Salofalk 500 mg prolonged-release granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Salofalk 500 mg prolonged-release granules

Mesalazine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Salofalk 500 mg granules is and what it is used for
2. What you need to know before taking Salofalk 500 mg granules
3. How to take Salofalk 500 mg granules
4. Possible adverse effects
5. How to store Salofalk 500 mg granules

Pack contents and additional information

1. What Salofalk 500 mg granules is and what it is used for

Salofalk granules contain the active substance mesalazina, an anti-inflammatory agent used to treat inflammatory bowel diseases.

Salofalk 500 mg granules are used for:

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

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

Do not take Salofalk granules:

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

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 experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mesalazine

Mesalazine may cause a harmless red-brown discoloration of urine when it comes into 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 wish to monitor you medically and may require regular blood and urine tests.

Kidney stones may occur with the use of mesalazine. Symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink an adequate amount of fluids during treatment with mesalazine.

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

If you experience severe or recurrent headache, vision disturbances, or tinnitus (ringing or buzzing in the ears), contact your doctor immediately.

Use of Salofalk 500 mg granules with other medicines

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

• Azathioprine, 6-mercaptopurine, or thioguanine (medicines used to treat immunological disorders)
• Certain agents that inhibit blood coagulation (medicines for thrombosis or blood thinning, such as warfarin)
• Lactulose (a medicine used for constipation) or other preparations that may alter the acidity of your stools

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should use Salofalk granules during pregnancy only if your doctor has instructed you to do so.

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

Driving and use of machines

The effect of Salofalk granules on the ability to drive and operate machinery is negligible or none.

Salofalk 500 mg granules contain aspartame, sucrose, and sodium

This medicine contains 1 mg of aspartame per 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 certain sugars, consult with him before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per sachet; therefore, it is essentially “sodium-free”.

3. How to take Salofalk 500 mg granules

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Salofalk granules are for oral use only.

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

Dosage

Adults and elderly

Unless your doctor prescribes otherwise, the usual dosage for the treatment of acute episodes of ulcerative colitis is, depending on the individual clinical requirements of each case, 3 to 6 sachets of Salofalk 500 mg granules (equivalent to 1.5 to 3 g of mesalazine per day) once daily, preferably in the morning, or 1 to 2 sachets three times daily (morning, midday, and evening).

For the prevention of relapses of ulcerative colitis

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

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

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

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

In general, when dosages higher than 1.5 g and up to 3 g of mesalazine per day are recommended, Salofalk 1000 mg, Salofalk 1.5 g, or Salofalk 3 g granules should preferably be used.

Use in children

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

Children aged 6 years and older

Please consult your doctor for the most appropriate dosage of Salofalk granules for your child.

During acute episodes

The dose should be determined individually, starting at 30–50 mg of mesalazine per kg of body weight per day, to be administered once daily, 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 must not exceed the maximum adult dose.

For prevention of relapses: The dose should be determined individually, starting at 15–30 mg of mesalazine per kg of body weight per day, to be administered divided into several doses. The total dose must not exceed the total recommended adult dose.

Generally, half the adult dose is recommended for children weighing up to 40 kg, and the full adult dose for children weighing more than 40 kg.

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 course of your disease.

To achieve the desired maximum therapeutic effect of this medicine, you must take Salofalk granules regularly and systematically, both during the acute inflammatory episode and during long-term treatment as prescribed.

If you feel that Salofalk granules are too strong or too weak, consult your doctor.

If you take more Salofalk granules than you should

Contact your doctor if you have any doubts so that he or she can decide what action to take.

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

If you forget to take Salofalk granules

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

If you stop taking Salofalk granules

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

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

4. Possible adverse effects

Like all medicines, Salofalk granules may have adverse effects, although not everyone experiences them.

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

• General allergic reactions such as skin rash, fever, joint pain and/or difficulty breathing, or generalized inflammation of the large intestine (causing severe diarrhoea and abdominal pain). These reactions are very rare.
• A significant worsening of your general health, especially if accompanied by fever and/or sore throat and mouth. 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 serious infections. Other blood cells may also be affected (such as platelets and red blood cells), causing aplastic anaemia or thrombocytopenia), which may lead to symptoms such as unexplained bleeding, small or large purple spots under the skin, and anaemia (feeling tired and weak, paleness, especially in the lips and nails). A blood test can confirm whether the symptoms are due to an effect of this medicine on the blood. These reactions are very rare.
• Severe skin rashes with non-elevated red circular spots or target-like lesions on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, generalized rash, fever, and swollen lymph nodes. These may 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 function problems (may occur very rarely), for example, a change in the colour or amount of urine produced, swelling of the limbs, or sudden pain in the side (caused by a kidney stone) (occur in an unknown number of people (frequency not known).
• Severe or recurrent headache, changes in vision, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from available data]).

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

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

Headache

• Skin rash, pruritus

Uncommon adverse effects (may affect up to 1 in 100 patients)

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

Severe abdominal pain due to acute inflammation of the pancreas

Changes in liver function parameters, changes in pancreatic enzymes

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

Dizziness

Jaundice or abdominal pain due to disorders of the liver or bile flow

Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)

Joint pain

Feeling of weakness or fatigue

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

Numbness and tingling in hands and feet (peripheral neuropathy)

Feeling of suffocation, 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 semen production

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the carton and on the sachets following EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Salofalk 500 mg granules

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

The other components are: aspartame (E 951); sodium carmellose; microcrystalline cellulose; citric acid; anhydrous colloidal silica; hypromellose; magnesium stearate; methacrylic acid and 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 flavour (containing sucrose).

Nature of the product and pack contents

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

Each sachet contains 913 mg of granules.

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

Only certain 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]

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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 medicinal product is authorised in the European Economic Area member states under the following names:

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

Belgium, Luxembourg: Colitofalk

Austria: Mesagran

France: Osperzo.

Date of the most recent review of this leaflet: November 2025

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