FLUCORIC Capsule Ref.[50943] Active ingredients: Fluconazole

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa

Product name and form

Flucoric 50 Capsules.

Flucoric 100 Capsules.

Flucoric 150 Capsules.

Flucoric 200 Capsules.

Pharmaceutical Form

Capsule.

Flucoric 50 Capsules: Blue/white hard gelatin, self locked capsules of size ‘4’ imprinted with ‘RANBAXY’ in black edible ink on both cap and body containing white to off-white powder.

Flucoric 100 Capsules: Blue/white hard gelatin, self locked capsules of size ‘2’ imprinted with ‘RANBAXY’ in black edible ink on both cap and body containing white to off-white powder.

Flucoric 150 Capsules: Blue/blue hard gelatin, self locked capsules of size ‘1’ imprinted with ‘RANBAXY’ in black edible ink on both cap and body containing white to off-white powder.

Flucoric 200 Capsules: Purple/white hard gelatin, self locked capsules of size ‘0’ imprinted with ‘RANBAXY’ in black edible ink on both cap and body containing white to off-white powder.

Qualitative and quantitative composition

Flucoric 50 Capsules

Each capsule contains fluconazole 50 mg.

Contains sugar: lactose monohydrate 38,5 mg per capsule.

Flucoric 100 Capsules

Each capsule contains fluconazole 100 mg.

Contains sugar: lactose monohydrate 77,5 mg per capsule.

Flucoric 150 Capsules

Each capsule contains fluconazole 150 mg.

Contains sugar: lactose monohydrate 115,5 mg per capsule.

Flucoric 200 Capsules

Each capsule contains fluconazole 200 mg.

Contains sugar: lactose monohydrate 154 mg per capsule.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluconazole

Fluconazole is a triazole antifungal agent. Its primary mode of action is the inhibition of fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.

List of Excipients

Flucoric Capsules:

colloidal anhydrous silica
lactose monohydrate
magnesium stearate
maize starch
sodium lauryl sulphate

Capsule shell – cap (Blue, opaque) – Flucoric 50/100/150 Capsules):

Patent Blue (Cl No. 42051) - (Flucoric 50/100/150 Capsules)
Phloxine B - (Flucoric 100 Capsules)
Titanium dioxide (Cl No. 77891) – (Flucoric 50/100/150 Capsules)
Gelatin – (Flucoric 50/100/150 Capsules)

Capsule shell – cap Purple, opaque (Flucoric 200 Capsules):

Patent Blue (Cl No. 42051)
Phloxine B
Titanium dioxide (Cl No. 77891)
Gelatin

Capsule Body (White, opaque) Flucoric 50/100/200 Capsules):

Titanium dioxide (Cl No. 77891)
Gelatin

Capsule Body (Blue, opaque) - (Flucoric 150 Capsules):

Patent Blue (Cl No. 42051)
Titanium dioxide (Cl No. 77891)
Gelatin

Composition of the printing ink (Flucoric 50/100/150/200 Capsules):

Shell USNF
Dehydrated alcohol USP
isopropyl alcohol USP
Butyl alcohol NF
Propylene glycol USP
Purified water USP
Black iron oxide (Cl No. 77499)

Pack sizes and marketing

Flucoric 50 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 14 capsules each.

Flucoric 100 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 14 capsules each.

Flucoric 150 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 1 or 4 capsules each.

Flucoric 200 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 28 capsules each.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

Flucoric 50 Capsules: 37/20.2.2/0114
Flucoric 100 Capsules: 37/20.2.2/0115
Flucoric 150 Capsules: 37/20.2.2/0116
Flucoric 200 Capsules: 37/20.2.2/0117

05 September 2003

Drugs

Drug Countries
FLUCORIC Lithuania, Romania, South Africa

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