Skip to Content

OLSALAZINE SODIUM 500MG TABLETS

Active substance(s): OLSALAZINE SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
Dipentum® 500mg Tablets
(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 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 "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 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.
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.
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 stated on the carton.
The expiry date refers to the last day of that month.
Do not store above 30°C. 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 tablet contains 500mg
olsalazine sodium.
The other ingredients are magnesium stearate, colloidal anhydrous
silica, polyvidone K30 and crospovidone.
What Dipentum looks like and the contents of the pack
Dipentum are yellow capsule-shaped tablets marked with D500 on one
side and a scored on the other side.
Dipentum comes in plastic bottles containing 60 tablets.
PL 10383/2171

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: 21.04.2016
Dipentum® is a registered trademark of UCB Pharma Limited, UK.

Olsalazine sodium 500mg Tablets
Your medicine is known by the above name but will be referred to as
Olsalazine sodium Tablets 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 Tablet are for
2) Before you take Olsalazine sodium Tablets
3) How to take Olsalazine sodium Tablets
4) Possible side effects
5) How to store Olsalazine sodium Tablets
6) Further information

1) What Olsalazine sodium Tablets are for
Olsalazine sodium Tablets belongs to a group of medicines called
aminosalicylates.
Olsalazine sodium Tablets works by reducing pain and swelling
(inflammation) in the intestine. It reduces the actions of substances in the
body that cause inflammation.
Olsalazine sodium Tablets 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 Tablets
Do not take if:
• You are allergic to olsalazine sodium or any of the other ingredients
of Olsalazine sodium Tablets (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 Tablets 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 Tablets 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 Tablets with food and drink
Always take Olsalazine Sodium Tablets 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 Tablets.
Driving and using machines
If you experience dizziness and/or blurred vision whilst taking Olsalazine
sodium Tablets do not drive or use machinery.

3) How to take Olsalazine sodium Tablets
Always use Olsalazine sodium Tablets 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 "flare-ups”.
• You may remain on this treatment, provided it remains effective, for
a long period of time.
If you take more Olsalazine sodium Tablets than you should
Do not take more Olsalazine sodium Tablets 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 Olsalazine sodium Tablets include nausea,
vomiting and diarrhoea.

If you forget to take Olsalazine sodium Tablets
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 Tablets
Do not stop taking Olsalazine sodium Tablets 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 Olsalazine sodium Tablets 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 Tablets





Keep out of the sight and reach of children.
Do not use Olsalazine sodium Tablets after the expiry date stated
on the carton. The expiry date refers to the last day of that month.
Do not store above 30°C. 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 Tablets contain
The active substance is olsalazine sodium. Each tablet contains 500mg
olsalazine sodium.
The other ingredients are magnesium stearate, colloidal anhydrous
silica, polyvidone K30 and crospovidone.
What Olsalazine sodium Tablets look like and the contents of the
pack
Olsalazine sodium Tablets are yellow capsule-shaped marked with D500
on one side and a scored on the other side.
Olsalazine sodium Tablets come in plastic bottles containing 60 tablets.
PL 10383/2171

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: 21.04.2016

Expand view ⇕

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.

Hide