Salofalk 500

Leaflet attached to the packaging: information for the user

SALOFALK 500 500 mg, enteric-coated tablets
Mesalazine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Salofalk 500 is and what it is used for
• 2. Important information before taking Salofalk 500
• 3. How to take 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. Thanks to the enteric coating of the tablet, which is insoluble in gastric juice, the medicine acts locally in the area affected by the inflammatory process.
Indications for use

• ulcerative colitis - in the exacerbation phase and to prevent relapses of the disease;
• Crohn's disease - in the exacerbation phase.

2. Important information before taking Salofalk 500

When not to take Salofalk 500

• If the patient is 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 the patient has severe kidney or liver dysfunction.

Warnings and precautions

Before starting treatment with the medicine, you should discuss it with your doctor or pharmacist:

• If the patient has had lung problems, especially bronchial asthma.
• If the patient is hypersensitive to sulfasalazine, a substance similar to mesalazine, Salofalk 500 may 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 the patient has liver problems.
• If the patient has kidney problems.
• If the patient has ever experienced skin rash of severe intensity or peeling of the skin, blisters, or ulcers in the mouth after taking mesalazine.

If chest pain, shortness of breath, or swelling of the limbs occurs, you should immediately consult a doctor, 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.
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Other precautions

Before and during treatment with the medicine, depending on the doctor's assessment, 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. It is recommended to perform these tests after 14 days from the start of treatment, and then 2-3 times at 4-week intervals. If the results are normal, the tests should be performed every three months. In case of additional symptoms of the disease, you should immediately contact a doctor to perform the necessary tests.
Note:
In rare cases, in patients with a removed section of the intestine or after surgery in the area of the transition of the small intestine to the large intestine, with the removal of the ileocecal valve, due to accelerated transport through the intestine, Salofalk 500 tablets were excreted in the stool in an undissolved form. If this phenomenon is observed, you should consult a doctor.
Taking 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 headaches, 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 using Salofalk 500 in children.

Salofalk 500 and other medicines

You should tell your doctor if you are taking or using any of the following medicines, as their effect may change (interactions):

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

You should tell your doctor or pharmacist about all other medicines you have taken recently, including those that are available without a prescription. This does not necessarily mean that Salofalk 500 cannot be used, but it will allow the doctor to make an informed decision about your treatment.
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Pregnancy and breastfeeding

Before taking any medicine, you should consult a doctor or pharmacist.
Salofalk 500 may be used during pregnancy if the doctor allows it.
Salofalk 500 may be used during breastfeeding only if the doctor allows it, as the medicine passes into the breast milk of a nursing mother.

Driving and using machines

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

Salofalk 500 contains sodium.

The maximum recommended daily dose of this medicine contains 441 mg of sodium (a component of common salt).
This corresponds to 22% of the maximum recommended daily intake in the diet for adults.
If you take 7 or more tablets per day for a long time, you, especially those controlling sodium intake in their diet, should consult a doctor or pharmacist.

3. How to take Salofalk 500

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist. If the doctor does not recommend otherwise, the medicine should be taken according to the dosage schedule below.
Salofalk 500 is used to treat inflammatory bowel diseases (Crohn's disease, ulcerative colitis).

Using Salofalk 500 in children

There is limited experience and documentation regarding the efficacy and safety of using Salofalk 500 in children.
If a dose greater than 1.5 g of mesalazine per day is recommended, Salofalk 500 should be used.

Dosage in adults

Depending on the type and severity of the disease, the following daily doses of mesalazine are recommended:

Dosage in children (6 years and older)

