Salaza

Leaflet attached to the packaging: patient information

Salaza, 1000 mg, enteric-coated tablets

mesalazine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Salaza and what is it 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 packaging and other information

1. What is Salaza and what is it used for

Salaza enteric-coated tablets contain 1000 mg of the active substance mesalazine (also known as 5-acetylsalicylic acid), which belongs to a group of medicines called enteric anti-inflammatory drugs.
Salaza is indicated for the treatment of ulcerative colitis (inflammatory bowel disease).

2. Important information before taking Salaza

When not to take Salaza:

• if the patient is allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to acetylsalicylic acid or any other salicylate,
• if the patient has a disease that increases their susceptibility to bleeding,
• if the patient has severe kidney and/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 a result of infection in the heart),
• if you have ever experienced severe skin rash or 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 (e.g., 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 lead to the formation of kidney stones. Symptoms may include pain on the sides of the abdomen 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 help immediately if you experience any of these severe skin reactions, listed in section 4.
Mesalazine may cause a reddish-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 medicine in children and adolescents is limited.
Do not use this medicine in children under 5 years of age.

Salaza and other medicines

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Experience with mesalazine during pregnancy and breastfeeding is limited.
Newborns may experience allergic reactions when breastfed, e.g., 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 influence or negligible influence on the ability to drive and use machines.

Salaza contains sodium

This medicine contains 4.26 mmol (98 mg) of sodium (main component of common salt/table salt) per enteric-coated tablet.
This corresponds to 5% of the maximum recommended daily intake of sodium in the diet for adults.
If you take 4 enteric-coated tablets per day for a long time, patients, especially those controlling their sodium intake, should consult their doctor or pharmacist.

3. How to take Salaza

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, consult your doctor or pharmacist.
The decision to continue treatment with this medicine is made by your doctor. Do not stop treatment early, even if you feel better, as symptoms may return due to premature discontinuation of treatment.
Strictly follow your doctor's recommendations for treatment, both in the acute phase and during maintenance treatment.
The recommended dose for adults is:

In order to treat an acute episode of ulcerative colitis, your doctor will usually prescribe a dose in the range of 1.5 (one 1000 mg tablet and one 500 mg tablet) to 4 grams (four 1000 mg tablets) of mesalazine per day, which may be given once daily or in divided doses.
In order to prevent further episodes, your doctor may prescribe a dose in the range of 1.5 (one 1000 mg tablet and one 500 mg tablet) to 3 grams (three 1000 mg tablets) of mesalazine per day, which may be given once daily or in divided doses.
Salaza enteric-coated tablets should be taken orally.
Swallow the tablets whole with a drink of water before a meal. Do not divide, chew, or crush the tablets.
In both cases, your doctor may prescribe Salaza 500 mg enteric-coated tablets to adjust the dose.

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 medicine 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.

Taking more than the recommended dose of Salaza

If you have taken more than the recommended dose of Salaza, contact your doctor, pharmacist, or hospital emergency department immediately. Take the packaging of Salaza with you.

Missing a 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 Salaza tablets every day, even if you do not have symptoms of ulcerative colitis. Always finish the prescribed treatment.
If you have any further questions about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Salaza can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, but severe allergic reactions are very rare. If you experience any of the following symptoms after taking this medicine, stop taking the tablets and seek medical help immediately:

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

If you experience fever or sore throat, or mouth ulcers, stop taking the tablets and seek medical help 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 help 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, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and swollen lymph nodes. The onset of such serious 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 1,000 people):

• abdominal pain, diarrhea, bloating, nausea, and vomiting;
• headache, dizziness;
• chest pain, shortness of breath, or swelling of the limbs due to the effect of the medicine 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 the limbs or pain in the sides of the body;
• 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 diseases;
• diarrhea and severe abdominal pain due to an allergic reaction to the medicine 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):

• kidney stones and associated kidney pain (see also section 2);
• severe skin side effects: drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and 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, consult your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal 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 medicine.

5. How to store Salaza

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

6. Contents of the packaging and other information

What Salaza contains

• Each enteric-coated tablet contains 1000 mg of mesalazine.
• The other ingredients are sodium carbonate, anhydrous, glycine, povidone K-30, microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, anhydrous, calcium stearate, methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30%, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), dibutyl sebacate, talc, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), red iron oxide (E 172).

What Salaza looks like and contents of the pack

This medicinal product is available in PVC/PVDC/Aluminum blisters packaged in a carton containing 60 or 100 enteric-coated tablets.
The enteric-coated tablets are oblong, with a uniform orange coating.

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria:Azzavix 1000 mg magensaftresistente tablette
Poland:Salaza
Czech Republic:Salcrozine
Ireland:Galtasa 1000 mg gastro-resistant tablets
Slovakia:Salcrozine 1000 mg gastrorezistentná tableta
Greece:Mecolzin 1000 mg γαστροανθεκτικό δισκίο
Spain:Mecolvix 1000 mg comprimidos gastroresistentes

Date of last revision of the leaflet: June 2025