Salazopirin En

Leaflet attached to the packaging: information for the user

SALAZOPYRIN EN, 500 mg, enteric-coated tablets

Sulfasalazine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for 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 possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Salazopyrin EN and what is it used for

Salazopyrin EN contains sulfasalazine as the active substance.
Salazopyrin EN belongs to a group of anti-inflammatory medicines used to treat:
rheumatoid arthritis that is resistant to treatment with non-steroidal anti-inflammatory drugs,
inflammatory bowel diseases (e.g. ulcerative colitis, Crohn's disease).

2. Important information before taking Salazopyrin EN

When not to take Salazopyrin EN

• if the patient is allergic to sulfasalazine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to sulfonamides or salicylates and their derivatives;
• if the patient has acute intermittent porphyria or mixed porphyria;
• if the patient has urinary or intestinal obstruction;
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Salazopyrin EN, the patient should discuss it with their doctor:

• if the patient has a severe allergy and/or asthma;
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase, as it may cause hemolytic anemia in these patients;
• if the patient has kidney or liver dysfunction
• if the patient has abnormal blood counts.

There have been reports of severe infections, including sepsis and pneumonia, associated with bone marrow suppression.
If the patient develops an infection during treatment with Salazopyrin EN, they should immediately consult their doctor. In patients with severe infections, the doctor will decide whether to discontinue treatment with the medicine.
In patients with a history of recurrent or chronic infections, or those with other diseases that may increase the risk of infection, the doctor will carefully consider the need to use sulfasalazine.
In cases of mild hypersensitivity, desensitization should be considered. In cases of severe hypersensitivity reactions, treatment with the medicine should be discontinued.
Severe hypersensitivity reactions may involve internal organs and can cause, for example, liver inflammation, kidney inflammation, heart muscle inflammation, and blood disorders and/or lung inflammation.
During treatment with Salazopyrin EN, severe, life-threatening hypersensitivity reactions have been reported, such as drug rash with eosinophilia and systemic symptoms (DRESS).
Early symptoms of hypersensitivity, such as fever and lymphadenopathy, may occur, even if a rash is not present.
During treatment with Salazopyrin EN, very rare but severe skin reactions have been reported (in some cases leading to death), such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The greatest risk of these adverse reactions exists in the early stages of treatment, and most cases occur within the first month. If the patient experiences symptoms such as flu-like symptoms, rash, mucosal lesions [e.g. oral ulcers, pharyngitis, nasal and genital lesions, and conjunctivitis (red and swollen eyes)], extensive blisters, or peeling of large areas of skin, they should immediately consult their doctor. In such cases, treatment with Salazopyrin EN should be discontinued.
The best results in the treatment of Stevens-Johnson syndrome and toxic epidermal necrolysis are achieved when these conditions are recognized as early as possible and the medicine is discontinued immediately. Early discontinuation of the medicine gives better prognosis.
If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis during treatment with Salazopyrin EN, they should never again be treated with this medicine.
The occurrence of clinical symptoms such as sore throat, fever, pallor, petechiae, and jaundice during sulfasalazine treatment may indicate bone marrow suppression, hemolysis (red blood cell destruction), and hepatotoxicity (liver damage). Sulfasalazine treatment should be discontinued pending blood test results.
In case of certain blood count disorders, the doctor may recommend folic acid supplementation.
During treatment, the patient should drink plenty of fluids due to the risk of kidney stone formation.
After opening the container with Salazopyrin EN, a strong odor may sometimes be noticeable, which is related to the manufacturing process and does not have a negative impact on the patient's health. The odor is due to the coating process of the enteric-coated tablets with a solvent.
The solvent evaporates during the manufacturing process, leaving trace amounts in the finished medicine, which can be detected by smell.
Note! To reduce the unpleasant odor, the tablets can be left in the fresh air to allow the solvents to evaporate from the tablets.
Control tests during treatment:
Before starting treatment, the doctor may recommend a control blood test, including a white blood cell count and liver function tests, and then repeat these tests every 2 weeks during the first 3 months of treatment. During the next 3 months, control tests should be performed every 4 weeks, and then every 3 months, as well as in situations where it is clinically indicated.
Assessment of kidney function (including urine analysis) should be performed in all patients at the start of treatment, as well as at least once a month during the first 3 months of treatment. Subsequently, control tests should be performed when clinically indicated.
During treatment with Salazopyrin EN, the doctor will closely monitor the patient for skin reactions.
The patient should inform their doctor about taking or recently taking Salazopyrin EN or other medicines containing sulfasalazine, as they may affect the results of blood and urine tests.

