Salaza

Package leaflet: Information for the patient

Salaza, 500 mg, enteric-coated tablets
mesalazine
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Salaza is and what it is used for
2. What you need to know 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-aminosalicylic acid), which belongs to a group of medicines called anti-inflammatory bowel agents.
Salaza is indicated for the treatment of ulcerative colitis (an 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 impairment of kidney and/or liver function.

Warnings and precautions
Before starting treatment with Salaza, discuss this with your doctor or pharmacist.
Before starting treatment with Salaza, inform your doctor:

• if the patient is pregnant or planning to become pregnant,
• if the patient is breastfeeding,
• if the patient has liver or kidney disease,
• if the patient has any lung disease, e.g. asthma,
• if the patient has previously been allergic to sulfasalazine,
• if the patient has active peptic ulcer disease of the stomach or duodenum,
• if the patient has previously had inflammation of the heart (which may have been caused by infection in the heart),
• if the patient has previously experienced severe skin rash, skin peeling, blisters or oral ulcers after using mesalazine.

If the patient experiences severe or recurring headache, vision disturbances, or ringing or buzzing in the ears, they should contact their doctor immediately.
If any allergic symptoms (e.g. rash, itching) or spasms, abdominal pain, severe headache, or fever occur during treatment, do not take further tablets and contact your doctor without delay.
Before and during treatment, your doctor may wish to perform regular blood and urine tests to monitor liver, kidney, blood and lung function.
Mesalazine use may lead to the formation of kidney stones. Symptoms may include flank pain and haematuria. Adequate fluid intake should be maintained during treatment with mesalazine.
Severe skin reactions have occurred with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Treatment with mesalazine must be discontinued and immediate medical attention sought if any of the symptoms of these severe skin reactions, listed in section 4, occur.
Mesalazine may cause a reddish-brown discoloration of urine when it comes into contact with sodium hypochlorite bleach present in toilet water. This results from a chemical reaction between mesalazine and the bleach and is harmless.

Children and adolescents
Safety data on the use of this medicine in children and adolescents are limited.
Do not use this medicine in children under 5 years of age.

Salaza with other medicines
In general, patients may continue taking other medicines during treatment with Salaza.
However, you should tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use, including those available without a prescription.
Salaza may interact with certain medicines when taken at the same time. In particular, with:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Experience with the use of mesalazine during pregnancy and breastfeeding is limited.
Allergic reactions may occur in the newborn during breastfeeding, e.g. diarrhoea. If diarrhoea occurs in the newborn, breastfeeding should be discontinued.
Do not take Salaza during pregnancy or breastfeeding unless advised by a doctor.

Driving and operating machinery
Salaza has no effect or has a negligible effect on the ability to drive and operate machinery.

Salaza contains sodium. This medicine contains 2.13 mmol (49 mg) of sodium (the main component of table salt) in each enteric-coated tablet. This corresponds to 2.5% of the maximum recommended daily dietary intake of sodium for adults.
Patients taking 8 tablets per day over a prolonged period, especially those monitoring their dietary sodium intake, should consult their doctor or pharmacist.

3. How to use Salaza

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The decision regarding the duration of treatment with this medicine is made by a physician. Do not stop treatment
earlier, even if symptoms improve, because symptoms may recur due to premature discontinuation
of treatment.
Strictly follow the physician's instructions for treatment, both during acute flare-ups of inflammation
and during maintenance therapy.
The recommended dose for adults is:
For the treatment of acute episodes of inflammation of the large intestine, the physician usually prescribes a dose of
1.5 grams (3 enteric-coated tablets) – 4 grams (8 enteric-coated tablets) of mesalazine per day,
which may be administered once daily or in divided doses.
For preventing further episodes, the physician may prescribe a dose of 1.5
grams (3 enteric-coated tablets) – 3 grams (6 enteric-coated tablets) of mesalazine per day, which may
be administered once daily or in divided doses.
Salaza enteric-coated tablets should be taken orally.
Enteric-coated tablets must be swallowed whole with liquid, before a meal. Tablets must not be
split, 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 lack of data
on safety and efficacy. This medicine should not be used 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 more than the recommended dose of Salaza is taken, contact a physician, pharmacist, or hospital emergency
department immediately. Bring the Salaza medicine packaging with you.
Missed dose of Salaza
Do not take a double dose to make up for a missed dose.
Stopping treatment with Salaza
It is important to take Salaza enteric-coated tablets every day, even if the patient does not
have symptoms of ulcerative colitis. Always complete the prescribed course of treatment.
If you have any further questions about the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
All medicines may cause allergic reactions, but severe allergic reactions are very rare.
If any of the following symptoms occur after taking this medicine, discontinue use of these tablets immediately and consult a doctor without delay:

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

If the patient develops fever, sore throat, or mouth irritation, discontinue use of these tablets immediately and consult a doctor without delay. These symptoms, although very rare, may be caused by a reduced number of white blood cells in the blood (a condition called agranulocytosis).

Severe adverse reactions:
Discontinue mesalazine and seek immediate medical attention if any of the following symptoms occur:

• red, flat, disc-shaped or circular spots on the trunk, often with blisters in their center, skin peeling, oral, throat, nasal, genital or ocular ulcers, widespread rash, fever, and enlarged lymph nodes. Such severe skin reactions may be preceded by fever and flu-like symptoms;
• severe or recurring headache, visual disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension).

The following adverse reactions have been reported in patients taking mesalazine:

Uncommon adverse reactions (may occur in up to 1 in 1,000 people):

• abdominal pain, diarrhoea, flatulence, nausea, and vomiting;
• headache, dizziness;
• chest pain, shortness of breath, or limb oedema due to the medicine's effect on the heart;
• increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity).

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

• kidney function disorders, sometimes associated with limb oedema or flank pain;
• severe abdominal pain due to acute pancreatitis;
• worsening of symptoms of colitis;
• fever, sore throat, or nausea due to changes in blood cell counts;
• shortness of breath, cough, wheezing, or patchy changes on lung X-ray due to allergic and/or inflammatory lung diseases;
• diarrhoea and severe abdominal pain due to an allergic reaction to the medicine in the intestines;
• skin rash or skin inflammation;
• muscle and joint pain;
• jaundice or abdominal pain due to liver function disorders or impaired bile flow;
• hair loss leading to alopecia;
• erythema multiforme;
• numbness and tingling in fingers and toes (peripheral neuropathy);
• transient reduction in semen production;
• blood cell count disorders.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• kidney stones and associated renal pain (see also section 2);
• severe skin reactions: drug reaction 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 disorders such as atopic dermatitis and allergic eczema.
If these symptoms persist or worsen, consult a doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Salaza

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after the abbreviation {EXP}. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 anhydrous sodium carbonate, glycine, povidone K30, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silicon dioxide, calcium stearate, polymethacrylic acid and ethyl acrylate copolymer (1:1) 30% dispersion, polymethacrylic acid and methyl methacrylate copolymer (1:1), polymethacrylic 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).

What Salaza looks like and contents of the pack

Salaza is an orange-coloured, elongated gastro-resistant tablet.

This medicinal product is supplied in aluminium blisters OPA/Aluminium/PVC/Aluminium, packed in a cardboard box containing 100 gastro-resistant tablets.

Marketing Authorisation 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

For further information, please contact the local representative of the Marketing Authorisation Holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
tel: +48 22 206 84 50

This medicinal product is authorised in 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