Instructions Fortrans powder for oral solution sachet No. 4
Composition
active ingredients: 1 sachet contains: macrogol 4000 64.00 g;
sodium sulfate anhydrous 5.70 g;
sodium bicarbonate 1.68 g;
sodium chloride 1.46 g;
potassium chloride 0.75 g;
excipients: sodium saccharin.
Dosage form
Powder for oral solution.
Basic physicochemical properties.
White powder that dissolves easily in water.
Pharmacotherapeutic group
Osmotic laxatives. ATX code A06A D65.
Pharmacological properties
Pharmacodynamics
By forming hydrogen bonds with water molecules, Fortrans® retains it in the intestine. Water hydrates and increases the intestinal contents along its entire length. After that, the drug is completely evacuated from the intestine along with its contents.
The volume of unabsorbed fluid in the intestine is responsible for the laxative effect of the drug solution.
Pharmacokinetics
The drug is not absorbed or metabolized. It is excreted from the body unchanged.
Indication
Colon cleansing to prepare patients for:
- endoscopic or X-ray examinations of the large intestine;
- surgical interventions on the large intestine.
Fortrans® is indicated for use in adults.
Contraindication
- Hypersensitivity to the active or auxiliary substances of the medicinal product.
- Severe disturbances in the patient's general condition, such as dehydration or severe heart failure.
- Advanced carcinoma or any other disease of the large intestine accompanied by widespread damage to the intestinal mucosa.
- Presence or risk of intestinal obstruction or gastrointestinal obstruction.
- Perforation or threat 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 types of interactions
The prescribing physician should be informed of any other concomitant oral medications that the patient is taking. Due to the gastric emptying caused by Fortrans®, other oral medications may not be absorbed and should therefore be taken at least 2 hours before the solution. Oral medications should be avoided before and after taking a laxative until the medical examination is complete. For medications with a narrow therapeutic range or a short half-life, efficacy may be particularly affected.
Application features
Elderly people with weakened health are recommended to use the drug only under the supervision of a doctor.
Diarrhea caused by the use of Fortrans® may interfere with the absorption of drugs taken simultaneously with the drug (see section "Interaction with other drugs and other types of interactions").
This medicine contains macrogol (polyethylene glycol or PEG).
Allergic reactions reported with macrogol-based medicinal products: anaphylactic shock, rash, urticaria, angioedema (see section "Adverse reactions").
The medicinal product should not cause electrolyte imbalance due to its isotonic composition; however, exceptional cases of water and electrolyte disturbances have been reported in patients at risk. Patients with signs of dehydration or electrolyte abnormalities should have these corrected before using the medicinal product for bowel cleansing. This medicinal product should be used with caution in patients suffering from such disorders, as well as in patients taking concomitant medicinal products that increase the risk of water 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 concomitant treatment with diuretics). In such cases, patients require appropriate monitoring.
In patients prone to aspiration, bedridden, or patients with neurological and/or motor impairments, due to the risk of aspiration pneumonia, it is recommended to use the drug with caution and only under medical supervision. In such patients, the drug should be administered in a sitting position and via a nasogastric tube.
Patients with heart or kidney failure may develop acute pulmonary edema due to excessive water intake.
This medicinal product contains sodium. The medicinal product contains 1.967 g of sodium per sachet. This should be taken into consideration by patients on a controlled salt diet.
Use during pregnancy or breastfeeding
Pregnancy
Fortrans® can be used only after careful assessment of the risk to the fetus and the benefit to the mother.
Breast-feeding
There are no or limited data on the use of Fortrans® during breastfeeding. It is not known whether macrogol 4000 is excreted in breast milk. A risk to newborns/infants cannot be excluded.
Fortrans® can be used only after careful assessment of the risk to the fetus and the benefit to the mother.
Fertility
There are no data on the effect of Fortrans® on fertility.
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®.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies on the effect on the ability to drive and use machines have been conducted.
Method of administration and doses
Fortrans® can only be used in adult patients.
For oral use.
Dissolve the contents of one sachet in 1 liter of water until the powder is completely dissolved.
The dosage should be set at approximately 1 liter of solution per 15–20 kg of body weight. The dose is 3–4 liters of solution depending on the patient's body weight.
The drug can be used in one stage or in 2 stages, provided that the prepared solution is used in full (on average 3–4 liters of solution depending on the patient's body weight).
Training scheme.
One-step preparation: 3–4 liters the evening before the procedure, a 1-hour break is possible after the first 2 liters.
Two-step preparation: 2 liters the evening before the procedure and 1–2 liters the morning of the procedure, the last glass should be taken 3–4 hours before the procedure; or 3 liters the evening before the procedure and 1 liter the morning of the procedure, the last glass should be taken 3–4 hours before the procedure.
The recommended rate of use of the drug is 1–1.5 liters per hour (i.e. 250 ml every 10–15 minutes).
The doctor may adjust the recommended dosage of the drug according to the patient's clinical condition and potential concomitant diseases.
Patients with renal impairment.
There are insufficient data for this category (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.
Do not use in children.
Overdose
There have been no reports of overdose.
However, the patient's fluid and electrolyte balance and hydration status should be monitored in case of overdose with severe diarrhea.
Adverse reactions
Diarrhea is an expected consequence of using the drug Fortrans®.
At the beginning of the intake, attacks of nausea and vomiting were noted, which usually disappeared with further use.
Adverse reactions from clinical trials and post-marketing experience are listed below. The frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to >1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
From the digestive system:
Very common: nausea, abdominal pain, bloating.
Common: vomiting.
On the part of the immune system:
Not known: hypersensitivity reactions including anaphylactic shock, angioedema, urticaria, rash, pruritus.
Expiration date
36 months.
Storage conditions
Does not require any special storage conditions. Keep out of the reach of children.
Packaging
73.69 g of powder per sachet; 4 sachets per carton.
Vacation category
According to the recipe.
Producer
BEAUFOUR IPSEN INDUSTRIE.
Location of the manufacturer and its business address
Rue Ethe Virton 28100 DREUX, France.
Applicant
IPSEN CONSUMER HEALTHCARE, Simplified Joint Stock company.
Location of the applicant and/or applicant's representative
65 Quai Georges Gorse 92100 Boulogne-Billancourt, France / 65 Quai Georges Gorse 92100 Boulogne-Billancourt, France.
