Salazopyrina 500 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Salazopyrina 500 mg tablets

sulfasalazine

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

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

Leaflet contents:

1. What Salazopyrina 500 mg tablets are and what they are used for.

2. What you need to know before taking Salazopyrina 500 mg tablets.

3. How to take Salazopyrina 500 mg tablets.

4. Possible side effects.

5. How to store Salazopyrina 500 mg tablets.

6. Contents of the pack and other information.

1. What Salazopyrina 500 mg tablets is and what it is used for

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

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

2. What you need to know before taking Salazopyrina 500 mg tablets

Do not take Salazopyrina

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

Warnings and precautions
Talk to your doctor or pharmacist before starting Salazopyrina

• inform your doctor if you are taking or have recently taken Salazopyrina or any other product containing sulfasalazine, as this may affect blood and urine test results.
• if you have a history of recurrent or chronic infections, or any underlying condition that may predispose you to infections.
• if you have impaired liver, kidney, heart, or blood function. Before starting treatment, your doctor should perform blood and urine tests to ensure that your liver and kidney functions are normal and that your blood cells are within normal ranges. These tests should be repeated regularly during treatment.
• if during treatment you develop sore throat, fever, paleness, bruising, or yellowing of the skin or whites of the eyes, you must stop treatment and consult your doctor immediately. Your doctor will perform blood tests to determine whether the treatment is causing toxic effects on your bone marrow (the tissue inside bones where blood cells are produced), liver, or red blood cells. Depending on test results, your doctor will decide whether you can restart sulfasalazine treatment.
• if you have a hereditary condition called glucose-6-phosphate dehydrogenase deficiency (also known as favism), which causes destruction of red blood cells during certain infections or after consuming certain foods or medications, including sulfasalazine.
• if you have severe allergies or asthma, as sulfasalazine should be administered with caution in such cases.
• while taking sulfasalazine, you should drink sufficient fluids to prevent kidney stone formation.
• sulfasalazine may cause male infertility. Although these effects may reverse after stopping treatment, this should be considered if you are planning to have children.
• sulfasalazine may cause folic acid deficiency (also known as vitamin B9). This should be considered, especially in pregnant women or those planning pregnancy, as this vitamin helps prevent brain and spinal cord abnormalities in the fetus (see section “Pregnancy and breastfeeding”).
• sulfasalazine may cause yellow-orange discoloration of the urine and skin, which is not a cause for concern.
• Serious skin reactions, which may be life-threatening, have been reported with sulfasalazine use (known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and exfoliative dermatitis). These reactions typically begin with red spots or circular lesions on the body, often with a blister at the center. Other signs and symptoms may include mouth, throat, nose, or genital ulcers, and conjunctivitis (redness and inflammation of the eyes). These skin rashes are often accompanied by flu-like symptoms. The rash may progress to large blisters or skin peeling. Such reactions are more common during the first weeks of treatment. Patients who experience such reactions while taking sulfasalazine must not take this medicine again. If any of the above symptoms occur, seek immediate medical attention and inform the healthcare provider that you are taking this medicine.
• if during treatment you develop fever or lymph node abnormalities such as swelling, enlargement, or inflammation, with or without skin rash, you must stop treatment and consult your doctor immediately, as this could indicate a systemic allergic reaction that may be life-threatening.

Using Salazopyrina with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Folic Acid (also known as vitamin B9, used to treat deficiency of this vitamin or as a supplement during pregnancy)
• Digoxin (used to treat heart problems)
• Cyclosporine (used to control the body's immune response after organ transplant surgery and to prevent organ rejection)
• Anticoagulants, such as phenprocoumon, dicumarol, and others (used to reduce blood clotting)
• Antibiotics, such as ampicillin, neomycin, rifamycin, ethambutol, and others (used to treat infections)
• Iron (used to treat deficiency of this mineral)
• Calcium (used to treat deficiency of this mineral)
• Anion-exchange resins, such as colestipol, cholestyramine, and others (used to lower blood cholesterol levels)
• Azathioprine and 6-mercaptopurine (used as immunosuppressants)
• Diuretics, such as hydrochlorothiazide, indapamide, and others (used to eliminate fluid from the body)
• Oral antidiabetic agents, such as glipizide, gliclazide, glyburide, tolbutamide, chlorpropamide, and others (used to lower blood glucose in diabetic patients)
• Medicines that, after administration, enter the bloodstream and bind strongly to blood proteins, 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.
• Medicines known to cause liver damage

Pregnancy, breastfeeding, and fertility

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

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

It has been shown that the active ingredient in Salazopyrina (sulfasalazine) passes into breast milk. Therefore, the use of Salazopyrina during breastfeeding is not recommended, especially if the infant is premature or has a congenital condition 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 follow-up information was available, the bloody stools or diarrhea resolved after the mother stopped taking sulfasalazine.

Sulfasalazine has been shown to cause infertility in men. Although these effects may reverse after stopping treatment, this should be considered if you are planning to have children.

Driving and using machines

The effect of Salazopyrina on the ability to drive and use machines has not been studied.

3. How to take Salazopyrina 500 mg tablets

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The tablets should be taken every day at approximately the same time, preferably after meals. They may be swallowed whole or dissolved in water or another liquid, provided that one complete tablet is dissolved.

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 patients:

No dose adjustment is necessary; the same doses as in adults should be used.

