Pegicol Plain 6.9 g Powder for oral solution

PEGICOL PLAIN is indicated for:

• the treatment of chronic constipation.

Posology

Chronic constipation

The usual starting dose is 1 sachet daily for children aged 2 to 6 years and 2 sachets a day for children aged 7 to 11 years. The dose should be adjusted up or down as required to produce regular soft stools.

The maximum dose needed does not normally exceed 4 sachets a day.

Special populations

Patients with impaired cardiovascular function

There is no clinical data for this group of patients.

Patients with renal insufficiency

There is no clinical data for this group of patients.

Paediatric population

PEGICOL PLAIN is not recommended for children below two years of age.

Method of administration

For oral administration

Each sachet should be dissolved in approximately 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 24 hours. For example, 4 sachets can be made up into 250 ml of water.

PEGICOL PLAIN is contraindicated in:

• Patients with hypersensitivity to macrogol (PEG), sodium bicarbonate, sodium chloride, potassium chloride or to any of the excipients in PEGICOL PLAIN (see section 6.1).
• Patients with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, gastric retention, peptic ulceration, and severe inflammatory conditions of the intestinal tract, such as Crohnu2019s disease, ulcerative colitis and toxic megacolon.
• PEGICOL PLAIN is not recommended for children below two years of age.

PEGICOL PLAIN should not be used in the presence of abdominal pain, nausea or vomiting.

PEGICOL PLAIN should not be used continuously. Frequent or prolonged use of laxatives, such as PEGICOL PLAIN may result in dependence and loss of normal bowel function.

If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure), PEGICOL PLAIN should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

If there is a sudden change in bowel habits that has persisted for a period greater than 2 weeks; a medical practitioner should be consulted.

Rectal bleeding or failure to have a bowel movement after use of PEGICOL PLAIN may indicate a serious underlying condition. PEGICOL PLAIN should be discontinued and medical advice obtained.

PEGICOL PLAIN raises the solubility of medicines that are soluble in alcohol and relatively insoluble in water. Therefore, theoretically it is possible that the absorption of medicines could be transiently altered.

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

Pregnancy

There is limited amount of data from the use of PEGICOL PLAIN in pregnant women. Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 (PEG), as in PEGICOL PLAIN, is negligible.

Lactation

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to macrogol (PEG), as in PEGICOL PLAIN, is negligible.

Fertility

There are no data on the effects of PEGICOL PLAIN on fertility in humans. There were no effects on fertility in studies in male and female rats.

PEGICOL PLAIN has no influence on the ability to drive and use machines. Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that PEGICOL PLAIN do not adversely affect their ability to do so safely (see section 4.8).

(a) Description of selected adverse reactions

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 PEGICOL PLAIN. Mild diarrhoea usually responds to dose reduction.

(b) Tabulated list of adverse reactions

System organ class Frequency unknown

• Immune system disorders: Allergic reactions (anaphylactic reactions, dyspnoea and skin reactions)
• Metabolism and nutrition disorders: Electrolyte disturbances (hyperkalaemia, hypokalaemia)
• Nervous system disorders: Headache
• Gastrointestinal disorders: Abdominal pain, abdominal cramps, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anorectal discomfort
• Skin and subcutaneous tissue disorders: Allergic skin reactions (angioedema, urticaria, pruritus, rash, erythema)
• General disorders and administrative site conditions: Peripheral oedema

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088/+27 (0)11 239-6200

Symptoms

In the case of gross accidental overdosage, extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances. Severe pain or distension, associated with overdosage.

Treatment

Can be treated by nasogastric aspiration.