For the treatment of chronic constipation.

For resolving faecal impaction. Faecal impaction is defined as refractory constipation with faecal loading in the rectum and/or colon confirmed by physical or radiological examination of the abdomen and rectum.

Posology

Chronic constipation

A course of treatment for chronic constipation with CosmoCol Orange Lemon and Lime Flavour does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended.

Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's Disease, or induced by regular constipating medication in particular opioids and antimuscarincs.

Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily.

Children below 12 years old: Not recommended. Alternative products are available for children.

Patients with renal insufficiency: No dosage change is necessary.

Faecal impaction

Adults, adolescents and the elderly: A course of treatment for faecal impaction does not normally exceed 3 days.

Dosage is 8 sachets daily, all of which should be consumed within a 6-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 patient follows an appropriate bowel management programme to prevent reimpaction.

Children below 12 years old: Not recommended. Alternative products are available for children.

Patients with impaired cardiovascular function: For the treatment of faecal impaction, the dose should be divided so that no more than two sachets are taken in any one hour.

Patients with renal insufficiency: No dosage change is necessary for the treatment of either constipation or faecal impaction.

Method of administration

CosmoCol Orange Lemon and Lime Flavour is for oral use.

Each sachet should be dissolved in 125 ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.

CosmoCol Orange Lemon and Lime Flavour is contraindicated in intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract (e.g. ulcerative colitis, Crohn's disease and toxic megacolon).

Hypersensitivity to the active substances or any of the excipients listed in section 6.1.

The fluid content of CosmoCol Orange Lemon and Lime Flavour when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.

Confirm diagnosis of faecal impaction / faecal loading of the rectum by physical or radiological examination of the abdomen and rectum.

Mild adverse drug reactions are possible as indicated in Section 4.8. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) CosmoCol Orange Lemon and Lime Flavour should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

The absorption of other medicinal products could transiently be reduced due to an increase in gastrointestinal transit rate induced by CosmoCol Orange Lemon and Lime Flavour (see section 4.5).

When using high doses of this medicine to treat faecal impaction, use caution in patients with impaired gag reflex, reflux oesophagitis or reduced levels of consciousness.

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.

This medicine contains 0.63 mmol (25 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

This medicinal product contains 187 mg sodium per sachet, equivalent to 9.35% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

When used to treat chronic constipation, the maximum daily dose of this product is equivalent to 28.05% of the WHO recommended maximum daily intake for sodium.

CosmoCol Orange Lemon and Lime Flavour is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

This medicine contains 0.76mg sorbitol (E420) in each sachet.

Macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. It is a theoretical possibility that absorption of these drugs could be reduced transiently during use with CosmoCol Orange Lemon and Lime Flavour (see section 4.4).

There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

CosmoCol Orange Lemon and Lime Flavour 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.

Pregnancy

There are limited amount of data from the use of CosmoCol Orange Lemon and Lime Flavour 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.

CosmoCol Orange Lemon and Lime Flavour 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.

CosmoCol Orange Lemon and Lime Flavour can be used during breast-feeding.

Fertility

There are no data on the effects of CosmoCol Orange Lemon and Lime Flavour on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).

CosmoCol Orange Lemon and Lime Flavour has no influence on the ability to drive and use machines.

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 CosmoCol Orange Lemon and Lime Flavour powder for oral solution.

In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose.

Diarrhoea, abdominal distension, anal 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 effects is not known as it cannot be estimated from the available data.

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.

Severe distension or pain can be treated using nasogastric aspiration. Vomiting or diarrhoea may induce extensive fluid loss, possibly leading to electrolyte disturbances that should be treated appropriately.

Pharmacotherapeutic group: Osmotically acting laxatives. ATC code: A06A D65

Macrogol 3350 induces a laxative effect through its osmotic action in the gut. It increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defaecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.

For the indication of faecal impaction controlled comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, macrogol 3350 cleared the faecal impaction in 12/27 (44%) after 1 day's treatment; 23/27 (85%) after 2 days' treatment and 24/27 (89%) at the end of 3 days.

Clinical studies using the listed active substances for the treatment of chronic constipation have shown that the dose required to produce normally formed stools tends to decrease over time. Many patients, respond to between one and two sachets a day, but this dose should be adjusted depending on individual response.

Macrogol 3350 is virtually unabsorbed from the gastro-intestinal tract and is excreted, unaltered, in faeces. Any macrogol 3350 that is absorbed is excreted via the urine.

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity.

There were no direct embryotoxic or teratogenic effects in rats even at maternally toxic levels that are a multiple of 66 x the maximum recommended dose in humans for chronic constipation and 25 x for faecal impaction. Indirect embryofoetal effects, including reduction in foetal and placental weights, reduced foetal viability, increased limb and paw hyperflexion and abortions, were noted in the rabbit at a maternally toxic dose that was 3.3 x the maximum recommended dose in humans for treatment of chronic constipation and 1.3 x for faecal impaction. Rabbits are a sensitive animal test species to the effects of GI-acting substances and the studies were conducted under exaggerated conditions with high dose volumes administered, which are not clinically relevant. The findings may have been a consequence of an indirect effect of macrogol 3350 related to poor maternal condition as the result of an exaggerated pharmacodynamic response in the rabbit. There was no indication of a teratogenic effect.

There are long-term animal toxicity or carcinogenicity studies involving macrogol 3350. Results from these and other toxicity studies using high levels of orally administered high-molecular weight macrogols provide evidence of safety at the recommended therapeutic dose.

Colloidal anhydrous silica

Saccharin sodium

Orange flavour

(Orange flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum, alpha-tocopherol)

Lemon lime flavour

(Lemon lime flavour contains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (E420), acacia gum, colloidal anhydrous silica)

Not applicable.

36 months

Reconstituted solution: 24 hours

Sachet: Do not store above 25 ° C.

Reconstituted solution: Store covered in a refrigerator (2 ° C to 8 ° C).

The sachet is composed of paper, ethylene / methacrylic acid co-polymer and aluminium.

Sachets are packed in cartons of 20, 30, 50, 60 (2x30) and 100 (2x50).

Not all pack sizes may be marketed.

After 24 hours, any unused solution should be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.