Salazopyrin EN-tabs 500 mg gastro-resistant tablets – patient leaflet, side effects, dosage

1. What Salazopyrin En-Tabs are and what

they are used for

2. What you need to know before you take

Salazopyrin En-Tabs

1. 3. How to take Salazopyrin En-Tabs
2. 4. Possible side effects
3. 5. How to store Salazopyrin En-Tabs
4. 6. Contents of the pack and other information
5. 1.

   What Salazopyrin En ‑Tabs are and what

   they are used for

The active substance in Salazopyrin En ‑Tabs is sulfasalazine which is an anti-inflammatory drug and belongs to a group of medicines called aminosalicylates.

Your doctor may give you Salazopyrin En ‑Tabs to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis.

Inflammatory bowel disease

The main forms of inflammatory bowel disease are Ulcerative Colitis and Crohn’s disease. Although the diseases have some features in common, there are some important differences.

Ulcerative Colitis is an inflammatory disease which affects only the large bowel (colon and back passage). The lining of the bowel becomes inflamed (red and swollen) and symptoms include abdominal pain and diarrhoea (which may contain blood and mucus).

Salazopyrin En ‑Tabs are used to control the flare ‑ups of ulcerative colitis. They may also be used at lower doses to prevent more flare ‑ups of ulcerative colitis.

Crohn’s disease is an inflammatory disease which may affect any part of the digestive system from the mouth to the anus, but it most commonly affects the last part of the small bowel and the first part of the large bowel. Symptoms include abdominal pain and diarrhoea (which may be bloody). Salazopyrin En ‑Tabs are used to control the flare ‑ups of Crohn’s Disease.

Rheumatoid arthritis

Salazopyrin En ‑Tabs are usually given when a group of medicines known as non-steroidal

anti-inflammatory drugs (NSAIDs e.g., aspirin and ibuprofen) are not working. They help prevent damage to your joints and work slowly to reduce swelling and stiffness in your joints.

You must talk to a doctor if you do not feel better or if you feel worse.

1. 2. What you need to know before you take Salazopyrin En ‑Tabs

Your doctor will perform complete blood counts and liver function tests before starting Salazopyrin and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urine analysis and an assessment of kidney function should also be done in all patients initiating treatment with Salazopyrin. For patients with baseline renal impairment, treatment with Salazopyrin should only be initiated if the benefits are considered to outweigh risk. Thereafter, periodic renal function monitoring, especially in the early months of treatment, should be conducted by your doctor during treatment with Salazopyrin. Treatment should be discontinued if renal function deteriorates.

Do not take Salazopyrin En ‑Tabs:

• if you are allergic to sulfasalazine or any of the other ingredients of this medicine (listed in section 6).

• if you are allergic to salicylates (e.g.,

  aspirin) or sulfonamides (e.g., a certain type of

  antibiotic).

• if you have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease.

Salazopyrin En ‑Tabs are not to be used in

children under 2 years of age.

Warnings and precautions

Tell your doctor if you are taking or have recently taken Salazopyrin En-Tabs, or any other sulfasalazine containing products, because they may affect results of blood and urine tests.

Talk to your doctor or pharmacist before taking Salazopyrin En-Tabs:

• if you have ever had any problems with your liver or kidneys.
• if you have been told by your doctor that you have an inherited condition in which the body doesn’t have enough of an enzyme known as glucose-6-dehydrogenase which helps red blood cells function normally.
• if you have ever had asthma.
• if you are a child and have arthritis.
• if you have a history of recurring chronic infections or an underlying condition which may predispose you to infections.

Oral sulfasalazine inhibits the absorption and

metabolism of folic acid and may cause folic

acid deficiency potentially resulting in serious

blood disorders (e.g., red blood cells that are

larger than normal and lower ‑than-normal

number of red and white blood cells and

platelets in the blood), this can be normalised by

administration of folic acid or folinic acid

(leucovorin).

