Sulfasalazine 250mg/5ml Oral Suspension

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Sulfasalazine Suspension is and what it is used for
2. What you need to know before you take Sulfasalazine Suspension
3. How to take Sulfasalazine Suspension
4. Possible side effects
5. How to store Sulfasalazine Suspension
6. Contents of the pack and other information

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). Sulfasalazine is used to control the flare-ups of ulcerative colitis. It 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). Sulfasalazine is used to control flare-ups of Crohn’s Disease.

Do not take Sulfasalazine if you:

• are allergic (hypersensitive) to any of the ingredients of Sulfasalazine Suspension
• are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of antibiotic)
• have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease.

Sulfasalazine should not be used in children under 2 years of age.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of sulfasalazine, 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 Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of sulfasalazine, you must not be re-started on sulfasalazine at any time. If you develop a rash or these skin symptoms, stop taking sulfasalazine, seek urgent advice from a doctor and tell him that you are taking this medicine.

Warnings and precautions

If you answer YES to any of the questions below tell your doctor or pharmacist before taking this medicine:

• Have you ever had any problems with your liver or kidneys?
• Have you 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 or any serious blood disorders?
• Have you ever had asthma?
• If you are a child and have arthritis?

Other medicines and Sulfasalazine

Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Sulfasalazine:

• any medicine for high blood sugar/diabetes
• methenamine, an antibiotic for treating urinary tract infections
• digoxin, used to treat heart failure
• folate, folic acid or folinic acid, sometimes taken during the first few weeks of pregnancy to reduce the risk of neural tube defects, e.g. Spina Bifida
• azathioprine and mercaptopurine, drugs used to suppress your body’s immune response in organ transplantation and certain chronic inflammations (e.g. rheumatoid arthritis)
• methotrexate, used to treat rheumatoid arthritis.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Sulfasalazine Suspension with food and drink

Sulfasalazine Suspension should be taken with or after food.

Pregnancy

Tell your doctor if you are pregnant, planning to become pregnant or become pregnant whilst taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

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 sulfasalazine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Sulfasalazine is unlikely to affect your ability to drive or use machines.

Sulfasalazine Suspension contains:

• This medicine contains 4.7 mg of alcohol (ethanol) in each 5ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
• This medicine contains 5 mg sodium benzoate in each 5ml.
• This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’.

Ulcerative Colitis and Crohn’s Disease

Adults and the Elderly

Severe flare-ups: 20-40 ml four times a day, with other medicines such as steroids. Do not leave more than 8 hours between the evening and the following morning dose.

Mild/Moderate flare-ups: 20-40 ml four times a day, but not always with other medicines

Ulcerative Colitis

Maintenance: Once the flare-up is controlled the dose is slowly reduced to 40 ml 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.

How long should you use Sulfasalazine?

This depends on how well the suspension suits you. The suspension starts to work in a few days. If it works well, you may be using it for some time. Do not stop using the suspension just because you feel better without first talking to your doctor.

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

If you take more Sulfasalazine than you should

Contact your nearest hospital casualty department or tell your doctor immediately, if you have taken too much suspension or if a child has taken your medicine.

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

If you forget to take Sulfasalazine

If you forget to take a dose, take the next dose as usual. Do not take a double dose to make up for a missed one.

Stop taking Sulfasalazine and tell your doctor immediately if you experience any of the following symptoms after taking this medicine.

• An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2). Frequency: very rare (affects less than 1 person in 10,000)
• 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 immediately
• 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.

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 or bruising, paleness, tiredness, fever, rash, severe sore throat, bleeding under the skin, difficulty getting over an infection and generally feeling unwell.

These may be the first signs of an abnormality of the blood, including decreases in the number of red and white blood cells or platelets. Your doctor may take regular blood samples to test for these effects.

Very common side effects which may affect more than 1 person in 10:

• indigestion, heartburn
• feeling sick (nausea)
• stomach pain.

Common side effects which may affect more than 1 person in 100:

• dizziness
• headache
• changes in taste
• ringing in ears
• cough
• itching of the skin
• protein in urine
• abdominal pain
• severe chills
• joint pain
• mouth ulcers
• difficulty sleeping
• fever
• diarrhoea
• being sick
• inflamed mouth (stomatitis)
• blood shot eyes and eye infections.

Uncommon side effects which may affect more than 1 person in 1000:

• depression
• shortness of breath
• hair loss
• hives
• puffiness around the eyes and face
• loss of balance.

Unknown side effects which have been reported since marketing this product

• loss of appetite
• yellowing of the skin or whites of the eyes (jaundice)
• tingling, numbness, pains in hands and feet
• fits, jerky uncontrolled movements
• seeing and hearing things that are not there (hallucinations)
• inflammation of the lining of the brain
• inflammation of the sac surrounding the heart (pericarditis)
• severe diarrhoea
• changes in smell
• change in mental state, loss of memory
• inflammation of the salivary glands on either side of the face
• inflammation of the heart muscle (myocarditis)
• inflammation of the pancreas
• skin colour change (to a light blue)
• blood vessel inflammation
• blood in urine
• urine or motions may become a yellow/orange colour which is normal and harmless
• lung complications with breathlessness
• impaired folic acid absorption
• eczema of the skin
• kidney inflammation and kidney pain
• liver disease (hepatitis)
• temporary infertility in men. Fertility returns when treatment is stopped. Normal contraception should still be used
• other blood disorders including anaemia and enlarged glands (lymph nodes).

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) at regular intervals.

They may also test your urine for protein and blood.

Very rarely Sulfasalazine has caused permanent staining of extended wear soft contact lenses (see section 6 for further information).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can help provide more information on the safety of this medicine.

What Sulfasalazine Suspension contains

The active substance is sulfasalazine. Each 5ml of suspension contains 250mg of the active ingredient sulfasalazine.

The other ingredients are xanthan gum (E415), dispersible cellulose, acesulfame K (E950), orange flavour (containing ethanol and butylated hydroxyanisole (E320)), lemon flavour, polysorbate 80, sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331) and water.

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.

What Sulfasalazine Suspension looks like and contents of the pack

The suspension is orange/yellow in colour, with an orange-lemon flavour. The medicine comes in a brown glass bottle which contains 500ml of suspension. The suspension is the colour of the medicine itself. Contains no artificial colouring.

Marketing Authorisation Holder and Manufacturer