Sulfasalazin Krka

Package Leaflet: Information for the Patient

Sulfasalazin Krka, 500 mg, coated tablets

Sulfasalazinum

Read the package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Sulfasalazin Krka and what is it used for

Sulfasalazin Krka is an anti-inflammatory medicine.
Sulfasalazin Krka is a combination of 5-aminosalicylic acid and sulfapyridine. A smaller part of sulfasalazine is absorbed in the large intestine and mainly deposited in connective tissue. The larger part of the medicine is broken down into 5-aminosalicylic acid and sulfapyridine, which reduce inflammation.
Sulfapyridine reduces systemic inflammatory response; the anti-inflammatory effect of 5-aminosalicylic acid, due to its poor absorption, occurs only in the large intestine. Sulfasalazin Krka does not have analgesic effects.

Sulfasalazin Krka is used to treat:

• rheumatoid arthritis, resistant to treatment with non-steroidal anti-inflammatory drugs,
• inflammatory bowel diseases (e.g. ulcerative colitis, Crohn's disease).

2. Important information before taking Sulfasalazin Krka

Inform your doctor about any chronic diseases, metabolic disorders, hypersensitivity (allergies) to other medicines, and the use of other medicines.

When not to take Sulfasalazin Krka:

• if you are allergic to sulfasalazine or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to sulfonamides and salicylates,
• if you have acute intermittent porphyria, mixed porphyria,
• if you have urinary or intestinal obstruction,
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Sulfasalazin Krka, discuss it with your doctor or pharmacist if:

• you have severe allergies and (or) bronchial asthma;
• you have a deficiency of glucose-6-phosphate dehydrogenase, as it may cause hemolytic anemia;
• you have kidney or liver function disorders, or abnormal blood counts.

During treatment, drink plenty of fluids due to the possibility of kidney stone formation.
Inform your doctor about taking or recently taking Sulfasalazin Krka or other medicines containing sulfasalazine, as they may affect blood and urine test results.
Before starting treatment, your 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 when clinically indicated.
Kidney function assessment (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.
Control should then be performed when clinically indicated.
The occurrence of clinical symptoms such as sore throat, fever, pallor, petechiae, and jaundice during sulfasalazine treatment may indicate bone marrow suppression, hemolysis, and hepatotoxicity. Sulfasalazine treatment should be discontinued while waiting for blood test results.
During treatment with Sulfasalazin Krka, potentially life-threatening skin rashes have been observed (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), which initially have the shape of reddened lesions or round spots, often with centrally located blisters. Additional symptoms may occur, such as oral, throat, nose, genital, and conjunctival ulcers (red and swollen eyes). These life-threatening skin rashes are often accompanied by flu-like symptoms. In the further development of the rash, extensive blisters or peeling of large skin areas may appear.
The greatest risk of serious skin reactions exists in the first weeks of treatment.
If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Sulfasalazin Krka, they should never again take this medicine.
If a patient develops a rash, mucosal disorders, other hypersensitivity symptoms, or the aforementioned skin symptoms, they should immediately consult a doctor and inform them about taking this medicine.
During treatment with Sulfasalazin Krka, severe, life-threatening hypersensitivity reactions have been reported, such as drug rash with eosinophilia and systemic symptoms (DRESS).
It should be borne in mind that early symptoms of hypersensitivity may appear, even if a rash is not present.

Sulfasalazin Krka and other medicines

Inform your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Sulfasalazin Krka 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) causing its deficiency.

Concomitant oral administration of sulfasalazine and mercaptopurine (used to treat certain leukemias and autoimmune diseases) or azathioprine (used in transplantation and treatment of autoimmune diseases) may cause bone marrow disorders and leukopenia (reduced white blood cell count).

Sulfasalazin Krka with food and drink

Tablets should be taken during meals, washed down with a glass of water. Tablets should be swallowed whole, not chewed or crushed. During treatment, drink plenty of fluids.

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.
Since the risk associated with the use of this medicine during pregnancy cannot be excluded, sulfasalazine may be used in pregnant women only if absolutely necessary.
The medicine reduces sperm count and motility, which may affect fertility. This effect is usually reversible after treatment is stopped.
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. Bloody stools or diarrhea have been reported in breastfed infants whose mothers were taking sulfasalazine. In these cases, bloody stools or diarrhea resolved in infants after the mother stopped taking sulfasalazine.

Driving and using machines

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

3. How to take Sulfasalazin Krka

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not change the dose or stop treatment without consulting your doctor.
Tablets should be swallowed whole, not chewed or crushed. This reduces unwanted gastrointestinal effects. Tablets should be taken during meals, washed down with a glass of water.

