Purgolene 13,8 g Powder for oral solution

PURGOLENE is indicated for the treatment of chronic constipation.

Posology
Adults: 1 to 3 sachets daily in divided doses, according to individual response. The powder in each sachet should be dissolved in 125 ml water and taken orally.
Children (below 12 years old): not recommended.
Elderly: Initially one sachet per day is recommended. No dosage change is needed to be made for patients with renal insufficiency. A course of treatment with PURGOLENE should normally not exceed 2 weeks, although this can be repeated if required. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinsonu2019s Disease, or induced by regular constipating medication, in particular opioids and antimuscarinics. For extended use, the dose can be adjusted down to 1 or 2 sachets daily, in divided doses, each dissolved in 125 ml water and taken orally.
Method of administration
For oral administration.

PURGOLENE is contraindicated in:
u2022 Patients with known hypersensitivity to polyethylene glycol or any of the ingredients of PURGOLENE (see section 6.1).
u2022 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.
u2022 Not recommended for children under 12 years of age.

The fluid content of PURGOLENE when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. PURGOLENE should not be used in the presence of abdominal pain, nausea or vomiting. PURGOLENE should not be used continuously unless directed by your doctor. Frequent or prolonged use of laxatives 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) PURGOLENE 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 PURGOLENE may indicate a serious condition. PURGOLENE use should be discontinued and medical advice obtained. Adverse drug reactions are possible (see section 4.8.) If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) PURGOLENE should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately. The absorption of other medicines could transiently be reduced due to a decrease in gastrointestinal transit rate induced by PURGOLENE (see section 4.5). 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 PURGOLENE (see section 4.8). Diarrhoea usually responds to dose reduction. PURGOLENE contains 8,125 mmol sodium per dose, equivalent to 9,3 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 28 % of the WHO recommended maximum daily intake for sodium. PURGOLENE is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

Macrogol (PEG) raises the solubility of medicines that are soluble in alcohol and relatively insoluble in water. There is a possibility that the absorption of other medicines could be transiently reduced during use with PURGOLENE (see section 4.4). There have been reports of decreased efficacy with some concomitantly administered medicines, e.g. anti-epileptics.

Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 (PEG), as in PURGOLENE, is negligible. PURGOLENE can be used during pregnancy.
Breastfeeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to macrogol (PEG), as in PURGOLENE, is negligible. PURGOLENE can be used during breastfeeding.

PURGOLENE has no influence on the ability to drive and use machines.

a) Summary of the safety profile
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 PURGOLENE. Mild diarrhoea usually responds to dose reduction.
b) Tabulated summary of adverse reactions
system organ Class Frequency Side effects
Immune system disorders Frequency unknown Allergic reactions (anaphylactic reactions, dyspnoea and skin reactions)
Metabolism and nutrition disorders Frequency unknown Electrolyte disturbances (hyperkalaemia, hypokalaemia)
Nervous system disorders Frequency unknown Headache
Gastrointestinal disorders Frequency unknown Abdominal pain, abdominal cramps, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anorectal discomfort
Skin and subcutaneous tissue disorders Frequency unknown Allergic skin reactions (angioedema, urticaria, pruritus, rash, erythema)
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. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 and to Cipla Medpro (Pty) Ltd at [email protected] or telephone 080 222 6662 (toll free).

In the case of gross accidental over dosage, extensive fluid loss by diarrhoea or vomiting may require correction with generous amounts of fluid and electrolytes. Severe pain or distension associated with overdosage can be treated by nasogastric aspiration.