Colazide 750mg Capsules
Colazide® 750mg Capsules/Balzide® 750mg 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.
Your medicine is known by the above names, but will be referred to as Colazide throughout this:
Patient Information 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 (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, 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 Colazide
• Do not take your capsules after the expiry date shown on the pack.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop using your medicine, please take it back to the pharmacist for safe disposal. Only keep it if your doctor tells you to. If the capsules become discoloured or show signs of any deterioration, you should 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) Contents of the pack and other information What Colazide contain:
Each Colazide Capsule contains 750mg of the active ingredient balsalazide disodium.
Each hard capsule also contains magnesium stearate, colloidal anhydrous silica, gelatin, shellac, titanium dioxide (E171) and black iron oxide (E172) and Indigo carmine (E132).
What Colazide looks like and contents of the pack
The capsules are white imprinted with the menarini logo in black ink, and with a light blue cap.
Colazide capsules come in a white plastic bottle with a child resistant and tamper evident screw cap of 112 capsules.
PL 10383/1591 Colazide® 750mg Capsules/Balzide® 750mg Capsules
|PoM
Who makes and repackages your medicine?
Your medicine is manufactured by Doppel Farmaceutici s.r.l.,Via Volturno,
48, Quinto De Stampi, Rozzano, Milano, Italy. 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: 29.10.2015
Colazide and Balzide are registered trademarks of Almirall S.A. Spain.