Phygleton Hs 6,86 g Powder for oral solution

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
PHYGLETON HS is not recommended for children below two years of age.
Method of 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.

• Hypersensitivity to the active substances or to any of the excipients of PHYGLETON HS 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.

PHYGLETON HS should not be used in the presence of abdominal pain, nausea or vomiting. PHYGLETON HS 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) PHYGLETON HS 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 PHYGLETON HS may indicate a serious condition. PHYGLETON HS use should be discontinued, and medical advice obtained.
The fluid content of PHYGLETON HS 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 PHYGLETON HS (see section 4.5).
PHYGLETON HS contains 93,4 mg (4,062 mmol) sodium (main component of cooking/table salt) per sachet. This is equivalent to 4,6 % of the recommended maximum daily dietary intake of sodium for an adult.

Medicinal products in solid dose form taken within one hour of administration of large volumes of macrogol preparations (as used when treating faecal impaction) may be flushed from the gastrointestinal tract and not absorbed.
Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.
There is a possibility that the absorption of other medicinal products could be transiently reduced during use with PHYGLETON HS (see section 4.4). There have been reports of decreased efficacy with some concomitantly administered medicinal products, e.g., anti-epileptics.

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

PHYGLETON HS 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 PHYGLETON HS. Vomiting may be resolved if the dose is reduced or delayed.
b. Tabulated summary of adverse reactions
The adverse reactions are listed below according to system organ class and frequency.
MedDRA system organ class Frequency Adverse reactions
Immune system disorders Less frequent Allergic reactions, including anaphylactic reactions
Frequency unknown 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 Frequent Abdominal pain, borborygmi, diarrhoea, vomiting, nausea and anorectal discomfort
Less frequent Abdominal distension, flatulence
Frequency unknown Dyspepsia and peri-anal inflammation
General disorders and administration site conditions Frequency unknown 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. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Medicine Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

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