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DIPENTUM TABLETS 500MG

Active substance(s): OLSALAZINE SODIUM

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DIP-PIL-TAB-UK-CSP

Patient Information Leaflet
500 mg
Tablets
Olsalazine Sodium

• 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
Dipentum may causea greater
risk of Reye’s syndrome; a life
threatening condition)
• Any other medicine, including
medicinesobtained without a
prescription.
Taking Dipentum with food and
drink
Always take Dipentum 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
Dipentum.

Read all of this leaflet carefully
before you start taking this
medicine.
• Keep this leaflet. You may need
to read itagain.
• 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, Dipentum 500 mg
Tablets will be called Dipentum.
In this leaflet:
1. What Dipentum is for
2. Before you take Dipentum
3. How to take Dipentum
4. Possible side effects
5. How to store Dipentum
6. Further information.

1. What Dipentum is for
Dipentum belongs to a group of
medicines called aminosalicylates.
Dipentum works by reducing pain
and swelling (inflammation) in the
intestine. It reduces the actions of
substances in the body that cause
inflammation.
Dipentum is used to treat an
inflammationof 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. Before you take Dipentum
Do not take if:
• You are allergic to olsalazine
sodium or any of the other
ingredients of Dipentum (see
section 6)
• You have ever had an allergic
reactionto 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 Dipentum
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

Driving and using machines
If you experience dizziness and/or
blurred vision whilst taking
Dipentum do not drive or use
machinery.

3. How to take Dipentum
Always use Dipentum 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.
Maintenance treatment
• 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 “flareups”
• You may remain on this
treatment, provided it remains
effective, for a long period of
time.
If you take more Dipentum than
you should
Do not take more Dipentum than
you should. If you have taken too
much, immediately go to the
nearest hospital casualtydepartment or your doctor. Take your
tablets and this leaflet with you.
Signs of taking too much Dipentum
includenausea,
vomiting
and
diarrhoea.
If you forget to take Dipentum
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 Dipentum
Do not stop taking Dipentum
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 100mg per tablet.
If you have any further questions
about the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines Dipentum 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.

Marketing Authorisation Holder
and Manufacturer
UCB Pharma Limited,
208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
This leaflet was last updated on
April 2011.
If this leaflet is difficult to see or
read or you would like it in a
different format, please contact
UCB Pharma Limited,
208 Bath Road, Slough,
Berkshire SL1 3WE, UK.

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.

5. How to store Dipentum
Keep out of the reach and sight of
children.
Do not use Dipentum after the
expiry date on the carton. The
expiry date refers to the last day of
that month.
Store in a dry place.
Medicines should not be disposed
of via wastewater or household
waste. Return any medicine you no
longer need to your pharmacist.

6. Further information
What Dipentum contains
The active substance is Olsalazine
Sodium 500 mg.
The other ingredients are magnesium
stearate, colloidal silicon dioxide,
polyvidone 30, crospovidone and
ethanol.
What Dipentum looks like
Dipentum are yellow, capsuleshaped tablets debossed with
‚D500‘ on one side and scored on
the other side.
Dipentum comes in plastic bottles
containing 60 and 100 tablets. Not
all pack sizes may be marketed.

p/n CIA60342

DIP-PIL-TAB-UK-CSP

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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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