GIROTEC Tablet Ref.[51195] Active ingredients: Lamotrigine

It is important to adhere to the recommended dosages especially in combination therapy with valproate where one-tenth of the normal GIROTEC TABLETS dose is used. Do not exceed the maximum dosage (see “WARNINGS AND SPECIAL PRECAUTIONS”).

To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed if necessary. If the doses calculated for children, according to bodyweight, do not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets.

Epilepsy

DOSAGE IN MONOTHERAPY

Adults and children over 12 years of age

Initial dose in monotherapy: 25 mg once daily for two weeks, followed by 50 mg once daily for two weeks. The dosage may be increased by a maximum of 50 mg – 100 mg every 1 – 2 weeks until the optimal response is achieved.

Maintenance dose in monotherapy: The usual dose to achieve optimal response is 100 – 200 mg per day given in one dose or two divided doses. Some patients have required 500 mg/day of GIROTEC TABLETS to achieve the desired response.

Adults and Children over 12 years (total daily dose):

The recommended initial dose and subsequent dose escalation should not be exceeded to minimise the risk of skin rash (see “WARNINGS AND SPECIAL PRECAUTIONS”).

DOSAGE IN ADD-ON THERAPY

Adults and children over 12 years of age

With enzyme-inducing anticonvulsants only: The initial dose is 50 mg once a day for two weeks, then 100 mg a day, divided into two doses, for two weeks. The dosage may be increased by a maximum of 100 mg every 1 – 2 weeks until the optimal response is achieved. The usual maintenance dose is 200 – 400 mg/day given in two divided doses.

With enzyme-inducing anticonvulsants and valproic acid:The initial dose is 25 mg once every other day for two weeks, then 25 mg once a day for two weeks. The dosage may be increased by a maximum of 25 – 50 mg a day every 1 or 2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100 – 200 mg/day given once a day or in two divided doses.

In patients taking antiepileptic medicines where the pharmacokinetic interaction with GIROTEC TABLETS is currently not known, the dose escalation as recommended for GIROTEC TABLETS with concurrent valproate should be used. Thereafter, the dose should be increased until the optimal response is achieved.

Adults and Children over 12 years (total daily dose):

The recommended initial dose and subsequent dose escalation should not be exceeded to minimise the risk of skin rash (see “Warning and Special Precautions”).

Children aged 2 to 12 years

The initial GIROTEC TABLETS dose in those not taking sodium valproate is 0, 6 mg/kg body mass/day given in two divided doses for two weeks, followed by 1, 2 mg/kg/day for two weeks. Thereafter, the dose should be increased by a maximum of 1, 2 mg/kg every 1– 2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 5 – 15 mg/kg/day given in two divided doses. A maximum daily dose of 400 mg must not be exceeded.

In those patients taking sodium valproate, the initial GIROTEC TABLETS dose is 0,15 mg/kg body mass/day given once a day for two weeks, followed by 0,3 mg/kg/day given once a day for two weeks. Thereafter, the dose should be increased by a maximum of 0, 3 mg/kg every 1- 2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 1- 5 mg/kg/day given once a day or in two divided doses. A maximum daily dose of 200 mg must not be exceeded.

In patients taking antiepileptic medicines where the pharmacokinetic interaction with GIROTEC TABLETS is currently not known, the dose escalation as recommended for GIROTEC TABLETS with concurrent valproate should be used. Thereafter, the dose should be increased until the optimal response is achieved.

CHILDREN AGED 2 TO 12 YEARS (TOTAL DAILY DOSE):

The recommended initial dose and subsequent dose escalation should not be exceeded to minimise the risk of skin rash (see “WARNINGS AND SPECIAL PRECAUTIONS”).

Note: If the calculated daily dose is <5 mg then GIROTEC TABLETS should not be administered. Patients aged 2 – 6 years may require a maintenance dose at the higher end of the recommended range.

Dosage in seizures associated with Lennox-Gastaut Syndrome

The dosing guidelines outlined above for both adults and children aged 2 – 12 years apply for the treatment of seizures associated with Lennox-Gastaut Syndrome.

Children aged less than 2 years

There is insufficient information on the use of GIROTEC TABLETS in children aged less than two years.

BIPOLAR DISORDER

Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded (see “WARNINGS AND SPECIAL PRECAUTIONS”).

Lamotrigine is recommended for use in bipolar patients at risk for a future depressive episode. The following transition regimen should be followed to prevent recurrence of depressive episodes. The transition regimen involves escalating the dose of GIROTEC TABLETS to a maintenance stabilisation dose over six weeks (see table below) after which other psychotropic and/or antiepileptic medicines can be withdrawn, if clinically indicated.

Adjunctive therapy should be considered for the prevention of manic episodes, as efficacy with GIROTEC

TABLETS in mania has not been conclusively established.

Recommended dose escalation to the maintenance total stabilisation dose for adults (over 18 years of age) treated with BIPOLAR DISORDER:

NOTE: In patients taking antiepileptic drugs where the pharmacokinetic interaction with lamotrigine is currently not known, the dose escalation as recommended for lamotrigine with concurrent valproate should be used.

