Salofalk 500

Package leaflet: Information for the user

SALOFALK 500, 500 mg, enteric-coated tablets
Mesalazinum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Salofalk 500 is and what it is used for
2. What you need to know 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. Due to the enteric coating of the tablet, which is resistant to gastric juice, the drug acts locally in the area affected by inflammation.

Indications

• Ulcerative colitis – during exacerbation and for prevention of relapses;
• Crohn's disease – during exacerbation.

2. Important information before using Salofalk 500

When not to use 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 impairment of kidney or liver function.

Warnings and precautions
Before starting treatment, discuss 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 should be used only under medical supervision. If acute intolerance symptoms occur, such as cramps, acute abdominal pain, fever, severe headache, or rash, the drug must be discontinued immediately.
• If the patient has problems with the liver.
• If the patient has problems with the kidneys.
• If the patient has ever experienced the following after taking mesalazine: severe skin rash, skin peeling, blisters, or oral ulcers.

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If chest pain, shortness of breath, or swelling of the limbs occurs, 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 upon contact with sodium hypochlorite
bleach present in toilet water. This is due to a chemical reaction between mesalazine and bleach,
and is harmless.
Other precautions
Before and during treatment, blood tests (complete blood count with differential, liver function
parameters such as alanine aminotransferase or aspartate aminotransferase activity, serum
creatinine concentration) and urine tests (dipstick testing and urine sediment) will be performed,
depending on the treating physician's assessment. These tests are recommended after 14 days
from the start of treatment, then every 4 weeks for 2–3 times. If results are normal, tests should be
performed every three months. If additional disease symptoms occur, contact your doctor promptly
for appropriate evaluation.
Note:
In rare cases, in patients with resection of intestinal segments or surgery in the region of the ileocaecal
junction, including removal of the ileocaecal valve, tablets of Salofalk 500 have been excreted in the
faeces in undissolved form due to accelerated intestinal transit. If this phenomenon is observed,
consult your doctor.
Mesalazine use may lead to the formation of kidney stones. Symptoms may include flank pain and
haematuria. Adequate fluid intake is recommended during mesalazine treatment.
Serious 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. Mesalazine must be discontinued and immediate medical attention sought
if any of these severe skin reactions occur, as described in section 4.
If the patient experiences severe or recurrent headache, visual disturbances, or ringing or buzzing in
the ears, they should contact their doctor immediately.
Use of Salofalk 500 in children
There is limited experience and insufficient documentation regarding the efficacy and safety of
use in children.
Salofalk 500 and other medicines
Inform your doctor if the patient is taking or using any of the following medicines, as their effects
may be altered (interactions):

• azathioprine, 6-mercaptopurine, or thioguanine (medicines used in the treatment of immunological disorders);
• certain anticoagulant medicines (medicines used for thrombosis or blood thinning, e.g. warfarin).

Inform your doctor or pharmacist about any other medicines the patient is currently taking, including
those available without a prescription. This does not necessarily preclude the use of Salofalk 500
enteric-coated tablets, but will allow the doctor to make an appropriate treatment decision.
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Pregnancy and breastfeeding
Consult a doctor or pharmacist before using any medicine.
Salofalk 500 may be used during pregnancy only if approved by a doctor.
Salofalk 500 may be used during breastfeeding only if approved by a doctor, as the drug passes into
breast milk.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.
Salofalk 500 contains sodium.
The maximum recommended daily dose of this medicine contains 441 mg of sodium (a component of table salt).
This corresponds to 22% of the maximum recommended daily dietary intake for adults.
Patients taking 7 or more tablets per day over a prolonged period, especially those monitoring dietary sodium intake,
should consult their doctor or pharmacist.

3. How to use Salofalk 500

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist. If the doctor has not instructed otherwise, the medicine should be taken according
to the dosing regimen described below.
Salofalk 500 is used in the treatment of inflammatory bowel diseases (Crohn's disease,
ulcerative colitis).
Use in children
There is limited experience and limited documentation regarding the efficacy
and safety of use in children.
If a daily dose higher than 1.5 g of mesalazine 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 (aged 6 years and older)
Acute inflammatory conditions (applies to both indications):
Dosage should be individually determined, starting at 30–50 mg/kg body weight/day of mesalazine.
Maximum dosage: 75 mg/kg body weight/day of mesalazine. The total daily dose should not exceed
the maximum recommended dose for adults.
Long-term treatment (applies only to ulcerative colitis):
Dosage should be individually determined, starting at 15–30 mg/kg body weight/day.
The total daily dose should not exceed the maximum recommended dose for adults.
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For children with body weight up to 40 kg, the generally recommended dose may be half the adult dose.
In children with body weight above 40 kg, the normal adult dose may be used.

