OLSALAZINE SODIUM 500 MG TABLETS - patient leaflet, side effects, dosage

Olsalazine Sodium 500 mg Tablets

Your medicine is known by the above name but will be referred to as Olsalazine Tablets throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• 1. What Olsalazine Tablets are for

• 2. Before you take Olsalazine Tablets

• 3. How to take Olsalazine Tablets

• 4. Possible side effects

• 5. How to store Olsalazine Tablets

• 6. Further information.

• 1. What Olsalazine Tablets are for

Olsalazine Tablets belong to a group of medicines called aminosalicylates.

Olsalazine Tablets work by reducing pain and swelling (inflammation) in the intestine. They reduce the actions of substances in the body that cause inflammation.

Olsalazine Tablets are used to treat an inflammation of your large intestine (colon) called ulcerative colitis. They are 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. Before you take Olsalazine Tablets
  
  Do not take if:

• You are allergic to olsalazine sodium or any of the other ingredients of Olsalazine Tablets (see section 6)
• You have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirin-containing products, including those bought over the counter)
• You have severe kidney disease
• You are a child under 12.

If any of the above apply to you talk to your doctor or pharmacist.

Take special care

Before you start taking Olsalazine 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.

Tell your doctor if you are taking 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 Tablets may cause a greater risk of Reye’s syndrome; a life threatening condition)
• Any other medicine, including medicines obtained without a prescription.

Taking Olsalazine Tablets with food and drink

Always take Olsalazine Tablets with a glass of water after food.

Pregnancy and breast-feeding

If you are pregnant, or trying to become pregnant or breastfeeding, talk to your doctor before taking Olsalazine Tablets.

Driving and using machines

If you experience dizziness and/or blurred vision whilst taking Olsalazine Tablets do not drive or use machinery.

3. how to take olsalazine tablets

Always use Olsalazine Tablets exactly as your doctor has told you.

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.
• 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 Tablets than you should

Do not take more Olsalazine Tablets than you should. If you have taken too many, immediately go to the nearest hospital casualty department or your doctor. Take your tablets and this leaflet with you. Signs of taking too many Olsalazine Tablets include nausea, vomiting and diarrhoea.

If you forget to take Olsalazine Tablets

If you forget a dose take the next one as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Olsalazine Tablets

Do not stop taking Olsalazine Tablets without first talking to your doctor even if your symptoms have improved.

Information about the ingredients

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per tablet.

lf you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines Olsalazine Tablets 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

The frequency of the following side effects is unknown:

• 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: or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively you can call Freephone 0808 100 3352 (available 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store olsalazine tablets

Keep out of the sight and reach of children.

Do not use Olsalazine Tablets after the expiry date on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original packaging. Store in a dry place.

If your tablets show signs of deterioration or discolouration seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

• 6. Further information
  
  What Olsalazine Tablets contain

  Each tablet contains 500 mg olsalazine sodium.