The target stabilisation dose will alter depending on clinical response.

a) Adjunct therapy with enzyme inhibitors e.g. valproate:

In patients taking enzyme inhibiting medicines concomitantly such as valproate, the initial GIROTEC TABLETS dose is 25 mg every alternate day for two weeks, followed by 25 mg once a day for two weeks. The dose should be increased to 50 mg once a day (or in two divided doses) in week 5. The usual target dose to achieve optimal response is 100 mg/day given once a day or in two divided doses. However, the dose can be increased to a maximum daily dose of 200 mg, depending on clinical response.

b) Adjunct therapy with enzyme inducers e.g. carbamazepine and phenobarbitone in patients NOT taking valproate:

In those patients taking enzyme inducing medicines such as carbamazepine or phenobarbitone and NOT taking valproate, the initial lamotrigine dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks. The dose should be increased to 200 mg/day given as two divided doses in week 5. The dose may be increased in week 6 to 300 mg/day however, the usual target dose to achieve optimal response is 400 mg/day given in two divided doses, which may be given from week 7.

c) Adjunct therapy to medicines with no known clinical pharmacokinetic interaction with lamotrigine e.g. lithium, bupropion, or monotherapy with lamotrigine:

The initial lamotrigine dose in patients taking concomitant medicines with no known/theoretical pharmacokinetic interaction with lamotrigine, or in monotherapy, is 25 mg once a day for two weeks, followed by 50 mg once a day (or in two divided doses) for two weeks. The dose should be increased to 100 mg/day in week 5. The usual target dose to achieve optimal response is 200 mg/day given once a day as two divided doses. A range of 100 – 400 mg has been used in clinical trials.

Once the target daily maintenance stabilisation dose has been achieved, other psychotropic medications may be withdrawn as laid out in the dosage schedule below (see table below).

Maintenance stabilisation total daily dose in BIPOLAR DISORDER following withdrawal of concomitant psychotropic or antiepileptic medicines:

NOTE: In patients taking AEDs where the pharmacokinetic interaction with lamotrigine is currently not known, the dose escalation as recommended for lamotrigine with concurrent valproate should be used.

Dose may be increased to 400 mg/day as needed.

(a) Following withdrawal of adjunct therapy with enzyme inhibitors e.g. valproate:

The dose of GIROTEC TABLETS should be increased to double the original target stabilisation dose and maintained at this, once valproate has been terminated.

(b) Following withdrawal of adjunct therapy with enzyme inducers e.g. carbamazepine, depending on original maintenance dose:

The dose of GIROTEC TABLETS should be gradually reduced over 3 weeks as the enzyme inducer is withdrawn.

© Following withdrawal of adjunct therapy with other psychotropic or antiepileptic medicines with no known pharmacokinetic interaction with lamotrigine e.g. lithium, bupropion:

The target dose achieved in the dose escalation programme should be maintained throughout withdrawal of the other medication.

Adjustment of GIROTEC TABLETS daily dosing in patients with BIPOLAR DISPORDER following addition of other medicines:

There is no clinical experience in adjusting the GIROTEC TABLETS daily dose following the addition of other medications. However, based on medicine interaction studies, the following recommendations can be made (see below):

Adjustment of lamotrigine daily dosing in patients with BIPOLAR DISORDER following the addition of other medicines:

NOTE: In patients taking AEDs where the pharmacokinetic interaction with GIROTEC TABLETS is currently not known, the dose escalation as recommended for lamotrigine with concurrent valproate should be used.

Discontinuation of GIROTEC TABLETS in patients with bipolar disorder: Patients may terminate GIROTEC TABLETS without a step-wise reduction of dose.

Children (less than 18 years of age): Safety and efficacy of GIROTEC TABLETS in bipolar disorder has not been evaluated in this age group. Therefore, a dosage recommendation cannot be made.

GENERAL DOSING RECOMMENDATIONS

Administration: GIROTEC TABLETS (dispersible) should be dispersed in a small volume of water (at least enough to cover the whole tablet). The tablets may also be chewed, or swallowed whole with a little water, if preferred.

Symptoms and signs

Sedation, ataxia, diplopia, nausea and vomiting have been reported.

Treatment

In the event of overdosage, the patient should be admitted to hospital and given appropriate supportive therapy. Gastric lavage should be performed if indicated.

Store at or below 30°C. Keep blisters in the original carton until required for use. Keep the containers tightly closed.

KEEP OUT OF REACH OF CHILDREN.

GIROTEC 25 mg TABLETS

1) Blister Pack:

Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.

Each blister contains 10 tablets.

Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.

2) HDPE Container Pack:

Tablets are packed in 40 ml white opaque HDPE containers with white opaque polypropylene closures with induction sealing wad, containing cotton coil.

Each container contains 60 tablets.

Pack size: 60’s – One HDPE container contains 60 tablets.

GIROTEC 50 mg TABLETS

1) Blister Pack:

Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.

Each blister contains 10 tablets.

Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.

2) HDPE Container Pack:

Tablets are packed in 40 ml white opaque HDPE containers with white opaque polypropylene closures with
induction sealing wad, containing cotton coil.

Each container contains 60 tablets.

Pack size: 60’s – One HDPE container contains 60 tablets.

GIROTEC 100 mg TABLETS

1) Blister Pack:

Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.
Each blister contains 10
tablets.

Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.

2) HDPE Container Pack:

Tablets are packed in 60 ml white opaque HDPE containers with white opaque polypropylene closures with
induction sealing wad, containing cotton coil.

Each container contains 60 tablets.

Pack size: 60’s – One HDPE container contains 60 tablets

GIROTEC 200 mg TABLETS

1) Blister Pack:

Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.

Each blister contains 10 tablets.

Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.

2) HDPE Container Pack:

Tablets are packed in 120 ml white opaque HDPE containers with white opaque polypropylene closures with
induction sealing wad, containing cotton coil.

Each container contains 60 tablets.

Pack size: 60’s – One HDPE container contains 60 tablets.