FINIDE Film-coated tablet Ref.[50319] Active ingredients: Finasteride

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2020  Publisher: Alphapharm Pty Ltd, Level 1, 30 The Bond, 30 – 34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au

4.1. Therapeutic indications

Treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.

4.2. Posology and method of administration

The recommended dosage is one 5 mg tablet daily with or without food.

Dosage in impaired renal function

Adjustments in dosage are not necessary in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/minute) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.

Dosage in the elderly

No adjustment in dosage is required although pharmacokinetic studies indicated that the elimination of finasteride is somewhat decreased in patients aged over 70 years.

4.9. Overdose

Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months without adverse effects.

No specific treatment of overdosage with finasteride is recommended. General supportive care should be given.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4. Special precautions for storage

Store below 30°C. Protect from light.

Handling

Crushed or broken tablets of finasteride should not be handled by women when they are or may potentially be pregnant (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Section 4.6 FERTILITY, PREGNANCY AND LACTATION, EXPOSURE TO FINASTERIDE, RISK TO A MALE FOETUS).

6.5. Nature and contents of container

Available in blister packs containing 28 tablets (Al/Al) and 30 tablets (PVC/PE/PVDC/Al).

Some strengths, pack sizes and/or pack types may not be marketed.

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

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