Leaflet: Information for the user

Salazopyrin 500 mg tablets

sulfasalazine

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before starting to take Salazopyrin 500 mg tablets.

1. How to take Salazopyrin 500 mg tablets.

1. Possible side effects.

1. Storage of Salazopyrin 500 mg tablets.
2. Contents of the pack and additional information

Salazopyrina 500 mg tablets are indicated for the treatment of acute episodes and maintenance of remission of ulcerative colitis, as well as for the treatment of active Crohn's disease.

The active ingredient of Salazopyrina 500 mg tablets is sulfasalazine. Sulfasalazine belongs to the group of medicines called intestinal anti-inflammatory agents that show anti-inflammatory, immunosuppressive, and antibacterial activity. It is used to inhibit inflammatory conditions, particularly those related to intestinal mucosa.

Do not take Salazopyrina

• if you are allergic to sulfasalazine, its metabolites, sulfonamides, salicylates, or any other component of this medication (listed in section 6).
• if you have acute intermittent porphyria.
• if you have intestinal or urinary obstruction.
• if the patient is under two years old.

Warnings and precautionsConsult your doctor or pharmacist before starting to take Salazopyrina

• inform your doctor if you are taking or have taken recently Salazopyrina or any other product containing sulfasalazine, as it may affect the results of blood and urine tests.
• if you have a history of recurrent or chronic infections or any underlying condition that may predispose you to infections.
• if you have any liver, kidney, heart, or blood function abnormalities. Before starting treatment, your doctor will need to perform blood and urine tests to check that your liver and kidney function are not impaired, and that your blood cells are normal. Additionally, your doctor will need to repeat the tests regularly while you are on this medication.
• if during treatment you experience throat pain, fever, paleness, bruising, or the skin and white part of your eyes turn yellow, you should discontinue treatment and consult your doctor immediately. Your doctor will perform blood tests to determine if the treatment is causing toxic effects on your bone marrow (tissue inside the bone where blood cells are produced), liver, or red blood cells. Depending on the test results, your doctor will decide if you can resume treatment with sulfasalazine.
• if you have a hereditary disease called glucose-6-phosphate dehydrogenase deficiency (also known as favism), which causes destruction of red blood cells when certain infections or foods and medications, including sulfasalazine, are taken.
• if you have severe allergy or asthma, as sulfasalazine should be administered with caution if you have any of these conditions.
• while on treatment with sulfasalazine, you should drink sufficient amounts of fluids to prevent kidney stone formation.
• sulfasalazine causes infertility in men. Although these effects may disappear when treatment is discontinued, you should be aware of this if you are planning to have children.
• sulfasalazine may cause folate deficiency (also known as vitamin B9). This should be taken into account, especially in pregnant women or those planning to become pregnant, as this vitamin helps prevent brain and spinal cord abnormalities in the fetus (see section "Pregnancy and breastfeeding").
• sulfasalazine may cause orange-yellow discoloration of urine and skin, which should not be a concern.
• Severe skin reactions, including Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET), and exfoliative dermatitis, have been reported with the use of sulfasalazine. These reactions begin with the appearance of red patches or circles on the body, often with a blister in the center. Other signs and symptoms that may appear include mouth, throat, nose, or genital ulcers and conjunctivitis (inflammation of the eyes). These skin reactions often accompany flu-like symptoms. The rash may progress to large blisters or skin peeling. In general, these reactions are more common during the first weeks of treatment. Patients who develop these reactions while taking sulfasalazine should not use this medication again. If you experience any of the mentioned reactions or symptoms, seek medical attention immediately and inform your doctor that you are taking this medication.
• if during treatment you experience fever or lymph node enlargement, accompanied or not by skin rash, you should discontinue treatment and consult your doctor immediately, as it may be an allergic reaction that can be life-threatening.

