750 mg capsules
disodium balsalazide
1. What Colazid is and what it is used for
Colazide is used to treat ulcerative colitis ( inflammation and ulcers in the colon). It can also be used as a maintenance treatment to keep the disease under control and prevent a recurrence. It acts as an anti-inflammatory drug.
This medicine contains disodium balsalazide as an active substance.
Disodium balsalazide contained in Colazid may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Colazid
Do not take Colazid:
- if you are allergic to disodium balsalazide or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to mesalazine, acetylsalicylic acid, or other salicylates
- if you have severe liver disease
- if you have moderate or severe renal impairment
- if you are pregnant or breastfeeding
Warnings and cautions
- asthma
- any blood diseases
- mild kidney disease
- confirmed liver disease
- active stomach ulcer
If any of these apply to you, talk to your doctor or pharmacist before taking Colazid.
Control of your liver, kidney, and blood
Before starting treatment with Colazid, you will be given a blood and urine test to check how well your kidneys and blood are working.
During treatment, your doctor may take blood and urine samples to check that your liver, kidneys, and blood are functioning properly.
Children
Colazid is not recommended for use in children.
Other medicines and Colazid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies in particular to digoxin (used to treat heart problems), methotrexate (used to treat certain autoimmune diseases, such as rheumatoid arthritis, psoriasis, psoriatic arthritis, SLE, certain inflammatory bowel diseases ( Crohn’s disease ), and certain types of cancer, among other diseases), azathioprine (used to prevent rejection after organ transplantation and to treat rheumatoid arthritis, certain inflammatory bowel diseases ( Crohn’s disease and ulcerative colitis) and multiple sclerosis among other diseases) and 6-mercaptopurine (used in the treatment of leukemia and inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis ).
Colazide with food
Colazid should be taken with or after a meal.
Pregnancy, breastfeeding, and fertility
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 Colazid during pregnancy or breast-feeding.
Driving and using machines
There is no evidence that Colazid would affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Colazid
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adult and elderly patients:
Treatment of ulcerative colitis:
The recommended dose is 3 capsules 3 times a day with or after a meal. Swallow the capsules whole, with a glass of water if needed.
The treatment can last for up to 12 weeks.
Your doctor may also prescribe steroids to you while Colazide.
Maintenance treatment to prevent relapse:
The recommended starting dose is 2 capsules twice daily (3 g daily) with or after a meal. Swallow the capsules whole, with a glass of water if needed. Your doctor may change your dose depending on how you react to the medicine.
There may be an additional benefit to a dose of up to 6 g daily.
Drink enough fluids while taking this medicine to maintain your fluid level in the body, especially after severe or prolonged vomiting and/or diarrhea, high fever, or heavy sweating. This is to avoid kidney problems.
During treatment with Colazid, your doctor will take blood and urine samples.
Use for children
Colazid is not recommended for use in children.
If you forget to take Colazid
If you forget to take a dose at the right time, take it as soon as possible after a meal.
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.
Contact a doctor immediately if you get:
- a severe allergic reaction may occur as swelling of the face and swelling of the tongue, lips, and throat,
- abnormal bleeding, bruising, rash, fever, sore throat, or getting very tired.
A blood test will be taken to check the blood count and treatment will be stopped immediately if there is a suspicion of blood disease.
Other side effects that can occur with Colazid are:
- rash,
- diarrhea, stomach pain, nausea, vomiting, headache,
- gallstones, deterioration of ulcerative colitis,
- effect on blood count,
- difficulty breathing, cough, fever,
- abnormal feeling or function (eg weakness or numbness), joint pain, muscle aches,
- hair loss,
- hypersensitivity.
Kidney problems including renal impairment have been reported. Symptoms can be:
- blood or other changes in your urine,
- rash, fever,
- low back or joint pain,
- accumulation of fluid in the body,
- reduced urine output.
Inflammation of the heart, liver, and pancreas has been reported. Symptoms of these are:
- Inflammation of the heart: chest pain, palpitations, shortness of breath, 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.
The systemic lupus erythematosus ( SLE ) -like syndrome has been reported. The symptoms are:
- inflammation of the joints, connective tissue, tendons, and organs such as the heart, lungs, kidneys, and 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Colazid
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. or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 packaging and other information
Content declaration
- The active substance is balsalazide (as disodium balsalazide).
- Each capsule contains 750 mg of balsalazide (as disodium balsalazide).
- The other ingredients (excipients) are magnesium stearate, anhydrous colloidal silica, gelatin, shellac, the dyes titanium dioxide (E 171), and red, yellow, and black iron oxide (E 172).
What the medicine looks like and the contents of the pack
Colazid is a hard beige capsule.
Colazid is supplied in jars with child-resistant screw caps containing 130 capsules.
Marketing Authorisation Holder
Almirall, SA
Ronda General Miter, 151
08022 Barcelona
Spain
Manufacturer
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 + 2
D-73614 Schorndorf
Germany
This medicinal product is authorized under the European Economic Area under the names: Show larger
| Denmark | Premed 750 mg capsules |
| UK | Colazide 750 Mg Capsules |