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

4.1. Therapeutic indications

RIDAQ-12,5 is indicated for:

  • mild to moderate hypertension, alone or in combination with other antihypertensives.

4.2. Posology and method of administration

Posology

Adults

If a single dose is indicated, RIDAQ-12,5 should preferably be taken in the morning in order to minimise the effect of increased frequency of urination during sleep. RIDAQ-12,5 should be taken with or after meals to minimise stomach upset.

Hypertension

For the treatment of mild to moderate hypertension: Take one tablet (12,5 mg) daily.

As an adjunct in the treatment of hypertension: Take one to two tablets (12,5 mg to 25 mg) daily in conjunction with an antihypertensive medicine.

The dosage should not be higher than necessary to achieve the desired effect.

Prolonged treatment may result in potassium ion loss. Potassium supplements may be necessary.

Paediatric population

No data are available.

Method of administration

For oral administration.

4.9. Overdose

Symptoms

RIDAQ-12,5 can produce acute renal failure either from overdosage, producing saline depletion and hypovolaemia or, occasionally, as a result of a hypersensitivity reaction.

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalaemia may accentuate cardiac dysrhythmias.

Treatment

In massive overdosage, treatment is symptomatic and supportive. Recommended treatment for overdose includes immediate evacuation of the stomach (emesis or gastric lavage); supportive, symptomatic treatment; monitoring of serum electrolyte concentrations and renal function and immediate institution of appropriate treatment for hypokalaemia. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which RIDAQ 12,5 is removed by haemodialysis has not been established.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store at or below 25ยฐC in a well-closed container.

Protect from light and moisture.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

No special requirements.

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