URBANOL Capsule / Tablet Ref.[50584] Active ingredients: Clobazam

The normal adult dose ranges between 10–30 mg daily: doses of 20 mg and above should preferably be given at bedtime or in divided doses.

For elderly and debilitated patients as well as in children and light-weight patients, the daily dose should be halved.

Increased responsiveness and higher susceptibility to adverse effects may be present in these patients and low initial doses and gradual dose increments, under careful observation, are required.

Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.

Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.

Patients with renal or hepatic impairment

Increased responsiveness and higher susceptibility to adverse effects may be present in these patients and require low initial doses and gradual dose increments under careful observation (see section 4.4).

Secondary dose adjustment

After improvement of symptoms, the dose may be reduced.

Duration of treatment

The duration of treatment should be as short as possible. The patient should be reassessed after a period, not exceeding 4 weeks, and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. The overall duration of treatment generally should not be more than 8-12 weeks, including a tapering off process. In certain cases, extension beyond the maximum treatment period may be necessary. If so, it should not take place without re-evaluation of the patient’s status, using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since it may lead to dependence (see section 4.4).

Discontinuation of treatment

It is strongly recommended that after prolonged treatment, URBANOL is not withdrawn suddenly, but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur (see section 4.4).

ADMINISTRATION

The 10 mg tablets can be divided into equal halves of 5 mg.

The capsules are to be swallowed without chewing with a generous amount of liquid (approximately 1 glass).

URBANOL can be given with or without food.

Signs and symptoms

Overdose and intoxication with benzodiazepines, including URBANOL, may lead to central nervous system depression, associated with drowsiness, confusion and lethargy, possibly progressing to ataxia, respiratory depression, hypotension and, rarely, coma. The risk of a fatal outcome is increased in cases of combined poisoning with other CNS depressants, including alcohol.

Management

In treatment for intoxication, it is recommended that the possible involvement of multiple substances be taken into consideration.

Intravenous fluid replenishment and general supportive measures may be indicated in addition to monitoring of consciousness, respiration, pulse rate and blood pressure.

Secondary elimination of URBANOL (by forced diuresis or haemodialysis) is ineffective.

URBANOL 5 mg CAPSULES: 3 years/36 months.

URBANOL 10 mg TABLETS: 2 years/24 months.

Store at or below 25°C, in a dry place.

Protect from moisture.

URBANOL is available as 5 mg capsules and 10 mg tablets packed into opaque white PVC/acetochloride and aluminium blister packs, inserted into outer printed cardboard cartons, containing 100 capsules/tablets each (5x 20 blister packs).

No special requirements.