1. Name of the medicinal product
Advagraf 0.5 mg prolonged-release hard capsules

Advagraf 1 mg prolonged-release hard capsules

Advagraf 3 mg prolonged-release hard capsules

Advagraf 5 mg prolonged-release hard capsules

2. Qualitative and quantitative composition
Advagraf 0.5 mg prolonged-release hard capsules

Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate).

Excipients with known effect:

Each capsule contains 51.09 mg lactose.

The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).

Advagraf 1 mg prolonged-release hard capsules

Each prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate).

Excipients with known effect:

Each capsule contains 102.17 mg lactose.

The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).

Advagraf 3 mg prolonged-release hard capsules

Each prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate).

Excipients with known effect:

Each capsule contains 306.52 mg lactose.

The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).

Advagraf 5 mg prolonged-release hard capsules

Each prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate).

Excipients with known effect:

Each capsule contains 510.9 mg lactose.

The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Advagraf 0.5 mg prolonged-release hard capsules

Prolonged-release hard capsule.

Gelatin capsules imprinted in red with “0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder.

Advagraf 1 mg prolonged-release hard capsules

Prolonged-release hard capsule.

Gelatin capsules imprinted in red with “1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder.

Advagraf 3 mg prolonged-release hard capsules

Prolonged-release hard capsule.

Gelatin capsules imprinted in red with “3 mg” on the orange capsule cap and “ 637” on the orange capsule body, containing white powder.

Advagraf 5 mg prolonged-release hard capsules

Prolonged-release hard capsule.

Gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and ” 687” on the orange capsule body, containing white powder.

4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

4.2 Posology and method of administration
Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy