Lactulose Solution
PATIENT INFORMATION LEAFLET
LACTULOSE SOLUTION BP
Please read this leaflet carefully as it contains important information about this product. If you are unsure or have any questions concerning this product, please ask your doctor or pharmacist.
Lactulose Solution BP contains the following active ingredient:
Lactulose BP 3.4g/5ml
It also contains the following inactive ingredient: purified water.
The Product
A clear, viscous liquid, available in packs of 200ml and 300ml, and supplied to your pharmacist in packs of 500ml and 1000ml for dispensing purposes.
Product Type
Lactulose acts by softening the stools, thus making them easier to pass.
MA Holder
Transdermal Ltd
35 Grimwade Avenue
Croydon
CR0 5DJ
UK
Manufacturers
Infra Srl, via Fiorentina, 51100 Pistoia, Italy or
Morinaga Milk Industry Co. Ltd, Fuji Plant, Nakazato, Shizuoka, Japan or
Morinaga Milk Industry Co. Ltd, Milei Plant, D-7970 Leutkirch, Germany Assembler
BMS Laboratories, Riverview Road, Beverley, Humberside Uses
For the treatment of constipation and hepatic encephalopathy (portal systemic encephalopathy).
BEFORE USING LACTULOSE SOLUTION BP
The following information should be read before using this product:
1. Make sure this product is suitable for you to use - ask your doctor or pharmacist.
2. Do not use this product if you are pregnant or breastfeeding, unless it is prescribed by your doctor.
3. Do not use this product if you are allergic to any of the active ingredients listed at the beginning of this leaflet.
4. Do not use this product if you are on a galactose free diet
5. Do not use this product if you have a stomach or intestinal blockage - if in doubt, consult your doctor.
6. Do not use this product if you have undiagnosed stomach problems
7. Do not use this product if you have stomach pain or are feeling or being sick, unless your doctor tells you to.
8. Do not use this product if your bowel habit suddenly changes, and the changes persist for more than two weeks.
9. Do not use this product if you suffer from rectal bleeding or bleeding from the back passage.
10. Do not repeat use of this product if you fail to have a bowel motion following use of a laxative.
11. If you have diabetes mellitus or are intolerant to lactose, consult your doctor before using this product.
12. This product may take up to 48 hours to take effect.
13. Excessive and prolonged use is dangerous and could result in diarrhoea with loss of fluid. If this happens, consult your doctor straight away. Prolonged use of this product should be avoided.
DIRECTIONS FOR USING LACTULOSE SOLUTION BP
Constipation:
Adults (including the elderly): Initially 15ml (three x 5ml spoonsful)
twice daily
Children: 1-5 years 5ml (one x 5ml spoonsful) twice daily
5-10 years 10ml (two x 5ml spoonsful) twice daily
Dosage may vary depending on the condition. The above dosage serves as a guide.
Eventually the dose should be adjusted, usually reduced to meet the need of the individual.
If after three days, your symptoms continue or have worsened, you should consult your
doctor to establish the cause of the constipation.
Hepatic Encephalopathy
Adults (including the elderly): Initially 30 - 50ml (six - ten x 5ml spoonsful) three times daily; adjust dose to produce two or three soft stools daily.
Children: No dosage recommendations for this indication.
Overdose
If you accidentally take too much of the solution you should contact your doctor or nearest hospital casualty department immediately.
SIDE EFFECTS
The following side effects have been reported following use of this product:
i) diarrhoea - in all cases of diarrhoea, the dose should be reduced and fluid intake should be increased.
ii) flatulence (wind), stomach cramps.
iii) nausea (feeling sick) and vomiting (being sick) following high doses.
Should you experience these or any other reactions following use of this product, then discontinue its use immediately and please report it to your doctor or pharmacist who will advise you on the necessary action to take.
STORING YOUR MEDICINE
This product has a three year shelf life, which is given on the bottle label.
Do not use Lactulose Solution BP after the expiry shown on the label.
Lactulose Solution BP should be stored at or below 20°C, out of the reach of children.
Do not freeze.
Date of preparation: February 2016