Salofalk

Package Leaflet: Information for the User

SALOFALK, 4 g/60 ml, Rectal Suspension

Mesalazine

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What Salofalk is and what it is used for
• 2. Important information before using Salofalk
• 3. How to use Salofalk
• 4. Possible side effects
• 5. How to store Salofalk
• 6. Contents of the pack and other information

1. What Salofalk is and what it is used for

Salofalk contains the active substance mesalazine. Salofalk is a locally acting anti-inflammatory medicine used in inflammatory bowel diseases.
The rectal suspension Salofalk has a direct anti-inflammatory effect on the diseased connective tissue and mucous membrane of the colon.
The indication for use of Salofalk rectal suspension is the treatment of acute flare-ups of ulcerative colitis.

2. Important information before using Salofalk

When not to use Salofalk

• If you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin) or any of the other ingredients of this medicine (listed in section 6);
• If you have severe liver or kidney dysfunction.

Use of Salofalk in children

There is limited experience and documentation regarding the efficacy and safety of use in children.

Warnings and precautions

Before starting treatment with Salofalk, discuss with your doctor:

• If you have had lung problems, especially asthma.
• If you are sensitive to sulfasalazine, a substance similar to mesalazine, Salofalk should only be used under medical supervision. If acute intolerance symptoms occur, such as seizures, abdominal cramps, acute abdominal pain,

fever, severe headache, or rash, you should stop taking the medicine and consult a doctor immediately.
If you experience chest pain, shortness of breath, or swelling of the limbs, you should consult a doctor immediately, as these reactions may be caused by the effect of Salofalk on the heart.
Mesalazine may cause a reddish-brown discoloration of urine after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Other precautions

Before and during treatment with Salofalk, blood tests (blood count with smear, liver function parameters such as alanine or aspartate aminotransferase activity, serum creatinine concentration) and urine tests (dipstick tests and urine sediment) will be performed, depending on the doctor's assessment.
It is recommended to perform these tests 14 days after starting treatment, and then 2-3 times at 4-week intervals. If the results are normal, the tests should be performed every three months. If additional symptoms of the disease occur, you should immediately contact your doctor to perform the necessary tests.
Treatment with mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and hematuria. During treatment with mesalazine, you should drink an adequate amount of fluids.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with mesalazine treatment. You should stop taking mesalazine and seek medical attention immediately if you experience any symptoms of these severe skin reactions, listed in section 4.
If you experience severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears, you should consult a doctor immediately.

Salofalk and other medicines

Tell your doctor if you are taking or using any of the following medicines, as their effect may be altered (interactions):

• Azathioprine, 6-mercaptopurine, or thioguanine(medicines used to treat immune system disorders);
• Certain blood-thinning medicines(medicines used to treat blood clots or to thin the blood, e.g. warfarin).

Tell your doctor or pharmacist about all other medicines you have taken recently, including those obtained without a prescription. This does not necessarily mean that Salofalk rectal suspension cannot be used, but it will allow your doctor to make an informed decision about your treatment.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.
Salofalk may be used during pregnancy if your doctor allows it.
Salofalk may be used during breastfeeding only if your doctor allows it, as the medicine passes into the breast milk of a nursing mother.

Driving and using machines

The medicine has no effect on the ability to drive or use machines.

Salofalk rectal suspension contains potassium metabisulfite and sodium benzoate.

Potassium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains 60 mg of sodium benzoate in each Salofalk dose. Sodium benzoate may cause local irritation.

3. How to use Salofalk

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Usually, Salofalk rectal suspension should be taken according to the following instructions.
The contents of one bottle (60 ml suspension, equivalent to 4 g mesalazine) are introduced into the rectum as a rectal enema, once a day, in the evening before bedtime.
How and when to take Salofalk rectal suspension
The best treatment results are achieved when Salofalk rectal suspension is used immediately after previous bowel emptying.
The desired treatment result can only be achieved if Salofalk rectal suspension is administered regularly and consistently.
Before use, shake the bottle contents vigorously for at least 30 seconds to make the solution homogeneous. Then remove the protective cap. Hold the container upright to avoid spilling the contents. Then lie on your left side with your left leg straight and your right leg bent to maintain balance. Then carefully insert the applicator tip (which is coated with a thin layer of lubricant) into the rectum, directing the bottle towards the navel. Then, holding the bottle firmly, turn it so that the tip is directed towards the back. Now gently and slowly press the bottle to prevent defecation reflex. After administering the entire contents, remove the empty bottle.
After administering Salofalk rectal suspension, remain lying on your left side for at least 30 minutes to allow the medicine to spread evenly throughout the colon.
The best treatment result is achieved when Salofalk can act throughout the night.
How long to take Salofalk rectal suspension
The duration of treatment depends on the type, severity, and course of the disease.
After this period, Salofalk rectal suspension should not be used as a rule. The duration of treatment is decided by your doctor.

