Fortrans

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Fortrans
powder for oral solution
macrogol 4000, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Fortrans is and what it is 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 Fortrans is and what it is used for

Fortrans is used in adults to cleanse the bowel prior to 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 leading to bowel cleansing.

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 causing excessive fragility of the mucosal lining;
• if the patient has an acute phase of inflammatory bowel disease, including Crohn's disease and ulcerative colitis;
• if the patient has 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 disorders of gastric emptying (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 health only under medical supervision.
This medicine contains macrogol. Allergic reactions (including rash, urticaria, and severe allergic reactions with sudden swelling of the face, lips, tongue, wheezing or shortness of breath) 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 and other medicines").
If the patient is at risk of electrolyte imbalance (disturbances in water-electrolyte balance), for example patients with renal impairment, 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 disturbances.
Consult a doctor or pharmacist before taking Fortrans 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 liquid entering the airways);
• 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 experiences sudden abdominal pain or rectal bleeding, contact a doctor immediately or seek urgent medical attention.
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 and other medicines
Inform your doctor or pharmacist about all medicines currently or 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 (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 transiently reduced during treatment with Fortrans, which may reduce their effectiveness.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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 g of sodium (the main component of table salt) per sachet. This corresponds to 144.5% of the maximum recommended daily sodium intake in the adult diet.
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 considered in patients with reduced kidney function and in patients monitoring dietary potassium intake.

3. How to use Fortrans

Fortrans should always be used according to the doctor's instructions. 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 an average dosage of 3 to 4 litres of solution.
To obtain one litre of solution, the contents of one sachet should be dissolved in one litre of water. Mix thoroughly until the powder is completely dissolved. After dissolving the powder, administration of the solution should begin immediately. One litre of solution should be taken 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 1-hour break after drinking 2 litres of solution.

As directed by the physician, the patient should drink one 250 ml glass of solution every 10 to 15 minutes.
It is recommended that the patient take the last portion of the solution 3–4 hours before the examination or procedure.
Accidental overdose of Fortrans
If the patient believes they have taken an excessive dose of Fortrans, they should inform their doctor 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 stay close to a toilet until the effect of the medicine subsides.
Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
If any of the following symptoms occur, stop using
Fortrans and contact your doctor or the Emergency Department of the nearest hospital immediately.
Take the medicine package 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 breathing difficulties 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 shortness of breath).

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

5. How to store Fortrans
The medicine should be stored in a place out of sight and reach of children.
No special storage instructions apply.
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 should not be disposed of via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Fortrans contains

• The active substances in this medicine are: macrogol 4000, sodium sulfate anhydrous, sodium hydrogen carbonate, sodium chloride, potassium chloride.
• The excipient is sodium saccharin.

What Fortrans looks like and contents of the pack
One sachet contains 73.69 g of powder for oral solution.
The pack contains: 4 sachets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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, 28 100 Dreux, France
Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Romania, the country of export: 1992/2009/01
Parallel import licence number: 110/16