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LACTUGAL

Active substance(s): LACTULOSE SOLUTION

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lactugal®
Lactulose Solution
Liquid medicine for the relief of constipation and for the treatment of hepatic
encephalopathy.
For oral administration
Banana Flavour.
500 ml

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lactugal®
Lactulose Solution 500 ml
Read all of this label carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
have told you.





Keep this leaflet. You may need to read it again.
Ask your doctor pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve.
If any of the side effects gets serious, or if you notice any side effect (see section 4) not
listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet:
1.

What lactugal is and what it is used for

2.

What you need to know before you take Lactugal

3.

How to take Lactugal

4.

Possible side effects

5.

How to store Lactugal

6.

Contents of the pack and other information

1.

What Lactugal is and what it is used for

Lactugal contains the active ingredient lactulose. It is a type of sugar that is broken down into
mild acids in the colon (the end part of the intestinal tract). These acids draw water into the
colon and thereby soften the stool and easier to pass. It is not absorbed into your body.
Lactugal is used to treat constipation (infrequent bowl movement, hard and dry stools).
Lactugal is sometimes used in patients with a liver condition called hepatic encephalopathy (a
liver disease causing confusion, tremor, decreased level of consciousness including coma). It
helps prevent dangerous toxins from being absorbed into the blood stream.

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2.

What you need to know before you take Lactugal

Do not take Lactugal if:




You are allergic (hypersensitive) to lactulose or any of the other ingredients of Lactugal
(listed in section 6)
You have a rare problem called ‘galactosaemia’.
You suffer from any blockages of the bowel, other than constipation (for which you are
taking Lactugal), digestive perforation or risk of digestive perforation

Do not take Lactugal if any of the above apply to you. If you are not sure, talk to your doctor
or pharmacist before taking Lactugal.
Warning and precautions:
Talk t o your doc tor or pharmacist b efore t aking Lactugal i f you s uffer f rom any m edical
conditions or illnesses, in particular:




If you are lactose intolerant (allergic to milk sugar)
If you suffer from unexplained tummy ache
If you have diabetes

If you have diabetes and are treated for hepatic encephalopathy, your dose of Lactugal will be
higher. T his hi gh dos e contains a l arge amount of s ugar. Therefore y our doc tor may
recommend that you need to adjust the dose of your anti-diabetic medicine.
Chronic use of unadjusted dosage ( exceeding 2-3 soft stools per da y) or misuse can lead to
diarrhoea and disturbance of the electrolytes balance.
Please seek your doctor’s advice if this medicine does not improve your condition after using
for several days.
Children
In s pecial ci rcumstances your d octor m ay prescribe Lactugal for a c hild, i nfant o r ba by. In
these cases your doctor will supervise the treatment carefully. Lactugal should only be given
to infants and smaller children if indicated as it can influence the normal reflexes for passing
stools.

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Other medicines and Lactugal
Lactugal has not been shown to interact negatively with other medicines. Always advise your
doctor or pha rmacist b efore t aking any ot her m edicines, i ncluding medicines obt ained
without a prescription.
Taking lactugal with food and drink
Lactugal can be taken with or without food. There are no r estrictions on what you can eat or
drink.
Pregnancy, breast-feeding and fertility
Talk t o your doc tor or p harmacist before taking th is medicine if you are p regnant, m ight
become p regnant o r ar e b reast-feeding. T here i s no pot ential r isk dur ing pregnancy a nd
breast-feeding if lactugal is used in the recommended dosage.
No effects on fertility are to be expected.
Driving and using machines
Lactugal has no or negligible influence on your ability to drive or operate machinery.
Important Information about some of the ingredients of Lactugal
Lactugal may contain small amounts of milk sugar (lactose), galactose, epilactose or fructose.
If you h ave b een t old b y your doc tor t hat you have a n i ntolerance t o s ome s ugars, contact
your doctor before taking this medicine.
3.

How to take Lactugal

Always take Lactugal exactly as described in this leaflet or as your doctor or pharmacist have
told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine


Lactugal should be taken orally.



