Pholipeg 13,125 g/0,3507 g/0,1785 g/0,0466 g Oral Solution

For the treatment of chronic constipation.

Posology
Adults: 1 to 3 sachets daily in divided doses, according to individual response. A course of treatment with PHOLIPEG does not normally exceed two 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.
Special populations
Elderly: Initially one sachet daily is recommended. No dosage change is needed for patients with renal insufficiency.
Method of administration
For oral administration. Each sachet is reconstituted in 125 ml water and taken orally.

• Hypersensitivity to the active substances or to any of the excipients of PHOLIPEG listed in section 6.1.
• 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 Crohn's disease, ulcerative colitis and toxic megacolon.
• Not recommended for children under 12 years of age.

PHOLIPEG should not be used in the presence of abdominal pain, nausea or vomiting. PHOLIPEG should not be used continuously unless directed by a medical practitioner. 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) PHOLIPEG 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 two weeks, a medical practitioner should be consulted. Rectal bleeding or failure to have a bowel movement after use of PHOLIPEG may indicate a serious condition. PHOLIPEG use should be discontinued, and medical advice obtained. The fluid content of PHOLIPEG when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. The absorption of other medicines could transiently be reduced due to an increase in gastro-intestinal transit rate induced by PHOLIPEG (see section 4.5). PHOLIPEG contains 186,87 mg (8,125 mmol) sodium per dose, equivalent to 9,3 % of the WHO recommended maximum daily intake for sodium. PHOLIPEG is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

Macrogol 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 PHOLIPEG (see section 4.4). There have been reports of decreased efficacy with some concomitantly administered medicines, e.g., anti-epileptics.

Pregnancy
There is limited amount of data from the use of PHOLIPEG in pregnant women. Studies in animals have shown indirect reive toxicity (see section 5.3). PHOLIPEG 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. PHOLIPEG can be used during breastfeeding.
Fertility
There are no data on the effects of PHOLIPEG on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).

PHOLIPEG 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 frequently. 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 PHOLIPEG. Mild diarrhoea usually responds to dose reduction.
b. Tabulated summary of adverse reactions
The adverse reactions are listed below according to system organ class. The frequency of the adverse effects is not known as it cannot be estimated from the available data.
MedDRA system organ class
Frequency
Adverse reactions
Immune system disorders
Frequency unknown
Allergic reactions, including anaphylactic reactions, dyspnoea and skin reactions (see below)
Skin and subcutaneous tissue disorders
Frequency unknown
Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema
Metabolism and nutrition disorders
Frequency unknown
Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia
Nervous system disorders
Frequency unknown
Headache
Gastrointestinal disorders
Frequency unknown
Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence and anorectal discomfort
General disorders and administration site conditions
Frequency unknown
Peripheral oedema

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