COSMOCOL HALF 6.9 G POWDER FOR ORAL SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

CosmoCol Half 6.9 g, powder for oral solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One sachet of CosmoCol Half contains the following active ingredients: Macrogol 3350, 6.563 g

Sodium chloride, 0.1754 g

Sodium hydrogen carbonate,

0.0893 g Potassium chloride,

0.0233 g

Content of electrolyte ions when one sachet is dissolved in 62.5 mL water: Sodium 65 mmol/l

Chloride 53 mmol/l

Hydrogen carbonate 17

mmol/l Potassium 5.0

mmol/l

Excipients with known effect

Each sachet contains:

– 12.22 mg (0.31 mmol) potassium

– 93.86 mg sodium

– 0.38 mg sorbitol (E420)

For the full list of excipients, see section 6.1.

Powder for oral solution

Free flowing white powder

4.1 Therapeutic indications

For the treatment of chronic constipation in adults, adolescents and the elderly.

For resolving faecal impaction in adults, adolescents and the elderly. 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.

4.2 Posology and method of administration

Chronic constipation

A course of treatment for constipation does not normally exceed two 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 antimuscarinics.

Adults, Adolescents and the Elderly

2–6 sachets daily in divided doses, accrding to individual response.

For extended use, dose can be adjusted down to 2–4 sachets daily.

Faecal impaction

Adults, Adolescents and the Elderly

A course of treatment for faecal impaction does not normally exceed 3 days.

Dosage is 16 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 of age)

Not recommended.

Patients with impaired cardiovascular function

For the treatment of faecal impaction, the dose should be divided so that no more than four 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.

Administration

The contents of each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. For use in faecal impaction the correct number of sachets can be reconstituted in advance and kept covered and refrigerated for up to 6 hours. For example, dissolved 16 sachets in one litre of water for the treatment of faecal impaction.

4.3 Contraindications

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

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special warnings and precautions for use

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

Rarely in adults taking macrogol there have been reports of symptoms indicating a shift of fluid and electrolyte balance, e.g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure. If these symptoms occur, stop treatment with CosmoCol Half immediately. Measure electrolytes and treat any abnormality with appropriate counter measures.

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.

This medicine contains 0.31 mmol (12.22 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 93.86 mg sodium per sachet, equivalent to 4.69% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

This medicine contains 0.38 mg sorbitol (E420) in each sachet.

4.5 Interaction with other medicinal products and other forms of interaction Medicines in solid-dose form that are taken within one hour of administration of CosmoCol Half may be flushed from the gastro-intestinal tract and not absorbed.

Absorption of other medicines could be transiently reduced due to an increased rate of gastro-intestinal transit induced by CosmoCol Half. There have been isolated reports of decreased efficacy with some concomitantly administered medicines, e.g. antiepileptics.

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

4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data from the use of CosmoCol Half 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 Half 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 Macrogol 3350 is negligible.

CosmoCol Half can be used during breastfeeding.

Fertility

There are no data on the effects of CosmoCol Half 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

CosmoCol Half has no influence on the ability to drive and the ability to operate machinery.

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 Compound Macrogol Oral Powder Sugar Free. Mild diarrhoea usually responds to dose reduction.

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:

4.9 Overdose

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

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: osmotically acting laxatives

ATC code: A06A D65

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. Macrogol 3350 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 comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, macrogol 3350 13.8g 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 in the use of macrogol 3350 in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time. Many patients respond to between 2–4 sachets of CosmoCol Half per day, but this dose should be adjusted depending on individual response.

5.2 Pharmacokinetic properties

Macrogol 3350 passes through the intestine unchanged. It is virtually unabsorbed from the gastrointestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

5.3 Preclinical safety data

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 embryofetal effects, including reduction in fetal and placental weights, reduced fetal 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 and 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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Colloidal Anhydrous Silica

Saccharin sodium

Orange flavour

Lemon Lime flavour

The lemon lime flavour contains:

Sorbitol (E420)

Alpha-tocopherol (E307)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened sachet: 3 years

Reconstituted solution: Discard any solution not used within 6 hours.

6.4 Special precautions for storage

Sachet: Do not store above 25°C.

Reconstituted Solution: Store at 2 – 8°C (refrigerated and covered).

6.5 Nature and contents of container

Sachet: four-layer laminate film consisting of ionomer coex, aluminum, polyethylene and paper.

Pack sizes: Packs of 30, 40, 50, 60 or 100 sachets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Stirling Anglian Pharmaceuticals Limited

Hillington Park Innovation Centre

1 Ainslie Road

Hillington

Glasgow G52 4RU

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 42582/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/07/2019