Use of Salazopyrina with other medications

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

Some medications may affect how Salazopyrina works, or Salazopyrina may affect how other medications work. Inform your doctor if you are taking any of the following medications:

• Folic acid (also known as vitamin B9, used to treat folate deficiency in the body or as a supplement during pregnancy)
• Digoxin (used to treat heart problems)
• Ciclosporin (used to control the body's immune response after an organ transplant and prevent organ rejection)
• Anticoagulants, such as phenprocoumon and others (used to reduce blood clotting)
• Antibiotics, such as ampicillin, neomycin, rifampicin, ethambutol, and others (used to treat infections)
• Iron (used to treat iron deficiency)
• Calcium (used to treat calcium deficiency)
• Anion exchange resins, such as colestipol, cholestyramine, and others (used to reduce blood cholesterol levels)
• Azathioprine and 6-mercaptopurine (used as immunosuppressants)
• Diuretics, such as hydrochlorothiazide, indapamide, and others (used to eliminate fluids from the body)
• Oral antidiabetic medications, such as glipizide, gliclazide, glibenclamide, tolbutamide, chlorpropamide, and others (used to reduce blood glucose levels in diabetic patients)
• Medications that, when passed into the blood after administration, bind intensely to proteins present in the blood, such as methotrexate (used to treat rheumatoid arthritis and other inflammatory diseases), phenylbutazone (used to relieve pain and reduce inflammation and fever), sulfinpyrazone (used to treat gout), and others.
• Medications known to cause liver damage

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Salazopyrina should only be used during pregnancy when clearly necessary and if your doctor considers that the expected benefit outweighs the potential risks to the fetus. If your doctor decides that you should start or continue treatment with Salazopyrina during pregnancy, they will do so under close medical supervision, as Salazopyrina may cause folate deficiency (also known as vitamin B9), which could affect the fetus.

The active ingredient in Salazopyrina (sulfasalazine) passes into breast milk. Therefore, it is not recommended to use Salazopyrina during breastfeeding, especially if the infant is premature or has a birth defect called glucose-6-phosphate dehydrogenase deficiency.

Cases of bloody stools or bloody diarrhea have been reported in infants whose mothers were taking sulfasalazine. In cases where the outcome was reported, the bloody stools or diarrhea resolved after the mother discontinued sulfasalazine treatment.

Sulfasalazine has been shown to cause infertility in men. Although these effects may disappear when treatment is discontinued, you should be aware of this if you are planning to have children.

Driving and operating machinery

No studies have been conducted on the effect of Salazopyrina on the ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose for you, depending on the characteristics of your disease, and will inform you of the duration of your treatment.

The tablets should be taken every day at approximately the same hours, preferably after meals. They can be swallowed whole or dissolved in water or another liquid as long as one complete tablet dissolves.

Dosage recommendations:

• Acute attacks:

Use in adults:

Severe attacks: 1,000 – 2,000 mg (2-4 tablets) divided into 2-4 doses per day.

Moderate and mild attacks: 1,000 mg (2 tablets) divided into 2 doses per day.

Use in elderly individuals:

No dosage adjustment is necessary, using the same doses as in adults

Use in children (from 6 years old):

The recommended dose in children is 40-60 mg/kg/day divided into 3-6 doses. This dose can be administered as long as it can be dosed in the form of complete tablets (without breaking).

• Prevention of relapses:

Use in adults:

1,000 mg (2 tablets) divided into 2 doses per day. Treatment with this dose should continue indefinitely, unless side effects appear. In case of worsening, the dose can be increased to 1,000 – 2,000 mg (2-4 tablets) divided into 2-4 doses per day.

Use in elderly individuals:

No dosage adjustment is necessary, using the same doses as in adults

Use in children (from 6 years old):

The recommended dose in children is 20-30 mg/kg/day divided into 3-6 doses per day.

This dose can be administered as long as it can be dosed in the form of complete tablets (without breaking).

The groove is only for breaking the tablet if it is difficult to swallow whole.

If you take more Salazopyrina than you should

The most frequent symptoms of overdose are nausea and vomiting. Patients with renal impairment have a higher risk of developing toxicity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at 91 562 04 20 indicating the medication and the amount ingested. You may need measures to help eliminate the medication from your body (gastric lavage, intestinal evacuation, alkalization of urine, abundant water intake) and/or specific treatment to alleviate possible symptoms of overdose.

If you forgot to take Salazopyrina

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as possible or, if it is close to the time of the next dose, wait and continue treatment as usual, as indicated by your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Salazopyrin may cause side effects, although not everyone will experience them.

The most common side effects associated with Salazopyrin treatment are: nausea, loss of appetite, stomach discomfort, and occasional mild body temperature increase. In most cases, treatment can continue, either by reducing the dose or after a few days without taking the treatment.

The side effects reported during clinical trials and in the post-marketing experience are:

Very common (affects more than 1 in 10 patients):Stomach discomfort, nausea.

