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Paediatric Worksharing - Art. 45
Clobazam (Frisium)
UK/W/018/pdWS/001
Finalisation procedure: 16 December 2010
Recommended text amendments for SmPC
Section 4.2 Posology and route of administration
Treatment of anxiety
The usual anxiolytic dose for adults and adolescents over 15 years of age is 20-30 mg daily in divided
doses or as a single dose given at night. Doses up to 60mg daily have been used in the treatment of
adult in-patients with severe anxiety.
The lowest dose that can control symptoms should be used. After improvement of the symptoms, the
dose may be reduced.
It should not be used for longer than 4 weeks. Long term chronic use as an anxiolytic is not
recommended. In certain cases, extension beyond the maximum treatment period may be necessary;
treatment must not be extended without re-evaluation of the patient's status using special expertise. It
is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they
may lead to dependence. Treatment should always be withdrawn gradually. Patients who have taken
Frisium for a long time may require a longer period during which doses are reduced.
Treatment of epilepsy in association with one or more other anticonvulsants
Adults
In epilepsy a starting dose of 20-30 mg/day is recommended, increasing as necessary up to a
maximum of 60 mg daily. The patient must be re-assessed after a period not exceeding 4 weeks and
regularly thereafter in order to evaluate the need for continued treatment. A break in therapy may be
beneficial if drug exhaustion develops, recommencing therapy at a low dose. At the end of treatment
(including in poor-responding patients), since the risk of withdrawal phenomena/rebound phenomena
is greater after abrupt discontinuation of treatment, it is recommended to gradually decrease the
dosage.
Elderly: Doses of 10-20 mg daily in anxiety may be used in the elderly, who are more sensitive to the
effects of psychoactive agents. Treatment requires low initial doses and gradual dose increments
under careful observation.
Paediatric patients aged 6 years and above and those who are able to swallow:
When prescribed for children, aged three years of age, dosage should not exceed half the
recommended adult dose. Treatment requires low initial doses and gradual dose increments under
careful observation. It is recommended that normally treatment should be started at 5 mg daily.
A maintenance dose of 0.3 to 1 mg/kg body weight daily is usually sufficient.
There is insufficient experience of the use of Frisium in children under three years of age to enable
any dosage recommendation to be made.
As there is no age appropriate formulation to enable safe and accurate dosing, no dosage
recommendations can be made in children under 6 years of age.
Tablets should to be swallowed without chewing with sufficient amount of liquid (1/2 glass).
The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter
in order to evaluate the need for continued treatment. A break in therapy may be beneficial if
drug exhaustion develops, recommencing therapy at a low dose. At the end of treatment
(including in poor-responding patients), since the risk of withdrawal phenomena/rebound
phenomena is greater after abrupt discontinuation of treatment, it is recommended to
gradually decrease the dosage.
UK/W/018/pdWS/001 - Clobazam (Frisium)
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Dutch text proposal for text additions
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SmPC
4.2 Dosering en wijze van toediening
Kinderen vanaf 6 jaar
De aanbevolen aanvangsdosering is 5 mg per dag. Een onderhoudsdosering van 0,3 mg tot 1,0
mg/kg lichaamsgewicht per dag is gewoonlijk voldoende.
Omdat er geen geschikte formulering is voor een veilige en nauwkeurige dosering bij jonge kinderen,
kunnen geen aanbevelingen worden gedaan voor de dosering bij kinderen jonger dan 6 jaar.
De patiënt moet opnieuw worden onderzocht na een behandelingsperiode van maximaal 4 weken en
regelmatig daarna om de noodzaak tot verder behandelen vast te stellen. Tijdelijk stopzetten van de
behandeling kan zinvol zijn, als de effectiviteit in de loop der tijd vermindert. De behandeling kan
vervolgens met een lage dosis opnieuw gestart worden.
Bij beëindiging van de behandeling, ook wanneer de respons op de behandeling onvoldoende was,
wordt aanbevolen geleidelijk af te bouwen, aangezien het risico op onthoudingsverschijnselen en
rebound-effecten hoger is na abrupt staken.
Patient Information Leaflet
Please note that text deletions may also be applicable. See recommended text amendments for
SmPC
Patients aged 6 years and above
It is recommended that normally treatment should be started at 5 mg daily. A maintenance
dose of 0.3 to 1 mg/kg body weight daily is usually sufficient.
Kinderen vanaf 6 jaar en ouder:
De startdosering is over het algemeen 5 mg per dag. Daarna is een onderhoudsdosering van 0,3 mg
tot 1,0 mg per kg lichaamsgewicht per dag meestal voldoende.
Na 4 weken zal de arts beoordelen of de behandeling moet worden voortgezet.
UK/W/018/pdWS/001 - Clobazam (Frisium)