Because sulfasalazine causes crystalluria and

kidney stone formation, adequate fluid intake

should be ensured during treatment.

Potentially life-threatening skin rashes (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Salazopyrin En ‑Tabs, appearing initially as reddish target ‑like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu ‑like symptoms. The rash may progress to widespread blistering or peeling of the skin.

The highest risk for occurrence of serious skin

reactions is within the first weeks of treatment.

If you have developed exfoliative dermatitis,

Stevens-Johnson syndrome or toxic epidermal

necrolysis with the use of Salazopyrin En ‑Tabs

you must not be re-started on Salazopyrin

En ‑Tabs at any time. If you develop a rash or

these skin symptoms, stop taking Salazopyrin

En ‑Tabs, seek immediate advice from a doctor

and tell your doctor that you are taking this

medicine.

Severe, life-threatening allergic reactions such

as Drug Rash with Eosinophilia and Systemic

Symptoms (DRESS) have been reported in patients taking various drugs including

Salazopyrin En ‑Tabs. It is important to note

that early signs of severe allergy, such as

fever or swollen lymph nodes, may be present

even though rash is not evident. If such signs

or symptoms are present, you should seek

immediate advice from a doctor. Salazopyrin

En ‑Tabs should be discontinued if an alternative

cause for the signs or symptoms cannot be

established.

Children and adolescents

Sulfasalazine is not recommended if you

are a child and have systemic-onset juvenile

rheumatoid arthritis (Stills disease).

Tests on your blood, kidneys, liver and urine

Your doctor will be taking blood tests to check your blood and your kidneys before you start treatment and regularly during treatment. They will also measure substances produced by your liver known as enzymes (liver function tests) before you start treatment and at regular intervals. They may also test your urine for protein and blood.

Other medicines and Salazopyrin En-Tabs

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, the following medicines may interact with Salazopyrin En ‑Tabs:

• any medicine for high blood sugar/diabetes.
• methenamine, an antibiotic for treating urinary tract infections.
• digoxin, used to treat heart failure.
• folate, sometimes taken during the first few weeks of pregnancy to reduce the risk of birth defects of the brain, spine or spinal cord, e.g., Spina Bifida.
• azathioprine and mercaptopurine – drugs used to help to suppress your body’s immune response in organ transplantation and certain chronic inflammations such as rheumatoid arthritis.

• methotrexate, used to treat rheumatoid

  arthritis.

  Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you MUST ask your doctor or pharmacist for advice before taking this medicine.

  You should avoid breast-feeding while taking this medicine. There have been reports of diarrhoea or blood in the stools of babies of breast-feeding mothers taking Salazopyrin En ‑Tabs. If this happens you must stop taking Salazopyrin En-Tabs and see your doctor as soon as possible.

  There have been reports of babies with birth

  defects of the brain, spine or spinal cord born to

  mothers who were exposed to sulfasalazine during pregnancy, although the role of sulfasalazine in these defects has not been established.

  Low sperm count and infertility may occur in men treated with sulfasalazine. Discontinuation of the medicine appears to reverse these effects within 2 to 3 months.

  Driving and using machines

  Salazopyrin En ‑Tabs is unlikely to affect your ability to drive or use machinery.

  Salazopyrin En-Tabs contains propylene

  glycol

  This medicine contains 5 mg propylene glycol in each tablet.

3. How to take Salazopyrin En ‑Tabs

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be taken with a glass of water and should be swallowed whole. Do not crush, break or chew the tablets.

The recommended doses for the following conditions are:

For Inflammatory bowel disease:

Ulcerative Colitis

• Adults and the Elderly

• Severe Flare ‑Ups 2 ‑4 tablets four times a day, with other medicines such as steroids.

  Do not leave more than 8 hours between the evening and following morning dose.

• Mild/Moderate Flare ‑Ups 2 ‑4 tablets four times a day, but not always with other medicines.

• Maintenance dose to control your flare-ups – Once the flare ‑up is controlled the dose is slowly reduced to 4 tablets each day. Your doctor will tell you how to reduce your dose.

