Fortrans^® (Powder) Instructions for Use

Marketing Authorization Holder

Ipsen Consumer Healthcare SAS (France)

Manufactured By

Beaufour Ipsen Industrie (France)

ATC Code

A06AD15 (Macrogol)

Active Substance

Macrogol (Rec.INN registered by WHO)

Dosage Form

Fortrans®

Powder for oral solution 64 g: pkg. 73.69 g 4 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution white in color; the prepared solution is a clear, colorless and odorless liquid.

Excipients: sodium chloride – 1.46 g, potassium chloride – 0.75 g, sodium bicarbonate – 1.68 g, anhydrous sodium sulfate – 5.7 g, sodium saccharin – 0.1 g.

73.69 g – sachets made of laminated paper (4) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug with osmotic properties, used for bowel lavage

Pharmacotherapeutic Group

Osmotic laxative

Pharmacological Action

Fortrans^® is an osmotic laxative containing Macrogol 4000 (polyethylene glycol) and electrolytes (sodium, potassium, bicarbonate and chlorides).

The high molecular weight compound Macrogol 4000 consists of long linear polymers capable of retaining water molecules via hydrogen bonds. After oral administration, the drug increases the volume of fluid in the intestine. The volume of non-absorbed fluid contained in the intestine provides the laxative effect of the drug solution.

The electrolytes contained in the drug help maintain blood plasma composition. The concentration of electrolytes in the Fortrans^® solution is such that electrolyte exchange between the intestinal contents and blood plasma is practically reduced to zero. Thus, the presence of electrolytes in Fortrans^® prevents their loss from the body during the passage of a large volume of fluid through the gastrointestinal tract during drug use.

Pharmacokinetics

The solution prepared by dissolving 1 sachet of the drug in 1 liter of water is isotonic and isoosmotic with the contents of the large intestine in terms of electrolyte composition.

Results of pharmacokinetic studies confirm the absence of absorption and biotransformation of macrogol 4000 after oral administration.

Indications

Cleansing of the large intestine when preparing a patient for

• Endoscopic or radiological examination of the large intestine;
• Surgical interventions requiring the absence of contents in the large intestine.

ICD codes

Dosage Regimen

The drug can be used only in adult patients.

For oral administration.

Preparation of the drug solution pour the contents of one sachet into 1 liter of water and stir well until completely dissolved. The resulting solution should be clear and colorless. Prepare the required amount of solution (3-4 liters) in the same way, using only intact (unruptured) sachets. To obtain 4 liters of Fortrans^® solution, it is necessary to dissolve the contents of 4 sachets in 4 liters of water.

To improve the taste, it is better to take the solution chilled.

Recommended dose: 1 sachet/1 liter of solution per 15-20 kg of patient body weight or, on average, from 3 to 4 liters of the resulting solution.

It is recommended to drink one full glass (250 ml) of the resulting drug solution every 15 minutes until the entire prepared volume of solution is consumed.

Usually, taking the drug takes 4-6 hours. The full dose can be divided into two doses (2 liters in the evening and from 1 to 2 liters the next morning). It is usually recommended to complete the last dose of the drug no later than 3 hours before the examination or surgery. When taking the full dose of 3-4 liters of solution at one time, take it in the evening on the eve of the scheduled procedure, with a possible break of 1 hour after taking the first 2 liters.

When administering the drug through a gastric tube, the rate of administration should be 15-20 ml per minute.

Fortrans^® is intended for cleansing the gastrointestinal tract and promotes evacuation of intestinal contents as in diarrhea. The first liquid stool should appear within 1-2 hours after starting the drug.

Use in special patient groups

Patients with impaired renal function

Caution should be exercised when taking this drug in patients with altered renal function.

Elderly patients

No dose adjustment is required.

Children

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

Adverse Reactions

Nausea and vomiting may develop at the beginning of drug administration. These adverse reactions (AR) usually stop with continued use of the drug.

The table below summarizes the most frequent ARs reported in clinical trials and post-marketing surveillance.

The frequency of AR was determined according to the following gradation: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), very rare (<1/10000, including isolated cases), frequency not known (cannot be estimated from the available data).

Contraindications

• Hypersensitivity to the active substance or any other component of the drug;
• Severe general condition of the patient (dehydration or severe heart failure);
• Widespread malignant tumor or other disease of the large intestine accompanied by extensive damage to the intestinal mucosa;
• Acute phase of inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis;
• Gastrointestinal obstruction or risk of perforation;
• Patients who may have or already have intestinal obstruction (ileus);
• Perforation or risk of perforation of the gastrointestinal tract;
• Impaired gastric emptying (including gastroparesis, gastrostatis);
• Toxic colitis or toxic megacolon;
• Age under 18 years (efficacy and safety have not been established).

