What is a Patient Information Leaflet and why is it useful?

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.

  • 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, Olsalazine sodium 250 mg Capsules will be called Olsalazine Sodium Capsule.

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:

  • 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 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:

  • 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 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”

  • 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.

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 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

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

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:

Atnahs Pharma UK Limited
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FRUK