Common (affects less than 1 in 10 patients):

• Decreased white blood cell count in the blood (leucopenia),
• Diarrhea, vomiting, abdominal pain
• Loss of appetite, altered taste
• Dizziness, headache, ringing in the ears (tinnitus)
• Cough,
• Itching
• Red or blue spots on the skin (purpura)
• Joint pain
• Fever
• Presence of proteins in urine

Rare (affects less than 1 in 100 patients):

• Decreased platelet count in the blood (thrombocytopenia)
• Depression
• Difficulty breathing
• Hair loss
• Urticaria, facial swelling (edema)
• Abnormal liver function test results
• Yellow discoloration of the skin and mucous membranes (jaundice)

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

• Worsening of chronic inflammatory bowel disease (ulcerative colitis), inflammation of the final portion of the intestine (pseudomembranous colitis), inflammation of the pancreas (pancreatitis), inflammation of the mucous membrane of the mouth (stomatitis), inflammation of the glands that produce saliva (parotiditis)
• Inflammation of the liver (hepatitis), decreased liver function (hepatic failure), sudden and severe deterioration of liver function (fulminant hepatitis)
• Inflammation of the membrane that covers the heart (pericarditis), inflammation of the heart muscle (myocarditis)
• Lung damage, sore throat.
• Inflammation of blood vessels
• Damage to the white part of the eye and the transparent membrane that covers the outer surface of the eye.
• Swelling around the eyes
• Alteration of the glands that produce tears and saliva
• Inflammation of the membranes that surround the brain (aseptic meningitis)
• Hallucinations, insomnia, brain alteration (encephalopathy), alteration of peripheral nerves, alteration of the sense of smell, loss of coordination of movements, convulsions, temporary damage to the back of the vertebrae, inflammation of the spinal cord that causes weakness and numbness of the limbs
• Decreased white blood cell count in the blood (agranulocytosis), decreased red blood cell count in the blood (anemia), presence of large red blood cells in the blood (macrocytosis), decreased count of all blood cells (pancytopenia), decreased ability of red blood cells to transport oxygen to tissues (methemoglobinemia)
• Decreased protein levels in the blood
• Decreased folate
• Severe allergic reaction throughout the body, abnormal immune system reaction similar to an allergy (serum disease)
• Blue discoloration of the skin and mucous membranes
• Pale skin discoloration
• Diverse types of skin reactions, some that can threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis) (see section 2: Before using Salazopyrin).
• Allergic reactions such as drug eruption with eosinophilia and systemic symptoms. This syndrome is characterized by skin rash, fever, presence of an abnormally high number of a type of white blood cell (eosinophils) in the blood (eosinophilia), and other symptoms that may include general discomfort, fatigue, muscle and joint pain, blisters, mouth lesions, conjunctivitis, and liver inflammation (see section 2: Before using Salazopyrin).
• Abnormal skin response to sunlight, yellow discoloration of the skin and body fluids, bruises
• Rapid inflammation of the skin and mucous membranes due to fluid accumulation (angioedema).
• Chronic disease of connective tissue (systemic lupus erythematosus)
• Appearance of crystals and blood in urine, inflammation, damage, and kidney stones

• Decreased sperm count recovered upon suspending treatment, male infertility
• Drug-induced fever
• Formation of antibodies directed against the body's own tissues

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 30°C.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging..The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofSalazopyrina

• The active ingredient is sulfasalazine. Each tablet contains 500 mg of sulfasalazine.
• The other components are: povidone, cornstarch, magnesium stearate, and colloidal silicon dioxide.

Appearance of the product and size of the packaging

Salazopyrina 500 mg tablets are yellow-orange, round, convex, with the letters “KPh” printed on one face and the other face is scored and has the product code “101” printed.

The score is solely for breaking and facilitating swallowing, but not for dividing into equal doses.

The tablets are packaged in polyethylene bottles with a polypropylene screw cap. The packaging contains 50 tablets.

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the marketing authorization: Pfizer, S.L. Avda. de Europa, 20-B. Parque Empresarial La Moraleja. 28108, Alcobendas (Madrid). Spain

Responsible for manufacturing: Recipharm Uppsala AB. Bjökgatan, 30. Uppsala. Domkyrkofors. Uppsala, 753 23. Sweden

This leaflet was approved in November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/