  This lower dose may be continued for some

  time to help stop other flare ‑ups.

• Children 2 years of age and over

  Your doctor will tell you what dose your child

  will need to use. This will be based on your

  child’s weight.

Crohn’s Disease

• Adults and the Elderly

• Severe Flare ‑Ups - 2 ‑4 tablets four times a day, with other medicines such as steroids.

  Do not leave more than 8 hours between the evening and following morning dose.

• Mild/Moderate Flare ‑Ups - 2 ‑4 tablets four

  times a day, but not always with other

  medicines.

  • Children 2 years of age and over - Your doctor will tell you what dose your child will need to use. This will be based on your child’s weight.

For Rheumatoid arthritis

• Adults and the Elderly - Start on one tablet each day for the first week.

  Then, increase the dose by one tablet a day each week to a maximum of 6 tablets daily as shown in table.

*etc., to a maximum of 6 tablets per day.

Do not take more than 6 tablets a day.

• Children and adolescents - No recommendations.

How long should you use these tablets?

How long you use these tablets depends on how well the tablets suit you.

For Inflammatory bowel disease (Ulcerative Colitis and Crohn’s Disease)

• The tablets should start to work in a few days.
• If they work well, you may be using them for some time because inflammatory bowel disease may be a lifelong condition.

For Rheumatoid arthritis

• Salazopyrin En ‑Tabs may take some months to have a full effect, so you should keep taking them.
• You may notice some effect after a few weeks.
• When they start to work you will feel less stiffness in your joints, especially in the mornings.
• If they work well, you may be using them for some time.

Ensure that you drink adequate fluids whilst you are taking this medicine. This is to avoid problems with your kidneys.

If you take more Salazopyrin En ‑Tabs than you should

The most common symptoms of overdose are nausea and vomiting. If you experience any of these contact your nearest hospital casualty department or tell your doctor immediately, if you have taken too many tablets (an overdose) or if a child has taken your medicine.

Please take this leaflet and these tablets with you to the hospital casualty department or to your doctor.

If you forget to take Salazopyrin En-Tabs

If you forget to take a dose, just take the next dose as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Salazopyrin En ‑Tabs

Do not stop taking this medicine or alter the dose you are currently taking without seeing your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Salazopyrin En ‑Tabs and tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.

• An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

• If you develop a severe skin rash that causes

  blistering, (this can affect the mouth and tongue). Potentially life-threatening skin rashes (exfoliative dermatitis, Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN)) have been reported very rarely (see section 2 for a list of some of the possible symptoms). Your doctor will stop your treatment in these cases.

• If you have a serious skin condition with a rash

  (sometimes confined to the cheeks and bridge

  of the nose) peeling skin or blistering. It may

  be triggered or aggravated by sunlight. Should

  this occur, stop taking this medicine, avoid

  strong sunlight and contact your doctor

  promptly.

• If you are generally feeling unwell, have a fever, have pains in your joints, hives, swollen glands, rash and itching. These may be signs of a condition known as serum sickness. Your doctor will stop your treatment in these cases.
• If you are breast feeding stop taking this medicine, once you notice blood in stools or diarrhoea in newborn.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine as they will stop treatment in these cases:

• If you notice any unexplained bleeding.

• If you notice bruising, fever, rash, pallor (paleness), a severe sore throat or tiredness. These may be the first signs of an abnormality of the blood, including decreases in the number of red cells, white cells or platelets. Your doctor may take regular blood samples to test for these effects.

  Discontinue treatment with Salazopyrin while

  awaiting the results of blood tests.

