Active ingredient
- olsalazine sodium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 43252/0001.
Olsalazine Sodium 250 mg Capsules
Package leaflet: Information for the patient
Olsalazine Sodium® 250 mg Capsules
Olsalazine Sodium
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Olsalazine Sodium Capsule is and what it is used for
2. What you need to know before you take Olsalazine Sodium Capsule
3. How to take Olsalazine Sodium Capsule
4. Possible side effects
5. How to store Olsalazine Sodium Capsule
6. Content of the pack and other information
1. What Olsalazine Sodium Capsule is and what it is used for
Olsalazine Sodium belongs to a group of medicines called aminosalicylates.
Olsalazine Sodium Capsule works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation.
Olsalazine Sodium Capsule 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 Capsule
Do not take Olsalazine Sodium Capsules if you:
If any of the above apply to you talk to your doctor or pharmacist.
Warning and precautions
Before you start taking Olsalazine Sodium Capsule 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:
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 Capsules.
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”
Maintenance treatment
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):
Other possible side effects:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data :
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 Capsules
Keep this medicine 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 that month.
Store in a dry place.
Do not throw away 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. Contents of the pack and other information
What Olsalazine Sodium Capsules contains
The active substance is Olsalazine Sodium 250 mg.
The other ingredients are:
Capsules contents: Magnesium stearate
Capsules shell: Gelatin, caramel (E150) and titanium dioxide (E171) Printing ink: Shellac, iron oxide black (E172) and propylene glycol.
What Olsalazine Sodium Capsules looks like and content of the pack
Olsalazine Sodium Capsules are beige colour and marked Dipentum 250 mg. Olsalazine Sodium Capsules comes in plastic bottles containing 112 capsules.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in May 2021
If this leaflet is difficult to see or read or you would like it in a different format, please contact:
Sovereign House, Miles Gray Road, Basildon, SS14 3FR
01748 827215
+44 (0)1279 406759
+44 (0)1268 594777
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