Salofalk

Leaflet attached to the packaging: information for the user

Salofalk, 1000 mg, prolonged-release granules

Mesalazine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 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 packaging and other information

1. What Salofalk is and what it is used for

Salofalk, 1000 mg 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, 1000 mg in the form of prolonged-release granules is used in:

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

2. Important information before taking Salofalk

When not to take Salofalk

Warnings and precautions

Before starting to take Salofalk, discuss it with your doctor:

bronchial asthma,allergy to sulfasalazinein the past, a substance related to mesalazine,liver function disorders,kidney function disorders,

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

During treatment, your doctor may decide on close medical supervision, 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 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 stop taking mesalazine and seek medical help immediately if you experience any symptoms of these severe skin reactions, listed in section 4.

Salofalk and other medicines

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

• 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 currently taking or have taken recently, including those that are available without a prescription. This does not necessarily mean that you cannot take Salofalk granules, 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 child, consult your doctor or pharmacist before taking this medicine.
Salofalk granules can be taken during pregnancy only on the advice of a doctor.
During breastfeeding, Salofalk granules 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 2 mg of aspartame in each sachet of Salofalk granules. 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 excretion.
If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means that the medicine is considered "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 granules can only be taken orally.
Do not chew the granules.Place the granules directly on the tongue and then swallow them, washing them down with a large amount of fluid, without chewing.

Dosage

Adults and elderly

If your doctor does not prescribe a different dosage, the usual dose for treatment of acute episodes of ulcerative colitisis:
Depending on the individual patient's clinical needs, 3 sachets of Salofalk, 1000 mg in the form of granules (equivalent to 3 g of mesalazine per day) once a day, preferably in the morning, or 1 sachet three times a day (morning, noon, evening).

Prevention of relapses of ulcerative colitis

The usual dose for prevention of relapses of ulcerative colitis is:
500 mg of mesalazine three 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:

3 sachets of Salofalk, 1000 mg in the form of granules once a day, preferably in the morning (equivalent to 3 g of mesalazine per day).

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

Children from 6 years old

Your doctor will determine the exact dose of Salofalk, 1000 mg in the form of granules for your child.
Acute episode:
The dose should be determined individually; usually starting from 30 to 50 mg of mesalazine per kg of body weight per day, once a 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.
Prevention of relapses:
The dose should be determined individually; usually starting from 15 to 30 mg of mesalazine per kg of body weight per day, in divided doses. The total dose should not exceed the dose recommended for 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 dose of the medicine is used as in adults.

Duration of treatment

Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you need to take the medicine. The duration of treatment depends on the patient's condition.
To get the most benefit from taking Salofalk granules, it is necessary to take them regularly and systematically, both during an acute inflammatory episode and during long-term treatment, as directed.

Taking a higher dose of Salofalk than recommended

In case of doubt, consult your doctor. The doctor will decide what to do next.
In case of accidental ingestion of a higher dose of Salofalk granules than recommended, 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 the medicine without consulting your doctor first.
If you have any further doubts about taking this medicine, consult 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, stop taking Salofalk and consult your doctor immediately:

The following are very rare:

• General allergic reactions, such as skin rash, fever, joint pain, and (or) difficulty breathing or general inflammation of the colon (causing severe diarrhea and abdominal pain).
• A significant worsening of the general state of 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 thrombocytopenia) and may cause symptoms that may include unexplained bleeding, purple spots or rashes under the skin, anemia (feeling tired, weak, and pale, especially of the lips and nails). A blood test 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, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and enlarged 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 hypersensitivity reactions. These reactions are rare.
• Kidney problems(may occur very rarely), such as a change in the color or amount of urine produced, and swelling of the limbs or sudden pain in the lower abdomen (caused by a kidney stone) (the frequency of these reactions is unknown).

Patients taking mesalazine have also 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 (bloating), 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 and bile flow disorders,
• 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, or shadow on a chest X-ray due to allergic and (or) inflammatory reactions of the lungs,
• 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 Monitoring of Adverse Reactions to Medicinal Products, 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 that 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Salofalk contains

• The active substance of Salofalk is mesalazine: one sachet contains 1000 mg of mesalazine.
• The other ingredients of the medicine are: microcrystalline cellulose, hypromellose (50 mPas), colloidal anhydrous silica, polyacrylate dispersion 40%, magnesium stearate, simethicone, 33% emulsion. 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 aromas, maltodextrin, sucrose, propylene glycol.

What Salofalk looks like and contents of the pack

Salofalk, 1000 mg, prolonged-release granules are beige or brownish granules of elongated or round shape, with possible yellowish spots on the surface.
Each sachet contains 1.83 g of granules.
Salofalk, 1000 mg in the form of granules is available in packs containing 20, 50, 60, 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
Email: [email protected]

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

Bulgaria, 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