Salazopyrin EN and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Salazopyrin EN may:
reduce the absorption of digoxin (used to treat heart failure and atrial fibrillation);
reduce the absorption of folic acid (prescribed by a doctor as a dietary supplement) and cause its deficiency.
Concomitant oral administration of sulfasalazine and mercaptopurine (used to treat certain leukemias and autoimmune diseases) or azathioprine (used in transplantology and treatment of autoimmune diseases) may cause bone marrow suppression and leukopenia (reduced white blood cell count).
In patients taking sulfasalazine or its metabolites — mesalamine or mesalazine, falsely elevated urinary normetanephrine levels may be obtained using liquid chromatography.

Salazopyrin EN with food and drink

See section 3.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Since the risk associated with the use of the medicine during pregnancy cannot be excluded, sulfasalazine may be used in pregnant women only when absolutely necessary.
The medicine reduces the number and motility of sperm, which may affect fertility. This effect is usually reversible after treatment is discontinued.
Sulfasalazine and sulfapyridine pass into breast milk in small amounts. This should not pose a risk to a healthy child.
Caution is advised in premature infants and newborns with physiological jaundice. There have been reports of bloody stools or diarrhea in breastfed infants whose mothers were taking Salazopyrin EN. In these cases, the bloody stools or diarrhea resolved in the infants after the mother discontinued Salazopyrin EN.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

Salazopyrin EN contains propylene glycol

The medicine contains 5 mg of propylene glycol in each tablet.

3. How to take Salazopyrin EN

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Rheumatoid arthritis

Adults and the elderly
The recommended dose is 1 g to 3 g per day. The most commonly used dose is 2 enteric-coated tablets twice a day. Treatment starts with smaller doses, which are gradually increased according to the scheme presented in the table below.
If after 2-3 months the doctor finds that the patient's response to treatment is unsatisfactory, the daily dose of sulfasalazine may be increased to a maximum of 3 g.
In patients who have experienced side effects, the dose can be temporarily reduced.

Inflammatory bowel diseases (e.g. ulcerative colitis, Crohn's disease)

The doctor will recommend the appropriate dose based on the patient's clinical condition, tolerance to the medicine, and response to treatment.
It is recommended that in patients who have never been treated with sulfasalazine before, the dose be increased gradually (over several weeks). The daily dose should be divided into equal doses.
Acute phase of the disease
Adults and the elderly
Severe exacerbations of the disease: 2 to 4 tablets 3 to 4 times a day (3 g to 8 g per day).
Mild and moderate exacerbations: 2 tablets 3 to 4 times a day.
Children
40-60 mg/kg body weight per day in 3 to 6 divided doses.
Maintenance treatment
Adults and the elderly
The recommended maintenance dose in the treatment of patients with ulcerative colitis and Crohn's disease in remission is 2 tablets 2 to 3 times a day. Treatment with this dose should not be discontinued and should be continued long-term, provided that no side effects occur.

In case of disease exacerbation, the doctor may decide to increase the dose to 2 to 4 tablets 3 to 4 times a day.
Children
20-30 mg/kg body weight per day in 3 to 6 divided doses.

Method of administration:

The tablets should be taken during meals, swallowed whole, and not crushed or broken.
The patient should drink plenty of fluids while taking sulfasalazine (see "Warnings and precautions" in section 2).

Taking a higher dose of Salazopyrin EN than recommended

Single ingestion of large amounts of the medicine has rarely caused severe poisoning.
Symptoms of poisoning may include: nausea, vomiting, crystalluria (formation of crystals in the urine), hematuria, oliguria, and anuria, hypoglycemia, and in single cases methemoglobinemia (loss of hemoglobin's ability to transport oxygen), cyanosis, liver symptoms, sulfhemoglobinemia. Hypersensitivity reactions, such as changes in blood morphology (which can lead to fatal agranulocytosis), urticaria, polyneuritis, and central nervous system symptoms.
In case of taking a higher dose of Salazopyrin EN than recommended, the patient should contact their doctor. Depending on the symptoms, the doctor will provide appropriate treatment.

Missing a dose of Salazopyrin EN

The patient should not take a double dose to make up for a missed dose.

