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OLSALAZINE SODIUM 250MG CAPSULES

Active substance(s): OLSALAZINE SODIUM

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Ref: 1759060218/1/F

Olsalazine Sodium 250mg Capsules
Patient Information 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.
Your medicine is called Olsalazine Sodium 250mg Capsules but will be
referred to as Olsalazine Sodium Capsules, throughout the leaflet.
In this leaflet:
1

What Olsalazine Sodium Capsules are for

2

Before you take Olsalazine Sodium Capsules

3

How to take Olsalazine Sodium Capsules

4

Possible side effects

5

How to store Olsalazine Sodium Capsules

6

Further information.

1

What Olsalazine Sodium Capsules are for

Olsalazine sodium belongs to a group of medicines called aminosalicylates.
Olsalazine Sodium Capsules work by reducing pain and swelling
(inflammation) in the intestine. They reduce the actions of substances in the
body that cause inflammation.
Olsalazine Sodium 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 Sodium Capsules

Do not take if:
* You are allergic to olsalazine sodium or any of the other ingredients of
Olsalazine Sodium Capsules (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.
lf any of the above apply to you talk to your doctor or pharmacist.
Take special care
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.
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 Sodium
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 Sodium Capsules with food and drink
Always take Olsalazine Sodium Capsules with a glass of water after food.
Pregnancy and breast-feeding
lf you are pregnant, or trying to become pregnant or breast-feeding, talk to
your doctor before taking Olsalazine Sodium Capsules.

Driving and using machines
lf 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 Olsalazine Sodium 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
* lf 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 many, immediately go to the nearest hospital casualty department
or your doctor. Take your capsules and this leaflet with you. Signs of taking
too many Olsalazine Sodium Capsules include nausea, vomiting and
diarrhoea.
If you forget to take Olsalazine Sodium 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.
lf 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.
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 Sodium 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

Ref: 1759/060218/1/B

Olsalazine Sodium 250mg Capsules
Patient Information Leaflet (continued)
Uncommon (affects less than 1 in 100 people):
* Fever
* Being sick
* lndigestion
* 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 or pharmacist. This includes
any possible side effects not listed on 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

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How to store Olsalazine Sodium Capsules

Store in the original package.
Store in a dry place
Do not store above 25°C.
Keep out of the sight and reach of children.
Do not take Olsalazine Sodium Capsules after the expiry date which is
stated on the container label or carton. The expiry date refers to the last
day of the month. If your doctor tells you to stop taking this medicine,
return any unused capsules to your pharmacist (chemist) for safe disposal.
Only keep this medicine if your doctor tells you to.
If the capsules become discoloured or show any other signs of
deterioration, you should 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 that are no longer
required. These measures will help to protect the environment.

6

Further information

What Olsalazine Sodium Capsules contain
Each capsule contains 250mg of olsalazine sodium
Also contains, magnesium stearate, caramel (E150), titanium dioxide (E171),
iron oxide (E172) and gelatine.
What Olsalazine Sodium Capsules looks like and contents of the pack
Beige capsules marked ‘DIPENTUM 250mg’ in black ink on the cap.
Each pack contains 100 capsules.
Manufacturer and Licence Holder
Manufactured by Waymade plc, Sovereign House, Miles Gray Road,
Basildon, Essex SS14 3FR United Kingdom and is procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1759

Olsalazine Sodium 250mg Capsules

Revision date: 06/02/18

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

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Further information

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