Seroquel 25 mg film-coated tablets

Seroquel 100 mg film-coated tablets

Seroquel 150 mg film-coated tablets

Seroquel 200 mg film-coated tablets

Seroquel 300 mg film-coated tablets

Seroquel 25 mg contains 25 mg quetiapine (as quetiapine fumarate)

Excipient : 18 mg lactose (anhydrous) per tablet

Seroquel 100 mg contains 100 mg quetiapine (as quetiapine fumarate)

Excipient : 20 mg lactose (anhydrous) per tablet

Seroquel 150 mg contains 150 mg quetiapine (as quetiapine fumarate)

Excipient : 29 mg lactose (anhydrous) per tablet

Seroquel 200 mg contains 200 mg quetiapine (as quetiapine fumarate)

Excipient : 39 mg lactose (anhydrous) per tablet

Seroquel 300 mg contains 300 mg quetiapine (as quetiapine fumarate)

Excipient : 59 mg lactose (anhydrous) per tablet

For a full list of excipients, see Section 6.1.

Film-coated tablet

Seroquel 25 mg tablets are peach coloured, round biconvex and engraved with SEROQUEL 25 on one side

Seroquel 100 mg tablets are yellow, round biconvex and engraved with SEROQUEL 100 on one side

Seroquel 150 mg tablets are pale yellow, round biconvex and engraved with SEROQUEL 150 on one side

Seroquel 200 mg tablets are white, round biconvex and engraved with SEROQUEL 200 on one side

Seroquel 300 mg tablets are white, capsule-shaped and engraved with SEROQUEL on one side and 300 on the other side

Seroquel is indicated for:

• treatment of Schizophrenia.

• treatment of bipolar disorder:

- For the treatment of moderate to severe manic episodes in bipolar disorder

- For the treatment of major depressive episodes in bipolar disorder

- For the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.

Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition.

Seroquel can be administered with or without food.

Adults:

For the treatment of schizophrenia

For the treatment of schizophrenia, Seroquel should be administered twice a day. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4) From Day 4 onwards, the dose should be titrated to the usual effective dose of 300 to 450 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750 mg/day.

For the treatment of moderate to severe manic episodes in bipolar disorder

For the treatment of manic episodes associated with bipolar disorder, Seroquel should be administered twice a day. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.

The dose may be adjusted depending on clinical response and tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800 mg/day.

For the treatment of major depressive episodes in bipolar disorder

Seroquel should be administered once daily at bedtime. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). The recommended daily dose is 300 mg. In clinical trials, no additional benefit was seen in the 600 mg group compared to the 300 mg group (see Section 5.1). Individual patients may benefit from a 600 mg dose. Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder. In individual patients, in the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200 mg could be considered.

For preventing recurrence in bipolar disorder

For preventing recurrence of manic, mixed or depressive episodes in bipolar disorder, patients who have responded to quetiapine for acute treatment of bipolar disorder should continue therapy at the same dose. The dose may be adjusted depending on clinical response and tolerability of the individual patient, within the range of 300 to 800 mg/day administered twice daily. It is important that the lowest effective dose is used for maintenance therapy.

Elderly:

As with other antipsychotics, Seroquel should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of quetiapine was reduced by 30 - 50% in elderly subjects when compared to younger patients.

Efficacy and safety has not been eva luated in patients over 65 years with depressive episodes in the framework of bipolar disorder.

Paediatric Population:

Seroquel is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group. The available evidence from placebo-controlled clinical trials is presented in Sections 4.4, 4.8, 5.1 and 5.2.

Renal Impairment:

Dosage adjustment is not necessary in patients with renal impairment.

Hepatic Impairment:

Quetiapine is extensively metabolised by the liver. Therefore, Seroquel should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Patients with known hepatic impairment should be started with 25 mg/day. The dosage should be increased daily with increments of 25 - 50 mg/day until an effective dosage, depending on the clinical response and tolerability of the individual patient.

Hypersensitivity to the active substance or to any of the excipients of this product.

Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated. (See also Section 4.5.)