Rheumatoid arthritis

Adults and the elderly
The recommended dose is from 1 g to 3 g per day. The most commonly used dose is 2 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 (i.e. ulcerative colitis, Crohn's disease)

The doctor will recommend the appropriate dose depending 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 parts.
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, unless 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.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Taking a higher dose of Sulfasalazin Krka than recommended

In case of taking a higher dose of the medicine than recommended, contact your doctor or pharmacist.
Symptoms of overdose may include: nausea, vomiting, crystalluria (formation of crystals in urine), hematuria, oliguria, and anuria, hypoglycemia, and in single cases methemoglobinemia (loss of hemoglobin's ability to carry oxygen), cyanosis, liver symptoms, sulfhemoglobinemia. Hypersensitivity reactions, such as changes in blood morphology (which can lead to death, agranulocytosis - a lack of a certain type of white blood cell, granulocytes), urticaria, polyneuritis, central nervous system symptoms.
In case of taking a higher dose of Sulfasalazin Krka than recommended, contact your doctor. Depending on the symptoms, the doctor will apply appropriate treatment.

Missing a dose of Sulfasalazin Krka

Do not take a double dose to make up for a missed dose.
Missed doses should be taken as soon as possible, unless the next dose is already due. In this case, wait and take only one dose - at the right time.

Stopping treatment with Sulfasalazin Krka

Only your doctor can decide to stop treatment.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sulfasalazin Krka can cause side effects, although not everybody gets them.
Most side effects caused by Sulfasalazin Krka are mild.
Side effects usually disappear on their own, after reducing the dose or stopping treatment.
Sulfapyridine side effects are mainly related to its blood concentration, especially in patients who metabolize it more slowly.

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 people):

• changes in the nails,
• jaundice.

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

• potentially life-threatening skin rashes: toxic epidermal necrolysis (Lyell's syndrome) - a disease characterized by the occurrence of large, flaccid blisters on erythematous patches (especially in areas exposed to pressure), which quickly rupture, resulting in extensive erosions; bullous erythema multiforme (Stevens-Johnson syndrome, fever, severe rash with blister formation on mucous membranes) (see section 2).

Frequency not known side effects (cannot be estimated from available data):

• aseptic meningitis, pseudomembranous colitis,
• agranulocytosis (complete or almost complete lack of granulocytes in the blood), aplastic anemia (bone marrow failure to produce new red or white blood cells), hemolytic anemia (abnormal premature breakdown of red blood cells), macrocytosis (excessive enlargement of red blood cells), megaloblastic anemia (anemia due to vitamin B12 or folic acid deficiency), pancytopenia (reduced count of all blood cell elements: red blood cells, white blood cells, and platelets),
• anaphylactic shock (severe allergic reaction)* (symptoms of anaphylactic shock are: rapidly worsening condition, itching, urticaria, pale and moist skin, rapid and shallow breathing, dyspnea, tachycardia, significant decrease in blood pressure, vomiting, diarrhea, swelling of the throat and tongue, disorders of consciousness), serum sickness (allergic, systemic reaction to administered foreign serum or medicine),
• encephalopathy (brain function disorders), peripheral neuropathy (nerve disorders in limbs), disorders of smell,
• pericarditis, cyanosis,
• fibrosing alveolitis, interstitial lung disease*, eosinophilic infiltrates,
• worsening of symptoms in ulcerative colitis, pancreatitis,
• liver failure*, fulminant hepatitis*, hepatitis,
• drug rash with eosinophilia and systemic symptoms*, angioedema*, toxic, vesicular skin rashes, 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, kidney stones, hematuria,
• transient oligospermia (low sperm count),
• yellow discoloration of skin and body fluids*,
• induction of autoantibodies.

* Side effects reported after the medicine was placed on the market.
Very rarely, serious side effects occur, which may require the doctor to discontinue treatment.
If you experience symptoms such as itching, rash, difficulty breathing or swallowing, swelling of the eyelids, face, or other parts of the body, fever for unknown reasons, or chills, sore throat, cough, unusual fatigue, pallor, severe abdominal pain, jaundice, skin bleeding, unusual bruising, or central nervous system disorders (dizziness, tinnitus, uncoordinated movements, seizures, insomnia, and hallucinations), contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.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 this medicine.

5. How to store Sulfasalazin Krka

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 pack and other information

What Sulfasalazin Krka contains

• The active substance of the medicine is sulfasalazine. Each coated tablet contains sulfasalazine in the form of granules with povidone, equivalent to 500 mg of sulfasalazine.
• Other ingredients are: corn starch, magnesium stearate, anhydrous colloidal silica, hypromellose, propylene glycol.

What Sulfasalazin Krka looks like and contents of the pack

Round, slightly biconvex coated tablets, brown-yellow in color.
Packaging: 50 coated tablets in blisters, in a cardboard box.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Poland
phone: +48 22 573 75 00

Date of last revision of the leaflet: