FORTRANS®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FORTRANS®

Composition:

Active substances: 1 sachet contains: macrogol 4000 64.00 g;

anhydrous sodium sulfate 5.70 g;

sodium bicarbonate 1.68 g;

sodium chloride 1.46 g;

potassium chloride 0.75 g;

Excipients: sodium saccharin.

Pharmaceutical form. Oral powder for solution.

Main physicochemical properties.

White powder, readily soluble in water.

Pharmacotherapeutic group.

Osmotic laxatives. ATC code A06AD65.

Pharmacological properties

Pharmacodynamics

Fortrans**®** retains water in the intestine by forming hydrogen bonds with water molecules. The water hydrates and increases the intestinal contents throughout its entire length. Subsequently, the drug is completely evacuated from the intestine along with its contents.

The volume of non-absorbed liquid in the intestine determines the laxative effect of the medicinal solution.

Pharmacokinetics

The medicinal product is neither absorbed nor metabolized. It is excreted from the body in unchanged form.

Clinical characteristics.

Indications.

Bowel cleansing for preparation of patients prior to:

• endoscopic or radiological examinations of the colon;
• surgical procedures on the colon.

Fortrans® is indicated for use in adults.

Contraindications.

• Hypersensitivity to the active substances or excipients of the medicinal product.
• Severe impairment of general condition, such as severe dehydration or severe heart failure.
• Advanced carcinoma or any other disease of the colon associated with extensive mucosal damage.
• Presence or risk of intestinal obstruction or gastrointestinal obstruction.
• Perforation or risk of perforation of the gastrointestinal tract.
• Abdominal pain of unknown origin.
• Gastric emptying disorders (e.g., gastroparesis).
• Toxic colitis or toxic megacolon.

Interaction with other medicinal products and other forms of interaction.

The healthcare provider prescribing treatment should be informed about any other medicinal products the patient is concurrently taking orally. Due to the gastric emptying induced by Fortrans®, other orally administered medicinal products may not be absorbed; therefore, they should be taken no later than 2 hours before the intake of the solution. The administration of oral medicinal products should be avoided before and after taking the laxative until completion of the medical examination. For medicinal products with a narrow therapeutic index or a short elimination half-life, a special impact on efficacy is possible.

Special precautions for use

Elderly and debilitated patients are advised to use the medicinal product only under medical supervision.

Diarrhea induced by the use of the medicinal product Fortrans® may interfere with the absorption of medicinal products taken concomitantly with this product (see section "Interaction with other medicinal products and other forms of interaction").

This medicinal product contains macrogol (polyethylene glycol or PEG).

Allergic reactions reported with macrogol-based medicinal products include: anaphylactic shock, rash, urticaria, angioneurotic edema (see section "Side effects").

Due to its isotonic composition, this medicinal product should not cause electrolyte imbalance; however, rare cases of fluid and electrolyte disturbances have been reported in patients at risk. Patients presenting signs of dehydration or with electrolyte abnormalities should be corrected prior to administration of the bowel cleansing agent. This medicinal product should be used with caution in patients with such disorders, as well as in patients receiving concomitant medicinal products that may increase the risk of fluid and electrolyte disturbances, including hyponatremia and hypokalemia, or that may increase the risk of potential complications (e.g., patients with impaired renal function, heart failure, or those receiving concomitant diuretic therapy). In such cases, appropriate patient monitoring is required.

Patients at risk of aspiration, bedridden patients, or patients with neurological disorders and/or motor dysfunction should use the medicinal product with caution and under medical supervision due to the risk of developing aspiration pneumonia. These patients should receive the medicinal product in a sitting position and via a nasogastric tube.

Acute pulmonary edema due to excessive water intake may develop in patients with cardiac or renal insufficiency.

This medicinal product contains sodium. The product contains 1.967 g of sodium per sachet. This should be taken into account for patients on a low-salt diet.

Use during pregnancy or breastfeeding

Pregnancy

Data on the use of Fortrans® in pregnant women are lacking or limited. Preclinical data on reproductive toxicity are insufficient.

Fortrans® should be administered only after careful assessment of the benefit-risk ratio to the fetus and mother.

Breastfeeding

Data on the use of Fortrans® during breastfeeding are lacking or limited. It is unknown whether macrogol 4000 is excreted in breast milk. Risk to newborns/infants cannot be excluded.

Fortrans® should be administered only after careful assessment of the benefit-risk ratio to the infant and mother.

Fertility

Data on the effect of Fortrans® on fertility are lacking.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using Fortrans®.

Effect on ability to drive and use machines

No studies on the effect on the ability to drive and operate machinery have been conducted.

Dosage and Administration

Forteans® is intended for use in adults only.

For oral administration.

The contents of one sachet should be dissolved in 1 liter of water until the powder is completely dissolved.

Dosage should be calculated at approximately 1 liter of solution per 15–20 kg of body weight. The total dose is 3–4 liters of solution, depending on the patient's body weight.

The preparation may be administered in a single phase or in two phases, provided that the entire prepared solution is consumed (on average, 3–4 liters, depending on the patient's body weight).

Preparation Regimen

Single-phase preparation: 3–4 liters in the evening before the procedure; a break of 1 hour after the first 2 liters is allowed.

Two-phase preparation: 2 liters in the evening before the procedure and 1–2 liters in the morning on the day of the procedure, with the last glass taken 3–4 hours before the procedure; alternatively, 3 liters in the evening before the procedure and 1 liter in the morning on the day of the procedure, with the last glass taken 3–4 hours before the procedure.

The recommended rate of administration is 1–1.5 liters per hour (i.e., 250 mL every 10–15 minutes).

The physician may adjust the recommended administration rate according to the patient’s clinical condition and potential comorbidities.

Patients with Renal Impairment

There are insufficient data available for this patient group (see section "Special Warnings and Precautions for Use").

Children

The safety and efficacy of Fortrans® in children (under 18 years of age) have not been established.

Children

Not recommended for use in children.

Overdose

There have been no reports of overdose.

However, in the event of overdose associated with severe diarrhea, monitoring of fluid and electrolyte balance and hydration status should be performed.

Adverse reactions.

Diarrhea is an expected consequence of using the medicinal product Fortrans®.

At the beginning of administration, episodes of nausea and vomiting were observed, which usually disappeared with continued use.

The undesirable reactions listed below are based on clinical trial data and adverse events reported during post-marketing surveillance. Frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Gastrointestinal disorders:

Very common: nausea, abdominal pain, bloating.

Common: vomiting.

Immune system disorders:

Not known: hypersensitivity reactions, including anaphylactic shock, angioneurotic edema, urticaria, rash, pruritus.

Shelf life.

36 months.

Storage conditions.

No special storage conditions required. Keep out of reach of children.

Packaging.

Each sachet contains 73.69 g of powder; 4 sachets in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

BOFUR IPSEN INDUSTRIE / BEAUFOUR IPSEN INDUSTRIE.

Manufacturer's address.

Rue Ethe Virton 28100 DREUX, France.

Marketing authorization holder.

IPSEN CONSUMER HEALTHCARE, Simplified Joint Stock Company.

Address of the marketing authorization holder and/or its representative.

65 Quai Georges Gorse, 92100 Boulogne-Billancourt, France.