RIDAQ 12.5 mg Tablet Ref.[107965] Active ingredients: Hydrochlorothiazide

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

RIDAQ-12,5 tablets.

Pharmaceutical Form

Tablets.

RIDAQ-12,5 is a round, white tablet, flat with bevelled edges, bisected on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet of RIDAQ-12,5 contains 12,5 mg hydrochlorothiazide.

Contains sugar: Lactose monohydrate 62,6 mg.

For full list of excipients, see section 6.1.

Active Ingredient Description
Hydrochlorothiazide

Hydrochlorothiazide is a diuretic with antihypertensive properties. It acts by inhibiting the renal tubular re-absorption of sodium and chloride ions, which are excreted with an accompanying volume of water. Potassium excretion is also promoted.

List of Excipients

Lactose monohydrate
Magnesium stearate
Maize starch
Microcrystalline cellulose PH 101
Polysorbate 80
Purified talc
Sodium starch glycolate (Type A)

Pack sizes and marketing

Tablets are available in one of the following packaging:

Metallised layflat bags: Silver metallised layflat “bank bag” sealed with a perforated tear line (tender purposes only). Filled patient ready packs are stored in an outer clear, low density polyethylene bag (60 ยตm) along with leaflets for distribution. Each metallised layflat bag will contain 28 tablets.

HDPE bottle: The tablets are packed in a white 60 ml high density polyethylene (HDPE) bottle, together with a rayon insert and sealed with a sealing foil and a white 33 mm polypropylene cap. A leaflet is placed on top of the rayon insert prior to capping and a label is placed on the bottle. Each bottle will contain 30 tablets.

Securitainers: The tablets are packed in a white, polypropylene securitainer (49 mm x 100 mm), together with a white foam insert and sealed with a white, low-density polyethylene (LDPE), closure (49 mm) with a tamper evident seal. A leaflet is placed on top of the foam insert prior to capping and a label is placed on the securitainer. Each securitainer will contain 500 tablets.

Blisters: The tablets are packed in a PVC or PVC/PVDC blister of 28 and 30 tablets. The blisters are packed in a cardboard carton.

Not all packs and pack sizes are necessarily marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

A39/18.1/0399

Date of first authorization: 23 September 2005

Drugs

Drug Countries
RIDAQ South Africa

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