SUMMARY CMI

SALAZOPYRIN^® and SALAZOPYRIN EN^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I taking SALAZOPYRIN?

SALAZOPYRIN contains the active ingredient sulfasalazine. SALAZOPYRIN is used to treat and manage ulcerative colitis and Crohn's disease which are inflammatory bowel diseases.

Salazopyrin EN tablets are also used to treat rheumatoid arthritis, which is a painful joint disease.

For more information, see Section 1. Why am I using SALAZOPYRIN? in the full CMI.

2. What should I know before I take SALAZOPYRIN?

Do not take if you have ever had an allergic reaction to sulfasalazine, sulfur-containing medicines, some oral sugar-controlling medicines, some diuretics (thiazide diuretics) salicylates, or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take SALAZOPYRIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SALAZOPYRIN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take SALAZOPYRIN?

• Your doctor will tell you how many tablets you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.
• Continue taking SALAZOPYRIN for as long as your doctor recommends.
• SALAZOPYRIN should be swallowed whole after meals with a full glass of water, taken at evenly spaced intervals over a 24 hour period.
• Do not crush, break or chew SALAZOPYRIN EN tablets

More instructions can be found in Section 4. How do I take SALAZOPYRIN? in the full CMI.

5. What should I know while taking SALAZOPYRIN?

For more information, see Section 5. What should I know while taking SALAZOPYRIN? in the full CMI.

6. Are there any side effects?

Common side effects include nausea or vomiting, diarrhoea and cold and flu symptoms. More serious side effects may be severe allergic reactions, serious skin infections or reactions or liver disease.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

SALAZOPYRIN^® and SALAZOPYRIN EN^®

Active ingredient(s): Sulfasalazine

Consumer Medicine Information (CMI)

"SALAZOPYRIN" will be used in this leaflet to refer to the "plain" and "EN" tablets unless specified otherwise.

This leaflet provides important information about using SALAZOPYRIN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using SALAZOPYRIN.

Where to find information in this leaflet:

1. Why am I taking SALAZOPYRIN?
2. What should I know before I take SALAZOPYRIN?
3. What if I am taking other medicines?
4. How do I take SALAZOPYRIN?
5. What should I know while taking SALAZOPYRIN?
6. Are there any side effects?
7. Product details

1. Why am I taking SALAZOPYRIN?

SALAZOPYRIN contains the active ingredient sulfasalazine. It has a number of effects in the body. It suppresses the immune system and is an anti-inflammatory medicine.

SALAZOPYRIN is used to treat and manage ulcerative colitis and Crohn's disease which are inflammatory bowel diseases.

SALAZOPYRIN EN tablets are also used to treat rheumatoid arthritis, which is a painful joint disease.

SALAZOPYRIN EN tablets help prevent damage to your joints. It works to slowly reduce the swelling and stiffness in your joints. It is usually given when a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) are not working.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor's prescription.

There is no evidence that SALAZOPYRIN is addictive.

2. What should I know before I take SALAZOPYRIN?

Warnings

Do not take SALAZOPYRIN if:

1. you are allergic to:

• sulfasalazine
• sulfur-containing medicines e.g. sulfonamides;
• some oral sugar-controlling medicines for diabetes (hypoglycaemics) e.g. glipizide;
• medicines knows as thiazide diuretics e.g. chlorothiazide
• medicines known as salicylates e.g. aspirin
• any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can take this medicine.

Symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

2. If you have the following medical conditions

• kidney or liver problems
• any form of blood disorder
• any form of intestinal or urinary obstruction
• porphyria (rare disease of blood pigments).

3. If the packaging is torn or shows signs of tampering or the tablets do not look quite right
4. If the expiry date (Exp.) on the carton has passed.

Do not give SALAZOPYRIN to children under two years of age.

Check with your doctor if you:

• have any other medical conditions, including if you:
• have a glucose-6-phosphate dehydrogenase (G-6-P) deficiency. This is a rare blood disorder which means that your body cannot get rid of some medicines
• have bronchial asthma (wheezing or shortness of breath)
• have a history of recurring or chronic infections.
• are allergic to any other medicines or any other substances such as foods, preservatives or dyes
• take any medicines for any other condition

Your doctor will send you to have blood tests to help assess your liver and kidney function and the levels of various cells in your bloodstream before you start treatment with SALAZOPYRIN. You may also have a urine test to monitor your kidney function.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

If you have any of the above, tell your doctor before you start taking SALAZOPYRIN.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the possible risks and benefits of taking SALAZOPYRIN during pregnancy and breast-feeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with SALAZOPYRIN and affect how it works. These include:

• oral medicines used to prevent blood clots e.g. warfarin
• methotrexate, a medicine used to treat arthritis and some cancers
• medicines to lower blood sugar or control diabetes
• mercaptopurine and azathioprine: medicines used to treat some cancers
• antacids: medicines that help to control heartburn or symptoms of indigestion
• digoxin: a medicine used to treat heart failure
• oxyphenbutazone, phenylbutazone, indomethacin and sulfinpyrazone which are medicines used to treat arthritis and gout
• salicylates: medicines used to treat minor relief of pain e.g. aspirin
• oxacillin and penicillins, which are types of antibiotics
• certain local anaesthetics
• medicines used to make the urine more acidic
• iron tablets

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SALAZOPYRIN.

