ETHAMBUTOL Film-coated tablet Ref.[8342] Active ingredients: Ethambutol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Fannin (UK) Ltd., DCC Vital, Westminster Industrial Estate, Repton Road, Measham, Swadlincote, Derbyshire, DE12 7DT, England

Product name and form

Ethambutol 100 mg Tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, round biconvex, film coated tablet.

Qualitative and quantitative composition

Each tablet contains Ethambutol hydrochloride 100 mg.

Active Ingredient Description
Ethambutol

Ethambutol is bacteriostatic. It is effective against Mycobacterium tuberculosi and M.bovis with an MIC of 0.5–8ยตg per ml. The exact mechanism of action is unknown. While it has activity against some atypical mycobacteria including M.Kansasii, activity against other micro-organisms has not yet been reported.

List of Excipients

Sodium starch glycolate
Maize starch
Povidone
Colloidal anhydrous silica
Microcrystalline cellulose
Magnesium stearate
Opadry II 45F32810 (polydextrose, hypromellose, titanium Dioxide (E171), macrogol, iron oxide yellow (E172)

Pack sizes and marketing

Al/PVC/PVDC blisters. Pack size of 56 tablets. PP tablet containers. Pack size of 56 tablets.

Marketing authorization holder

Fannin (UK) Ltd., DCC Vital, Westminster Industrial Estate, Repton Road, Measham, Swadlincote, Derbyshire, DE12 7DT, England

Marketing authorization dates and numbers

PL 20417/0102

16/11/2012

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