Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Olsalazine Sodium 500 mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Olsalazine sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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. Itreduces 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 "flareups"), and at alower 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).
What you need to know before you take it
e 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 fouryears 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 driveor use machinery.
How to take it
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 shownclearly 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 elderlyAcute 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. 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 yoursymptoms 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: 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 thisleaflet, 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.
How to store it
Olsalazine Sodium tablets Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to thelast day of that month. Store in a dry place. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Content of the pack and other information What Olsalazine Sodium tablets contains The active substance is Olsalazine Sodium 500 mg. The other ingredients are magnesium stearate, colloidal silicon dioxide, polyvidone 30, crospovidone and ethanol. What Olsalazine Sodium tablets looks like and content of the pack Olsalazine Sodium tablets are yellow, capsule-shaped tablets debossed with 'D500' on one side andscored on the other side. Olsalazine Sodium tablets comes in plastic bottles containing 60 and 100 tablets. Not all pack sizesmay be marketed. Marketing Authorisation Holder Atnahs Pharma UK Limited Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK. Manufacturer Waymade plc Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK. UCB Pharma Limited 208 Bath Road Slough
Berkshire SL1 3WE United Kingdom Coripharma ehf Reykjavíkurvegur 78 IS-220 Hafnarfjörður Iceland This leaflet was last revised in August 2023 If this leaflet is difficult to see or read or you would like it in a different format, please contact: Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK.
Frequently asked questions about Olsalazine Sodium 500 mg Tablets
How do I take Olsalazine Sodium 500 mg Tablets?
Olsalazine Sodium 500 mg Tablets comes as tablet containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Olsalazine Sodium 500 mg Tablets?
The active substance in Olsalazine Sodium 500 mg Tablets is olsalazine sodium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Olsalazine Sodium 500 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Olsalazine Sodium 500 mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: olsalazine sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Oral treatment of mild active ulcerative colitis and maintenance of remission.
4.2. Posology and method of administration
Acute mild disease:
Adults including elderly: Commence on 1 g daily in divided doses and depending upon the patient response, titrate the dose upwards to a maximum of 3 g daily over one week.
A single dose should not exceed 1 g.
Olsalazine should be taken with food.
Remission:
Adults including the elderly: one tablet (0.5 g) twice daily, taken with food.
Olsalazine has been used concomitantly with gluco-corticosteroids.
4.3. Contraindications
Hypersensitivity to olsalazine or other salicylates or any other of the excipients listed in section 6.1.
There is no experience of the use of olsalazine in patients with significant renal impairment. Olsalazine is contra-indicated in patients with significant renal impairment.
4.4. Special warnings and precautions for use
It is recommended to monitor patients with impaired kidney or liver function.
Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions.
Baseline renal function measurement is required in all patients initiating treatment with olsalazine.
For patients with baseline renal impairment, treatment with olsalazine should only be initiated if the benefits are considered to outweigh risk. In addition, periodic renal function monitoring, especially in the early months of treatment, should be conducted based on clinical judgment taking baseline renal function into account. It is recommended to monitor renal function in patients receiving olsalazine, by estimating serum creatinine before treatment, every 3 months for the first year, every 6 months for the next 4 years, and annually after 5 years of treatment. Treatment should be discontinued if renal function deteriorates.
Serious blood dyscrasias have been reported very rarely with olsalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever, sore throat or mouth ulcers. Treatment should be stopped if there is a suspicion or evidence of a blood dyscrasia.
Patients or their carers should be instructed how to recognise the signs of haematotoxicity and should be advised to contact their physicians immediately if the symptoms develop.
4.5. Interaction with other medicinal products and other forms of interaction
The coadministration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding, more specifically hematomas following neuraxial anaesthesia. Salicylates should be discontinued prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it is recommended to monitor patients closely for bleeding.
Increased prothrombin time in patients taking concomitant warfarin has been reported.
The coadministration of olsalazine and 6-mercaptopurine or thioguanine may result in an increased risk of myelosuppression. If coadministered with 6-mercaptopurine, it is recommended to use the lowest possible doses of each drug and to monitor the patient, especially for leukopenia. In case of coadministration with thioguanine, careful monitoring of blood counts is recommended.
It is recommended not to give salicylates for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye's syndrome.
4.6. Fertility, pregnancy and lactation
Pregnancy:
Olsalazine has been shown to produce fetal developmental toxicity as indicated by reduced fetal weights, retarded ossifications and immaturity of the fetal visceral organs when given during organogenesis to pregnant rats in doses 5 to 20 times the human dose (100 to 400 mg/kg).
There are no adequate and well-controlled studies in pregnant women. Olsalazine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
There is a reported risk of stillborn or pre-term birth but with no substantial risk of malformation.
Breast-feeding:
Small amounts of the active metabolite of olsalazine (5-ASA) may pass into breast milk. Harmful infant effects (diarrhoea) have been reported when 5-ASA was used during breastfeeding. Unless the benefit of the treatment outweighs the risks, olsalazine should not be taken by breast-feeding women, or patients should be advised to discontinue breastfeeding if using olsalazine.
4.7. Effects on ability to drive and use machines
On the basis of the pharmacodynamic profile and reported adverse events, olsalazine has minor or moderate influence on the ability to drive and use machines in patients that experience dizziness and /or blurred vision when taking olsalazine. Caution is recommended in patients that experience these symptoms.
4.8. Undesirable effects
Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
The most common side effect is diarrhoea which is usually transient. Where it does not, taking the drug at the end of a more substantial meal, dose titration or dose reduction are usually effective. Withdrawal in clinical studies when the drug was taken at the end of meals was around 3%. Where diarrhoea persists, the drug should be stopped.
In addition, the following undesirable effects have been reported:
General disorders and administration site conditions:
Common:
headache
Uncommon:
pyrexia
Blood and lymphatic system disorders:
Uncommon:
thrombocytopenia
Not known:
aplastic anaemia, eosinophilia, haemolytic anemia, leukopenia, neutropenia, pancytopenia
Gastrointestinal disorders:
Common:
diarrhoea, nausea
Uncommon:
vomiting, dyspepsia
Not known:
abdominal pain upper, pancreatitis
Hepatobiliary disorders:
Uncommon:
hepatic enzyme increased
Not known:
hepatitis, increased bilirubin
Skin and subcutaneous tissue disorders:
Common:
rash
Uncommon:
pruritus, alopecia, photosensitivity reaction, urticaria
Not known:
angioneurotic oedema
Cardiac disorders:
Uncommon:
tachycardia
Not known:
myocarditis, palpitations, pericarditis
Renal and urinary disorders:
Not known:
interstitial nephritis
Respiratory, thoracic and mediastinal disorders:
Uncommon:
dyspnoea
Not known:
interstitial lung disease
Musculoskeletal and connective tissue disorders:
Common:
arthralgia
Uncommon:
myalgia
Nervous system disorders:
Uncommon:
dizziness, paraesthesia
Not known:
peripheral neuropathy
Psychiatric disorders:
Uncommon:
depression
Eye disorders:
Not known:
vision blurred
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
The knowledge of overdosage is limited. Possible overdose symptoms include nausea, vomiting and diarrhoea. It is recommended to check haematology, acid-base, electrolyte, liver and kidney status, and to provide supportive treatment. There is no specific antidote to olsalazine sodium.
As a salicylate, interference in biochemical and other tests characteristic of salicylates may occur.
💬 Ask about this leaflet
Ask anything about Olsalazine Sodium 500 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.