Salofalk 500

Package Leaflet: Information for the User

SALOFALK 500, 500 mg, suppositories

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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What Salofalk 500 is and what it is used for
• 2. Important information before using Salofalk 500
• 3. How to use Salofalk 500
• 4. Possible side effects
• 5. How to store Salofalk 500
• 6. Contents of the pack and other information

1. What Salofalk 500 is and what it is used for

Salofalk 500 contains 500 mg of mesalazine as the active substance. It belongs to a group of medicines called anti-inflammatory drugs.
After rectal administration, mesalazine acts mainly locally on the mucous membrane and submucous tissue of the intestine.
Indications for use
Ulcerative proctitis - during exacerbation.

2. Important information before using Salofalk 500

When not to use Salofalk 500

• 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 kidney or liver dysfunction.

Warnings and precautions

Before starting treatment with Salofalk 500, discuss with your doctor:

• If you have had lung problems, especially bronchial asthma.
• If you are hypersensitive to sulfasalazine, a substance similar to mesalazine, Salofalk 500 can only be used under medical supervision. If acute intolerance symptoms occur, such as cramps, severe abdominal pain, fever, severe headaches, or rash, the medicine should be discontinued immediately.
• If you have liver problems.
• If you have kidney problems.
• If you have ever experienced skin rash of severe intensity or peeling of the skin, blisters, or ulcers in the mouth after using mesalazine.

If you experience chest pain, shortness of breath, or swelling of the limbs, you should immediately consult a doctor, as these reactions may be caused by the effect of Salofalk 500 on the heart.
Mesalazine may cause 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 500, blood tests (morphology with smear, liver function parameters, such as alanine or aspartate aminotransferase activity, serum creatinine concentration) and urine tests (strip 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.
Mesalazine treatment may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and hematuria. During mesalazine treatment, 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 discontinue 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 immediately consult a doctor.

Using Salofalk 500 in children

There is limited experience and documentation regarding the efficacy and safety of Salofalk 500 in children.

Salofalk 500 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 thinners(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 500 suppositories cannot be used, but it will allow your doctor to make an informed decision about your treatment.

Pregnancy and breastfeeding

Before using any medicine, consult your doctor or pharmacist.
Salofalk 500 can be used during pregnancy if your doctor allows it.
Salofalk 500 can be used during breastfeeding only if your doctor allows it, as the medicine passes into breast milk.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Salofalk 500 contains cetyl alcohol.

The medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Salofalk 500

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. If your doctor has not prescribed otherwise, use the medicine according to the dosage schedule below.
Acute conditions of ulcerative proctitis:
Depending on the clinical needs, one Salofalk 500 mg suppository (corresponding to 1500 mg of mesalazine per day) is inserted into the rectum three times a day.
How and when to use Salofalk 500
Salofalk 500 suppositories are inserted through the anus. With a three-times-daily dosage schedule, use them in the morning, at noon, and in the evening.
For the treatment to be effective, it is essential to use Salofalk 500 suppositories regularly and consistently, as this is the only way to achieve effective healing.
How long to use Salofalk 500
Your doctor will determine the duration of treatment, taking into account the type, severity, and course of the disease.

Using Salofalk 500 in children

There is limited experience and documentation regarding the efficacy and safety of Salofalk 500 in children.

Using more than the recommended dose of Salofalk 500

In case of accidental ingestion of a larger dose of Salofalk 500 suppositories, take the next dose as usual, without reducing it.
If you have any further questions, inform your doctor about the overdose, so they can decide on further action.

Missing a dose of Salofalk 500

Do not take a double dose to make up for a missed dose.
Continue treatment as previously advised.
If you realize you have missed a dose soon after the missed dose, you can take it immediately. If you remember a missed dose just before the time of the next dose, do not take the missed dose, only take the dose that is due.

Stopping treatment with Salofalk 500

Always inform your doctor about stopping treatment with Salofalk 500 suppositories or ending it prematurely (e.g., due to side effects).
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Salofalk 500 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 500:

• General allergic reactions, such as skin rash, fever, joint pain, and (or) breathing difficulties 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 number of white blood cells, resulting in 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, 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 circular patches on the torso, often with blisters, peeling of the skin, 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 cardiac 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) (frequency 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) (frequency unknown).

The following side effects have been reported in patients taking mesalazine:
Common(less than 1 in 10 patients)

• skin 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;
• pale skin and general weakness due to reduced red blood cell count (anemia);
• bruising and bleeding due to reduced platelet count;
• shortness of breath, cough, wheezing, lung shadowing on X-ray due to allergic or inflammatory lung reaction;

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędowy Rejestr Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 500

Keep this 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.
Store in a temperature below 25°C. Protect from light.
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 pack and other information

What Salofalk 500 contains

• The active substance is mesalazine.
• The other ingredients are: solid fat, cetyl alcohol, sodium docuzate.

What Salofalk 500 looks like and contents of the pack

Salofalk 500 is a suppository packed in PVC/LDPE blisters in a cardboard box.
1 suppository contains 500 mg of mesalazine.
Pack sizes: 10, 30 suppositories.
Not all pack sizes may be marketed.

Marketing authorization holder, manufacturer, and importer

DR. FALK PHARMA GmbH, Leinenweberstrasse 5, 79108 Freiburg, Germany. For more detailed information, please contact the representative of the marketing authorization holder in Poland: Ewopharma AG Sp. z o.o., ul. Leszno 14, 01-192 Warsaw, Tel. 22 620 11 71.

Date of last revision of the package leaflet: 01/2025