Acute inflammatory conditions (for both indications):
The dose should be determined individually, starting from 30-50 mg/kg body weight per day of mesalazine.
The maximum dose: 75 mg/kg body weight per day of mesalazine. The total dose should not exceed the maximum recommended dose for adults.
Long-term treatment (only for ulcerative colitis):
The dose should be determined individually, starting from 15-30 mg/kg body weight per day.
The total dose should not exceed the maximum recommended dose for adults.
Children with a body weight of up to 40 kg may generally be recommended half the dose used in adults. In children with a body weight over 40 kg, the dose normally recommended for adults may be used.
How and when to take Salofalk 500
Salofalk 500 should be taken 1 hour before a meal, three times a day: in the morning, at noon, and in the evening. The tablets should be swallowed whole, without chewing, with a large amount of fluid.
To make the treatment effective, it is essential to use Salofalk 500 regularly and consistently, both during the treatment of acute inflammatory conditions and long-term treatment.
How long to take Salofalk 500
The doctor determines the duration of treatment, taking into account the type, severity, and course of the disease.
Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks.
In the prevention of relapses of ulcerative colitis, the dose can usually be reduced to 1.5 g of mesalazine per day (adults and adolescents with a body weight over 40 kg).

Taking a higher dose of Salofalk 500 than recommended

In case of taking too many Salofalk 500 tablets at once, the next dose should be taken normally, without reducing it.
If you have any further doubts, you should inform your doctor about the overdose, so that they can decide on further action.

Missing a dose of Salofalk 500

You should not take a double dose to make up for a missed dose.
You should continue treatment according to the previous recommendations.
If you realize you have missed a dose shortly after, you can take it immediately. If you remember about the missed dose just before the time of taking the next dose, you should not take the missed dose, but only the dose that is due.

Stopping treatment with Salofalk 500

You should always inform your doctor about stopping treatment with Salofalk 500 tablets or ending it prematurely (e.g. due to side effects).
If you have any further doubts about using this medicine, you should consult a 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, you should immediately contact your doctor and stop taking Salofalk 500:

• 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) throat and mouth pain. In very rare cases, these symptoms may be caused by a reduced number of white blood cells, resulting in an increased susceptibility to severe infections (agranulocytosis). It may also lead to disorders of other blood cells (e.g. platelets or red blood cells, causing aplastic anemia or

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thrombocytopenia) and may cause symptoms that may include unexplained bleeding, purpura, or petechiae under the skin, anemia (feeling tired, weak, and pale, especially of the lips and nails). A blood test can confirm whether the symptoms occurring in the patient are due to the effect of the 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, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and swollen lymph nodes. This may be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of patients (frequency not known).
• Shortness of breath, chest pain, or irregular heartbeat, or swelling of the limbs, which may indicate heart 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 a kidney stone) (occurring in an unknown number of patients (frequency not known)).
• Severe or recurrent headaches, vision disturbances, or ringing or buzzing in the ears.These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension) (frequency not known [frequency cannot be estimated from the available data]).

Patients taking mesalazine have reported the following side effects:
Common side effects(occurring in less than 1 in 10 patients)

• headache;
• rash, itching.

Uncommon side effects(occurring in less than 1 in 100 patients)

• abdominal pain, diarrhea, digestive disorders, gas, nausea, and vomiting;
• severe abdominal pain due to acute pancreatitis;
• changes in liver function parameters, changes in pancreatic enzyme activity;

Rare side effects(occurring in less than 1 in 1,000 patients)

• dizziness;
• jaundice or abdominal pain due to liver function disorders or abnormal bile flow;
• increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity);
• joint pain;
• feeling of weakness or fatigue.

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

• numbness and tingling of hands and feet (peripheral neuropathy);
• shortness of breath, cough, wheezing, lung shadowing on the X-ray due to an allergic or inflammatory reaction of the lungs;
• hair loss and alopecia;
• muscle pain;
• reversible decrease in sperm count in semen.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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
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Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Salofalk 500

Store in a place out of 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 at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should 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 500 contains

• The active substance of the medicine is mesalazine.
• The other ingredients are: sodium carbonate, glycine, povidone K25, microcrystalline cellulose, sodium carboxymethylcellulose, colloidal silica, calcium stearate, hypromellose, macrogol 6000, eudragit L 100, talc, titanium dioxide (E 171), yellow iron oxide (E 172), eudragit E.

What Salofalk 500 looks like and contents of the pack

Salofalk 500 are enteric-coated tablets packaged in PVC/PVDC/aluminum blisters in a cardboard box. One tablet contains 500 mg of mesalazine.
Packaging contains 50 and 100 tablets packaged in blisters.
Each blister contains 10 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: 01/2025

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