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BALSALAZIDE DISODIUM 750MG CAPSULES

Active substance(s): BALSALAZIDE DISODIUM

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Package Leaflet: Information for the user
Colazide 750mg capsules
(balsalzide disodium)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. ‘See section 4.’
- The name of your medicine is Colazide 750mg capsules but will be referred as Colazide throughout this leaflet.
What is in this leaflet
1.
What Colazide is and what it is used for
2.
What you need to know before you take Colazide
3.
How to take Colazide
4.
Possible side effects
5.
How to store Colazide
6.
Contents of the pack and other information
1. What Colazide is and what it is used for
Colazide is used for the treatment of ulcerative colitis
(ulceration of the large intestine). It may also be used to
keep the disease under control by preventing further
episodes. It works as an anti-inflammatory agent.
This medicine contains balsalazide disodium as the
active ingredient.
2. What you need to know before you take Colazide
Do not take Colazide:
- if you are allergic to balsalazide or any of the
other ingredients of this medicine (listed in
section 6)
- if you are allergic (hypersensitive) to
mesalazine, aspirin or other salicylates
- if you have a severe liver disease
- if you have a moderate to severe kidney disease
- if you are pregnant or breast feeding
Colazide is not recommended for use in children.
Warnings and precautions
- asthma
- any blood disorders
- a mild kidney disorder
- a confirmed liver disease
- an active ulcer
If any of these apply to you, talk to your doctor or
pharmacist before taking Colazide.
Tests on your liver, kidney and blood
Before you start treatment with Colazide you will have a
blood and urine test to check how well your kidneys are
working and what your blood is doing.
During treatment your doctor will check how well your
liver, kidney and blood is working by taking blood and
urine samples periodically during your treatment.
Children
Colazide is not recommended in children.
Other medicines and Colazide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. In
particular digoxin (used to treat heart problems),
methotrexate (used as treatment for some autoimmune
diseases, including rheumatoid arthritis, psoriasis,
psoriatic arthritis, lupus, some inflammatory bowel
diseases (Chron’s disease) and some types of cancer,
among other diseases), azathioprine (used to prevent
rejection following organ transplantation, and to treat
rheumatoid arthritis, some inflammatory bowel diseases
(Chron’s disease and ulcerative colitis) and multiple
sclerosis among other diseases) and 6-mercaptopurine

(used to treat leukaemia and inflammatory bowel
diseases such as Chron’s disease and ulcerative colitis).
Colazide with food
Colazide should be taken preferably with or after food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
You should not take Colazide during pregnancy or while
breast-feeding.
Driving and using machines
There is no evidence of any effect of Colazide on your
ability to drive or use machines.
3. How to take Colazide
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Adults and elderly patients:
Treatment of ulcerative colitis:
The recommended dose is 3 capsules three times
daily to be taken with or after food. Swallow the
capsules whole, with a glass of water if necessary.
Treatment may be given for a maximum of 12 weeks.
Your doctor may also give you steroids at the same
time as Colazide.
Maintenance treatment to prevent further
episodes:
The starting dose is 2 capsules twice daily (3g daily)
to be taken with or after food. Swallow the capsules
whole, with a glass of water if necessary. Your doctor
may adjust your treatment based on your response to
the medicine.
There may be an additional benefit with a dose up to
6g daily. Whilst taking this medicine ensure you drink
adequate fluids to remain well hydrated, especially
after severe or prolonged episodes of vomiting and/or
diarrhoea, high fever or heavy sweating. This is to
avoid problems with your kidneys.
During your treatment with Colazide your doctor will
carry out blood and urine tests.
Children:
Colazide is not recommended for use in children.
If you take more Colazide than you should
If you think you have taken too many capsules contact
your doctor or pharmacist. Take any remaining
capsules and the packaging with you.

