NITROFURANTOIN Tablet Ref.[7492] Active ingredients: Nitrofurantoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Dr Reddys Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

Product name and form

Nitrofurantoin 50 mg Tablets.

Aratoin 50 mg Tablets.

Pharmaceutical Form

Tablet to be taken orally.

Flat yellow, bevelled and scored tablets.

Qualitative and quantitative composition

Nitrofurantoin 50.00 mg.

For the full list of excipients see section 6.1.

Active Ingredient Description
Nitrofurantoin

Nitrofurantoin is a broad spectrum antibacterial agent, active against the majority of urinary pathogens. It is bactericidal in renal tissue and throughout the urinary tract. The wide range of organisms sensitive to the bacterial activity include Escherichia coli, Enteroccus faecalis, Klebsiella species, Enterobacter species, Staphylococcus species: (e.g. S. aureus, S. saprophyticus, S. epidermidis).

List of Excipients

Lactose
Maize starch
Pregelatinised maize starch
Sodium starch glycollate
Magnesium stearate
Purified water

Pack sizes and marketing

High density polystyrene containers with polythene lids and/or polypropylene containers with polypropylene or polythene lids.

Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000.

250 micron, pharmaceutical grade, green rigid PVC

20 micron, hard-tempered aluminium foil, coated on the dull side with 6-7 gsm heat-seal lacquer and printed on the bright side.

Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000.

Marketing authorization holder

Dr Reddy’s Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

Marketing authorization dates and numbers

08553/0087

14/03/2011

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