Salaza

Package leaflet: Information for the patient

Salaza, 1000 mg, suppositories
mesalazine
Please read carefully the entire leaflet before using 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 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 reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Salaza is and what it is used for
2. Important information before using Salaza
3. How to use Salaza
4. Possible adverse reactions
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 the active substance mesalazine, an anti-inflammatory agent used in the treatment of ulcerative colitis.
Salaza is indicated for use in ulcerative proctitis, an inflammatory disease affecting the distal portion of the large intestine, i.e. the rectum and rectosigmoid colon, for:

• treatment of mild to moderate acute exacerbations;
• maintenance of remission.

2. Important information before using Salaza

When not to use Salaza

• if the patient is allergic (hypersensitive) to mesalazine, salicylates (for example: aspirin), or to 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 this with your doctor or pharmacist.

• if the patient has previously had problems with the liver or kidneys.
• if the patient has previously had lung problems, particularly if they suffered from bronchial asthma.
• if the patient has previously been allergic to sulfasalazine (a medicine used in the treatment of rheumatic or inflammatory diseases), a substance similar to mesalazine. If during treatment the patient develops symptoms such as cramps, abdominal pain, fever, headache, skin rash or itching, the patient should stop using the suppositories and consult a doctor immediately.
• if the patient has gastric or intestinal ulcers.
• if the patient has ever experienced severe skin rash, skin peeling, blisters, or oral mucosal ulcers after using mesalazine.

If the patient experiences severe or recurring headache, vision disturbances, or ringing or buzzing in the ears, they should contact a doctor immediately.
Kidney stones may form during treatment with mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Adequate fluid intake is recommended during mesalazine treatment.
During treatment, the doctor may monitor the patient's condition more frequently and may 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. Treatment with mesalazine should be discontinued and immediate medical help 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 upon contact with sodium hypochlorite bleach present in toilet water. This results from 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 currently taking or has recently taken, as well as any medicines they plan to take.
Before starting treatment with Salaza, inform the doctor if the patient is taking any of the following medicines (as dose adjustment by the doctor may be necessary):

• Medicines that inhibit blood coagulation (medicines used for thrombosis or to thin the blood), for example warfarin, because mesalazine may reduce its effect.
• Medicines used to treat immune system disorders, such as azathioprine, 6-mercaptopurine, or thioguanine, because mesalazine may enhance their effect.
• Medicines such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, because they may have harmful effects on the kidneys.

Pregnancy, breastfeeding and fertility
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.
Salaza may be used during pregnancy or while breastfeeding only if so advised by a doctor.

Driving and operating machinery
This medicine has no influence on the ability to drive vehicles or operate machinery.

3. How to use Salaza

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Method of administration:
This medicine is for rectal use only, 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 to remain in this
position for about 1 hour.
Suppositories should be inserted deeply into the rectum. The suppositories should remain in the
rectum for 1 to 3 hours to increase effectiveness.
The doctor may adjust the dose depending on the patient's characteristics and the nature of the disease.
The recommended dose for adults is:

• Treatment during flare-up phase: one suppository once daily (1000 mg);
• Maintenance of remission: one suppository once daily (1000 mg). A lower effective dose may be considered (in such case, use 500 mg suppositories).

Use in children and adolescents
There is limited information on the use of Salaza in children under 18 years of age.
If you use more Salaza than you should
If more than the recommended dose of Salaza has been used, contact your doctor, hospital, or
emergency department for advice on possible risks and further management. Take the Salaza
suppository packaging with you.
If you forget to use Salaza
Do not use 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 have symptoms
of ulcerative colitis. Continue treatment as directed by your doctor.
Stopping Salaza
Do not stop treatment without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
All medicines can cause allergic reactions, but severe allergic reactions are very rare.
If any of the following symptoms occur after using this medicine, stop using these suppositories immediately and contact your doctor without delay:

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

If the patient develops fever, sore throat, or oral cavity irritation, stop using these suppositories and contact your doctor immediately. In very rare cases, these symptoms may be caused by a decrease in the number of white blood cells in the blood (a condition called agranulocytosis).

Severe adverse effects:
Stop using mesalazine and seek immediate medical help if the patient experiences any of the following symptoms:

• red, flat, disc-shaped or circular spots on the trunk, often with blisters in their center, skin peeling, mouth ulcers, throat, nose, genital organs or eye involvement, extensive rash, fever and swollen lymph nodes. Such severe skin rashes may be preceded by fever and flu-like symptoms;
• if the patient experiences 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 effects have been reported in patients using mesalazine:

Uncommon adverse effects (may affect up to 1 in 1,000 people):

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

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

• kidney function disorders, sometimes accompanied by limb swelling 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, patchy changes on chest X-ray due to allergic and/or inflammatory lung diseases;
• diarrhoea and severe abdominal pain due to drug hypersensitivity reaction in the intestine;
• 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 baldness;
• erythema multiforme;
• numbness and tingling in fingers and toes (peripheral neuropathy);
• transient reduction in semen production;
• blood cell count disorders.

Adverse effects of unknown frequency (frequency cannot be estimated from available data):

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

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

5. How to store Salaza

Do not store above 30°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if signs of deterioration are observed.
Medicines must not be disposed of via sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Salaza contains

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

What Salaza looks like and contents of the pack
Greyish-white to slightly violet-red, torpedo-shaped suppositories in soft blisters made of PVC/PE foil.
This medicine is available in packs of 12, 24, 30 or 100 suppositories.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa, Bizkaia
Spain

Manufacturer
Faes Farma Portugal, S.A.
Rua Elias Garcia 28
2700-327 Amadora
Portugal

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