TEXAMER Film-coated tablet Ref.[51219] Active ingredients: Levocetirizine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa

Product name and form

TEXAMER Film-coated tablets.

Pharmaceutical Form

Film coated tablets.

White, round, biconvex film-coated tablets, 7 mm in diameter, with bevelled edges.

Qualitative and quantitative composition

Each film coated tablet contains 5 mg Levocetirizine dihydrochloride.

Each tablet contains sugar (lactose monohydrate 93,29 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levocetirizine

Levocetirizine, the ® enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.
List of Excipients

Tablet Cores:

Colloidal silica anhydrous
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose

Film coating – Opadry white:

Hypromellose 6cP
Lactose monohydrate
Macrogol 3000
Titanium dioxide
Triacetin

Pack sizes and marketing

TEXAMER is packed into two different blister strips:

  • Silver OPA/Al/PVC and aluminium foil blister strips.
  • Clear transparent PVC/PVDC and aluminium foil blister strips.
  • 7 or 10 tablets are packed into a blister strip.
  • 1 blister strip of 7 tablets is packed into an outer carton.
  • 1 or 3 blister strips of 10 tablets are packed into an outer carton.

Not all pack sizes and pack types are marketed.

Marketing authorization holder

Pharma Dynamics (Pty) Ltd, 1st Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa

Marketing authorization dates and numbers

A45/5.7.1/1064

Date of registration: 16 February 2017

Drugs

Drug Countries
TEXAMER South Africa
 
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