Summary of medicine characteristics - LACTUGAL
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTLactugal.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4.1. Therapeutic Indications
4.2 Posology and method of administration
For oral administration.
The lactulose solution may be administered diluted or undiluted. Each dose may, if necessary, be taken with water or fruit juices etc.
Each dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
All dosages should be adjusted to the needs of the individual.
In case of single daily dose, this should be taken at the same time, e.g. during breakfast.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5–2 litres, equal to 6–8 glasses) during the day.
Dosing in constipation:
Lactulose may be given as a single daily dose or in two divided doses.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2–3 days) of treatment may be needed before treatment effect occurs.
| Starting dose daily | Maintenance dose daily | |
| Adults and adolescents | 15–45 ml | 15–30 ml |
| Children (7–14 years) | 15 ml | 10–15 ml |
| Children (1–6 years) | 5–10 ml | 5–10 ml |
| Infants under 1 year | Up to 5 ml | Up to 5 ml |
Dosing in Hepatic Encephalopathy (for adults only):
Starting dose: 3 to 4 times daily 30–45ml (6–9 × 5ml spoonfuls). This dose may be adjusted to the maintenance dose to achieve two or three soft stools each day.
Paediatric population:
The safety and efficacy in children (newborn to 18 years of age) with Hepatic Encephalopathy have not been established. No data are available.
Elderly patients and patients with renal or hepatic insufficiency:
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.
4.3 Contraindications
Lactugal is contra-indicated in patients with:
Galactosaemia
Gastro-intestinal obstruction, digestive perforation or risk of digestive perforation
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Consultation of a physician is advised in case of:
– Painful abdominal symptoms of undetermined cause before the treatment is started.
– Insufficient therapeutic effect after several days.
Lactulose should be administered with care to patients who are intolerant to lactose (see section ‚List of excipients‘).
The dose normally used in constipation should not pose a problem for diabetics.
The dose used in the treatment of hepatic encephalopathy is usually much higher and may need to be taken into consideration for diabetics.
Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.
This product contains lactose, galactose and small amounts of fructose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Paediatric population
Use of laxatives in children should be exceptional and under medical supervision.
It should be taken into account that the defaecation reflex could be disturbed during the treatment.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy:
No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
Lactulose can be used during pregnancy.
Breast-feeding:
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Lactugal can be used during breast feeding.
Fertility:
No effects are to be expected, since systemic exposure to lactulose is negligible.
4.7 Effects on ability to drive and use machines
Lactulose has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
A normal dosage of lactulose may cause mild abdominal pain and flatulence which will disappear spontaneously after a few days. High doses may provoke nausea in some patients and this can be minimised by administration with water, fruit juice or meals. Administration of higher doses than those instructed can result in abdominal pain and diarrhoea, in this instance the dose should be decreased (see also section 4.9).
If high doses (such as those associated with the treatment of portosystemic encephalopathy) are used for extended periods of time, the patient may experience an electrolyte imbalance due to diarrhoea. The dose should be adjusted to obtain two to three formed stools per day.
Tabulated list of adverse events
The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients:
very common (>1/10);
common (>1/100 to <1/10);
uncommon (>1/1,000 to <1/100)
rare (>1/10,000 to <1/1,000)
very rare (<1/10,000)
| MedDRA SOC | Frequency category | |||
| Very common | Common | Uncommon | Rare | |
| Gastrointestinal disorders | Diarrhoea | Flatulence, abdominal pain, nausea, vomiting | ||
| Investigations | Electrolyte imbalance due to diarrhoea | |||
Paediatric population
The safety profile in children is expected to be similar as in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseIf the dose is too high, the following may occur: diarrhoea and abdominal pain
Treatment: A dose reduction or cessation of therapy should be considered. Excessive fluid loss due to diarrhoea or vomiting may result in clinically important electrolyte disturbances, and suitable corrective measures should be taken.
There is no specific antidote and supportive, symptomatic treatment should be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Osmotically acting laxatives,
ATC code: A 06A D11
Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular weight acids (chiefly lactic and acetic acids). There is no endogenous metabolising enzyme in the human gut.
Its mode of action in constipation is as an osmotic agent producing soft stools.
In the colon lactulose is broken down by colonic bacteria into low molecular organic acids. These acids lead to a lowering of pH in the colonic lumen and via an osmotic effect to an increase of the volume of colonic contents. These effects stimulate peristalsis of the colon and return the consistency of the stool. The constipation is cleared and the physiological rhythm of the colon is reinstated.
In hepatic encephalopathy (HE) the effect has been attributed to suppression of proteolytic bacteria by an increase of acidophilic bacteria (e.g. lactobacillus), trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the colon as well as an osmotic effect, and alteration of the bacterial nitrogen metabolism by stimulating the bacteria to utilize ammonia for bacterial protein synthesis.
5.2 Pharmacokinetic properties
Lactulose is poorly absorbed from the gastro-intestinal tract and it reaches the colon unchanged.
There are no human lactulose disaccharide enzymes; metabolism of lactulose to lactic acid occurs via gastro-intestinal microbial flora only. Due to its poor bioavailability, plasma lactulose concentrations are negligible.
Metabolism is complete at doses up to 25–50 g or 40–75 ml; at higher dosages, a proportion may be excreted unchanged.
There are no known changes in kinetic properties in patients with organic diseases which may alter drug disposition.
5.3 Preclinical safety data
5.3 Preclinical safety dataThe results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity. In reproduction and teratology experiments in rabbits, rats or mice, no adverse effects were found.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Banana Flavour (17.41.0042)
Quinoline Yellow (E104)
6.2. Incompatibilities
There are no known incompatibilities.
6.3. Shelf Life
36 months from the date of manufacture.
6.4. Special Precautions for Storage
Store at a temperature not exceeding 20°C. Do not freeze
6.5 Nature and contents of container
Amber glass winchesters with polypropylene caps as closures: pack sizes 300 ml, 500 ml, 1000 ml and 2000 ml.
Polyethylene containers with polypropylene caps as closures: pack sizes 250 ml, 300 ml, 500 ml, 1000 ml and 2000 ml.
Not all pack sizes may be marketed.
6.6. Instructions for Use, Handling and Disposal
6.6. Instructions for Use, Handling and DisposalThere are no special storage or handling instructions for this product.
7 MARKETING AUTHORISATION HOLDER
7 MARKETING AUTHORISATION HOLDERIntrapharm Laboratories Ltd
The Courtyard Barns
Choke Lane
Maidenhead
Berkshire SL6 6PT
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 17509/0011
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION24th November 2004