Salaza

Package Leaflet: Information for the Patient

Salaza, 500 mg, Gastro-Resistant Tablets

Mesalazine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What Salaza is and what it is used for
• 2. Important information before taking Salaza
• 3. How to take Salaza
• 4. Possible side effects
• 5. How to store Salaza
• 6. Contents of the pack and other information

1. What Salaza is and what it is used for

Salaza contains 500 mg of the active substance mesalazine (also known as 5-acetylsalicylic acid), which belongs to a group of medications called gastro-resistant anti-inflammatory medications.
Salaza is indicated for the treatment of ulcerative colitis (inflammatory bowel disease).

2. Important information before taking Salaza

When not to take Salaza:

• if you are allergic to mesalazine or any of the other ingredients of this medication (listed in section 6),
• if you are allergic to acetylsalicylic acid or any other salicylate,
• if you have a disease that increases your risk of bleeding,
• if you have severe kidney or liver dysfunction.

Warnings and precautions

Before starting to take Salaza, discuss it with your doctor or pharmacist.
Before starting treatment with Salaza, inform your doctor:

• if you are pregnant or planning to have a child,
• if you are breastfeeding,
• if you have liver or kidney disease,
• if you have any lung disease, such as asthma,
• if you have been allergic to sulfasalazine in the past,
• if you have active stomach or duodenal ulcers,
• if you have had heart inflammation (which could be caused by an infection in the heart),
• if you have ever experienced severe skin rash or skin peeling after taking mesalazine.

If you experience severe or recurring headache, vision disturbances, or ringing or buzzing in the ears, you should contact your doctor immediately.
In case of any allergic symptoms (such as rash, itching) or bronchospasm, abdominal pain, severe headache, and fever during treatment, do not take any more tablets and inform your doctor immediately.
Before and during treatment, your doctor may want to perform regular blood and urine tests to check liver, kidney, blood, and lung function.
Mesalazine may cause kidney stones. Symptoms may include abdominal pain and blood in the urine. During treatment with mesalazine, you should drink an adequate amount of fluids.
Severe skin reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with mesalazine. You should stop taking mesalazine and seek medical attention immediately if you experience any of these severe skin reactions, listed in section 4.
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents

Information on the safety of this medication in children and adolescents is limited.
Do not use this medication in children under 5 years of age.

Salaza and other medications

Generally, you can continue to take other medications while taking Salaza.
However, you should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take, including those available without a prescription.
Salaza may interact with certain medications if taken at the same time. In particular, with:

• medications that lower blood sugar levels (antidiabetic medications),
• medications that lower blood pressure (antihypertensive medications and/or diuretics),
• medications used to treat gout attacks or prevent them,
• medications that help with bowel movements (laxatives containing lactulose),
• medications that prevent blood clotting (anticoagulants),
• medications used to reduce the activity of the immune system (such as azathioprine or 6-mercaptopurine or tioguanine),
• medications used to treat pain and inflammation (anti-inflammatory medications).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medication.
Experience with mesalazine during pregnancy and breastfeeding is limited.
Newborns may experience allergic reactions when breastfed, such as diarrhea. If the newborn experiences diarrhea, breastfeeding should be stopped.
Do not take Salaza during pregnancy or breastfeeding unless your doctor advises you to do so.

Driving and using machines

Salaza has no or negligible influence on the ability to drive and use machines.
Salaza contains sodium. This medication contains 2.13 mmol (49 mg) of sodium (a major component of table salt) per gastro-resistant tablet. This corresponds to 2.5% of the maximum recommended daily intake of sodium in the diet for adults.
If you take 8 tablets per day for a long time, you, especially those on a low-sodium diet, should consult your doctor or pharmacist.

3. How to take Salaza

Always take this medication exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Your doctor will decide the duration of treatment with this medication. Do not stop treatment early, even if you feel better, as symptoms may return if treatment is stopped too early.
Follow your doctor's instructions for treatment, both during the acute phase and during maintenance treatment.
The recommended dose in adults is:

In order to treat an acute episode of ulcerative colitis, your doctor will usually prescribe a dose of 1.5 grams (3 gastro-resistant tablets) to 4 grams (8 gastro-resistant tablets) of mesalazine per day, which can be taken once daily or in divided doses.
In order to prevent further episodes, your doctor may prescribe a dose of 1.5 grams (3 gastro-resistant tablets) to 3 grams (6 gastro-resistant tablets) of mesalazine per day, which can be taken once daily or in divided doses.
Salaza gastro-resistant tablets should be taken orally.
The gastro-resistant tablets should be swallowed whole with a drink of water, before meals. The tablets should not be divided, chewed, or crushed.

