Package Insert: Information for the User

Salofalk 500 mg Delayed-Release Granules

Mesalamine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Salofalk granulated contains the active ingredient mesalazine, an anti-inflammatory used to treat inflammatory intestinal diseases.

Salofalk500 mg granulated is used for:

The treatment of acute episodes and the prevention of new episodes (relapses) of mild to moderate ulcerative colitis, a chronic inflammatory disease of the large intestine (colon).

Do not takeSalofalkgranules:

• If you are allergic to mesalazine, acetic acid, salicylates such asacetylsalicylic acid (for example, Aspirin®)or to any of the other components ofthis medication(listed in section 6).
• If you have severe liver or kidney function disorders.

Warnings and precautions

Consult your doctor before starting to take Salofalk 500 mg granules

• If you have a history of lung disease, particularly if you suffer frombronchial asthma
• If youhave a history of allergy to sulfasalazine, a related substance to mesalazine
• If you have liver problems
• If you have kidney problems
• If you have ever experienced intense skin rash or peeling, blisters or mouth sores after using mesalazine
• Mesalazine may cause urine discoloration to brown-red after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Additional precautions

Your doctor may want to keep you under medical supervision during treatment, and may require regular blood and urine tests.

Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain on the sides and presence of blood in the urine. Ensure you drink a sufficient amount of liquid during mesalazine treatment.

Severe skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

Use of Salofalk 500 mg granules with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, particularly:

• Azathioprine, 6-mercaptopurine, or thioguanine(medications for treating immunological disorders)
• Certain anticoagulants(medications for thrombosis or to thin the blood, such as warfarin)
• Lactulose(medication used for constipation) orother preparations that may change the acidity of your stools

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription. You may still be able to use Salofalk granules and your doctor will decidewhat is most appropriate for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You must use Salofalk granules during pregnancy only if your doctor has indicated it.

Similarly, you should only use Salofalk granules during breastfeeding if your doctor has indicated it, as this medication may pass into breast milk.

Driving and operating machinery

The influence of Salofalk granules on the ability to drive and operate machinery is negligible or insignificant.

Salofalk 500 mg granules contain aspartame, saccharose, and sodium

This medication contains 1 mg of aspartame in each Salofalk 500 mg granule. Aspartame is a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. This medication contains less than 1 mmol of sodium (23 mg) per granule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration Form

Salofalk granule is exclusively for oral use.

Salofalk granulemust not be chewed. Salofalk granule should be taken by placing the granules directly on the tongue and then swallowing them with plenty of liquid but not chewing them.

Dosage

Adults and elderly patients

Unless your doctor prescribes otherwise, the usual dosage for the treatment of acute episodes of ulcerative colitis is:

Depending on individual clinical requirements, from3 to 6 packets of Salofalk 500 mg granule (equivalent to1.5 to 3 g of mesalazine per day) once a day, preferably in the morning, or1 to 2 packets, three times a day (morning, noon, and night).

Prevention of relapses of ulcerative colitis

The usual dosage for preventing new episodes of ulcerative colitis is:

1 packet of Salofalk 500 mg granule three times a day (equivalent to 1.5 g of mesalazine per day).

If, in your doctor's opinion, you are at higher risk of relapse, the dosage for preventing new episodes of ulcerative colitis is:

6 packets of Salofalk 500 mg granule, once a day, preferably in the morning (equivalent to 3 g of mesalazine per day).

In general, when recommending dosages greater than 1.5 g of mesalazine and up to 3 g of mesalazine, Salofalk 1000 mg, Salofalk 1.5 g, or Salofalk 3 g granule should be used whenever possible.

Use in children

There is limited documentation on the effect in children (6 to 18 years old).

Children aged 6 years or older

Please ask your doctor about the correct dosage of Salofalk granule for your child.

Acute episodes

The dose should be determined individually, starting with 30-50 mg of mesalazine per kg of body weight and per day, which should be administered once a day, preferably in the morning, or divided into several 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 for adults.

Prevention of relapses:The dose should be determined individually, starting with 15-30 mg of mesalazine per kg of body weight and per day, which should be administered divided into several doses. The total dose should not exceed the total dose recommended for adults.

Generally, half the adult dose is recommended for children up to40 kgand the adult dose for children over 40 kg of body weight.

Treatment duration

The treatment of acute episodes of ulcerative colitis usually lasts 8weeks.Your doctor will decide how long you need to continue treatment with this medication. This will depend on the progression of your disease.

To achieve the maximum desired therapeutic effects of this medication, you should take Salofalk granule regularly and systematically both during the acute episode of inflammation and during long-term treatment as prescribed.

