Salofalk 1000 mg prolonged-release granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Salofalk 1000 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 could 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 1000 mg granules is and what it is used for
2. What you need to know before taking Salofalk 1000 mg granules
3. How to take Salofalk 1000 mg granules
4. Possible adverse effects
5. How to store Salofalk 1000 mg granules

Pack contents and additional information

1. What Salofalk 1000 mg granules is and what it is used for

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

Salofalk 1000 mg granules are 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).

2. What you need to know before taking Salofalk 1000 mg granules

Do not take Salofalk granules:

• If you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid (for example, 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

Talk to your doctor before starting treatment with Salofalk 1000 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 had a severe skin rash, peeling skin, blisters, or mouth sores after taking mesalazine

Mesalazine may cause a harmless discoloration of urine to red-brown 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 wish to keep you under medical supervision 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 notice any symptoms related to these serious skin reactions described in section 4.

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

Use of Salofalk 1000 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, especially:

• 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 other medicines, including those obtained without a prescription. It may still be appropriate for you to use Salofalk granules, and your doctor will determine what is best for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may 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 using machines

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

Salofalk 1000 mg granules contain aspartame, sucrose, and sodium

This medicine contains 2 mg of aspartame per sachet of Salofalk 1000 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; i.e., essentially "sodium-free".

3. How to take Salofalk 1000 mg granules

Follow exactly the instructions for use of this medicine as 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, without chewing.

Dosage:

Adults and elderly

Unless your doctor has prescribed otherwise, the usual dosage for the treatment of acute episodes of ulcerative colitis is, depending on the individual clinical requirements, 3 sachets of Salofalk 1000 mg granules (equivalent to 3 g of mesalazine per day) once daily, preferably in the morning, or 1 sachet of Salofalk 1000 mg granules 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:

3 sachets of Salofalk 1000 mg granules once daily, 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 of age).

Children aged 6 years and older

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

In acute episodes: the dose should be individually determined, 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 individually determined, starting at 15–30 mg of mesalazine per kg of body weight per day, to be administered in divided doses. The total dose must not exceed the total recommended adult dose.

Generally, half the adult dose is recommended for children up to 40 kg body weight, 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 therapeutic effects of this medicine, you should take Salofalk granules regularly and consistently, both during acute inflammatory episodes 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 lower 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 general 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 infection. Other blood cells may also be affected (such as platelets and red blood cells), leading to aplastic anaemia or thrombocytopenia), which may cause symptoms such as unexplained bleeding, small or large purple spots under the skin, and anaemia (feeling tired and weak, and 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 flat, red, circular lesions or target-shaped lesions on the trunk, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals and eyes, widespread rash, fever and enlarged 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, visual disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension) (frequency not known [cannot be estimated from available data]).

The following adverse effects have also been reported in 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 sensitivity of the skin 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 conditions of the lungs
• Hair loss and development of baldness
• Muscle pain
• Reversible decrease in semen production

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 1000 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 packaging and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Salofalk 1000 mg granules

The active substance is mesalazine. Each sachet of Salofalk 1000 mg granules contains 1000 mg of mesalazine.

The other components are: aspartame (E-951); sodium carmellose; microcrystalline cellulose; citric acid; colloidal anhydrous silica; hypromellose; magnesium stearate; methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L-100); methylcellulose; polyacrylate dispersion 40% (Eudragit NE 40 D containing 2% nonoxinol 100); povidone K-25; simethicone; sorbic acid; talc; triethyl citrate; vanilla cream flavour (containing sucrose).

Nature of the product and contents of the container

Salofalk 1000 mg prolonged-release granules are rounded or elongated in shape, beige or brown in colour, with or without yellowish surface areas.

Each sachet contains 1.83 g of granules.

Salofalk 1000 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, 19-1º D
28023 Madrid
Tel +34 913 729 508
Fax +34 913 729 437
E-mail: [email protected]

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

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

Belgium, Luxembourg: Colitofalk

Austria: Mesagran

France: Osperzo.

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

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