DICLOXACILLIN ORION Capsule Ref.[8254] Active ingredients: Dicloxacillin

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Product name and form

Dicloxacillin Orion 250 mg capsules, hard.

Dicloxacillin Orion 500 mg capsules, hard.

Pharmaceutical Form

Capsule, hard.

Dicloxacillin Orion 250 mg capsules, hard: Off-white/Off-white size ‘2’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘Y’ on off-white cap & ‘14’ on off-white body with black ink.

Dicloxacillin Orion 500 mg capsules, hard: Off-white/Off-white size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘Y’ on off-white cap & ‘15’ on off-white body with black ink.

Qualitative and quantitative composition

Dicloxacillin Orion 250 mg capsules, hard: Each capsule contains dicloxacillin sodium equivalent to 250 mg of dicloxacillin.

Dicloxacillin Orion 500 mg capsules, hard: Each capsule contains dicloxacillin sodium equivalent to 500 mg of dicloxacillin.

One Dicloxacillin Orion 250 mg capsule contains 12.7 mg sodium.

One Dicloxacillin Orion 500 mg capsule contains 25.3 mg sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dicloxacillin

Dicloxacillin is a penicillinase stable, acid-stable semisynthetic penicillin. It inhibits bacterial cell wall synthesis and has bactericidal effect on penicillin susceptible bacteria in the growth phase.

List of Excipients

Capsule content:

Silica colloidal anhydrous
Magnesium stearate
Capsule shell:
Gelatin
Water
Titanium dioxide (E171)

Printing ink:

Shellac
Dehydrated alcohol
Isopropyl alcohol
Butyl alcohol
Propylene glycol
Strong ammonia solution
Black iron oxide (E172)
Potassium hydroxide
Purified water

Pack sizes and marketing

30, 50 or 100 capsules in HDPE plastic jar with PP closure.

Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

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