DIPENTUM CAPSULES 250MG

Active substance: OLSALAZINE SODIUM

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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 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 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
• 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

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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.

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

15.01.2013

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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
casualty department or your doctor. Take
your tablets and this leaflet with you.
Signs of taking too much Dipentum
include nausea, 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.
If you have any further questions about
the use of this medicine, ask your doctor
or pharmacist.

Techn. Colours

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.

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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
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).

Dipentum Cap 250

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.

Product Name

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, Dipentum 250mg
Capsules will be called Dipentum.

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
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.

Note:

250 mg
Capsules

Olsalazine sodium

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

AW CIA70264B_MU1
PT# CIA60342

Patient Information Leaflet

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

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vaccination (taking Dipentum may
cause a greater risk of Reye’s
syndrome; a life threatening
condition)
• Any other medicine, including
medicines obtained without a
prescription.

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
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Other possible side effects:
Common (affects less than 1 in 10
people):

18.01.13 10:38

What Dipentum contains
The active substance is Olsalazine
Sodium 250 mg.
The other ingredients are:
Capsule contents: Magnesium stearate
Capsule shell: Gelatin, caramel (E150)
and titanium dioxide (E171)
Printing ink: Shellac, iron oxide black
(E172) and propylene glycol.
What Dipentum looks like
Dipentum are beige colour and marked
Dipentum 250 mg.
Dipentum comes in plastic bottles
containing 112 capsules.
Marketing Authorisation Holder
and Manufacturer
UCB Pharma Limited,
208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
This leaflet was last updated on
January 2013.

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

15.01.2013

Horschel

18.01.2013

03

Creation Date

Amended by

Modific. Date

Edition No.

Technical Changes

8 Pt

Horschel

Dimensions

Operator

Fontsize Bodytext

2“ x 27“

external Id.-No.

Artwork Information

Dispatched to
cut
p/n CIA60342

Id.-No. / Countr.

Remarks: ATTENTION: Mock-Up! No techn. approval by Rochester!

8,5 Pt
Linespacing

Manufacturing Site

Operator
techn. info
black
CIA70264B_MU1 / UK

6. Further information

PT Approval

Techn. Colours

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.

Print Colours

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

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.

Dipentum Cap 250
Product Name

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Note:

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

Date

• 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

Approver

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Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

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Technical information:
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BACK

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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.

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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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