Other side-effects that may occur are:

Very common (may affect more than 1 in 10 people)

• Indigestion, heartburn
• Feeling sick (nausea)

Common (may affect up to 1 in 10 people)

• Dizziness
• Difficulty sleeping
• Headache
• Changes in taste
• Abdominal pains
• Diarrhoea
• Being sick
• Ringing in the ears
• Blood shot eyes
• Inflamed mouth (stomatitis)
• Cough
• Itching of the skin
• Purple discolourations on the skin
• Joint pain
• Protein in urine
• Fever

Uncommon (may affect up to 1 in 100 people)

• Depression
• Fits, jerky, uncontrolled movements
• Loss of balance
• Shortness of breath
• Hair loss
• Hives

• Puffiness around the eyes and face

  • Yellowing of the skin or whites of the eyes

    (jaundice)

Not known (frequency cannot be estimated from the available data)

• Inflammation of the lining of the brain
• Severe diarrhoea

• Other blood disorders including anaemia,

  enlarged glands (lymph nodes), glandular

  fever, persistant sore throat

• Blood vessel inflammation
• Loss of appetite
• Hallucinations
• Changes in mental state
• Changes in smell

• Inflammation of the sac surrounding the heart

  (pericarditis)

• Inflammation of the heart muscle (myocarditis)

• Bluish tint or paleness to skin due to poor

  circulation

• Lung complications with breathlessness

• Inflammation of the salivary glands on either

  side of the face

• Kidney inflammation and kidney pain, kidney

  stones

• Liver disease (hepatitis)

• Inflammation of pancreas, which causes

  severe pain in the abdomen and face

• Rash, reddening or blistering of the skin,

  eczema, swelling of the skin

• Tingling, numbness, pain in hands and feet
• Blood and crystals in urine

• Urine or motions may become a yellow/

  orange colour which is normal and harmless.

  (See section 6)

• Temporary infertility in men. Fertility returns

  when treatment is stopped. Normal

  contraception should still be used.

• Dryness of the mouth and eyes
• Deficiency in folic acid (may cause fatigue)

Very rarely sulfasalazine has caused permanent staining of extended wear soft contact lenses. See section 6.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Salazopyrin En ‑Tabs

Keep out of the sight and reach of children.

Do not store above 30^o C.

Store in a dry place.

Do not use Salazopyrin En ‑Tabs after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Salazopyrin En-Tabs contain

The active substance is sulfasalazine. Each tablet contains 500mg of sulfasalazine.

Other ingredients are povidone, maize starch, magnesium stearate, colloidal silicon dioxide, cellulose acetate phthalate, propylene glycol (see section 2 (Salazopyrin En-Tabs contains propylene glycol), white wax, carnauba wax, glyceryl monostearate self-emulsifying, macrogol 20000 and talc.

What Salazopyrin En ‑Tabs looks like and contents of the pack

The tablets are yellow-orange in colour and are oval-shaped. They have “KPh” imprinted on one side and “102” on the other. They are coated with a film, which stops them breaking up until they leave the stomach. The tablets are the colour of the medicine itself. They contain no artificial colouring.

Salazopyrin En-Tabs are available in bottles containing 100 tablets.

Manufacturer

Recipharm Uppsala AB, Björkgatan 30,

SE-751 82 Uppsala, Sweden.

Procured from within the EU and repackaged by the Product Licence holder:

Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park, Ashby de la Zouch, Leicestershire LE65 2UY, UK.

For any information about this medicinal product, please contact the Product Licence Holder.

General Advice

Because the tablets are coloured yellow they may cause your urine or motions to become a yellow/orange colour. This is normal and harmless but can stain fabric. Any Salazopyrin soiled fabric should be put in to soak.

Difficult stains may be removed with a solution of washing soda. Always test the effect of soda on a small piece of the fabric first. Then apply a mild acid such as white vinegar.

Sulfasalazine has caused permanent staining of extended wear soft contact lenses. Although this happened very rarely. Daily ‑wear soft contact lenses and gas permeable lenses respond to standard cleaning if this happens.

PL 33652/0292

Leaflet edit date: 04.06.2025

Salazopyrin^® is a registered trademark of Pfizer Health AB.

Is this leaflet hard to see and read? Please call 01530 410920 to obtain the leaflet in a format suitable for you.

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