Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Colazide 750mg Capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Balsalazide disodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 it
e 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 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 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 for use 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 (Crohn'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 (Crohn's disease and ulcerative colitis) and multiple sclerosis among other diseases) and 6-mercaptopurine(used to treat leukaemia and inflammatory bowel diseases such as Crohn's disease and ulcerative colitis). Colazide with food Colazide should be taken preferably with or after food. Pregnancy, breast-feeding 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 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 it
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.
Use in 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
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 use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Colazide contains
- The active substance is balsalazide Each capsule contains 750 mg of balsalazide (as balsalazide disodium)
- The other ingredients (excipients) are magnesium stearate, colloidal anhydrous silica, gelatine, shellac, titanium dioxide (E 171) and red, yellow and black iron oxide (E 172)
What Colazide looks 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 and Manufacturer 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. United Kingdom
Colazide 750 mg hard capsules
This leaflet was last revised in 06/2024
Frequently asked questions about Colazide 750mg Capsules
How do I take Colazide 750mg Capsules?
Colazide 750mg Capsules comes as capsule containing 750mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Colazide 750mg Capsules?
The active substance in Colazide 750mg Capsules is balsalazide disodium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Colazide 750mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Colazide 750mg Capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: balsalazide disodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Colazide is indicated for the treatment of mild-to-moderate active ulcerative colitis and maintenance of remission.
4.2. Posology and method of administration
Posology
Adults:
Treatment of active disease:
2.25g Balsalazide disodium (3 capsules) three times daily (6.75g daily) until remission or for 12 weeks maximum.
Rectal or oral steroids can be given concomitantly if necessary.
Maintenance treatment:
The recommended starting dose is 1.5g Balsalazide disodium (2 capsules) twice daily (3g daily). The dose can be adjusted based on each patient's response; there may be an additional benefit with a dose up to 6g daily.
Elderly:
No dose adjustment is anticipated.
Paediatric Population:
Colazide is not recommended in children.
Method of administration
To be swallowed whole with or after food.
4.3. Contraindications
Hypersensitivity to the active substance, to its metabolites, including mesalazine, or to any of the excipients listed in section 6.1.
History of hypersensitivity to salicylates.
Severe hepatic impairment, moderate-severe renal impairment.
Pregnant and breast feeding women.
4.4. Special warnings and precautions for use
Colazide should be used with caution in patients with asthma, bleeding disorders, active ulcer disease, mild renal impairment or those with established hepatic disease.
Renal function should be monitored before starting an oral aminosalicylate, at 3 months of treatment, and then annually during treatment (more frequently in renal impairment). Blood disorders can occur with aminosalicylates (see recommendation below).
Blood disorders
During treatment with Colazide blood counts, BUN/creatinine and urine analysis should be performed. Patients receiving aminosalicylates should be advised to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise that occurs during treatment. A blood count should be performed and the drug stopped immediately if there is suspicion of a blood dyscrasia.
4.5. Interaction with other medicinal products and other forms of interaction
Formal interaction studies have not been performed with Colazide. Available data suggest that the systemically available amounts of balsalazide and its metabolites may be increased if Colazide is administered in the fasting as compared with the fed state. Therefore, Colazide should preferably be administered with food.
The acetylated metabolites of balsalazide are actively secreted in the renal tubule to a high degree. Therefore, plasma levels of co-prescribed drugs also eliminated by this route may be raised and this should be noted in the case of those with a narrow therapeutic range, such as methotrexate.
Pharmacodynamic interactions have not been studied. However, while balsalazide, mesalazine, and N-acetylmesalazine are salicylates chemically, their properties and kinetics make classical salicylate interactions such as those found with acetylsalicylic acid very unlikely.
The uptake of digoxin has been impaired in some individuals by concomitant treatment with sulphasalazine. Even if it is not known whether this would occur also during treatment with balsalazide, it is recommended that plasma levels of digoxin should be monitored in digitalised patients starting Colazide.
Mesalazine inhibits thiopurine methyltransferase. In patients receiving azathioprine or 6-mercaptopurine, caution is recommended for concurrent use of mesalazine as this can increase the potential for blood dyscrasias.
4.6. Fertility, pregnancy and lactation
Pregnancy
Human experience with balsalazide is limited, therefore Colazide should not be given to pregnant women.
Breast-feeding
Colazide should not be given to breast feeding women as the active metabolite mesalazine has produced adverse effects in nursing infants.
Fertility
Animal studies on fertility and reproductive function did not reveal adverse effects of balsalazide.
4.7. Effects on ability to drive and use machines
Colazide has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The adverse effects are expected to be those of mesalazine.
Reactions reported during treatment with oral mesalazine are listed in the table below.
Organ group
Adverse Event
Blood and lymphatic system disorders
Blood dyscrasias
Aplastic anaemia Leucopenia
Neutropenia Agranulocytosis
Thrombocytopenia
Nervous system disorders
Headache
Neuropathy
Cardiac disorders
Myocarditis
Pericarditis
Respiratory, thoracic and mediastinal disorders
Bronchospasm
Allergic alveolitis
Eosinophilic pneumonia
Gastrointestinal disorders
Abdominal pain
Diarrhoea
Nausea, vomiting
Aggravation of ulcerative colitis
Acute pancreatitis
Hepatobiliary disorders
Hepatitis
Cholelithiasis
Skin and subcutaneous tissue disorders
Alopecia
Angioedema
Rash
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus-like syndrome
Arthralgia
Myalgia
Renal and urinary disorders
Interstitial nephritis
Acute renal failure
Renal insufficiency
Renal impairment
Immune system disorders
Hypersensitivity
See Section 4.4 Special warnings and precautions for use.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
To date, there are no reports of overdosage with mesalazine-releasing products. Overdose with large amounts of balsalazide may result in symptoms resembling mild salicylate intoxication. Treatment should be symptomatic.
💬 Ask about this leaflet
Ask anything about Colazide 750mg Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.