SALOFALK 500 MG PROLONGED-RELEASE GRANULES

Introduction

Package Leaflet: Information for the User

Salofalk 500 mg Prolonged-Release Granules

Mesalazine

Read all of this leaflet carefully before you start 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Salofalk 500 mg granules are and what they are used for
2. What you need to know before you take Salofalk 500 mg granules
3. How to take Salofalk 500 mg granules
4. Possible side effects
5. Storage of Salofalk 500 mg granules

Contents of the pack and further information

1. What Salofalk 500 mg granules are and what they are used for

Salofalk granules contain the active substance mesalazine, an anti-inflammatory that is used to treat inflammatory bowel diseases.

Salofalk 500 mg granules are used for:

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

2. What you need to know before you take Salofalk 500 mg granules

Do not takeSalofalkgranules:

• If you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (e.g. Aspirin) or any of the other components of this medicine (listed in section 6).
• If you have severe liver or kidney dysfunction.

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 from bronchial asthma
• if you have a history of allergy to sulfasalazine, a substance related to mesalazine
• if you have liver problems
• if you have kidney problems
• If you have ever suffered from a severe skin rash, skin peeling, blisters, or ulcers in the mouth after using mesalazine
• Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Additional precautions

During treatment, your doctor may want to keep you under medical supervision, and you may need to have regular blood and urine tests.

Kidney stones may occur with the use of mesalazine. The symptoms include pain in the sides of the abdomen and the presence of blood in the urine. Make sure to drink a sufficient amount of liquid during treatment with mesalazine.

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

Using Salofalk 500 mg granules with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular:

• Azathioprine, 6-mercaptopurine or thioguanine(medicines for treating immune system disorders)
• Certain agents that inhibit blood clotting(medicines for thrombosis or to thin the blood, such as warfarin)
• Lactulose(a medicine used for constipation) or other preparations that may change the acidity of your stools

Tell your doctor or pharmacist if you are using or have recently used other medicines, even those obtained without a prescription. It may still be appropriate for you to use Salofalk granules, and your doctor will be able to decide what is best for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should use Salofalk granules during pregnancy only if your doctor has told you to.

Also, you should only use Salofalk granules during breastfeeding if your doctor has told you to, as this medicine may pass into breast milk.

Driving and using machines

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

Salofalk 500 mg granules contain aspartame, sucrose, and sodium

This medicine contains 1 mg of aspartame in each sachet of Salofalk 500 mg granules. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

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

3. How to take Salofalk 500 mg granules

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Method of administration

Salofalk granules are for oral use only.

Salofalk granules must not be chewed. The granules should be taken by placing them directly on the tongue and then swallowing them with plenty of liquid, but without chewing.

Posology

Adults and elderly

Unless your doctor has prescribed otherwise, the normal dosage for the treatment of acute episodes of ulcerative colitisis, depending on individual clinical requirements, 3 to 6 sachets of Salofalk 500 mg granules (equivalent to 1.5 to 3 g of mesalazine per day) once a day, preferably in the morning, or 1 to 2 sachets, three times a day (morning, noon, and night).

For the prevention of relapses of ulcerative colitis

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

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

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

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

In general, in the case of recommended dosages greater than 1.5 g of mesalazine and up to 3 g of mesalazine, Salofalk 1000mg, Salofalk 1.5 g, or Salofalk 3 g granules should be used, if possible.

Use in children

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

Children 6 years and older

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

In acute episodes

The dose should be determined individually, starting with 30-50 mg of mesalazine per kg 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 body weight per day. The total dose should not exceed the maximum dose in adults.

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

It is generally recommended to use half the adult dose for children up to 40 kg and the normal adult dose for children over 40 kg body weight.

Duration of treatment

Treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. Your doctor will decide how long you need to continue treatment with this medicine, depending on the progression of your disease.

In order to achieve the maximum therapeutic effects of this medicine, you should take Salofalk granules regularly and systematically, both during the acute episode of inflammation and during long-term treatment, as prescribed.

