Fortrans

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Fortrans, Powder for Oral Solution, in Sachet

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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Fortrans and what is it used for
• 2. Important information before taking Fortrans
• 3. How to take Fortrans
• 4. Possible side effects
• 5. How to store Fortrans
• 6. Contents of the pack 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 area.
Fortrans is an osmotic laxative containing macrogol with a 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 content, which leads to the cleansing of the intestines.

2. Important information before taking Fortrans

When not to take 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 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 be used only under medical supervision.
This medicine contains macrogol. Allergic reactions (including rash, hives, 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 taking 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 (water and electrolyte imbalance), for example, in patients with kidney failure, heart failure, or taking diuretics, the doctor may decide to monitor electrolyte levels in the blood before and after taking the medicine. Caution should be exercised in patients with a tendency to water and electrolyte imbalance.
Before taking Fortrans, consult a doctor or pharmacist if:

• the patient has heart disease (including heart failure);
• the patient has kidney disease;
• the patient has swallowing disorders 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 intake of Fortrans for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, they should contact their doctor or seek medical attention immediately.

Children and adolescents

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

Fortrans and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Diarrhea caused by taking Fortrans may cause significant disruption to the absorption of other medicines. 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 cancer treatment and after organ transplants), may be temporarily reduced when taken with Fortrans, which may reduce their effectiveness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Fortrans contains sodium and potassium

The medicine contains 2.890 g of sodium (the main component of table 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 patients controlling potassium intake in their diet.

3. How to take Fortrans

Always take Fortrans exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Fortrans is intended for use in adults only. 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 prepare 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, 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 surgery and 1-2 liters in the morning of the examination or surgery;
• or 3 liters in the evening before the examination or surgery and 1 liter in the morning of the examination or surgery;

in a single dose:

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

According to the doctor's recommendation, 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 surgery.

Overdose of Fortrans

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

4. Possible side effects

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

If you experience any of the following symptoms, stop taking Fortrans and contact your doctor or the Emergency Department of the nearest hospital immediately. Take the package leaflet with you to inform the doctor which medicine you have taken:

the medicine taken:

• Allergic reaction - symptoms may include skin rash, itchy swelling of the skin (hives), or itching.
• 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 (feeling sick).
• 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, tell your doctor, pharmacist, or nurse. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fortrans

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

6. Contents of the pack and other information

What Fortrans contains

• -The active substances of Fortrans are macrogol 4000, anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride.
• The excipient is: sodium saccharin.

What Fortrans looks like and contents of the pack

The sachet contains 73.69 g of powder.
The pack contains: 4 sachets.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

IPSEN CONSUMER HEALTHCARE
65, quai Georges Gorse
92650 Boulogne Billancourt Cedex
France

Manufacturer:

Beaufour Ipsen Industrie
Rue d’Ethe Virton
28100 Dreux
France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 1992/2009/01

Parallel import authorization number: 42/19

Date of leaflet approval: 25.01.2024

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