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OLSALAZINE SODIUM 250 MG HARD CAPSULES

Active substance(s): OLSALAZINE SODIUM / OLSALAZINE SODIUM

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Patient Information Leaflet

Olsalazine Sodium 250 mg Hard Capsules
Your medicine is known by the above name but will be referred to as Olsalazine Capsules
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.
In this leaflet:
1. What Olsalazine Capsules are for
2. Before you take Olsalazine Capsules
3. How to take Olsalazine Capsules
4. Possible side effects
5. How to store Olsalazine Capsules
6. Further information.
1. What Olsalazine Capsules are for
Olsalazine Capsules belong to a group of medicines called aminosalicylates.
Olsalazine Capsules work by reducing pain and swelling (inflammation) in the intestine.
They reduce the actions of substances in the body that cause inflammation.
Olsalazine Capsules 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 Capsules
Do not take if:
• You are allergic to olsalazine sodium or any of the other ingredients of Olsalazine
Capsules (see section 6)
• You have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirincontaining 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 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.
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 Capsules may cause
a greater risk of Reye’s syndrome; a life threatening condition)
• Any other medicine, including medicines obtained without a prescription.
Taking Olsalazine Capsules with food and drink
Always take Olsalazine Capsules 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 Capsules.
Driving and using machines
If you experience dizziness and/or blurred vision whilst taking Olsalazine Capsules do not
drive or use machinery.
3. How to take Olsalazine Capsules
Always use Olsalazine Capsules 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 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 Capsules than you should
Do not take more Olsalazine Capsules than you should. If you have taken too many,
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 Capsules include
nausea, vomiting and diarrhoea.
If you forget to take Olsalazine Capsules
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 Capsules
Do not stop taking Olsalazine 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 Olsalazine Capsules 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 get 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
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Olsalazine Capsules
Keep out of the sight and reach of children.
Do not use Olsalazine Capsules after the expiry date on the carton. The expiry date refers
to the last day of that month.
Do not store above 25°C. Keep the container tightly closed to protect from moisture.
If your capsules 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 Capsules contain
Each capsule contains 250 mg olsalazine sodium.
Also includes magnesium stearate (E572).
The capsule shell contains caramel (E150),titanium dioxide (E171) and gelatin.
The printing ink contains shellac (E904), black iron oxide (E172) and propylene glycol
(E1520). It may also contain potassium hydroxide.
What Olsalazine Capsules look like
Hard gelatin capsules with a beige-coloured body and cap. The cap is marked
DIPENTUM® 250 mg in black ink.
Available in plastic bottles containing 112 capsules.
Who manufactured your medicine
Manufactured by Waymade plc, Sovereign House, Miles Gray Road, Basildon, Essex,
SS14 3FR, UK. Procured from within the EU and repackaged by Product Licence Holder
Ennogen Healthcare Limited, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford,
Kent, DA1 5BS.
PL 40739/0119

POM

Leaflet date: 25 January 2017

Ref: Ols250/v1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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