Fortrans

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – the information on the outer packaging is in a foreign language!
Fortrans
powder for oral solution, in sachet
macrogol 4000, anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride
Please read carefully all the information in this leaflet before taking the 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, 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 someone else, 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 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 before an examination or intestinal surgical procedure.
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 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 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 gastrointestinal tract perforation or 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 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 and electrolyte balance), for example in patients with renal impairment, heart failure, or those taking diuretics, the doctor may decide to monitor blood electrolyte levels before and after administration of Fortrans. Caution should be exercised when using Fortrans in patients prone to disturbances in water and electrolyte balance.
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 experiences sudden abdominal pain or rectal bleeding, contact a doctor or seek immediate 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 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
The medicine contains 2.890 g 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 reduced kidney function and in patients monitoring potassium intake in their diet.

3. How to use Fortrans

Fortrans must always be used in accordance with the doctor's instructions. If in doubt, consult
your 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 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 doctor, 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.
Taking more than the recommended dose of Fortrans
If the patient believes they have taken too much Fortrans, inform the doctor and drink
an adequate amount of water or clear fluids to prevent dehydration.

4. Possible adverse effects

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 effects, although not everybody will experience them.
If any of the following symptoms occur, stop using
Fortrans and contact a doctor or the Emergency Department of the nearest hospital immediately.
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 breathing difficulties or dizziness (anaphylactic reaction). Other adverse effects 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Fortrans medicine
Keep the medicine out of the sight and reach of children.
No special storage conditions are required.
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 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 package and other information

What Fortrans contains

• The active substances in the medicine 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
Pouches Paper/Aluminium/PE in a cardboard box.

The pack contains 4 sachets of 73.69 g of powder.
For further information, please contact the marketing authorisation holder or 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’Ethe Virton
28 100 Dreux
France

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Number of marketing authorisation in Romania, country of export: 1992/2009/01
Number of parallel import authorisation: 256/22