Discontinuing Salazopyrin EN

The decision to discontinue treatment is made by the doctor.
In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Salazopyrin EN can cause side effects, although not everybody gets them.
Side effects occur in about 1/3 of patients treated with sulfasalazine. These are usually gastrointestinal disorders or headaches. Some side effects are dose-dependent. About 75% of side effects occur within 3 months of starting treatment.
The assessment of side effects is based on the following frequency criteria:
Very common(may occur in more than 1 in 10 people)

• gastrointestinal disorders, nausea

Common(may occur in up to 1 in 10 people)

• leukopenia (reduced white blood cell count in peripheral blood)
• loss of appetite
• dizziness, headache, taste disorders
• tinnitus
• cough
• abdominal pain, diarrhea *, bloating, vomiting *
• hemorrhagic diathesis *, itching
• joint pain
• proteinuria (presence of protein in the urine)
• fever

Uncommon(may occur in up to 1 in 100 people)

• thrombocytopenia (reduced platelet count)
• jaundice *
• depression
• dyspnea (breathing difficulties)
• alopecia, urticaria
• facial edema
• increased liver enzyme activity

Rare(may occur in up to 1 in 1,000 people)

• nail changes

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

• potentially life-threatening skin rashes: toxic epidermal necrolysis (Lyell's syndrome) - a disease characterized by the presence of large, flaccid blisters on erythematous patches (especially in areas subject to pressure), which quickly rupture, resulting in extensive erosions; Stevens-Johnson syndrome (fever, severe rash with blistering on mucous membranes) .

Frequency not known(cannot be estimated from available data)

• aseptic meningitis, pseudomembranous colitis
• agranulocytosis, aplastic anemia, hemolytic anemia, macrocytosis, megaloblastic anemia, pancytopenia (reduced number of all blood cell elements: red blood cells, white blood cells, and platelets), pseudo-mononucleosis *
• anaphylactic shock* (symptoms of anaphylactic shock include: rapidly deteriorating condition, itching, urticaria, pale and moist skin, rapid and shallow breathing, dyspnea, tachycardia, significant decrease in blood pressure, vomiting, diarrhea, throat and tongue swelling, and impaired consciousness), serum sickness (allergic, systemic reaction to intravenously administered foreign serum or medicine)
• folic acid deficiency *
• encephalopathy, peripheral neuropathy, olfactory disorders, pericarditis, cyanosis, myocarditis *
• pallor*
• pulmonary fibrosis, interstitial lung disease*, eosinophilic infiltrates, oral and pharyngeal pain *
• exacerbation of symptoms in ulcerative colitis *, pancreatitis
• liver failure*, fulminant hepatitis*, hepatitis, cholestatic hepatitis *, cholestasis (bile stasis) *
• drug rash with eosinophilia and systemic symptoms*, angioedema*, toxic, pustular dermatitis, erythema, rash, exfoliative dermatitis, lichen planus, photosensitivity
• systemic lupus erythematosus (a chronic autoimmune disease that can cause damage to various organs, especially the skin, joints, blood, and kidneys), Sjögren's syndrome
• nephrotic syndrome (a set of symptoms caused by excessive loss of protein in the urine), interstitial nephritis, urinary crystals, hematuria, kidney stones *
• transient oligospermia
• yellow discoloration of the skin and body fluids*
• induction of autoantibodies

*
Side effects reported after the medicine was placed on the market.
†
See "Warnings and precautions" in section 2

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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 or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Salazopyrin EN

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30 °C.
Do not use this medicine after the expiry date stated on the carton after (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Salazopyrin EN contains

• The active substance of the medicine is sulfasalazine. 1 enteric-coated tablet contains 500 mg of sulfasalazine.
• The other ingredients are: povidone, corn starch, magnesium stearate, colloidal silicon dioxide.
• The coating contains: cellulose acetate phthalate, propylene glycol (E1520) (see section 2 "Salazopyrin EN contains propylene glycol"), white wax, carnauba wax, self-emulsifying glycerol monostearate, macrogol 20,000, talc.

What Salazopyrin EN looks like and contents of the pack

Salazopyrin EN, 500 mg are yellow-orange, oval, convex enteric-coated tablets, marked with the symbol "KPh" on one side and "102" on the other side of the tablet.
The packaging contains a white HDPE container closed with an orange PP cap containing 50 or 100 tablets in a cardboard box.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Manufacturer

Recipharm Uppsala AB, Björkgatan 30, Uppsala Domkyrkofors, Uppsala, 753 23, Sweden
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-salazopyrinen and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl.