URBANOL Capsule / Tablet (2022)

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Περιεχόμενα

1. Name of the medicinal product

URBANOL 5 mg CAPSULES. URBANOL 10 mg TABLETS.

2. Qualitative and quantitative composition

URBANOL 5 mg CAPSULES: Each capsule contains 5 mg clobazam as active ingredient. Contains sugar (lactose): 127 mg. For a full list of excipients, see section 6.1. URBANOL 10 mg TABLETS: Each ...

3. Pharmaceutical form

URBANOL 5 mg CAPSULES URBANOL 5 mg CAPSULES: opaque blue and white unprinted capsules (size no.4) containing a white powder. URBANOL 10 mg TABLETS URBANOL 10 mg TABLETS: white bi-planar round tablets scored ...

4.1. Therapeutic indications

URBANOL is used in the treatment of anxiety in neurotic patients and for pre-operative medication. It may be effective in relieving the acute symptoms of alcohol withdrawal syndrome but has not specific ...

4.2. Posology and method of administration

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 ...

4.3. Contraindications

Known hypersensitivity to benzodiazepines, or hypersensitivity to clobazam or any of the excipients of URBANOL. Patients with any history of drug or alcohol dependence (increased risk of development of ...

4.4. Special warnings and precautions for use

Amnesia Anterograde amnesia may occur even if benzodiazepines are used in normal dose range, but especially at higher dose levels. In case of loss or bereavement psychological adjustment may be inhibited ...

4.5. Interaction with other medicinal products and other forms of interaction

Alcohol Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% (see section 5.2) and therefore lead to increased clobazam effects (see section 4.4). Central nervous system ...

4.6. Pregnancy and lactation

Pregnancy URBANOL should be used judiciously during pregnancy and preferably avoided. Administration of URBANOL before or during childbirth can result in the occurrence of respiratory depression (including ...

4.7. Effects on ability to drive and use machines

Some adverse effects (e.g., sedation, muscle weakness) may impair the patients ability to concentrate and react, and therefore constitute a risk in situations where these abilities are of special importance ...

4.8. Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1 000 to ≤1/100); rare (≥1/10 000 to ≤1/1 000); very rare (≤1/10 000); not known ...

4.9. Overdose

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 ...

5.1. Pharmacodynamic properties

Category and class: A. 2.6 Tranquillisers Pharmacotherapeutic group: Benzodiazepine derivatives ATC Code: N05BA Clobazam is a 1,5-benzodiazepine, with anxiolytic properties.

5.2. Pharmacokinetic properties

Absorption After oral administration, clobazam is well-absorbed. Relative bioavailability of clobazam capsules, tablets or solution (in propylene glycol) was not significantly different. Time to peak plasma ...

6.1. List of excipients

URBANOL 5 mg CAPSULES Excipients: Lactose Talc Magnesium stearate Capsule shell: Gelatine Titanium dioxide (E171) Indigotin URBANOL 10 mg TABLETS Excipients: Maize starch Lactose monohydrate ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

URBANOL 5 mg CAPSULES: 3 years/36 months. URBANOL 10 mg TABLETS: 2 years/24 months.

6.4. Special precautions for storage

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

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand,1685, South Africa

8. Marketing authorization number(s)

URBANOL 5 mg CAPSULES: L/2.6/52 URBANOL 10 mg TABLETS: M/2.6/128

9. Date of first authorization / renewal of the authorization

URBANOL 5 mg CAPSULES: 8 November 1978 URBANOL 10 mg TABLETS: 20 July 1979

10. Date of revision of the text

27 September 2022

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