With caution

• In case of impaired renal function, heart failure, in patients with concomitant diuretic therapy;
• In patients prone to developing water-electrolyte imbalance, or in patients taking concomitant medications that increase the risk of water-electrolyte imbalance, including hyponatremia and hypokalemia;
• In patients with neurological disorders, in bedridden patients and/or in patients with impaired motor functions, in patients prone to aspiration and/or in a semi-conscious state (see section “Special Precautions”).

Use in Pregnancy and Lactation

Pregnancy

Experience with the use of macrogol 4000 in pregnant women is limited. Data from preclinical studies on reproductive toxicity are insufficient. The drug can be used during pregnancy only after careful assessment of the risk to the fetus and the benefit to the mother.

Breastfeeding period

Experience with the use of macrogol 4000 during breastfeeding is limited. It is not known whether Macrogol 4000 passes into breast milk. The risk to the newborn/infant cannot be ruled out.

The drug can be used during breastfeeding only if the benefit to the mother outweighs the possible risk to the infant.

Fertility

There are no data on the effect of macrogol 4000 on fertility.

Use in Renal Impairment

Use with caution in case of impaired renal function.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age (efficacy and safety have not been established).

Geriatric Use

Elderly individuals in poor health are recommended to use the drug only under the supervision of medical personnel. No dose adjustment is required.

Special Precautions

Elderly individuals in poor health are recommended to use the drug only under the supervision of medical personnel.

Solid food intake should be avoided at least 2 hours before using Fortrans^® and until the end of the examination. The intake of beverages such as tea, coffee (without milk) and other non-alcoholic drinks is allowed.

Diarrhea caused by taking Fortrans^® may lead to significant impairment of absorption of concomitantly administered drugs.

The drug contains Macrogol 4000 (polyethylene glycol). Allergic reactions (anaphylactic shock, angioedema, urticaria, rash) have been reported after administration of drugs containing polyethylene glycol.

Caution should be exercised when prescribing Fortrans^® to patients with inflammation of the intestinal mucosa, including the rectum.

The drug should be used with caution and only under the supervision of medical personnel in patients prone to aspiration, in bedridden patients, in patients with neurological disorders and/or in patients with impaired motor functions due to the risk of developing aspiration pneumonia. In such patients, the drug is administered in a “sitting” position and through a nasogastric tube.

Patients in a semi-conscious state should be carefully monitored during drug use. If symptoms of abdominal pain or distension appear, the rate of drug administration should be reduced or administration should be suspended until these symptoms disappear.

Due to the isotonic composition of Fortrans^®, the development of electrolyte imbalance is not expected in patients after its administration, except for patients at risk of water-electrolyte balance disorders. Patients with water-electrolyte balance disorders should receive appropriate therapy to correct them before the bowel cleansing procedure. The drug should be used with caution in patients prone to developing water-electrolyte imbalance, or in patients taking concomitant medications that increase the risk of water-electrolyte imbalance, including hyponatremia and hypokalemia, as well as in patients with a higher risk of developing side effects (in patients with impaired renal function, heart failure or in patients with concomitant diuretic therapy). The use of the drug in such patients should be carefully monitored.

Particular caution should be exercised in patients with heart and renal failure, as they are at risk of developing acute pulmonary edema due to fluid overload. Medical experience with the drug in patients with impaired renal function is limited.

Fortrans^® contains 2.890 g of sodium per sachet, which must be taken into account in patients on a strict low-salt diet.

Effect on ability to drive vehicles and operate machinery

Considering the pharmacological action of the drug and the possibility of adverse reactions, caution should be exercised when driving a car and working with machinery.

Overdose

Cases of overdose have not been reported to date.

Nevertheless, nausea, vomiting, diarrhea and water-electrolyte imbalance can be expected.

Oral rehydration therapy is recommended for the treatment of overdose symptoms. In rare cases of overdose accompanied by severe metabolic disorders, intravenous rehydration is recommended.

Drug Interactions

The physician prescribing Fortrans^® should be informed about all oral medications taken by the patient concomitantly. Due to the action of Fortrans^®, other oral medications may not be absorbed and should be taken by the patient more than 2 hours before taking the Fortrans^® solution.

The intake of oral medications should be avoided before and after taking Fortrans^® until the medical examination is completed. The effectiveness of drugs with a narrow therapeutic index or short T_1/2, for example, digoxin, antiepileptic drugs, coumarins, immunosuppressants, may be reduced.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.