Use in children (from 6 years of age):

The recommended dose in children is 40-60 mg/kg/day divided into 3-6 doses. This dose may be administered only if it can be measured in whole tablets (without splitting).

• 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 occur. If symptoms worsen, the dose may be increased to 1,000 – 2,000 mg (2-4 tablets) divided into 2-4 doses per day.

Use in elderly patients:

No dose adjustment is necessary; the same doses as in adults should be used.

Use in children (from 6 years of age):

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

This dose may be administered only if it can be measured in whole tablets (without splitting).

The score line is intended solely for dividing the tablet if you have difficulty swallowing it whole.

If you take more Salazopyrina than you should

The most common symptoms of overdose are nausea and vomiting. Patients with impaired renal function are at higher risk of developing toxicity.

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

If you forget to take Salazopyrina

Do not take a double dose to make up for missed doses. Take the missed dose as soon as possible, or if it is almost time for the next dose, wait and continue treatment as directed by your doctor.

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

4. Possible adverse effects

Like all medicines, Salazopyrina may cause adverse effects, although not everyone experiences them.

The most common adverse effects associated with treatment with Salazopyrina are: nausea, loss of appetite, stomach discomfort, and occasionally a slight increase in body temperature. In most cases, treatment can be continued, either by reducing the dose or after a few days without taking the medicine.

Adverse effects reported during clinical trials and post-marketing experience are:

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

Common (affects less than 1 in 10 people):

• Decrease in the number of white blood cells in the blood (leucopenia),
• Diarrhea, vomiting, abdominal pain
• Loss of appetite, taste disturbances
• Dizziness, headache, ringing in the ears (tinnitus)
• Cough,
• Itching
• Red or bluish spots on the skin (purpura)
• Joint pain
• Fever
• Presence of protein in urine

Uncommon (affects less than 1 in 100 people):

• Decrease in the number of platelets in the blood (thrombocytopenia)
• Depression
• Difficulty breathing
• Hair loss
• Urticaria, swelling of the face (facial edema)
• Abnormal results in liver function tests
• Yellowing 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 mouth lining (stomatitis), inflammation of the glands producing saliva (parotitis)

• Inflammation of the liver (hepatitis), decreased liver function (liver failure), sudden and severe deterioration of liver function (fulminant hepatitis)

• Inflammation of the membrane surrounding the heart (pericarditis), inflammation of the heart muscle (myocarditis)

• Lung lesions, sore throat

• Inflammation of blood vessels

• Lesions in the white part of the eye and in the transparent membrane covering the outer surface of the eye

• Swelling around the eyes

• Dysfunction of glands producing tears and saliva

• Inflammation of the membranes surrounding the brain (aseptic meningitis)

• Hallucinations, insomnia, brain dysfunction (encephalopathy), peripheral nerve disorders, smell disturbances, loss of coordination of movements, seizures, transient injury to the posterior part of the vertebrae, inflammation of the spinal cord causing weakness and numbness in the limbs

• Decrease in the number of white blood cells in the blood (agranulocytosis), decrease in the number of red blood cells in the blood (anemia), presence in the blood of red blood cells larger than normal (macrocytosis), decrease in all blood-forming cells (pancytopenia), reduced capacity of red blood cells to transport oxygen to tissues (methemoglobinemia)

• Decrease in protein levels in the blood

• Folate deficiency

• Severe allergic reaction affecting the whole body, abnormal immune system reaction resembling an allergy (serum sickness)

• Bluish discoloration of the skin and mucous membranes

• Whitish discoloration of the skin (pallor)

• Various types of skin reactions, some of which may be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis) (see section 2: Before using Salazopyrina).

• Allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). This syndrome is characterized by skin rash, fever, abnormally high levels of a type of white blood cells (eosinophils) in the blood (eosinophilia), and other symptoms which may include general malaise, fatigue, muscle and joint pain, blisters, mouth lesions, conjunctivitis, and liver inflammation (see section 2: Before using Salazopyrina).

• Abnormal skin reaction to sunlight exposure, yellowish discoloration of the skin and body fluids, bruising

• Rapid swelling of the skin and mucous membranes due to fluid accumulation (angioedema)

• Chronic connective tissue disease (systemic lupus erythematosus)

• Appearance of crystals and blood in urine, inflammation, injury, and kidney stones

• Decrease in sperm count, which recovers upon discontinuation of treatment, male infertility

• Drug-induced fever

• Formation of antibodies directed against the body's own tissues

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Salazopyrina 500 mg tablets

Do not store at temperatures above 30°C.

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Salazopyrina

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

Appearance of the product and pack sizes

Salazopyrina 500 mg tablets are orange-yellow in colour, round, biconvex, with the letters “KPh” printed on one side and the other side scored with the product code “101” printed on it.

The score is intended solely to facilitate breaking the tablet and swallowing, and is not intended to divide the tablet into equal doses.

The tablets are packed in polyethylene bottles with polypropylene screw caps. The pack contains 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Pfizer, S.L. Avda. de Europa, 20-B. Parque Empresarial La Moraleja. 28108, Alcobendas (Madrid). Spain

Manufacturer: Recipharm Uppsala AB. Bjökgatan, 30. Uppsala. Domkyrkofors. Uppsala, 753 23. Sweden

This leaflet was last approved in November 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/