Package leaflet: Information for the patient

WARNING: Keep the leaflet. The information on the immediate packaging is in a foreign language.
Fortrans, powder for oral solution in a sachet
macrogol 4000, anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Fortrans is and what it is used for
Important information before taking Fortrans
How to take Fortrans
Possible side effects
How to store Fortrans
Contents of the pack and other information

1. What Fortrans is and what it is used for

Fortrans is used in adults to cleanse the bowel before an examination or surgical procedure involving the intestine.
Fortrans is an osmotic laxative containing high molecular weight macrogol (polyethylene glycol, PEG) and additional salts. Fortrans increases the amount of fluid in the intestine, resulting in more frequent watery bowel movements, thereby cleansing the bowel.

2. 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 has advanced stage cancer or another disease leading 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 wall or there is an increased risk of gastrointestinal wall perforation;
if the patient has colitis or toxic megacolon;
if the patient has intestinal obstruction or suspected intestinal obstruction;
if the patient has gastric emptying disorders (such as gastroparesis – delayed gastric emptying);
in children and adolescents under 18 years of age.

Warnings and precautions
Fortrans should be used in elderly patients with poor general condition only under medical supervision.
This medicine contains macrogol. Allergic reactions (including rash, urticaria, and severe allergic reaction with sudden swelling of the face, lips, tongue, wheezing or breathing difficulties) have been reported after administration of products containing macrogol.
Diarrhea induced by Fortrans may significantly impair the absorption of concomitantly administered medicines (see section "Fortrans with other medicines").
If the patient is at risk of electrolyte imbalance (disturbances in water-electrolyte balance), for example in patients with renal failure, heart failure, or those taking diuretics, the physician may decide to monitor blood electrolyte levels before and after administration of Fortrans. Caution is advised when using Fortrans in patients prone to water-electrolyte imbalances.
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 (entry of food or fluid into the respiratory tract);
the patient is seriously ill;
the patient is taking diuretics (medicines that increase urine production).

If, during administration of Fortrans for bowel cleansing, the patient develops sudden abdominal pain or rectal bleeding, contact a doctor or seek immediate medical assistance.

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 population.

Fortrans with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Diarrhea resulting from the use of Fortrans may cause significant disturbances in the absorption of concomitantly administered medicines. The absorption of other medicines, such as digoxin (a medicine used in heart conditions), antiepileptic drugs, coumarins (blood-thinning medicines), and immunosuppressive medicines (used, for example, in cancer treatment and after organ transplantation) may be temporarily reduced during treatment with Fortrans, which could reduce their effectiveness.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Fortrans contains sodium and potassium
Fortrans contains 2,890 mg of sodium (main component of table salt) per sachet. This corresponds to 144.5% of the maximum recommended daily dietary sodium intake for adults.
This should be taken into account in patients on a strict low-sodium diet.
Fortrans contains 393 mg of potassium per sachet, which should be taken into account in patients with impaired kidney function and in patients controlling potassium intake in their diet.

3. How to use Fortrans

Fortrans should always be used exactly as recommended by the doctor. If in doubt, consult a doctor or pharmacist.
Fortrans is intended for use in adults only. The recommended dose is approximately one litre of solution per 15 to 20 kg of body weight, corresponding to a total dosage of 3 to 4 litres of solution.
To prepare one litre of solution, dissolve the contents of one sachet in one litre of water. Mix thoroughly until the powder is completely dissolved. Once the powder is dissolved, administration of the solution should begin immediately. One litre of solution should be consumed within one hour.
Fortrans may be administered:
in divided doses:

either 2 litres in the evening on the day before the examination or procedure and 1–2 litres in the morning on the day of the examination or procedure;
or 3 litres in the evening on the day before the examination or procedure and 1 litre in the morning on the day of the examination or procedure;

in a single dose:

3–4 litres in the evening on the day before the examination or procedure, with a possible one-hour break after drinking 2 litres of solution.

As directed by the physician, drink one 250 ml glass of solution every 10 to 15 minutes.
It is recommended that the patient consume the last portion of the solution 3 to 4 hours before the examination or procedure.
Accidental overdose of Fortrans
If the patient suspects having taken an excessive dose of Fortrans, inform the doctor immediately and drink sufficient water or clear fluids to prevent dehydration.

4. Possible adverse reactions

After taking the medicine, frequent passage of loose stools will occur. This is normal and indicates effective action of the medicine. You should remain near a toilet until the effect of the medicine subsides.
Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
If any of the following symptoms occur, stop using Fortrans immediately and contact a doctor or the Emergency Department of the nearest hospital without delay. Take the medicine packaging with you so that you can inform the doctor which medicine has been taken:

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

Other adverse reactions include:
Very common (may affect more than 1 in 10 people)

Nausea
Abdominal 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, urticaria, and severe allergic reaction with sudden swelling of the face, lips, tongue, wheezing or breathing difficulty)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.

5. How to store Fortrans

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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. Package contents and other information

What Fortrans contains

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

What Fortrans looks like and contents of the pack
Fortrans is a powder for oral solution (73.69 g) in sachets made of paper/aluminium/PE foil,
packaged in a cardboard box. It is available in cardboard boxes containing 4 sachets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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 in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Marketing authorisation number in Romania, country of export: 1992/2009/01
Parallel import authorisation number: 49/22