Use in children

There is limited experience and documentation regarding the efficacy and safety of use in children.

Using more than the recommended dose of Salofalk

If you have taken more than the recommended dose of Salofalk, consult your doctor so that they can decide on the further course of action.
In case you have taken more than the recommended dose, consult your doctor.

Missing a dose of Salofalk

Do not take a double dose to make up for a missed dose, but continue treatment as before.
If you realize you have missed a dose in a short time, you can take it immediately. If you remember about the missed dose just before the time of the next dose, do not take the missed dose, just take the next scheduled dose.

Stopping treatment with Salofalk

Always, in case of a decision to stop treatment with Salofalk or premature termination (e.g. due to side effects), inform your doctor.

4. Possible side effects

Like all medicines, Salofalk can cause side effects, although not everybody gets them.

If you experience any of the following symptoms after taking this medicine, contact your doctor immediately and stop taking Salofalk:

• General allergic reactions, such as skin rash, fever, joint pain, and (or) difficulty breathing or general colitis (causing severe diarrhea and abdominal pain). These reactions are very rare.
• Significant deterioration of general health, especially if accompanied by fever and (or) sore throat and mouth. In very rare cases, these symptoms may be caused by a reduced white blood cell count, resulting in an increased susceptibility to severe infections (agranulocytosis). It may also lead to disorders affecting other blood cells (e.g. platelets or red blood cells, causing aplastic anemia or thrombocytopenia) and may cause symptoms that may include unexplained bleeding, purpura, or rash under the skin, anemia (feeling tired, weak, and pale, especially lips and fingernails). Blood tests can confirm whether the symptoms you are experiencing are due to the effect of this medicine on the blood. These reactions are very rare.
• Severe skin rasheswith reddened flat, plate-like, or round patches on the torso, often with blisters in their center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and swollen lymph nodes. It may be preceded by fever and flu-like symptoms. The frequency of these reactions is unknown.
• Shortness of breath, chest pain, or irregular heartbeat, or swelling of the limbs, which may indicate heart-related hypersensitivity reactions. These reactions are rare.
• Kidney problems(may occur very rarely), such as changes in urine color or amount, and swelling of the limbs or sudden abdominal pain (caused by kidney stones) (the frequency of these reactions is unknown).
• Severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension) (the frequency of these reactions is unknown).

Patients taking mesalazine have reported the following adverse reactions:
Common(less than 1 in 10 patients)

• rash, itching.

Rare(less than 1 in 1000 patients)

• abdominal pain, diarrhea, gas, nausea, and vomiting;
• headache, dizziness;
• increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity).

Very rare(less than 1 in 10,000 patients)

• severe abdominal pain due to acute pancreatitis;
• pallor and general weakness due to reduced red blood cell count (anemia);
• petechiae and bleeding due to reduced platelet count;
• shortness of breath, cough, wheezing, and lung shadowing on X-ray due to allergic or inflammatory lung reaction;
• muscle and joint pain;
• jaundice or abdominal pain due to liver dysfunction or bile flow disorders;
• hair loss and alopecia;
• numbness and tingling of hands and feet (peripheral neuropathy);
• reversible reduction in sperm count in semen.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salofalk

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Store in the original package to protect from light.
Take the medicine out of the blister pack immediately before use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Salofalk contains

• The active substance of Salofalk is mesalazine.
• The other ingredients are: sodium benzoate (E 211), potassium metabisulfite (E 224, max. 0.28 g, equivalent to max. 0.16 g sulfur dioxide), disodium edetate, carbomer, potassium acetate, xanthan gum, purified water.

The rectal suspension Salofalk contains the active substance mesalazine (i.e. 5-aminosalicylic acid) in a quantity of 4 g in 60 ml suspension in a bottle.
Round, white low-density polyethylene (LDPE) bottles with green protective caps, in two PVC/paper blisters in a carton.
Pack size: 7 bottles of 60 ml rectal suspension.

Marketing authorization holder, manufacturer, and importer

DR. FALK PHARMA GmbH
Leinenweberstrasse 5
79108 Freiburg
GermanyEwopharma AG Sp. z o.o.
ul. Leszno 14
01-192 Warsaw
Tel. 22 620 11 71

Date of last revision of the leaflet: 01/2025