY:
Adults: Initially 30-50 ml three tim
Subsequently adjust the t
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The CE mark only covers the measuring cup
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Solution may be taken with water or fruit juice or with quired.
WARNING: DO NOT EXCEED THE STATED DOSE.
Manufacturer of the measuring cup: TEVA UK Limited,
Ridings Point, Whistler Drive, Castleford,
West Yorkshire, WF10 5HX.
PL 00289/0285 63177-ZA
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
25°C. Do not
Do not store
N.B. The special action of Lactulose Solution may take 2-3 days to show results hence it is important to take the medicine regularly as directed. If symptoms persist, consult your doctor.
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If you stop taking Lactulose
If your doctor has prescribed you this medicine, you should take it for as long as the doctor has instructed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Lactulose can cause side effects, although not everybody gets them.
If the following happens, stop taking the solution and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
The following side effects have been reported:
• cramps
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• increased wind and feeling bloated. This may happen during the first few days of treatment. These effects usually disappear after a few days
• abdominal pain, being sick
• loose stools. This may happen if you take high doses of Lactulose. If this happens, lower your dose. If you have loose stools, drink plenty of fluids to prevent dehydration. High doses may make you feel sick, which can be minimised by taking Lactulose solution with water, fruit juice or with a meal.
These effects are often mild and usually wear off after a few days of treatment. If they are severe or last for more than a few days, tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
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5. HOW TO STORE LACTULOSE
Keep out of the reach and sight of children. Do not store above 25°C. Do not freeze. This solution must be stored in the original package or container supplied. Do not transfer it into another container. Do not use Lactulose after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.
6. FURTHER INFORMATION What Lactulose solution contains:
• The active ingredient is lactulose.
• The other ingredients are lactose and galactose.
What Lactulose solution looks like and contents of the pack:
• Lactulose solution contains 3.35 g of lactulose per 5 ml.
• The product is available in pack sizes of 100, 150, 200, 300, 500, 1000, 2500, and 5000 ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: May 2015
PL 00289/0285
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Each 5 ml of lactulose solution contains 3.35 g of lactulose. Also includes lactose and galactose. Gentle relief of constipation for all ages.
TEVA UK Limited, Eastbourne, BN22 9AG.
The CE mark only covers the measuring cup.
Manufacturer of the measuring cup: TEVA UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX.
63177-ZA
DOSAGE: Use as directed by a doctor or pharmacist.
Please read the leaflet.
CONSTIPATION:
Adults:
Children 5-10 years:
Children 1-5 years:
Babies (under 1 year):
HEPATIC ENCEPHALOPATHY:
Adults: Initially 30-50 ml three times a day.
Subsequently adjust the dose to produce 2-3 soft stools each day. Lactulose Solution may be taken with water or fruit juice or with
The CE mark measuring cup.
WARNING: DO NOT EXCEED THE STATED DOSE.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25°C. Do not freeze.
, on of lactulose solution may take 2-3 days
to show results hence it is important to take the medicine regularly as directed. If symptoms persist, consult your doctor.
the measuring cup: TEVAUK Limited,
Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX.
PL 00289/0285 63177-ZA
m
®UK Reg'd TM.
Code may be changed by Danipharm
CODE 39: A2 WHEN READ FROM RIGHT TO LEFT
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LACTULOSE SOLUTION
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 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 2-3 days.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Lactulose is and what it is used for
2. Before you take Lactulose
3. How to take Lactulose
4. Possible side effects
5. How to store Lactulose
6. Further information
1. WHAT LACTULOSE IS AND WHAT IT IS USED FOR
• Lactulose belongs to a group of medicines called osmotic laxatives, which help to retain water in the bowels and soften the stools. Lactulose solution encourages normal bowel action.
• Lactulose is used to:
• relieve constipation
• treat the brain disturbance associated with liver disease known as hepatic encephalopathy including unconsciousness caused by liver problems.
2. BEFORE YOU TAKE LACTULOSE DO NOT take Lactulose if you:
• are allergic (hypersensitive) to lactulose or any of the other ingredients of this medicine (listed in section 6)
• are lactose intolerant (because this medicine contains lactose)
• suffer from galactosaemia (which results in an accumulation of galactose-1-phosphate and /or galactose in the blood) or require a galactose-free diet (because this medicine contains galactose)
• suffer from gastro-intestinal obstruction (a blockage of the gut). Take special care with Lactulose
Talk to your doctor before you start to take this medicine if you:
• have diabetes. Lactulose contains the sugar lactose. In normal doses, this should not affect your blood sugar levels
• have taken Lactulose for several days and you do not feel it is working properly please tell your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
• Lactulose should be used with caution during the first 3 months of pregnancy.
• If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine. Lactulose can be used during pregnancy if necessary.
• Lactulose can be used when breast-feeding if necessary. Important information about some of the ingredients of Lactulose
Lactulose contains galactose and lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Driving and using machines
• Lactulose is not known to affect your ability to drive or operate machinery.
3. HOW TO TAKE LACTULOSE
If your doctor or pharmacist has prescribed this medicine, always take Lactulose exactly as they have told you. If you are not sure how to take this medicine, talk to your doctor or pharmacist.
If your symptoms persist after taking this medicine, consult your doctor.
The solution should be swallowed with a drink of water, fruit juice or taken with a meal.
Always use the measuring cup supplied with the pack. Rinse the measuring cup with water after use.
The usual dose is:
Constipation
• Adults: 15 ml twice daily
• Children 5-10 years: 10 ml twice daily
• Children 1-5 years: 5 ml twice daily
• Babies under 1 year: 2.5 ml twice daily.
Hepatic Encephalopathy • Adults including the elderly
30 to 50 ml three times a day, which should then be adjusted
to a daily dosage which produces 2 - 3 soft stools each day.
It may be two or three days before the full benefit of treatment is obtained. After this time, you may be able to reduce the dose you take according to your needs.
If you take more Lactulose than you should If you (or someone else) swallow a lot of the solution all together, or if you think a child has swallowed any of the solution contact your nearest hospital casualty department or your doctor immediately.
Please take this leaflet, any remaining solution, and the container with you to the hospital or doctor so that they know which solution has been consumed. You may have loose stools and abdominal pain.
If you forget to take Lactulose Solution If you forget to take the solution, take it as soon as you remember, unless it is nearly time to take the next dose. DO NOT take a double dose to make up for a forgotten dose.
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