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Lactugal

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INFORMATION FOR THE USER Read all of this label carefully before you start taking this medicine.

This medicine is available without prescription. However, you still need to use Lactugal carefully to get the best results from it.

•Ask your doctor or 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 not listed in this leaflet please tell your doctor or pharmacist.

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. Lactugal is used to treat constipation. Lactugal is sometimes used in patients with a liver condition called hepatic encephalopathy. It helps prevent dangerous toxins from being absorbed into the blood stream.

2.    Before you take Lactugal Do not take Lactugal if you:

•are allergic (hypersensitive) to lactulose or any of the other ingredients listed in section 6.

•suffer from any blockages of the bowel, other than constipation (for which you are taking Lactugal), digestive perforation or risk of digestive perforation

•suffer from galactose or fructose intolerance, Lapp lactase deficiency or glucose galactose malabsorption

Take special care with Lactugal and seek a doctor's advice if you:

•are lactose intolerant (allergic to milk sugar)

• have unexplained tummy ache •have diabetes

Your doctor will decide if you can safely take Lactugal Please seek your doctor's advice if this medicine does not improve your condition after using for several days. Taking Lactugal with other medicines


Lactugal has not been shown to interact negatively with other medicines. Always advise your doctor or pharmacist before taking any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Always ask your doctor for advice before using any medicines. There is no potential risk during pregnancy and breastfeeding if Lactugal is used in the recommended dosage.

Driving and using machines

Lactugal is not known to affect your ability to drive


or operate machinery.

3. How to take Lactugal

Lactugal should be taken orally. It may take up to 48 hours before Lactugal begins to have an effect. Once the medicine has started to work you may gradually reduce the amount you take.

Dosage:

•    To treat constipation:

Adults, the elderly and children over 10 years:

Usual dose is three 5ml spoons (15ml) once or twice daily.

Children 5-10 years:

Usual dose is two 5ml spoonfuls (10ml) twice daily. Children aged 1-5 years:

Usual dose is one 5ml spoonful (5ml) twice daily. Children under 1 year:

Usual dose is 2.5 ml (half a 5 ml spoonful) twice daily.

•    To treat hepatic encephalopathy:

Adults:

Initial dose is six to ten 5ml spoons three times daily. Your doctor will advise you on a dose suitable for


your condition.

If you take too much Lactugal

If you have taken too much of this medicine, contact your doctor or local hospital immediately.

If you forget to take Lactugal

Take the forgotten dose as soon as you remember. However, if it is nearly time for your next dose, ignore the missed dose and continue as usual with the next dose. Do not take a double dose to make up for a forgotten dose. If you forgot to take this medicine it might be because your symptoms have


lactugal

Lactulose Solution


been relieved and you may not need to take it any more.


Liquid medicine for the relief of constipation and for the treatment of hepatic encephalopathy.


For oral administration

Banana Flavour


4.    Possible side effects

Like all medicines, Lactugal can cause side effects, although not everybody gets them. The following side effects have been reported:

•    flatulence (wind) • stomach pain • feeling sick • loose stools

•    vomiting (being sick) • diarrhoea • electrolyte imbalance (imbalance of salts in your body - usually from vomiting and diarrhoea)

These side effects should disappear after a few days.

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.

5.    How to store Lactugal

Keep Lactugal out of the sight and reach of children.

Do not store above 20°C. Do not freeze. Do not use Lactugal after the expiry date which is stated on the label.

6.    Further information What Lactugal contains:

The active substance is Lactulose Solution. Each 5ml spoonful contains (approx) 3.4g 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 December 2014.


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500ml


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