Pegclear

Pegclear Concentrate for Oral Solution

Each 25 ml contains:

Polyethylene Glycol 3350 USP 13.125 gm

Sodium Chloride IP 0.3507 gm

Sodium Bicarbonate IP 0.1785 gm

Potassium Chloride IP 0.0466 gm

Concentrate for oral solution, clear and colourless liquid.

4.1. Therapeutic indication

For the treatment of chronic constipation.

For bowel cleansing prior to colonoscopy in adult patients only.

4.2. Posology and method of administration

Posology

A course of treatment for constipation with Pegclear should not normally exceed 2 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 case 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 & elderly :

25 ml (13.125 gm) of solution diluted in 100 ml of water 1-3 times daily in divided doses, according to individual’s response. For extended use, the dose can be adjusted down to 1 or 2 doses per day of 25 ml of solution diluted in 100 ml of water.

Children :

2 to 6 years : usual starting daily dose is 12.5 ml solution diluted in 50 ml of water.

7 to 11 years : Usual starting daily dose is 25 ml solution diluted in 100 ml of water. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs increasing, this is best done every second day. The maximum dose of PEG 3350 does not normally exceed 26.252 gm per day.

Geriatric use

Can be administered to elderly patients in the same dosage as recommended for adults

Method of administration

Pegclear must not be taken undiluted and may only be diluted in water. Dilute required dose (volume) of Pegclear with water as recommended under dosage. Any unused solution should be discarded within 24 hours.

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients of the formulation; intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus; severe inflammatory conditions of the intestinal tract, such as crohn's disease and ulcerative colitis; toxic megacolon.

4.4. Special warnings and precautions for use

If patients develop any symptoms indicating shifts of fluids/electrolytes like oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure; PEG 3350 should be stopped immediately, electrolytes should be measured and any abnormality should be treated appropriately.

PEG 3350 increases gastro-intestinal transit rate which may transiently reduce absorption of other medicinal products. The sodium content should be taken into consideration when administering the product to patients on a controlled sodium diet. No dosage change is necessary for the treatment of constipation in patients with renal insufficiency.

4.5. Interaction with other medicinal products and other forms of interaction

Polyethylene glycol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. PEG 3350 increases gastro-intestinal transit rate which may transiently reduce absorption of other medicinal products. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is limited data on the use of PEG 3350 in pregnant women. Studies in animals have shown indirect reproductive toxicity like reduction in fetal and placental weights, reduced fetal viability, increased limb and paw hyperflexion and abortions. Clinically, no effects during pregnancy are anticipated, since systemic exposure to PEG 3350 is negligible. PEG 3350 can be used during pregnancy.

Lactation

As systemic exposure of the breast-feeding woman to PEG 3350 is negligible, no effects on the breastfed newborn/infant are anticipated, and PEG 3350 can be used during breast-feeding.

Fertility

There are no data on the effects of PEG 3350 on fertility in humans. There were no effects on fertility in studies in male and female rats.

4.7. Effects on ability to drive and use machines

Pegclear concentrate for oral solution has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Gastrointestinal tract related reactions 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 PEG 3350. Mild diarrhoea usually responds to dose reduction.

Other adverse reactions which may occur are : Immune system disorders: allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, erythema, urticaria, and pruritis.

Metabolism and nutrition disorders: electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.

Nervous system disorders: headache

Gastrointestinal disorders: abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, and anal discomfort.

General disorders and administration site conditions: peripheral oedema.

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 email to: medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting By reporting side effects, you can help provide more information on the safety of this medicine.

4.9. Overdose

Severe pain or distension, diarrhoea, vomiting may occur in case of overdosage.

Severe pain or distention can be treated by nasogastric aspiration.

Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group : osmotically acting laxative.

Polyethylene glycol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. PEG 3350 increases the stool volume, triggering the colon motility via neuromuscular pathways leading to an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation. Electrolytes combined with PEG 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.

5.2 Pharmacokinetic properties

PEG 3350 passes unchanged along the gut. It is virtually unabsorbed from the gastro- intestinal tract. Any polyethylene glycol 3350 that is absorbed is excreted via the urine.

Preclinical studies provide evidence that macrogol or PEG 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 PEG 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.

Polyethylene glycols or Macrogols are addition polymers of ethylene oxide and water, represented by the chemical formula H(OCH CH ) OH, where n represents the average 2 2 n number of oxyethylene groups. Each macrogol is usually designated by a number that corresponds approximately to its average molecular weight. The chemical structure of PEG is given below:

n represents average no. of oxyethylene groups

Polyethylene glycol (PEG) 3350, a white or almost white solid with a waxy or paraffin like appearance has an approximate average molecular weight of 3350 daltons. Pegclear contains PEG 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride. When a 25 ml dose of Pegclear is made up to 125 ml of solution, it provides 65 mmol/l of Sodium, 53 mmol/l of Chloride, 5.4 mmol/I of Potassium & 17 mmol/l of Bicarbonate which corresponds to 8.125 mmol of Sodium, 6.625 mmol of Chloride, 0.675 mmol of Potassium and 2.125 mmol of Bicarbonate in each diluted dose of 125 ml.

8.1. Incompatibilities

Not applicable.

8.2. Shelf-life

24 months

8.3. Packaging information

A bottle of 200 ml

8.4. Storage and handing instructions

Store at a temperature not exceeding 30°C.

Do not refrigerate or freeze.

Keep out of reach of children.

Discard product 30 days after first opening. The diluted solution should be kept covered. Throw away any solution not used within a 24 hour period

Advise the patient to read the Patient Information Leaflet Instruct. patients:

• To reconstitute Pegclear oral solution with water prior to ingestion.
• Not to take other laxatives while they are taking Pegclear oral solution.
• Not to take oral medications within 1 hour before the start or during the administration of Pegclear oral solution.
• To take only clear liquids but avoid red and purple liquids.
• To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
• To follow the directions in the Instructions for Use on how to prepare and administer the product.
• If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.
• To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures.
• To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction

12th June 2024