4.1. Therapeutic indications

For the treatment of chronic constipation in children 1 to 11 years of age.

For the treatment of faecal impaction in children from the age of 5 years, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2. Posology and method of administration

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 – 12 months). However, safety and efficacy of Movicol Paediatric Plain has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs.

Faecal impaction

A course of treatment for faecal impaction with Movicol Paediatric Plain is for up to 7 days as follows:

Daily dosage regimen:

Number of MOVICOL Paediatric Plain sachets

Age (years)

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

5 - 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. After disimpaction it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above).

Movicol 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 Movicol.

Patients with impaired cardiovascular function:

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

Method of administration

Each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 6 hours.

4.3. Contraindications

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon.

Hypersensitivity to the active substances.

4.4. Special warnings and precautions for use

The fluid content of Movicol Paediatric Plain when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.

Diagnosis of faecal impaction/faecal loading of the rectum should be confirmed by the physical or radiological examination of the abdomen and rectum.

Rarely symptoms indicating shifts of fluid/electrolytes e.g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol. If this occurs Movicol 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.

Movicol Paediatric Plain solution when reconstituted has no calorific value.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by Movicol Paediatric Plain (see section 4.5).

Movicol Paediatric Plain contains 93.4 mg (4.062 mmol) sodium (main component of cooking/table salt) per sachet. This is equivalent to 4.6% of the recommended maximum daily dietary intake of sodium for an adult.

In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.

4.5. 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 gastrointestinal tract and not absorbed.

Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with Movicol Paediatric Plain (see section 4.4).There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before, during and for one hour after taking Movicol Paediatric Plain.

Movicol 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.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data from the use of Movicol in pregnant women. Studies in animals have shown indirect reproductive toxicity (see section 5.3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

Movicol can be used during pregnancy.

Breastfeeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible.

Movicol can be used during breast-feeding.

Fertility

There are no data on the effects of Movicol on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).

4.7. Effects on ability to drive and use machines

Movicol Paediatric Plain has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Reactions related to the gastrointestinal tract occur most commonly.

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of Movicol 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 (≥1/1,000, <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

Immune system disorders

Rare

Allergic reactions including anaphylactic reaction.

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.

Gastrointestinal disorders

Very common

Abdominal pain, borborygmi.

Common

Diarrhoea, vomiting, nausea and anorectal discomfort.

Uncommon

Abdominal distension, flatulence.

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Severe abdominal pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.