Package Insert: Information for the User

Salofalk 3 g Delayed-Release Granule

Mesalazine

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 read 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.

Salofalk 3 g 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 take Salofalk granulated:

• If you are allergic to mesalazine, salicylic acid, salicylates such asacetylsalicylic acid (e.g., Aspirin®)or any of the other components of this 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 3 g granulated

• If you have a history of lung disease, particularly if you suffer frombronchial asthma
• If you havea 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 need to perform regular blood and urine tests.

Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain and presence of blood in the urine. Ensure you drink enough 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 symptoms related to these severe skin reactions described in section 4.

Use of Salofalk 3 g granulated 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 anticoagulant agents(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 stool

Inform your doctor or pharmacist if you are using or have used recently other medications, even those purchased without a prescription. You may still be able to use Salofalk granulated and your doctor will decide what 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 granulated during pregnancy only if your doctor has indicated it.

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

Driving and operating machines

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

Salofalk 3 g granulated contains aspartame, saccharose, and sodium

This medication contains 6 mg of aspartame in each packet of Salofalk 3 g granulated. 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 packet; 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 granuleshould not be chewed. Salofalk granule should be taken by placing the granules directly on the tongue and then swallowing them with abundant liquid but not chewing them.

Dosage

Adults and elderly

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

1 packet of Salofalk 3g granule once a day, preferably in the morning (equivalent to 3 g of mesalazine per day).

For the prevention of relapse of ulcerative colitis

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

1 packet of Salofalk 500 mg 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:

1 packet of Salofalk 3 g granule once a day, preferably in the morning (equivalent to 3 g of mesalazine per day).

Use in children

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

Children 6 years or older

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

It is generally recommended for children with a body weight of up to 40 kg to take half the adult dose and for those with a body weight over 40 kg to take the usual adult dose.

Due to its high active ingredient content, Salofalk 3 g granule is not suitable for children weighing less than 40 kg. Instead, use Salofalk 500mg or 1000mg granule.

Treatment Duration

The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks.Your doctor will decide for 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 more Salofalk granule than you should

Contact your doctor if you are unsure, so they can decide 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 smaller dose.

If you forgot to take Salofalk granule

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

If you interrupt treatment with Salofalk granule

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

If you have any other doubts 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 following symptoms 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, circular, or target-shaped red 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 (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

Rare 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)

• Fever, sore throat, or discomfort due to changes in blood counts
• Numbness and tingling in hands and feet (peripheral neuropathy)
• Feeling of suffocation, cough, wheezing, and shadow on chest 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 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 storage conditions.

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

Composition of Salofalk 3 g granule

The active ingredient of Salofalk 3g granule is mesalazine, and a pack of Salofalk 3 g granule contains 3 g 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; 40% polyacrylate dispersion (Eudragit NE40 D containing 2% nonoxinol 100); povidone K 25; simethicone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; vanilla cream essence (containing saccharose).

Appearance of the product and contents of the package

The granules of Salofalk 3 g granule of prolonged release are round or elongated, of a greyish white color.

Each pack contains 5.58g of granule.

Salofalk 3g granule is available in packs of 10, 15, 20, 30, 50, 60, 90 and 100 sachets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

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- 1º D

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, Bulgaria, Denmark, Slovakia, Slovenia, Spain, Finland, Greece, Hungary, Ireland, Italy, Latvia, Norway, Netherlands, Poland, Portugal, United Kingdom, Czech Republic and 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/