FORTRANS

Patient Information Leaflet

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

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

Table of contents:

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

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 serious general condition, e.g. is dehydrated;
• if the patient has advanced stage cancer or another disease causing 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 gastrointestinal tract perforation or there is an increased risk of gastrointestinal tract 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 health 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 shortness of breath) have been reported after taking products containing macrogol.
Diarrhea caused by taking Fortrans may significantly impair the absorption of concomitantly administered medicines (see section: "Fortrans and other medicines").
If the patient is at risk of electrolyte imbalances (disturbances in water and electrolyte balance), for example patients with kidney failure, heart failure, or those taking diuretics, the doctor may decide to monitor blood electrolyte levels before and after administration of Fortrans. Caution is advised when using in patients prone to water and 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 (food or fluid 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 develops sudden abdominal pain or rectal bleeding, contact a doctor immediately or seek urgent medical help.
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 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 may 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 g of sodium (main component of table salt) in each 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 monitoring dietary potassium intake.

3. How to use Fortrans

Fortrans must always be used as directed by the physician. In case of doubt, contact 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 until the powder is completely dissolved. After dissolving the powder, administration of the solution should begin promptly. 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, 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 to 4 hours before the examination or procedure.
Taking more Fortrans than recommended
If the patient believes they have taken too much 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.
As with any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, you must stop using
the Fortrans medicine and immediately contact your doctor or the Emergency Department of the
nearest hospital. You should bring the medicine package with you to 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 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, pharmacist, or nurse. Adverse reactions can also 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Fortrans

The medicine should be stored in a place inaccessible and out of sight of children.
There are no special storage instructions.
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 in use. 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
Each sachet contains: 74 g of powder for oral solution.
Pack contains: 4 sachets.
For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Greece, country of export:
Ipsen Consumer HealthCare
65, Quai Georges Gorse
92100 Boulogne Billancourt
France
Manufacturer:
Beaufour Ipsen Industrie
20 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Greece, country of export: 30629/10-5-2010
Parallel import authorisation number: 603/15