LAXIDO PAEDIATRIC PLAIN

Laxido Paediatric Plain is for oral use.

Posology Chronic constipation:

The usual starting dose is 1 sachet daily for children aged 1 to 6 years, and 2 sachets daily for children aged 7 to 11 years. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs increasing this is best done every second day.

For children below 2 years of age, the maximum recommended dose should not exceed 2 sachets a day. For children aged 2 to 11 years, the maximum recommended dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6 to 12 months).

However, safety and efficacy have only been proven for a period of up to 3 months. Treatment should be stopped gradually and resumed if constipation recurs.

Faecal impaction:

A course of treatment for faecal impaction with Laxido Paediatric Plain is for up to 7 days as follows: Daily dosage regimen: Number of Laxido Paediatric Plain sachets Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 5 to 11 4 6 8 10 12 12 12 The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period.

The above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. ) Laxido Paediatric Plain is not recommended for children below 5 years of age for the treatment of faecal impaction, or in children below 1 year of age for the treatment of chronic constipation.

For patients of 12 years and older it is recommended to use Laxido.

Patients with impaired cardiovascular function:

There are no clinical data for this group of patients. Therefore Laxido Paediatric Plain is not recommended for treating faecal impaction in children with impaired cardiovascular function.

Patients with renal insufficiency:

There are no clinical data for this group of patients. Therefore Laxido Paediatric Plain is not recommended for treating faecal impaction in children with impaired renal function. 5 ml (quarter of a glass) of water, to make a clear or slightly hazy solution.

The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 24 hours. For example, for use in faecal impaction, 12 sachets can be made up into 750 ml of water.

8. g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol. If this occurs Laxido Paediatric Plain should be stopped immediately, electrolytes measured, and any abnormality should be treated appropriately.

When used in high doses to treat faecal impaction this medicinal product should be administered with caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness. Laxido Paediatric Plain solution when reconstituted has no calorific value.

5). 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 5. 5 Interaction with other medicinal products and other forms of interaction Medicinal products in solid dose form taken within one hour of administration of large volumes of macrogol preparations (as used when treating faecal impaction) may be flushed from the gastro-intestinal tract and not absorbed.

Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. 4). g. anti-epileptics. Laxido Paediatric Plain may result in a potential interactive effect if used with starch-based food thickeners.

The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems. 6 Fertility, pregnancy and lactation Pregnancy There is a limited amount of data from the use of the Laxido formulation in pregnant women.

3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. Laxido Paediatric Plain can be used during pregnancy. Breast-feeding No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to macrogol 3350 is negligible.

Laxido Paediatric Plain can be used during breast-feeding. Fertility There are no data on the effects of the Laxido formulation on fertility in humans. 3). 7 Effects on ability to drive and use machines Laxido Paediatric Plain has no influence on the ability to drive and use machines.

8 Undesirable effects Reactions related to the gastro-intestinal tract occur most commonly. These reactions may occur as a consequence of expansion of the contents of the gastro-intestinal tract, and an increase in motility due to the pharmacological effects of Laxido Paediatric Plain.

In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose. Diarrhoea, abdominal distension, anorectal discomfort and mild vomiting are more often observed during the treatment for faecal impaction.

Vomiting may be resolved if the dose is reduced or delayed. The frequency of the adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10,000, < 1/1000); and very rare (< 1/10,000); not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse event Rare Allergic reactions including anaphylactic reaction. Immune system disorders Not known Dyspnoea and skin reaction (see below). Skin and subcutaneous tissue disorders Not known Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.

Metabolism and nutrition disorders Not known Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia. Nervous system disorders Not known Headache. Very common Abdominal pain, borborygmi. Common Diarrhoea, vomiting, nausea and anorectal discomfort.

Uncommon Abdominal distension, flatulence. Gastro-intestinal disorders Not known Dyspepsia and peri-anal inflammation. General disorders and administration site conditions Not known Peripheral oedema. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The fluid content of Laxido Paediatric Plain when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen.

8. g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol. If this occurs Laxido Paediatric Plain should be stopped immediately, electrolytes measured, and any abnormality should be treated appropriately.

When used in high doses to treat faecal impaction this medicinal product should be administered with caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness. Laxido Paediatric Plain solution when reconstituted has no calorific value.

5). 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 5.

Hypersensitivity to the active substances. g. ulcerative colitis, Crohn’s disease and toxic megacolon).