Dipentum Tablets 500 mg

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.
• In this leaflet, Dipentum 500 mg Tablets will be called Dipentum tablets.

1. What Dipentum tablets is and what it is used for
2. What you need to know before you take Dipentum tablets
3. How to take Dipentum tablets
4. Possible side effects
5. How to store Dipentum tablets
6. Content of the pack and further information

• if you are allergic to olsalazine sodium or any of the other ingredients of this medicine (listed in section 6)
• If you have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirin- containing products, including those bought over the counter)
• If you have severe kidney disease

If any of the above apply to you talk to your doctor or pharmacist.

Before you start taking Dipentum tablets your doctor will do a blood test. This will be repeated every three months for the first year, every six months for the next four years and then once a year. This is to see how well your liver and kidneys are functioning.

You should also check for signs of worsening of allergies such as asthma.

Tell your doctor immediately if you develop unexplained bruising or bleeding accompanied with fever, dizziness, sore throat and mouth ulcers. You could have developed a blood disorder.

Do not take Dipentum tablets if you are under 12 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might have taken any of the following medicines:

• Aspirin or any other aspirin-containing medicines or salicylates
• Other drugs to treat ulcerative colitis
• Blood thinning agents such as warfarin or heparin or heparinoids
• Drugs that treat irritable bowel syndrome and cancer such as thioguanine and 6 mercaptopurine
• If you have recently had chickenpox vaccination (taking Dipentum tablets may cause a greater risk of Reye's syndrome; a life threatening condition)
• Any other medicine, including medicines obtained without a prescription.

Always take Dipentum tablets with a glass of water after food.

If you are pregnant, or trying to become pregnant or breastfeeding, talk to your doctor before taking Dipentum tablets.

If you experience dizziness and/or blurred vision whilst taking Dipentum tablets do not drive or use machinery.

• The usual starting dose is two tablets a day (one in the morning, one in the evening at the end of a meal).
• Your doctor may increase your dose until your condition improves.
• You must not take more than six tablets a day or more than two tablets at a time.
• If a "flare-up" is severe you are likely to be given additional medicines.

• Once the "flare-up" is controlled your doctor may gradually reduce your dose to one tablet twice a day (one in the morning, one in the evening at the end of a meal).
• This is to prevent further "flare-ups”
• You may remain on this treatment, provided it remains effective, for a long period of time.

Do not take more Olsalazine Sodium tablets than you should. If you have taken too much, immediately go to the nearest hospital casualty department or your doctor.

Take your tablets and this leaflet with you.

Signs of taking too much Dipentum tablets include nausea, vomiting and diarrhoea.

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

Do not stop taking Dipentum tablets without first talking to your doctor even if your symptoms have improved.

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

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per tablet.

• Swelling of face, lips, tongue or throat which may cause difficulty in swallowing/breathing
• Blood disorders (reduced number of blood cells) where you could have the following symptoms: bruise or bleed easily, have a persistent sore throat, mouth ulcers, dizziness and feeling tired and feverish
• Pancreatitis where you could have the following symptoms: severe stomach pain, fever, feeling sick/being sick
• Liver disease where you could have the following symptoms: feeling sick/being sick, loss of appetite, feeling generally unwell, itching and the whites of the eyes may become yellow.

Common: affects less than 1 in 10 people

• Headache
• Diarrhoea. It does not usually last very long, but taking your medicine at the end of a meal helps to reduce diarrhoea.
• Feeling sick
• Rash
• Joint pain

Uncommon: affects less than 1 in 100 people

• Fever
• Being sick
• Indigestion
• Raised liver enzymes (tests your doctor may perform will show changed liver function)
• Itching and/or hives, a nettle-like rash
• Unusual hair loss
• Light sensitivity.
• Increased heart rate
• Shortness of breath
• Muscle pain
• Pins and needles
• Depression
• Dizziness

Not known: frequency cannot be estimated from the available data:

• Altered breakdown of blood cells in the liver which could result in jaundice (yellowing of skin/eyes)
• Stomach pain
• Inflammation of heart muscle
• Awareness of your heartbeat
• Inflammation of sac around heart muscle
• Pain in passing urine or blood in the urine
• Difficulty in breathing
• Blurred vision
• Loss of touch sensation/numbness

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

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 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.

The active substance is Olsalazine Sodium 500 mg.

The other ingredients are magnesium stearate, colloidal silicon dioxide, polyvidone 30, crospovidone and ethanol.

Dipentum tablets are yellow, capsule-shaped tablets debossed with ‘D500' on one side and scored on the other side.

Dipentum tablets comes in plastic bottles containing 60 and 100 tablets. Not all pack sizes may be marketed.