Patient leaflet - Olsalazine Sodium 500 mg tablets
1. What Olsalazine Sodium tablets are and what it is used for
Olsalazine Sodium tablets belongs to a group of medicines called aminosalicylates.
Olsalazine Sodium tablets works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation. Olsalazine Sodium tablets is used to treat an inflammation of your large intestine (colon) called ulcerative colitis. It is used for short-term (acute) attacks (called "flare-ups"), and at a lower dose to maintain the improvement (maintenance treatment) and keep away further "flare-ups".
If untreated, a severe attack of ulcerative colitis may cause death due to dehydration and bursting of the colon (peritonitis).
2. What you need to know before you take Olsalazine Sodium tablets
Do not take Olsalazine Sodium tablets:
- 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.
Warning and Precautions
Before you start taking Olsalazine Sodium 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.
Children and adolescents
Do not take Olsalazine Sodium tablets if you are under 12 years of age.
Other medicines and Olsalazine Sodium tablets
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 Olsalazine
Sodium tablets may cause a greater risk of Reye's syndrome; a life threatening condition)
- Any other medicine, including medicines obtained without a prescription.
Olsalazine Sodium tablets with food and drink
Always take Olsalazine Sodium tablets with a glass of water after food.
Pregnancy, breast-feeding and fertility
If you are pregnant, or trying to become pregnant or breastfeeding, talk to your doctor before taking Olsalazine Sodium tablets.
Driving and using machines
If you experience dizziness and/or blurred vision whilst taking Olsalazine Sodium tablets do not drive or use machinery.
3. How to take Olsalazine Sodium tablets
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Remember: Your medicine should always be taken after food.
Adults, children over 12 and the elderly
Acute flare-ups
- 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.
Maintenance treatment
- 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.
If you take more Olsalazine Sodium tablets than you should
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 Olsalazine Sodium tablets include nausea, vomiting and diarrhoea.
Package leaflet: Information for the patient
Olsalazine Sodium 500 mg tablets
If you forget to take Olsalazine Sodium tablets
Do not take a double dose to make up for a forgotten dose. If you forget a dose take the next one as usual.
If you stop taking Olsalazine Sodium tablets
Do not stop taking Olsalazine Sodium 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.
Information about the ingredients
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per tablet.
If you have any further questions about 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.
Seek immediate medical help if you have any of the following symptoms (the frequency of these side effects is unknown):
- 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.
Other possible side effects:
Common (may affect up to 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 (may affect up to 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.
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 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 Olsalazine Sodium tablets
Keep out of the sight and reach of children.
Do not use Olsalazine Sodium tablets after the expiry date on the carton. The expiry date refers to the last day of that month.
Store in a dry place.
Store in the original container.
Store at room temperature (15-25 oC)
If this medicine becomes discoloured or shows any other signs of deterioration, please contact your pharmacist who will advise you on what to do.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
6. Contents of the pack and other information
What Olsalazine Sodium tablets contain
The active substance is olsalazine sodium 500 mg.
The other ingredients are magnesium stearate, colloidal silicon dioxide, polyvidone 30, crospovidone and ethanol 99,5%.
What Olsalazine Sodium tablets look like
Olsalazine Sodium tablets are yellow, capsule-shaped tablets debossed with ‘D500' on one side and scored on the other side.
Olsalazine Sodium tablets come in plastic bottles containing 100 tablets.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product Licence holder Orifarm A/S, Energivej 15, 5260 Odense S, DK
For any information about this medicine, please contact the Product Licence Holder on
www.orifarm.com/uk
Or phone: (+44) 1923 204333
Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, CZ Manufactured by Coripharma ehf, Reykjavikurvegur 78, IS-220 Hafnarfjörður, Iceland
Olsalazine Sodium 500 mg tablets
PL 46927/0018
Leaflet revision date: 22/08/2025
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