Patient leaflet - Olsalazine Sodium 250 mg hard capsules
1. What Olsalazine Sodium Capsules is and what it is used for
Olsalazine Sodium belongs to a group of medicines called aminosalicylates.
Olsalazine Sodium Capsules works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation.
Olsalazine Sodium Capsules 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 Capsules
Do not take Olsalazine Sodium Capsules if you:
- are allergic to olsalazine sodium or any of the other ingredients of this medicine (listed in section 6)
- have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirin- containing products, including those bought over the counter)
- 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 Capsules 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 Capsules if you are under 12 years of age.
Other medicines and Olsalazine Sodium Capsules
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 Capsules may cause a greater risk of Reye’s syndrome; a life threatening condition)
- Any other medicine, including medicines obtained without a prescription.
Olsalazine Sodium Capsules with food and drink
Always take Olsalazine Sodium Capsules 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.
Driving and using machines
If you experience dizziness and/or blurred vision whilst taking Olsalazine Sodium Capsules do not drive or use machinery.
3. How to take Olsalazine Sodium Capsules
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 capsules twice a day (two in the morning, two 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 twelve capsules a day or more than four capsules 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 two capsules twice a day (two in the morning, two 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 Capsules than you should
Do not take more Olsalazine Sodium Capsules than you should. If you have taken too much, immediately go to the nearest hospital casualty department or your doctor. Take your capsules and this leaflet with you.
Signs of taking too much Olsalazine Sodium Capsules include nausea, vomiting and diarrhoea.
If you forget to take Olsalazine Sodium Capsules
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 Capsules
Do not stop taking Olsalazine Sodium Capsules without first talking to your doctor even if your symptoms have improved. 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.
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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, 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 Olsalazine Sodium Capsules
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton.
The expiry date refers to the last day of the month.
Do not store above 25°C. Keep the container tightly closed to protect from moisture.
If your medicine shows any signs of discoloration or deterioration consult your pharmacist for advice. If damaged, please tell your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw to throw away medicines you no longer use. These measures will help to protect the environment.
6. Content of the pack and other information
What Olsalazine Sodium Capsules contains
The active substance is Olsalazine Sodium 250 mg.
The other ingredients are:
Capsule contents: Magnesium stearate (E572)
Capsule shell: Gelatin, caramel (E150) and titanium dioxide (E171)
Printing ink: Shellac (E904), black iron oxide (E172) and propylene glycol (E1520).
May also contain potassium hydroxide.
What Olsalazine Sodium Capsules look like and contents of the pack
Olsalazine Sodium Capsules are beige colour and marked DIPENTUM® 250mg in black ink.
Available in bottles containing 112 capsules.
Manufactured by: Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK or Atnahs Pharma Denmark ApS, Copenhagen Towers, Ørestads Boulevard 108, 5th floor 2300 Copenhagen, Denmark or Coripharma ehf, Reykjavikurvegur 78, IS-220 Hafnarfjörður, Iceland. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Limited, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by: Maxearn Limited, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.
PL 20774/1583 – Olsalazine Sodium 250 mg Hard Capsules
This leaflet was revised on 20th August 2024.
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Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471 269
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