Fortrans

The powder for oral solution is a white to whitish-colored powder.
Each sachet of 73.690 g contains: Macrogol 4000* 64.000 g; Anhydrous sodium sulfate 5.700 g; Sodium bicarbonate 1.680 g; Sodium chloride 1.460 g; Potassium chloride 0.750 g.
* P.E.G. 4000 = Polyethylene glycol 4000.
Excipient with known effect: Each sachet contains 2.890 g of sodium.
Excipients/Inactive Ingredients: Sodium saccharin.

Pharmacotherapeutic class: OSMOTIC LAXATIVE. ATC code: A06AD65 (A: digestive system and metabolism).
Pharmacology: Pharmacodynamics: High molecular weight (4000) macrogols are long-chain linear polymers on which water molecules are retained by hydrogen bonds. Following oral administration, they increase the volume of the intestinal fluids.
The volume of non-absorbed intestinal fluid is responsible for the laxative properties of the solution.
Pharmacokinetics: The electrolyte content of the powder is such that the reconstituted solution does not give rise to intestine/plasma electrolyte exchange.
Pharmacokinetic data confirm the absence of intestinal resorption and bioconversion of macrogol 4000 after oral ingestion.
Toxicology: Preclinical safety data: Preclinical data from acute and repeated dose toxicity studies and genotoxicity studies performed with macrogol 4000 have not revealed any particular risk for humans. Due to the short duration of use of the product, no carcinogenicity studies have been performed.

Cleansing of the colon as bowel prep for patients before: endoscopic and radiological examinations; colonic surgery.
FORTRANS is indicated only for use in adults.

Dosage: FOR USE IN ADULTS ONLY.
Oral administration.
Dissolve the contents of the sachet in one litre of water. Stir until the powder is completely dissolved.
The dosage is about 1 litre of solution for every 15 to 20 kg of body weight which corresponds to an average dose of 3 to 4 litres.
Method of administration: The preparation can be taken either as a single dose or as divided doses, as long as the total amount of the prepared solution is fully ingested (average of 3 to 4 litres of solution according to the patient's body weight).
In divided doses: Either 2 litres ingested the evening before the procedure and 1 to 2 litres the morning of the procedure, with the last glass being ingested 3 to 4 hours before the procedure, or alternatively, 3 litres ingested the evening before the procedure and 1 litre the morning of the procedure, with the last glass being ingested 3 to 4 hours before the procedure.
As a single dose: 3 to 4 litres the evening before the procedure, possibly with a break of one hour after the first 2 litres.
The recommended ingestion rate is 1 to 1.5 litres an hour (i.e. 250 ml every 10 to 15 minutes). The doctor may adjust the recommended rate according to the patient's clinical condition and to potential comorbidities.
Patients with renal impairment: Insufficient data are available for this population (see Precautions).
Pediatric population: The safety and efficacy of FORTRANS in children aged <18 years have not been established.

Intentional or accidental ingestion of more than the recommended dose of FORTRANS powder for oral solution may result in severe diarrhea and electrolyte imbalance, including hyponatremia and hypokalemia, as well as dehydration and hypovolemia with the associated signs and symptoms.
In this case, the patient should be monitored, and copious amounts of fluids, especially fruit juices, should be administered. In rare cases of overdose resulting in severe metabolic imbalance, intravenous rehydration may be performed.

Hypersensitivity to the active substances or to any of the excipients mentioned in Description.
Severe heart failure.
Serious deteriorations in general health, such as dehydration.
Advanced carcinoma or any other colonic pathology causing excessive mucosal fragility.
Acute phases of intestinal tract inflammation including Crohn's disease and ulcerative colitis.
Gastrointestinal perforation or risk of perforation.
Toxic colitis or toxic megacolon.
Patients likely to have or who already have an ileus.
Patients likely to have or who already have a gastrointestinal obstruction or stenosis.
Gastric emptying disorders (e.g.: gastroparesis, gastric stasis).
Children and teenagers under 18 years of age.