If you forget to take Colazide
If you forget to take a dose at the right time, take it as
soon as possible after food.
If you miss a dose completely, do not take a double dose
to make up for a forgotten dose. Take the next dose as
usual.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Immediate medical attention must be sought if you
experience:
a severe allergic reaction including swelling of
the face, tongue, throat and lips
unusual bleeding, bruising, rash, fever, sore
throat or excessive tiredness.
A blood count will be performed and the drug stopped
immediately if there is suspicion of a blood disorder.
Other side effects that may occur with Colazide are:
rash,
diarrhoea, stomach pain, nausea,vomiting,
headache,
gallstones,worsening of ulcerative colitis,
problems with the blood,
difficulty breathing, cough, fever,
abnormal sensation or function (such a weakness
or numbness), joint pains, muscle ache,
hair loss,
hypersensitivity.
Problems with the kidneys including renal malfunction
have been reported. Symptoms may include:
blood or any other changes in your urine,
rash, fever,
loin or joint pain,
fluid retention,
decreased urine.
Inflammation of the heart, liver and pancreas have
been reported. Symptoms of these are:
Inflammation of the heart: chest pain,
palpitations, breathlessness and fatigue.
Inflammation of the liver: flu like
symptoms,jaundice (yellowing of the skin and
whites of the eyes) and abdominal pain.
Inflammation of the pancreas: abdominal pain,
nausea and vomiting.
Systemic lupus erythematosus (SLE) like syndrome
has been reported. Symptoms are:
inflammation of the joints, connective tissue,
tendons and organs such as the heart, lungs,
kidneys or skin.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 Colazide
Do not use after the expiry (Exp) date shown on the
carton and bottle. The date refers to the last day of that
month
Keep out of the sight and reach of children.
Remember to return any unused medicine to 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.
If your medicine becomes discoloured or show any signs
of deterioration, seek the advice of your pharmacist.
6. Contents of the pack and other information
What Colazide contains
Each capsule contains 750mg of balsalazide disodium
corresponding to 612.8mg of balsalazide and 262.5mg of
mesalazine.
Also contains magnesium stearate, colloidal anhydrous
silica, gelatin, shellac, titanium dioxide (E171) black iron
oxide (E172) and indigo carmine (E132).
What Colazide looks like and contents of the pack
Colazide are hard gelatin capsules with a white body and
blue which come in packs of 112 capsules.
Colazide is converted in the large intestine to
mesalazine, which lessens and prevents inflammation,
soreness and ulcers of the lower bowel that occur in
ulcerative colitis.
Manufactured by: A Menarini industrie Sud s.r.l., Via
campo di pile, 67100 l’Aquila, italy.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Colazide 750mg capsules;
Leaflet date: 16.10.2015

PL 18799/1294
POM

Colazide is a Registered Trademark Of Shire
Pharmaceuticals Group Plc

Package Leaflet: Information for the user
Balsalazide 750mg capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. ‘See section 4.’
- The name of your medicine is Balsalazide 750mg capsules but will be referred as Balsalazide throughout this
leaflet.
What is in this leaflet
1.
What Balsalazide is and what it is used for
2.
What you need to know before you take Balsalazide
3.
How to take Balsalazide
4.
Possible side effects
5.
How to store Balsalazide
6.
Contents of the pack and other information
1. What Balsalazide is and what it is used for
Balsalazide is used for the treatment of ulcerative colitis
(ulceration of the large intestine). It may also be used to
keep the disease under control by preventing further
episodes. It works as an anti-inflammatory agent.
This medicine contains balsalazide disodium as the
active ingredient.
2. What you need to know before you take
Balsalazide
Do not take Balsalazide:
- if you are allergic to balsalazide or any of the
other ingredients of this medicine (listed in
section 6)
- if you are allergic (hypersensitive) to
mesalazine, aspirin or other salicylates
- if you have a severe liver disease
- if you have a moderate to severe kidney disease
- if you are pregnant or breast feeding
Balsalazide is not recommended for use in children.
Warnings and precautions
- asthma
- any blood disorders
- a mild kidney disorder
- a confirmed liver disease
- an active ulcer
If any of these apply to you, talk to your doctor or
pharmacist before taking Balsalazide.
Tests on your liver, kidney and blood
Before you start treatment with Balsalazide you will have
a blood and urine test to check how well your kidneys are
working and what your blood is doing.
During treatment your doctor will check how well your
liver, kidney and blood is working by taking blood and
urine samples periodically during your treatment.
Children
Balsalazide is not recommended in children.
Other medicines and Balsalazide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. In
particular digoxin (used to treat heart problems),
methotrexate (used as treatment for some autoimmune
diseases, including rheumatoid arthritis, psoriasis,
psoriatic arthritis, lupus, some inflammatory bowel
diseases (Chron’s disease) and some types of cancer,
among other diseases), azathioprine (used to prevent
rejection following organ transplantation, and to treat
rheumatoid arthritis, some inflammatory bowel diseases

