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DIPENTUM 250MG HARD CAPSULES

Active substance(s): OLSALAZINE SODIUM

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Dipentum® 250mg hard capsules
(olsalazine sodium)

Your medicine is known by the above name but will be referred to as
Dipentum throughout this:
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.

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
"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 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 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.

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
much, immediately go to the nearest hospital casualty department or
your doctor. Take your capsules 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.

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 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, 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 Dipentum 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 container tightly close to protect
from moisture.
Store in a dry place.
Medicine 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. Each capsule contains
250mg olsalazine sodium.
The other ingredients are:
Capsule contents: magnesium stearate (E572).
Printing ink: shellac (E904), iron oxide black (E172) and propylene glycol
(E1520). It may also contain potassium hydroxide.
Capsule shell: caramel (E150), titanium dioxide (E171) and gelatin.
What Dipentum look like and the contents of the pack
Dipentum are hard gelatin capsules with a beige-coloured body and cap.
The cap is marked with Dipentum 250 mg in black ink. Dipentum comes
in plastic bottles containing 112 capsules.
PL 10383/2173 Dipentum 250mg hard capsules

POM

Who makes and repackages your medicine?
Your medicine is manufactured by UCB Pharma Limited, 208 Bath Road,
Slough, Berkshire, SL1 3WE, UK, Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 20.04.2016
Dipentum® is a registered trademark of UCB Pharma Limited, UK.

Olsalazine sodium 250mg hard capsules
Your medicine is known by the above name but will be referred to as
Olsalazine sodium capsules throughout this:
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.

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 works by reducing pain and swelling
(inflammation) in the intestine. It reduces 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. 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 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.

If 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
If you are pregnant, or trying to become pregnant or breastfeeding, talk
to your doctor before taking Olsalazine sodium capsules.
Driving and using machines
If 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
• 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 capsules than you should
Do not take more Olsalazine sodium capsules than you should. If you
have taken too much, 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 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.
If you stop taking Olsalazine sodium capsules
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 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 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, 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 capsules






Keep out of the sight and reach of children.
Do not use Olsalazine sodium 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 container tightly close to protect
from moisture.
Store in a dry place.
Medicine should not be disposed of via wastewater or household
waste. Return any medicine you no longer need to your pharmacist.

6) Further information
What Olsalazine sodium capsules contain
The active substance is olsalazine sodium. Each capsule contains
250mg olsalazine sodium.
The other ingredients are:
Capsule contents: magnesium stearate (E572).
Printing ink: shellac (E904), iron oxide black (E172) and propylene glycol
(E1520). It may also contain potassium hydroxide.
Capsule shell: caramel (E150), titanium dioxide (E171) and gelatin.
What Olsalazine sodium capsules look like and the contents of the
pack
Olsalazine sodium are hard gelatin capsules with a beige-coloured body
and cap. The cap is marked with Dipentum 250 mg in black ink.
Olsalazine sodium capsules comes in plastic bottles containing 112
capsules.
PL 10383/2173

POM

Who makes and repackages your medicine?
Your medicine is manufactured by UCB Pharma Limited, 208 Bath Road,
Slough, Berkshire, SL1 3WE, UK, Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 20.04.2016

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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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