You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids
(approximately 2 litres equal to 6-8 glasses throughout the day).



Swallow the dose immediately. Do not keep it in your mouth as the sugar content may
lead to tooth decay, particularly if Lactugal is taken for long periods.



It may take up to 2 to 3 days before Lactugal begins to have an effect.



Once the medicine has started to work you may gradually reduce the amount you take.

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Constipation:
Adults and adolescents:
The starting dose is 15-45 ml per day. After this the dose can be adjusted to 15-30 ml daily.
Children 7 to 14 years:
The starting dose is 15ml daily. After this the dose can be adjusted to 10-15ml daily.
Children aged 1 to 6 years:
The usual dose is 5 – 10 ml daily.
Infants under 1 year:
The usual dose is up to 5 ml daily.
Use in Children: Use of laxatives in children, infants, and babies should be exceptional and
under medical supervision because it can influence the normal reflexes for passing stools.
Please do not g ive Lactugal to c hildren ( under 14 years) be fore c onsulting your doc tor f or
prescription and careful supervision.
Hepatic encephalopathy (adults only)
Adults: The usual starting dose is 3 to 4 times a day of 30-45 ml.
Use in Children: No information is available for treatment of children (newborn to 18 years
of age) with hepatic encephalopathy.
Use in elderly patents and patients with Kidney or liver insufficiency: No special dosage
recommendations exist.
If you take more Lactugal than you should
If y ou take more Lactugal t han you s hould stop t aking Lactugal an d contact your doctor or
local hospital immediately.
If you forget to take Lactugal
If you forget a dos e o f Lactugal, do not worry. Just take t he forgotten d ose as s oon as you
remember. However, i f it i s n early t ime f or your n ext d ose, ignore t he m issed dos e a nd
continue as usual with t he next dose. Do not take a double dose to make up for a forgotten
dose. I f you f orgot t o t ake t his m edicine i t m ight be be cause your s ymptoms ha ve be en
relieved and you may not need to take it any more.
If you stop taking Lactugal
Do not stop or change the treatment before talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4.

Possible side effects

Like all medicines, Lactugal can cause side effects, although not everybody gets them.
The following side effects have been reported with Lactugal:
Very common (may affect more than 1 in 10 people)
•diarrhoea
Common (may affect up to 1 in 10 people)
•flatulence (wind)
•nausea (feeling sick)
•vomiting
•abdominal pain
Uncommon (may affect up to 1 in 100 people)
•electrolyte imbalance due to diarrhoea
Flatulence may occur during the first few days of treatment. As a rule it disappears after a few
days. When dos ages hi gher t han i nstructed a re us ed, a bdominal pa in and di arrhoea m ay
occur. In such a case the dosage should be decreased.
If you us e hi gh doses ( normally onl y a ssociated w ith he patic e ncephalopathy, H E) f or a n
extended period of time, you may experience an electrolyte imbalance due to diarrhoea.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects n ot lis ted in this le aflet. By r eporting side affects you can h elp pr ovide m ore
information on t he s afety of t his medicine. Y ou can also r eport s ide e ffects d irectly v ia t he
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store.
5.

How to store Lactugal

Keep Lactugal out of the sight and reach of children.
Do not store above 20º C. Do not refrigerate or freeze. Do not use Lactugal after the expiry
date which is stated on the label. 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 t o di spose of m edicines no l onger r equired. T hese m easures w ill he lp t o pr otect t he
environment.

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6.

Contents of the pack and other information

What Lactugal contains:
The active substance is Lactulose Solution. Each 5 ml contains (approx) 3.4 g lactulose. The
other ingredients are banana flavour and quinoline yellow (E104).
What Lactugal looks like and contents of the pack:
Lactugal is available in 250 ml, 300 ml, 500 ml, 1,000 ml and 2,000 ml white plastic
containers with plastic caps. Not all bottle sizes may be marketed.
Marketing authorisation holder and manufacturer
Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berks SL6
6PT, UK.
This leaflet was last revised in February 2018.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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