Use in children and adolescents

Salaza is not recommended for use in children and adolescents under 18 years of age due to a lack of data on safety and efficacy. Do not use this medication in children under 5 years of age.

Use in elderly patients

In elderly patients, Salaza should be used with caution and only in patients with normal kidney function.

Overdose of Salaza

If you take more Salaza than you should, contact your doctor, pharmacist, or hospital emergency department immediately. Take the package leaflet and any remaining tablets with you.

Missed dose of Salaza

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

Stopping treatment with Salaza

It is important to take the gastro-resistant tablets of Salaza every day, even if you do not have symptoms of ulcerative colitis. You should always finish the prescribed treatment.
If you have any further questions on the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Salaza can cause side effects, although not everybody gets them.
All medications can cause allergic reactions, but severe allergic reactions are very rare. If you experience any of the following symptoms after taking this medication, stop taking the tablets and contact your doctor immediately:

• allergic skin rash,
• fever,
• breathing difficulties.

If you experience fever or sore throat or mouth, stop taking the tablets and contact your doctor immediately. These symptoms can very rarely be caused by a decrease in the number of white blood cells in the blood (a condition called agranulocytosis).
Severe side effects:
Stop taking mesalazine and seek medical attention immediately if you experience any of the following symptoms:

• red, flat, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and swollen lymph nodes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms;
• if you experience severe or recurring headache, vision disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension).

The following side effects have been reported in patients taking mesalazine:

Rare side effects (may affect up to 1 in 1000 people)

• abdominal pain, diarrhea, bloating, nausea, and vomiting;
• headache, dizziness;
• chest pain, shortness of breath, or swelling of limbs due to the effect of the medication on the heart;
• increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity).

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

• -kidney dysfunction, sometimes with swelling of limbs or abdominal pain;
• -severe abdominal pain due to acute pancreatitis;
• -worsening of ulcerative colitis symptoms;
• -fever, sore throat, or feeling of nausea due to changes in blood cell count;
• -shortness of breath, cough, wheezing, patchy changes in chest X-ray due to allergic and/or inflammatory lung disease;
• -diarrhea and severe abdominal pain due to an allergic reaction to the medication at the intestinal level;
• -skin rash or skin inflammation;
• -muscle and joint pain;
• jaundice or abdominal pain due to liver dysfunction or abnormal bile flow;
• -hair loss leading to baldness;
• -erythema multiforme;
• -numbness and tingling of fingers and toes (peripheral neuropathy);
• -temporary reduction in sperm production;
• blood cell count disorders.

Side effects with unknown frequency (frequency cannot be estimated from available data)

(available data):

• kidney stones and associated kidney pain (see also section 2);
• severe skin reactions: drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

Photosensitivity

More severe reactions have been reported in patients with pre-existing skin conditions, such as atopic dermatitis and allergic eczema.
If these symptoms persist or worsen, you should consult your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Salaza

Keep this medication out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medication after the expiry date stated on the carton and blister after {EXP}. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Salaza contains

• The active substance is mesalazine.
• Each gastro-resistant tablet contains 500 mg of mesalazine.
• The other ingredients are sodium carbonate anhydrous, glycine, povidone K30, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, calcium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), dibutyl sebacate, talc, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), red iron oxide (E 172).

Mesalazine and the other ingredients may cause a hypersensitivity reaction in some people.

What Salaza looks like and contents of the pack

Salaza is an orange, oblong, gastro-resistant tablet.
This medicinal product is packaged in aluminum blisters (OPA/Aluminum/PVC/Aluminum) packed in a cardboard box containing 100 gastro-resistant tablets.

Marketing authorization holder

Faes Farma S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain

Manufacturer

Faes Farma, S.A.
Maximo Agirre Kalea, 14
48940 Leioa (Bizkaia)
Spain
Faes Farma, S.A.
Parque Científico y Tecnológico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain
To obtain more detailed information, contact your local representative of the marketing authorization holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel: + 48 22 206 84 50

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:Azzavix 500 mg magensaftresistente tablette
Czech Republic:Salcrozine
Ireland:Galtasa 500 mg gastro-resistant tablets
Poland:Salaza
Slovakia:Salcrozine 500 mg gastrorezistentná tableta
Spain:Mecolvix 500 mg comprimidos gastroresistentes
Greece:Mecolzin 500 mg γαστροανθεκτικό δισκίο
United Kingdom (Northern Ireland):Salcrozine 500 mg gastro-resistant tablets

Date of last revision of the package leaflet: June 2025