Fortrans

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

Fortrans, powder for oral solution, in a sachet

macrogol 4000, anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Fortrans and what is it used for
• 2. Important information before using Fortrans
• 3. How to use Fortrans
• 4. Possible side effects
• 5. How to store Fortrans
• 6. Package contents and other information

1. What is Fortrans and what is it used for

Fortrans is used in adults to cleanse the intestine before an examination or surgical procedure in the intestine.
Fortrans is an osmotic laxative containing macrogol of high molecular weight (polyethylene glycol, PEG) and additional salts. Fortrans increases the amount of fluid in the intestine, causing more frequent bowel movements with a watery stool, which ultimately leads to cleansing of the intestines.

2. Important information before using Fortrans

When not to use Fortrans:

• if the patient is allergic to macrogol (PEG), anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe heart failure;
• if the patient is in a severe general condition, e.g., is dehydrated;
• if the patient is in an advanced stage of cancer or has another disease that leads to excessive fragility of the mucous membrane;
• if the patient has an acute phase of inflammatory bowel disease, including Crohn's disease and ulcerative colitis;
• if the patient has a perforation of the gastrointestinal tract wall or there is an increased risk of perforation of the gastrointestinal tract wall;
• if the patient has colitis or toxic colitis;
• if the patient has intestinal obstruction or suspected intestinal obstruction;
• if the patient has gastric emptying disorders (such as gastroparesis - slowed gastric emptying);
• in children and adolescents under 18 years of age.

Warnings and precautions

In elderly patients in poor general condition, the medicine should only be used under medical supervision.
This medicine contains macrogol. Allergic reactions (including rash, itching, and severe allergic reaction with sudden swelling of the face, lips, tongue, wheezing, or shortness of breath) have been reported after taking products containing macrogol.
Diarrhea caused by Fortrans may significantly disrupt the absorption of other medicines taken at the same time (see section "Fortrans and other medicines").
If the patient is at risk of changes in electrolyte levels (electrolyte imbalance), for example, in patients with renal failure, heart failure, or taking diuretics, the doctor may decide to monitor electrolyte levels in the blood before and after using the medicine. Caution should be exercised when using in patients with a tendency to develop electrolyte imbalance.
Before taking Fortrans, you should consult a doctor or pharmacist if:

• the patient has heart disease (including heart failure);
• the patient has kidney disease;
• the patient has a swallowing disorder or risk of aspiration (food or fluid entering the airways);
• the patient is bedridden;
• the patient is taking diuretics (medicines that increase urine production).

If during the use of Fortrans for intestinal cleansing, the patient experiences sudden abdominal pain or rectal bleeding, they should contact their doctor or seek medical help immediately.

Children and adolescents

Fortrans is not intended for use in patients under 18 years of age. The safety and efficacy of use in this group have not been established.

Fortrans and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Diarrhea caused by Fortrans may significantly disrupt the absorption of other medicines taken at the same time. The absorption of other medicines, such as digoxin (a medicine used for heart conditions), antiepileptic medicines, coumarins (blood-thinning medicines), and immunosuppressive medicines (used, for example, in the treatment of cancer and after organ transplants), may be temporarily reduced during use with Fortrans, which may reduce their effectiveness.

Pregnancy, breastfeeding, and fertility

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

Fortrans contains sodium and potassium

The medicine contains 2.890 g of sodium (the main component of common salt) in each sachet. This corresponds to 144.5% of the maximum recommended daily intake of sodium in the diet for adults.
This should be taken into account in patients on a strict low-sodium diet.
Fortrans contains 393 mg of potassium in one sachet, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to use Fortrans

Fortrans should always be used in accordance with the doctor's recommendations. In case of doubts, you should contact your doctor or pharmacist.
Fortrans is intended for use only in adults. The recommended dose is approximately one liter of solution per 15 to 20 kg of body weight, which corresponds to an average dose of 3 to 4 liters of solution.
To obtain one liter of solution, the contents of one sachet should be dissolved in one liter of water.
Mix until the powder is completely dissolved. After dissolving the powder, you should start taking the solution immediately. One liter of solution should be taken within one hour.
Fortrans can be administered:

• in divided doses:
• either 2 liters in the evening before the examination or procedure and 1-2 liters in the morning on the day of the examination or procedure;
• or 3 liters in the evening before the examination or procedure and 1 liter in the morning on the day of the examination or procedure;

in a single dose:

• 3-4 liters in the evening before the examination or procedure, with a possible 1-hour break after drinking 2 liters of solution.

According to the doctor's recommendation, you should drink one 250 ml glass of solution every 10 to 15 minutes.
It is recommended that the patient take the last part of the solution 3-4 hours before the examination or procedure.

Overdose of Fortrans

If you think you have taken too much of Fortrans, you should inform your doctor and drink enough water or clear fluids to prevent dehydration.

4. Possible side effects

After taking the medicine, frequent bowel movements with loose stools will occur. This is normal and indicates the effective action of the medicine. You should stay near a toilet until the effect of the medicine passes.
Like all medicines, Fortrans can cause side effects, although not everybody gets them.

In case of any of the following symptoms, you should stop using Fortrans and contact your doctor or the Emergency Department of the nearest hospital immediately. You should take the packaging of the medicine with you to inform the doctor which medicine you have taken:

the medicine that has been taken:

• Allergic reaction - symptoms may include skin rash, itching, or hives.
• Severe allergic reaction causing swelling of the face or throat (angioedema) or difficulty breathing or dizziness (anaphylactic reaction).

Other side effects include:

Very common (may affect more than 1 in 10 people)

• Nausea (nausea)
• Bloating or abdominal pain

Common (may affect up to 1 in 10 people)

• Vomiting

Frequency not known (cannot be estimated from the available data)

• Allergic reactions (including rash, hives, and severe allergic reaction with sudden swelling of the face, lips, tongue, wheezing, or shortness of breath)

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder or parallel importer.

5. How to store Fortrans

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fortrans contains

• The active substances of the medicine are macrogol 4000, anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride.
• The excipient is sodium saccharin.

What Fortrans looks like and what the pack contains

Fortrans is a powder for oral solution (73.69 g) in sachets made of paper/Aluminum/PE, in a cardboard box. It is available in cardboard boxes containing 4 sachets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Ipsen Consumer HealthCare, 65 Quai Georges Gorse, 92100 Boulogne-Billancourt, France

Manufacturer:

Beaufour Ipsen Industrie, Rue d’Ethé Virton, 28 100 Dreux, France

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warszawa
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Authorization number in Romania, the country of export:1992/2009/01

Parallel import authorization number: 49/22 Date of approval of the leaflet: 19.01.2022

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