Salaza

Leaflet attached to the packaging: patient information

Salaza, 1000 mg, suppositories

mesalazine

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. 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 using Salaza
• 3. How to use Salaza
• 4. Possible side effects
• 5. How to store Salaza
• 6. Package contents and other information

1. What is Salaza and what is it used for

Salaza contains the active substance mesalazine, which is an anti-inflammatory medicine used to treat ulcerative colitis.
Salaza is indicated for the treatment of ulcerative proctitis, which is an inflammatory disease of the last part of the large intestine, i.e., the large intestine and rectum, for the purpose of:

• treating mild or moderate exacerbations;
• maintaining remission.

2. Important information before using Salaza

When not to use Salaza

• if the patient is allergic (hypersensitive) to mesalazine, salicylates (e.g., aspirin), or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney or liver disease.
• if the patient has a condition that makes them prone to bleeding.

Warnings and precautions

Before starting treatment with Salaza, discuss it with your doctor or pharmacist.

• if the patient has had liver or kidney problems in the past.
• if the patient has had lung problems, especially if they have had asthma.
• if the patient has had an allergy to sulfasalazine (a medicine used to treat rheumatic or inflammatory diseases), a substance similar to mesalazine. If the patient experiences symptoms such as cramps, abdominal pain, fever, headache, or skin rash or itching during treatment, they should stop using the suppositories and consult their doctor immediately.
• if the patient has stomach or intestinal ulcers.
• if the patient has ever experienced severe skin rash or skin peeling, blisters, or ulcers in the mouth after using mesalazine.

During treatment with mesalazine, kidney stones may form. Symptoms may include pain in the sides of the abdomen and blood in the urine. It is recommended to drink sufficient fluids during treatment with mesalazine.
The doctor may monitor the patient's condition more frequently and order regular blood and urine tests.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with mesalazine treatment. If the patient experiences any symptoms of these severe skin reactions, they should stop using mesalazine and seek medical attention immediately (see section 4).
Mesalazine may cause 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.

Salaza and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
Before starting treatment with Salaza, tell your doctor if the patient is taking any of the following medicines (as the doctor may need to adjust the dose):

• blood-thinning substances (medicines used to treat blood clots or to thin the blood), such as warfarin, as mesalazine may reduce its effect.
• medicines used to treat immune system disorders, such as azathioprine, 6-mercaptopurine, or thioguanine, as mesalazine may increase their effect.
• medicines such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, as they may have a harmful effect on the kidneys.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Salaza can be used during pregnancy or breastfeeding only if the doctor recommends it.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

3. How to use Salaza

This medicine should always be used as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Method of administration:
This medicine can only be used rectally, i.e., it should be inserted into the rectum.
DO NOT take orally.
Before using the suppository, it is recommended to go to the toilet and empty the bowels.
It is recommended to insert the suppository while lying on the left side and remain in this position for about 1 hour.
The suppository should be inserted deeply into the rectum. The suppository should remain in the rectum for 1 to 3 hours to increase its effectiveness.
The doctor may adjust the dose depending on the patient's characteristics and the characteristics of the disease.
The recommended dose for adults is:

• Treatment of exacerbation: one suppository once a day (1000 mg);
• Maintenance of remission: one suppository once a day (1000 mg). A smaller effective dose (in this case, 500 mg suppositories) may be considered.

Use in children and adolescents

There is limited information on the use of Salaza in children under 18 years of age.

Overdose of Salaza

In case of overdose, consult a doctor, hospital, or emergency department for advice on the risk and further action. Take the packaging of the Salaza suppositories with you.

Missed dose of Salaza

Do not take a double dose to make up for a missed dose.
It is important to use Salaza suppositories every day, even if the patient does not experience symptoms of ulcerative colitis. Continue treatment as directed by the doctor.

Stopping treatment with Salaza

Do not stop treatment without consulting a doctor first.
If you have any further doubts about using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, but severe allergic reactions are very rare. If the patient experiences any of the following symptoms after using this medicine, they should stop using the suppositories and seek medical attention immediately:

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

If the patient experiences fever, sore throat, or mouth sores, they should stop using the suppositories and seek medical attention 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 using mesalazine and seek medical attention immediately if the patient experiences 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 onset of such severe skin rashes may be preceded by fever and flu-like symptoms.

The following side effects have been reported in patients using 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 problems, 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 nausea due to changes in blood cell count;
• shortness of breath, cough, wheezing, patchy changes on chest X-ray due to allergic and/or inflammatory lung diseases;
• diarrhea and severe abdominal pain due to an allergic reaction to the medicine in the gut;
• skin rash or skin inflammation;
• muscle and joint pain;
• jaundice or abdominal pain due to liver problems or abnormal bile flow;
• hair loss leading to baldness;
• erythema multiforme;
• numbness and tingling of fingers and toes (peripheral neuropathy);
• temporary decrease 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 reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Salaza

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not use this medicine if you notice signs of deterioration.
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. Package contents and other information

What Salaza contains

• The active substance is mesalazine. Each suppository contains 1000 mg of mesalazine.
• The other ingredients are: solid fat.

What Salaza looks like and contents of the pack

The suppositories are grayish-white to light purple-red, torpedo-shaped, in soft PVC/PE blister packs.
This medicine is available in packs of 12, 24, 30, or 100 suppositories.

Marketing authorization holder and manufacturer

Marketing authorization holder

Faes Farma, S.A.
Kalea Maximo Aguirre 14
48940 Leioa, Bizkaia
Spain

Manufacturer

Faes Farma Portugal, S.A.
Rua Elias Garcia 28
2700-327 Amadora
Portugal
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Recordati Polska sp. z o.o.
ul. Królewska 16
00-103 Warsaw
tel: +48 22 206 84 50

Date of last revision of the leaflet: January 2023