How and when to take Salofalk 500
Salofalk 500 should be taken 1 hour before meals, three times daily: in the morning, at noon, and in the evening. Tablets should be swallowed whole, without chewing, with a large amount of fluid.
For effective treatment, it is important that Salofalk 500 is taken regularly and consistently, both during treatment of acute inflammatory episodes and during long-term maintenance therapy.

How long to take Salofalk 500
The duration of treatment is determined by the physician, taking into account the type, severity, and course of the disease.
Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks.
For prevention of relapses of ulcerative colitis, the dose may usually be reduced to 1.5 g mesalazine per day (in adults and adolescents with body weight above 40 kg).

Taking more Salofalk 500 than recommended
If an excessive amount of Salofalk 500 tablets is taken at one time, the next dose should be taken at the usual time and in the usual amount, without reduction.
If in doubt, inform your doctor about the overdose so that appropriate decisions regarding further management can be made.

Missing a dose of Salofalk 500
Do not take a double dose to make up for a missed dose.
Continue treatment according to the previous instructions.
If the patient realizes shortly after the scheduled time that a dose was missed, the dose may be taken immediately. If the patient remembers the missed dose shortly before the next scheduled dose, the missed dose should not be taken; only the next scheduled dose should be taken.

Stopping treatment with Salofalk 500
Always inform your treating physician if you discontinue treatment with Salofalk 500 tablets on your own or stop treatment prematurely (e.g. due to adverse reactions).
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Salofalk 500 may cause adverse reactions, although they do not occur in everyone.
If any of the following symptoms occur in a patient after taking this medicine, contact a doctor immediately
and discontinue Salofalk treatment:

• General allergic reactions, such as skin rash, fever, joint pain and (or) breathing difficulties, or general inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• Significant deterioration in general health status, especially if accompanied by fever and (or) sore throat and oral cavity pain. 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 disturbances in other blood cells (e.g. platelets or red blood cells, causing aplastic anaemia or

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thrombocytopenia), and may cause symptoms which may include unexplained bleeding, purpuric spots or skin eruptions, anaemia (feeling of fatigue, weakness and pallor, especially of lips and nails). Blood tests may confirm whether the symptoms experienced by the patient are caused by the effect of this medicine on blood. These reactions are very rare.

• Severe skin rashes with red, flat, discoid or circular lesions on the trunk, often with blisters in their center, skin peeling, ulceration in the oral cavity, throat, nose, genital organs and eyes, extensive rash, fever and swollen lymph nodes. These may be preceded by fever and influenza-like symptoms. These reactions occur in an unknown number of patients (frequency unknown).
• Shortness of breath, chest pain or irregular heartbeat, or limb swelling, which may indicate hypersensitivity reactions affecting the heart. These reactions are rare.
• Kidney function problems (may occur very rarely), e.g. changes in color or amount of urine produced, limb swelling or sudden lower abdominal pain (caused by kidney stones) (occur in an unknown number of patients (frequency unknown)).
• Severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension) (frequency unknown [frequency cannot be estimated from available data]).

The following adverse drug reactions have been observed in patients treated with mesalazine:
Common adverse reactions (occurring in less than 1 in 10 patients)

• headache;
• rash, itching.

Uncommon adverse reactions (occurring in less than 1 in 100 patients)

• abdominal pain, diarrhoea, digestive disturbances, flatulence (bloating), nausea and vomiting;
• severe abdominal pain due to acute pancreatitis;
• changes in liver function parameters, changes in pancreatic enzyme activity.

Rare adverse reactions (occurring in less than 1 in 1,000 patients)

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

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

• numbness and tingling of hands and feet (peripheral neuropathy);
• dyspnoea, cough, wheezing, lung opacities on X-ray due to allergic or inflammatory lung reactions;
• hair loss and alopecia;
• muscle pain;
• reversible reduction in sperm count in semen.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
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Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Salofalk 500

Keep 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 stated month.
Store below 25°C.
Medicines must 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: sodium carbonate, glycine, povidone K25, microcrystalline cellulose, sodium carboxymethylcellulose, colloidal anhydrous silica, calcium stearate, hypromellose, macrogol 6000, eudragit L 100, talc, iron oxide yellow (E 172), eudragit E.

What Salofalk 500 looks like and contents of the pack
Salofalk 500 is an enteric-coated tablet packed in PVC/PVDC/aluminium foil blisters in a cardboard box. Each tablet contains 500 mg of mesalazine.
Pack sizes contain 50 and 100 tablets packed in blisters.
Each blister contains 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
DR. FALK PHARMA GmbH
Leinenweberstrasse 5
79108 Freiburg
Germany

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Ewopharma AG Sp. z o.o.
ul. Leszno 14
01-192 Warsaw
Tel. 22 620 11 71
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