Diarrhea provoked by administration of this medication is likely to cause considerable disturbance in the absorption of simultaneously administered drugs (see Interactions).
This medicine contains macrogol (polyethylene glycol or PEG). Allergic-type reactions have been reported with preparations based on macrogol: anaphylactic shock, rash, urticaria, angioedema (see Adverse Reactions).
Although not expected due to the isotonic composition of this product, rare cases of water electrolyte disturbances have been reported in at-risk patients. Patients with pre-existing electrolyte abnormalities should have them corrected before the bowel cleansing solution is administered. This product should also be used with caution in patients with these conditions or in patients treated with medications that may increase the risk of water electrolyte disturbances, including hyponatremia and hypokalemia, or may increase the risk of potential complications (such as patients with altered renal function, cardiac insufficiency, or those being treated concomitantly with diuretics). In this case, patients should be appropriately monitored.
The product should be administered carefully and only under attentive supervision in patients with a tendency towards regurgitation, bedridden patients, or those with disturbances in neurological and/or motor function, due to the risk of inhalation. The product should be administered to these patients after first putting them in a sitting position, and possibly even via gastric tube.
In patients with cardiac or renal insufficiency, there is a risk of acute pulmonary edema due to fluid overload.
This medicine contains sodium. This medicine contains 2.890 g of sodium per sachet. This fact must be taken into account in patients on a strict low-sodium diet.
Ischemic colitis: Post-marketing surveillance has revealed that cases of ischemic colitis, some of them serious, have been reported in patients treated with macrogol as part of their bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischemic colitis or if there is concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients presenting with sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis should be evaluated promptly.
Effects on ability to drive and use machines: There have been no studies conducted on what effects, if any, FORTRANS might have on the ability to drive and use machines.
Use in the Elderly: This product should be administered to elderly patients in a frail general condition only under medical supervision.

Pregnancy: There are no data, or a limited amount, relating to the use of FORTRANS in pregnant women. Animal studies have been insufficient for the purposes of determining whether or not it is a reproductive toxic agent. FORTRANS should only be used when necessary.
Lactation: There are no data, or a limited amount, relating to the use of FORTRANS in lactating women. There is no data available for determining whether or not FORTRANS is excreted in human milk. Risk to newborns/infants cannot be excluded. Animal studies have been insufficient for the purposes of determining whether or not it is a reproductive toxic agent. FORTRANS should only be used when necessary.
Fertility: There are no data documenting the effects on fertility with the use of FORTRANS.

Diarrhoea is an expected effect resulting from the use of FORTRANS. Nausea and vomiting have been reported at the start of administration, usually disappearing with continued administration.
The following table lists adverse reactions collected from clinical trial data, and adverse events reported from post-marketing sources. The frequency of adverse reactions are as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare (<1/10000), Unknown frequency (cannot be estimated from the available data). (See table.)

Click on icon to see table/diagram/image

Reporting of suspected adverse reactions: Reporting of suspected adverse reactions after a marketing authorization has been granted to the drug is important. It allows continuous surveillance of the medicine's benefit/risk ratio. Health professionals can report any suspected adverse reaction.

The prescriber should be informed of any other oral medicines being taken simultaneously by the patient. Oral medicines may not be absorbed due to the bowel emptying effect of the preparation, and should be administered over 2 hours before the bowel cleansing product is ingested. Avoid taking oral treatments before and after ingestion of the laxative, and until the medical examination has been completed. For medicines with a narrow therapeutic index or a short half-life, such as digoxin, antiepileptics, coumarins and immunosuppressants, efficacy may be particularly affected.

Special precautions for disposal and other handling: Any unused medicine or waste must be disposed of in accordance with the regulations in force.
Incompatibilities: Not applicable.

Do not store FORTRANS above 30°C.
Shelf life: 3 years.

Laxatives, Purgatives

A06AD65 - macrogol, combinations ; Belongs to the class of osmotically acting laxatives.

NP