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COLAZIDE 750MG CAPSULES

Active substance(s): BALSALAZIDE DISODIUM

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Package leaflet: Information for the user

Colazide* 750 mg capsules
Balsalazide 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.
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 (3 g
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 6 g 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 tablets contact
your doctor or pharmacist. Take any remaining
tablets 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 as
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, Website:
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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton after EXP.
No special precautions for storage.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer required. These
measures will help protect the environment.
6. Contents of the pack and other information
What Colazide contains
- The active substance is balsalazide (as
balsalazide disodium)
- The other ingredients (excipients) are
magnesium stearate, colloidal anhydrous silica,
gelatine, shellac, titanium dioxide (E171) and red,
yellow and black iron oxide (E172)
What Colazide look like and contents of the pack
Colazide is a hard beige-coloured capsule.
Colazide is available in bottles with child-resistant screw
caps containing 130 capsules.
Marketing Authorisation Holder:
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona (Spain)
Manufacturer:
Catalent Germany Schorndorf GmbH,
Steinbeisstrasse 1 + 2,
D-73614 Schorndorf, Germany.
This leaflet was last revised in 04/2015
* Trade Mark

427767

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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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