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OLSALAZINE SODIUM 250MG CAPSULES

Active substance(s): OLSALAZINE SODIUM

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Patient Information Leaflet
®

Dipentum 250mg capsules
(olsalazine sodium)

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.
The name of your medicine is Dipentum 250mg
capsules but will be referred to as Dipentum
throughout this leaflet.
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 inflammation of your
large intestine (colon) called ulcerative colitis. It is
used for short-term (acute) attacks (called ‘flareups’), 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 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 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.
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 breast-feeding, 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.
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.
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 Dipentum than you should
Do not take more Dipentum 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 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.
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.
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 heart beat
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
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 Dipentum
Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on
the carton and bottle label after 'Exp'. 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 become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
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 Dipentum contains
The active ingredient in Dipentum is olsalazine
sodium.
Each capsule contains 250mg olsalazine sodium.
The other ingredients are:
Capsule contents: Magnesium stearate (E572).
Capsule shell: gelatin, titanium dioxide (E171) and
caramel (E150).
Printing ink: shellac (E904), black iron oxide
(E172), propylene glycol (E1520) and potassium
hydroxide.
What Dipentum looks like and contents of the
pack
Dipentum are beige coloured capsules marked with
‘Dipentum 250mg’ in black ink.
Dipentum comes in plastic bottles containing 112
capsules.
Manufactured by: UCB Pharma Ltd, 208 Bath
Road, Slough, Berkshire, SL1 3WE, UK.
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4
0NU, UK.
®

Dipentum 250mg capsules
PL 18799/2644
POM
Leaflet date: 05.10.2015

Patient Information Leaflet

Olsalazine sodium 250mg
capsules
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.
The name of your medicine is Olsalazine sodium
250mg capsules but will be referred to as
Olsalazine sodium throughout this leaflet.
In this leaflet:
1. What Olsalazine sodium is for
2. Before you take Olsalazine sodium
3. How to take Olsalazine sodium
4. Possible side effects
5. How to store Olsalazine sodium
6. Further information.
1. What Olsalazine sodium is for
Olsalazine sodium belongs to a group of medicines
called aminosalicylates.
Olsalazine sodium works by reducing pain and
swelling (inflammation) in the intestine. It reduces
the actions of substances in the body that cause
inflammation.
Olsalazine sodium 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).
2. Before you take Olsalazine sodium
Do not take if:
You are allergic to olsalazine sodium or any of
the other ingredients of Olsalazine sodium (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 sodium 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 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 with food and drink
Always take Olsalazine sodium with a glass of
water after food.
Pregnancy and breast-feeding
If you are pregnant, or trying to become pregnant
or breast-feeding, talk to your doctor before taking
Olsalazine sodium.
Driving and using machines
If you experience dizziness and/or blurred vision
whilst taking Olsalazine sodium do not drive or use
machinery.
3. How to take Olsalazine sodium
Always use Olsalazine sodium 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 sodium than you
should
Do not take more Olsalazine sodium 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
include nausea, vomiting and diarrhoea.

If you forget to take Olsalazine sodium
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 sodium
Do not stop taking Olsalazine sodium 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 sodium 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 heart beat
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

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 sodium
Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on
the carton and bottle label after 'Exp'. 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 become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
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 sodium contains
The active ingredient in Olsalazine sodium is
olsalazine sodium.
Each capsule contains 250mg olsalazine sodium.
The other ingredients are:
Capsule contents: Magnesium stearate (E572).
Capsule shell: gelatin, titanium dioxide (E171) and
caramel (E150).
Printing ink: shellac (E904), black iron oxide
(E172), propylene glycol (E1520) and potassium
hydroxide.
What Olsalazine sodium looks like and
contents of the pack
Olsalazine sodium are beige coloured capsules
marked with ‘Olsalazine sodium 250mg’ in black
ink.
Olsalazine sodium comes in plastic bottles
containing 112 capsules.
Manufactured by: UCB Pharma Ltd, 208 Bath
Road, Slough, Berkshire, SL1 3WE, UK.
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4
0NU, UK.
Olsalazine sodium 250mg capsules
PL 18799/2644
POM
Leaflet date: 05.10.2015

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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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