If you feel that Salofalk granule is too strong or too weak, consult your doctor.

If you take moreSalofalkgranule than you should

Consult your doctor if you are unsure of what to do.

If you take too much Salofalk granule at one time, limit yourself to taking the next dose as prescribed. Do not take a lower dose.

If you forget to takeSalofalkgranule

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withSalofalkgranule

Do not stop taking this medication until you have spoken with your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Salofalk granulated may cause side effects, although not everyone will experience them.

If you experience any of the symptoms listed below after taking this medicine, you should contact your doctor and stop taking Salofalk granulated immediately:

• General allergic reactions such as skin rash, fever, joint pain, and/or difficulty breathing or general inflammation of the large intestine (which causes intense diarrhea and abdominal pain). These reactions are very rare.
• A significant worsening of your overall health, especially if accompanied by fever and/or throat and mouth pain. These symptoms, very rarely, may be caused by a decrease in the number of white blood cells in the blood (agranulocytosis), which may increase your susceptibility to a severe infection. Other blood cells (such as platelets and red blood cells) may also be affected (causing aplastic anemia or thrombocytopenia), which may cause symptoms such as unexplained bleeding, small or large purple spots under the skin, and anemia (feeling tired and weak and paleness, especially in the lips and nails). A blood test can confirm whether the symptoms are due to the effect of this medicine on the blood. These reactions are very rare.
• Severe skin eruptions with flat, red, circular or target-shaped spots on the trunk, often with central vesicles, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and swollen lymph nodes. They may be preceded by fever and symptoms similar to the flu. These reactions occur in an unknown number of people (unknown frequency).
• Difficulty breathing, chest pain, or irregular heartbeat, or swelling of the extremities, which may indicate cardiac hypersensitivity reactions. These reactions are rare.
• Renal function problems (which may occur very rarely), for example, a change in the color or amount of urine produced and swelling of the extremities or sudden pain in the side (caused by a kidney stone) (occur in an unknown number of people (unknown frequency).

The following side effects have also been reported by patients using mesalazine:

Frequent side effects (may affect up to 1 in 10 patients)

Headache

• Skin rash, pruritus

Less frequent side effects (may affect up to 1 in 100 patients)

Abdominal pain, diarrhea, indigestion, gas (flatulence), nausea, and vomiting

Severe abdominal pain due to acute pancreatitis inflammation

Changes in liver function parameters, changes in pancreatic enzymes

Rare side effects (may affect up to 1 in 1,000 patients)

Dizziness

Jaundice or abdominal pain due to liver or bile duct disorders

Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).

Joint pain

Feeling of weakness or fatigue

Very rare side effects (may affect up to 1 in 10,000 patients)

Numbness and tingling in hands and feet (peripheral neuropathy)

Feeling of suffocation, cough, wheezing, and lung shadow on X-rays due to allergic and/or inflammatory lung diseases

Hair loss and development of baldness

Muscle pain

Reversible decrease in semen production

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the packets after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Salofalk 500 mg granule

The active ingredient is mesalazine, and one packet of Salofalk 500 mg granule contains 500 mg of mesalazine.

The other components are: aspartame (E 951); sodium carmelose; microcrystalline cellulose; citric acid; anhydrous colloidal silica; hypromellose; magnesium stearate; copolymer of methacrylic acid and methyl methacrylate (1:1) (Eudragit L 100); methylcellulose; polyacrylate; dispersion at 40% (Eudragit NE40 D containing 2% nonoxinol 100); povidone K25; simethicone; sorbic acid; talc; titanium dioxide (E171); triethyl citrate; vanilla cream essence (containing saccharose).

Appearance of the product and contents of the package

The granules of Salofalk 500 mg prolonged-release granule are round or elongated, grayish-white in color.

Each packet contains 930 mg of granule.

Salofalk 500 mg granule is available in boxes of 50 and 100 packets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr.5

79108 Freiburg

Germany

Phone +49 (0) 761 / 1514-0

Fax +49(0) 761 / 1514-321

Email:[email protected]

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Spain

Dr. Falk Pharma España

Camino de la Zarzuela, 19- 1ºD

28023 Madrid

Phone +34 913 729 508

Fax +34 913 729 437

Email: [email protected]

This medicinal product is authorized in the member states of the European Economic Area, with the following names:

Germany, Denmark, Slovakia, Slovenia, Spain, Finland, Greece, Hungary, Ireland, Italy, Latvia, Norway, Netherlands, Portugal, United Kingdom, Czech Republic, Sweden: Salofalk

Belgium, Luxembourg: Colitofalk

Austria: Mesagran

France: Osperzo.

Last review date of this leaflet: January 2023

Detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/