(Chron’s disease and ulcerative colitis) and multiple
sclerosis among other diseases) and 6-mercaptopurine
(used to treat leukaemia and inflammatory bowel
diseases such as Chron’s disease and ulcerative colitis).
Balsalazide with food
Balsalazide should be taken preferably with or after food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
You should not take Balsalazide during pregnancy or
while breast-feeding.
Driving and using machines
There is no evidence of any effect of Balsalazide on your
ability to drive or use machines.
3. How to take Balsalazide
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Adults and elderly patients:
Treatment of ulcerative colitis:
The recommended dose is 3 capsules three times
daily to be taken with or after food. Swallow the
capsules whole, with a glass of water if necessary.
Treatment may be given for a maximum of 12 weeks.
Your doctor may also give you steroids at the same
time as Balsalazide.
Maintenance treatment to prevent further
episodes:
The starting dose is 2 capsules twice daily (3g daily)
to be taken with or after food. Swallow the capsules
whole, with a glass of water if necessary. Your doctor
may adjust your treatment based on your response to
the medicine.
There may be an additional benefit with a dose up to
6g daily. Whilst taking this medicine ensure you drink
adequate fluids to remain well hydrated, especially
after severe or prolonged episodes of vomiting and/or
diarrhoea, high fever or heavy sweating. This is to
avoid problems with your kidneys.
During your treatment with Balsalazide your doctor
will carry out blood and urine tests.
Children:
Balsalazide is not recommended for use in children.

If you take more Balsalazide than you should
If you think you have taken too many capsules contact
your doctor or pharmacist. Take any remaining
capsules and the packaging with you.

By reporting side effects you can help provide more
information on the safety of this medicine.

If you forget to take Balsalazide
If you forget to take a dose at the right time, take it as
soon as possible after food.
If you miss a dose completely, do not take a double dose
to make up for a forgotten dose. Take the next dose as
usual.

Do not use after the expiry (Exp) date shown on the
carton and bottle. The date refers to the last day of that
month
Keep out of the sight and reach of children.
Remember to return any unused medicine to 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.
If your medicine becomes discoloured or show any signs
of deterioration, seek the advice of your pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Immediate medical attention must be sought if you
experience:
a severe allergic reaction including swelling of
the face, tongue, throat and lips
unusual bleeding, bruising, rash, fever, sore
throat or excessive tiredness.
A blood count will be performed and the drug stopped
immediately if there is suspicion of a blood disorder.
Other side effects that may occur with Balsalazide are:
rash,
diarrhoea, stomach pain, nausea,vomiting,
headache,
gallstones,worsening of ulcerative colitis,
problems with the blood,
difficulty breathing, cough, fever,
abnormal sensation or function (such a weakness
or numbness), joint pains, muscle ache,
hair loss,
hypersensitivity.
Problems with the kidneys including renal malfunction
have been reported. Symptoms may include:
blood or any other changes in your urine,
rash, fever,
loin or joint pain,
fluid retention,
decreased urine.
Inflammation of the heart, liver and pancreas have
been reported. Symptoms of these are:
Inflammation of the heart: chest pain,
palpitations, breathlessness and fatigue.
Inflammation of the liver: flu like
symptoms,jaundice (yellowing of the skin and
whites of the eyes) and abdominal pain.
Inflammation of the pancreas: abdominal pain,
nausea and vomiting.
Systemic lupus erythematosus (SLE) like syndrome
has been reported. Symptoms are:
inflammation of the joints, connective tissue,
tendons and organs such as the heart, lungs,
kidneys or skin.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.

5. How to store Balsalazide

6. Contents of the pack and other information
What Balsalazide contains
Each capsule contains 750mg of balsalazide disodium
corresponding to 612.8mg of balsalazide and 262.5mg of
mesalazine.
Also contains magnesium stearate, colloidal anhydrous
silica, gelatin, shellac, titanium dioxide (E171) black iron
oxide (E172) and indigo carmine (E132).
What Balsalazide looks like and contents of the pack
Balsalazide are hard gelatin capsules with a white body
and blue which come in packs of 112 capsules.
Balsalazide is converted in the large intestine to
mesalazine, which lessens and prevents inflammation,
soreness and ulcers of the lower bowel that occur in
ulcerative colitis.
Manufactured by: A Menarini industrie Sud s.r.l., Via
campo di pile, 67100 l’Aquila, italy.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Balsalazide 750mg capsules;
Leaflet date: 16.10.2015

PL 18799/1294
POM

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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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