4. How do I take SALAZOPYRIN?

How much to take and when

Your doctor will tell you how many tablets you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.

Continue taking SALAZOPYRIN for as long as your doctor recommends.

Inflammatory Bowel Disease

• Adults:
  - the usual initial dose is 2 to 4 tablets, four times a day.
  - The usual maintenance dose is 4 tablets a day.
• Children:
  - your doctor will determine the proper dose, taking into account the age and weight of the child.

Rheumatoid Arthritis

• Adults:
  - the usual dose is 2 SALAZOPYRIN ENtablets, two to three times a day.
  - It is usual to start taking SALAZOPYRIN EN tablets at a lower dose and gradually increase. Your doctor will advise whether you should do this and how to do this.
• SALAZOPYRIN EN is not recommended for treating rheumatoid arthritis in children.

How to take SALAZOPYRIN

• SALAZOPYRIN should be swallowed whole after meals with a full glass of water.
• SALAZOPYRIN tablets are usually taken at evenly spaced intervals over a 24 hour period.
• It is important to maintain adequate fluid intake while taking SALAZOPYRIN.
• Do not crush, break or chew SALAZOPYRIN EN tablets.

If you forget to take SALAZOPYRIN

SALAZOPYRIN should be taken regularly at the same time each day. If you miss your dose at the usual time, take your next dose at the normal time it's due.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you take too much SALAZOPYRIN

If you think that you have taken too much SALAZOPYRIN, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

The symptoms of taking too many SALAZOPYRIN tablets may include stomach discomfort and other effects listed under the heading "Side effects" in this leaflet.

5. What should I know while taking SALAZOPYRIN?

Things you should do

• Drink plenty of fluids while on SALAZOPYRIN.
• Protect your skin when you are in the sun, especially between 10am and 3pm.
• SALAZOPYRIN may cause your skin to be more sensitive to sunlight than it is normally. If outdoors, wear protective clothing and sunscreen. If your skin does appear to be burning, tell your doctor immediately. Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn.
• Tell all doctors, dentists,pharmacists and specialists who are treating you that you are taking SALAZOPYRIN.
• Make sure that you keep all doctor's appointments for check-ups and any tests that your doctor may order for you while you are taking Salazopyrin.

Call your doctor straight away if you:

• notice any unusual symptoms.
• become pregnant while taking SALAZOPYRIN.

Remind any doctor or dentist you visit that you are using SALAZOPYRIN.

Things you should not do

• Do not take SALAZOPYRIN to treat any other complaints unless your doctor tells you to.
• Do not stop taking SALAZOPYRIN or change the dose without first checking with your doctor.
• Do not give SALAZOPYRIN to anyone else even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how SALAZOPYRIN affects you.

SALAZOPYRIN may cause dizziness or hallucinations in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight where the temperature stays below 25°C; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

If you take your tablets out of their bottle, they may not keep as well. Make sure the container is closed after use.

Do not take this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What SALAZOPYRIN contains

Do not take this medicine if you are allergic to any of these ingredients.

What SALAZOPYRIN looks like

SALAZOPYRIN tablets are yellow-orange, round and scored tablets, marked with '101' on one side and 'KPh' on the other side. They come in plastic bottles containing 100 tablets (AUST R 14486).

SALAZOPYRIN EN tablets are enteric coated 500mg tablets. They are yellow-orange, elliptical convex tablets, marked with '102' on one side and 'KPh' on the other side. Salazopyrin EN 500 mg tablets come in plastic bottles containing 100 tablets (AUST R 14485).

Who distributes SALAZOPYRIN

In Australia:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in March 2023.

Published by MIMS May 2023

1 Name of Medicine

Sulfasalazine.

2 Qualitative and Quantitative Composition

Salazopyrin tablets contain 500 mg of sulfasalazine.
Salazopyrin EN-tabs enteric coated tablets contain 500 mg of sulfasalazine.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Salazopyrin (sulfasalazine) 500 mg tablets.

Salazopyrin EN-tabs (sulfasalazine) 500 mg enteric coated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Ulcerative colitis and Crohn's disease.

