Sporogut

Polyethylene glycol 3350, mineral salts.

Each sachet contains: Macrogol 3350 (polyethylene Glycol 3350) 13.125 gm, Sodium Chloride 350.7 mg, Sodium Hydrogen Carbonate 178.5 mg, Potassium Chloride 46.6 mg.

Osmotically Acting Laxative.

For the treatment of chronic constipation. It is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

Chronic Constipation: A course of treatment for chronic constipation with Polyethylene Glycol 3350 and Mineral Salts (SPOROGUT) does 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 care 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, and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily.
Children below 12 years old: Ask a doctor.
Faecal Impaction: A course of treatment for faecal impaction with Polyethylene Glycol 3350 and Mineral Salts (SPOROGUT) does not normally exceed 3 days.
Adults, adolescents, and the elderly: 8 sachets daily, all of which should be consumed within a 6-hour period.
Children below 12 years old: Ask a doctor.
Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than two sachets are taken in any one hour.
Patients with renal insufficiency: No dosage change is necessary for treatment of either constipation or faecal impaction.
Direction for use: Open the sachet and pour the contents into a glass. Add about 125 mL of water to the glass. Stir well until all the powder has dissolved and solution is clear or slightly hazy, then drink it.
Method of administration: Each sachet should be dissolved in 125 mL water. For use in faecal impaction, 8 sachets may be dissolved in 1 litre of water.
What to do if the patient missed a dose: If the patient misses a dose, just take the next dose and the subsequent doses at the usual recommended schedule, i.e., once a day. Do not double the dose unless recommended by a doctor.

Patient can develop diarrhoea, which disappears when treatment is temporarily interrupted or the dose is reduced.
Severe distension or pain can be treated using nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
What to do when the patient has taken more than the recommended dosage: If the patient has taken more than the recommended dosage, consult a doctor or consult a poison control center immediately.

The patient is allergic (hypersensitive) to Macrogol (P.E.G. = polyethylene glycol) or any of the other excipients. The patient has any intestine or colon disease (such as ulcerative colitis, Crohn's disease). The patient has abdominal pain of undetermined cause. The patient has or suspect a gastrointestinal perforation. The patient has or suspect a bowel obstruction (Ileus).

Ask the doctor's opinion before administering this treatment to the child, in order to exclude any organic cause of constipation. After 3 months of treatment, the doctor should evaluate the child's clinical condition. In case of diarrhoea, attention should be given to patients subject to electrolytic disorders (for example elderly people or patients with impaired hepatic or renal function (patients using diuretics) and an electrolytic check-up should be considered.
This medicine contains Macrogol (P.E.G. = polyethylene glycol) very few cases of hypersensitivity reactions (rash, hives or oedema) have been notified.
When to consult a doctor: If any undesirable effect occurs.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Ask the doctor or pharmacist for advice before taking any medicine. Inform the doctor if the patient is pregnant or expect to be or if the patient is breastfeeding a child.
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to Polyethylene Glycol 3350 and Mineral Salts (SPOROGUT) is negligible. Polyethylene Glycol 3350 and Mineral Salts (SPOROGUT) can be used during pregnancy.
Breast-feeding: No effects on the breast-feeding newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to macrogol 3350 is negligible; Polyethylene Glycol 3350 and Mineral Salts (SPOROGUT) can be used during breast feeding.

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 Polyethylene Glycol 3350 Powder for Oral Solution. Mild diarrhoea usually responds to dose reduction.
Immune system disorders: Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, urticaria, and pruritus.
Skin and subcutaneous tissue disorders: Erythema.
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, anorectal discomfort.
General disorders and administration site conditions: Peripheral oedema.

Polyethylene Glycol 3350 raises the solubility of medicinal products that are soluble in alcohol and mainly insoluble in water. There is a possibility that the absorption of other medicinal products could be transiently reduced during use with Polyethylene Glycol 3350 and Mineral Salts (SPOROGUT). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.
If the patient uses or has recently used another medicine, including medicines obtained without a prescription, tell the doctor or the pharmacist.

Store at temperatures not exceeding 30°C.

Laxatives, Purgatives

A06AD - Osmotically acting laxatives ; Used in the treatment of constipation.

Non-Rx