If you think that Salofalk granules are too strong or too weak, talk to your doctor.

If you take moreSalofalkgranules than you should

Contact your doctor if you have any doubts, so that they can decide what to do.

If you take too much Salofalk granules at one time, just take the next dose as prescribed. Do not take a smaller dose.

If you forget to takeSalofalkgranules

Do not take a double dose to make up for forgotten doses.

If you stop takingSalofalkgranules

Do not stop taking this medicine until you have talked to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Salofalk granules can cause side effects, although not everybody gets them.

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

• General allergic reactions such as skin rash, fever, joint pain, and/or difficulty breathing or a general inflammation of the large intestine (which causes severe diarrhea and abdominal pain). These reactions are very rare.
• A significant worsening of your general health, especially if accompanied by fever and/or throat and mouth pain. These symptoms, very rarely, can be caused by a decrease in the number of white blood cells in the blood (agranulocytosis), which can increase your propensity to contract a serious infection. Other blood cells (such as platelets and red blood cells) may also be affected, causing anemia, aplastic anemia, or thrombocytopenia, which can cause symptoms such as unexplained bleeding, small purple spots on the skin, and anemia (feeling tired and weak and pale, especially in the lips and nails). A blood test can confirm if the symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
• Severe skin rashes with reddish, non-elevated, circular, or target-shaped spots on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and enlargement of the lymph nodes. They can be preceded by fever and flu-like symptoms. These reactions occur in an unknown number of people (frequency not known).
• Difficulty breathing, chest pain, or irregular heartbeat, or swelling of the limbs, which may indicate cardiac hypersensitivity reactions. These reactions are rare.
• Kidney problems (which can 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 side (caused by a kidney stone) (occurring in an unknown number of people (frequency not known).

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

Common side effects (may affect up to 1 in 10 people)

Headache

• Skin rash, itching

Uncommon side effects (may affect up to 1 in 100 people)

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

Severe abdominal pain due to acute pancreatitis

Changes in liver function parameters, changes in pancreatic enzymes

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

Dizziness

Jaundice or abdominal pain due to liver or bile duct disorders

Increased sensitivity of the skin 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 people)

Numbness and tingling in hands and feet (peripheral neuropathy)

Shortness of breath, cough, wheezing, lung shadow on X-rays due to allergic and/or inflammatory lung conditions

Hair loss and development of baldness

Muscle pain

Reversible decrease in sperm production

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Salofalk 500 mg granules

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

Do not use this medicine after the expiry date which is stated on the carton and sachets after EXP.

The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Salofalk 500 mg granules

The active substance is mesalazine, and one sachet of Salofalk 500 mg granules contains 500 mg of mesalazine.

The other ingredients are: aspartame (E 951); carmellose sodium; microcrystalline cellulose; citric acid; colloidal anhydrous silica; hypromellose; magnesium stearate; methacrylic acid - methyl methacrylate copolymer (1:1) (Eudragit L 100); methylcellulose; polyacrylate; 40% dispersion (Eudragit NE40 D containing 2% nonoxinol 100); povidone K25; simethicone; sorbic acid; talc; triethyl citrate; vanilla cream flavor (containing sucrose).

Appearance of the product and pack contents

Salofalk 500 mg prolonged-release granules are round or elongated, beige or brown in color, with or without yellowish surface parts.

Each sachet contains 913 mg of granules.

Salofalk 500 mg granules are available in packs of 50 and 100 sachets.

Not all pack sizes may be marketed.

Marketing authorisation 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]

You can obtain further information on this medicine from the representative of the marketing authorisation holder in your country:

Spain

Dr. Falk Pharma España

Camino de la Zarzuela, 19- 1ºD

28023 Madrid

Tel +34 913 729 508

Fax +34 913 729 437

E-mail: [email protected]

This medicine is authorised in the Member States of the European Economic Area under 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.

Date of last revision of this leaflet: May 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/