Rheumatoid arthritis.

4.2 Dose and Method of Administration

Inflammatory bowel disease.

Adults.

Children.

Adults.

Children.

Rheumatoid arthritis.

Adults.

Children.

4.3 Contraindications

Haematological, renal or hepatic dysfunction, allergic drug fever or skin eruptions due to sulphonamide derivatives including antibacterial sulphonamides, oral hypoglycaemics and thiazides.
Patients hypersensitive to sulfasalazine, its metabolites or any other component of the product, sulfonamides or salicylates.
Intestinal or urinary obstruction.
Patients with porphyria should not receive sulphonamides, as these drugs have been reported to precipitate an acute attack.
Children aged 2 years and younger.

4.4 Special Warnings and Precautions for Use

Serious infections.

Potential toxicity.

Monitoring for toxicity.

Hepatic or renal impairment and blood dyscrasias.

Hypersensitivity.

Drug rash with eosinophilia and systemic symptoms (DRESS).

Serious skin reactions.

Effects on folic acid.

G-6-PD deficiency.

Fluid intake.

Patients with atopic disease.

Interactions.

Reversible male infertility.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Sulphonamides may potentiate oral anticoagulants, methotrexate, and oral hypoglycaemics of the sulphonylurea type by displacing these drugs from their binding sites.
An increased incidence of gastrointestinal adverse events, especially nausea, has been reported with coadministration of oral sulfasalazine and methotrexate to rheumatoid arthritis patients.
Increased sulphonamide blood levels may occur in patients who are receiving urinary acidifiers, oral anticoagulants, indomethacin, or salicylates.

Antacids.

Penicillins.

Local anaesthetics derived from para-aminobenzoic acid.

Digoxin.

Folic acid.

Ferrous sulphate.

Thiopurine 6-mercaptopurine or azathioprine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Sulfasalazine shares the toxic potentialities of other sulphonamides, especially sulfapyridine, and the usual precautions of sulphonamide therapy should be observed. Moreover, it may be difficult to evaluate an adverse reaction in the individual case, since several of the untoward symptoms and signs encountered in conjunction with treatment with sulfasalazine may be part of the disease.. In assessing liver and joint complications, it should also be borne in mind that such are often associated with ulcerative colitis.
The acetylation rate of sulfapyridine is determined by genetic factors. Slow acetylators can be expected to show higher serum levels of sulfapyridine, and thus may show an increased tendency towards adverse reactions.
Many side effects are dose dependent, and the symptoms can often be alleviated by reducing the dosage by greater subdivision of the dose.
The most common side effects are nausea, vomiting and anorexia (which occur more frequently in patients receiving nonenteric coated sulfasalazine; to minimise the risk of gastrointestinal adverse reactions enteric coated tablets are used, which means that they do not disintegrate until they reach the small intestine); raised temperature; erythema and pruritus; headache; reversible oligospermia (oligospermia and infertility have been described in men treated with sulfasalazine. Withdrawal of the drug will reverse these effects).
The majority of the adverse reactions listed below have only seldom been reported, primarily in treatment of inflammatory bowel diseases and are typical of sulphonamides.

Infections and infestations.

Blood and lymphatic system disorders.

Immune system disorders.

Hypersensitivity reactions.

Metabolism and nutrition disorders.

Psychiatric disorders.

Nervous system disorders.

Ear and labyrinth disorders.

Cardiac disorders.

Vascular disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Hepatobiliary disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal and connective tissue disorders.

Renal and urinary disorders.

Reproductive system.

General disorders.

Investigations.

Reporting suspected adverse effects.

4.9 Overdose

The drug has low acute per oral toxicity in the absence of hypersensitivity. There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration.

Signs and symptoms.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Antibacterial effect.

Anti-inflammatory and immunoregulatory effect.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution and excretion.

Metabolism.

Protein binding.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Salazopyrin.

Salazopyrin EN-tabs.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Salazopyrin tablets and Salazopyrin EN tablets should be stored below 25°C.

6.5 Nature and Contents of Container

Salazopyrin (sulfasalazine) 500 mg tablets supplied in bottles of 100 tablets.
Salazopyrin EN-tabs (sulfasalazine) 500 mg enteric coated tablets supplied in bottles of 100 tablets.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Sulfasalazine is a bright yellow or brownish-yellow, fine powder. It is practically insoluble in water, very slightly soluble in ethanol (96 percent), practically insoluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides.
Chemical Name: 2-Hydroxy-5- [2-[4-(pyridin-2-ylsulphamoyl) phenyl]diazenyl] benzoic acid.
Molecular Formula: C₁₈H₁₄N₄O₅S.
Molecular Weight: 398.4.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes