Salofalk

Package Leaflet: Information for the User

Salofalk, 1.5 g, Prolonged-Release Granules

Mesalazine

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

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

Table of Contents of the Leaflet

• 1. What Salofalk is and what it is used for
• 2. Important information before taking Salofalk
• 3. How to take 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, 1.5 g in the form of prolonged-release granules, contains the active substance mesalazine, which has anti-inflammatory properties and is used to treat inflammatory bowel disease. Salofalk, 1.5 g in the form of prolonged-release granules is used for:

• treatment of acute episodes and prevention of further episodes (relapses) of mild to moderate ulcerative colitis, a type of inflammatory bowel disease (colon).

2. Important information before taking Salofalk

When not to take 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 disease.

Warnings and precautions

Before starting treatment with Salofalk, discuss with your doctor:

• if you have had problems with your lungs in the past, especially if you have had bronchial asthma,
• if you have had an allergy to sulfasalazine, a substance related to mesalazine,
• if you have liver function disorders,
• if you have kidney function disorders,
• if you have ever experienced severe skin rash or exfoliative dermatitis after taking mesalazine.

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

During treatment, your doctor may decide to monitor you closely, including regular blood and urine tests. Taking mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. While taking mesalazine, you should drink plenty 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.

Salofalk and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This is especially important for:

• 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),
• lactulose (a medicine used to treat constipation) or other medicines that may change the acidity of the stool.

Tell your doctor or pharmacist about all other medicines you are taking, including those that are available without a prescription. This does not necessarily mean that you cannot take Salofalk, but it will allow your doctor to make an informed decision about your treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Salofalk can be taken during pregnancy only on the advice of a doctor. During breastfeeding, Salofalk can be taken only if your doctor advises you to do so, as the medicine may pass into breast milk.

Driving and using machines

Salofalk has no or negligible influence on the ability to drive and use machines.

Salofalk contains aspartame, sucrose, and sodium.

The medicine contains 3 mg of aspartame in each sachet of Salofalk. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination. If you have been previously diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is essentially sodium-free.

3. How to take Salofalk

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Salofalk in the form of prolonged-release granules can only be taken orally. The granules must not be chewed. Place the granules directly on the tongue and then swallow, washing them down with a large amount of liquid, without chewing.

Dosage

Age and body weight Single dose Total daily dose

Adults, elderly, and children over 40 kg

Treatment of acute episodes up to 2 sachets of Salofalk, 1.5 g 1 x 1-2 sachets Prevention of further episodes 2 sachets of Salofalk, 1.5 g 1 x 2 sachets (in patients with increased risk of relapse)

Adults and elderly

If your doctor does not prescribe a different dosage, the usual dose for the treatment of acute episodes of ulcerative colitis is: 1-2 sachets of Salofalk, 1.5 g in the form of prolonged-release granules once a day, preferably in the morning (equivalent to 1.5-3 g of mesalazine per day), depending on the individual clinical needs of the patient.

Prevention of relapses of ulcerative colitis

The usual dose to prevent relapses of ulcerative colitis is: 500 mg of mesalazine 3 times a day (equivalent to 1.5 g of mesalazine per day). If your doctor considers that there is a higher risk of relapse, the dose used to prevent further episodes of ulcerative colitis is: 2 sachets of Salofalk, 1.5 g in the form of prolonged-release granules once a day, preferably in the morning (equivalent to 3 g of mesalazine per day).

Use in children

Documentation on the use of Salofalk in children (aged 6-18 years) is limited.

Children aged 6 and over

Your doctor will determine the exact dose of Salofalk, 1.5 g in the form of prolonged-release granules for your child.

Acute episode

The dose should be determined individually; usually starting with 30 to 50 mg of mesalazine per kg of body weight per day, preferably in the morning, or in divided doses. The maximum dose is 75 mg of mesalazine per kg of body weight per day. The total dose should not exceed the maximum dose used in adults. In children weighing up to 40 kg, the dose is usually half the dose used in adults, while in children weighing over 40 kg, the usual adult dose is used. Due to the high content of the active substance, Salofalk, 1.5 g in the form of prolonged-release granules is not suitable for children weighing less than 40 kg. Salofalk 1000 mg in the form of prolonged-release granules should be used instead.

Duration of treatment

Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The duration of treatment will be decided by your doctor, depending on the patient's condition. To get the most benefit from Salofalk, it is essential to take it regularly and consistently, both during acute episodes and during long-term treatment, as advised.

Taking a higher dose of Salofalk than recommended

In case of doubt, consult your doctor. Your doctor will decide what to do next. If you have taken more than the recommended dose of Salofalk, take the next dose at the usual time. Do not take a lower dose.

Missing a dose of Salofalk

Do not take a double dose to make up for a missed dose.

Stopping treatment with Salofalk

Do not stop taking Salofalk without consulting your doctor first. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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 worsening 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 an increased risk of severe infections (agranulocytosis). It may also lead to disorders of other blood cells (e.g., platelets or red blood cells, causing aplastic anemia or thrombocytopenia) and may cause symptoms such as unexplained bleeding, purple spots or rashes under the skin, anemia (feeling tired, weak, and pale, especially of the 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 red, flat, plate-like, or circular patches on the torso, often with blisters in the center, exfoliative dermatitis, 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. 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 allergic 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).

Patient reports with mesalazine have also included the following side effects. Common side effects(occurring in less than 1 in 10 patients)

• headache,
• skin 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, 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 and bile flow disorders,
• increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity),
• joint pain,
• feeling weak or tired.

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, shadow on chest X-ray due to allergic and (or) inflammatory lung reaction,
• hair loss and baldness,
• muscle pain,
• 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 this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and sachet after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. 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 contains

• The active substance of Salofalk is mesalazine: one sachet contains 1.5 g of mesalazine.
• The other ingredients of Salofalk are: microcrystalline cellulose, hypromellose (50 mPas), silicon dioxide, anhydrous colloidal, polyacrylate dispersion 40%, magnesium stearate, simethicone, emulsion 33% Otter shell: methacrylic acid and methyl methacrylate copolymer (1:1), triethyl citrate, talc, magnesium stearate, hypromellose (50 mPas), sodium carmellose, aspartame (E 951), citric acid, povidone (K 25) Vanilla Custard flavor (GIV: 75016-32/PHP-132872): natural identical flavoring, maltodextrin, sucrose, propylene glycol.

What Salofalk looks like and contents of the pack

Salofalk, 1.5 g, prolonged-release granules are beige or brownish granules of elongated or round shape, with possible yellowish spots on the surface. Each sachet contains 2.74 g of granules. Salofalk, 1.5 g in the form of prolonged-release granules is available in packs containing 20, 30, 35, 45, 50, 60, 70, 90, 100, and 150 sachets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

DR. FALK PHARMA GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany, Tel.: +49 (0) 761/1514-0, Fax: +49 (0) 761/1514-321, E-mail: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark, Finland, Greece, Spain, Netherlands, Ireland, Latvia, Germany, Norway, Poland, Portugal, Czech Republic, Slovakia, Slovenia, Sweden, Hungary, United Kingdom, Italy: Salofalk. Belgium, Luxembourg: Colitofalk. Austria: Mesagran. France: Osperzo.

Date of last revision of the leaflet: 05/2025