COLAZIDE Capsule, hard (2018)
Βιβλιογραφική αναφορά
Συγγραφείς
Almirall, S.A.
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Περιεχόμενα
1. Name of the medicinal product
Colazide 750 mg hard capsules.
2. Qualitative and quantitative composition
Each capsule contains 750 mg of balsalazide disodium corresponding to balsalazide 612.8 mg and to mesalazine 262.5 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard. Size 00 beige gelatin capsules.
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 ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Aminosalicylic and similar agents <b>ATC code:</b> A07EC Balsalazide consists of mesalazine linked to a carrier molecule (4-aminobenzoyl-ß-alanine) via an azo bond. Bacterial ...
5.2. Pharmacokinetic properties
The pharmacokinetics of balsalazide and its metabolites have been studied in healthy subjects and patients in remission. The systemic uptake of balsalazide itself is low (<1%) and the major part of the ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity, carcinogenic potential, toxicity to reproduction, safety pharmacology and validating kinetics and metabolism. ...
6.1. List of excipients
Magnesium stearate Colloidal anhydrous silica Gelatin Shellac Titanium dioxide (E171) Yellow, red and black iron oxide (E172)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of container
High density polyethylene container fitted with tamper-evident, child-resistant, high density polyethylene screw caps. Pack sizes are: 50, 54, 56, 100, 112, 130, 224 (2 112), 260 (2 130), 300 (3 100), ...
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
8. Marketing authorization number(s)
PL 16973/0019
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 18 December 1997 Date of latest renewal: 11 August 2009
10. Date of revision of the text
17 September 2018
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