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SPC, UK: Rivotril 0.5 mg and 2 mgTablets (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Roche Products Limited
Διεύθυνση :
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
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Name of the medicinal product

Rivotril 0.5mg Tablets. Rivotril 2mg Tablets.

Qualitative and quantitative composition

Rivotril 0.5mg Tablets: Each tablet contains 0.5mg clonazepam. Excipients: Also contains 40mg lactose monohydrate. Rivotril 2mg Tablets: Each tablet contains 2mg clonazepam. Excipients: Also contains 121.5mg ...

Pharmaceutical form

Tablets. Rivotril 0.5mg Tablets: Round, dull pinkish-buff tablets with ROCHE 0,5 imprinted on one face and a single break mark on the other. The Tablets can be broken into equal halves to facilitate dosing. ...

Therapeutic indications

Tablets: All clinical forms of epileptic disease and seizures in infants, children and adults, especially absence seizures (petit mal) including atypical absence; primary or secondarily generalised tonic-clonic ...

Posology and method of administration

The scored 0.5mg tablets facilitate the administration of lower daily doses in the initial stages of treatment. Adults Initial dosage should not exceed 1mg/day. The maintenance dosage for adults normally ...

Contraindications

Patients with known sensitivity to benzodiazepines; or any of the drugs excipients; acute pulmonary insufficiency; severe respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis, severe hepatic ...

Special warnings and precautions for use

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs ...

Interaction with other medicinal products and other forms of interaction

Not recommended In combination with Rivotril, alcohol may modify the effects of the drug, compromise the success of therapy or give rise to unpredictable side-effects (see also section 4.4). Take into ...

Fertility, pregnancy and lactation

Preclinical studies in animals have shown reproductive toxicity (see section 5.3 Preclinical safety data). From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. ...

Effects on ability to drive and use machines

As a general rule, epileptic patients are not allowed to drive. Even when adequately controlled on Rivotril, it should be remembered that any increase in dosage or alteration in timings of dosage may modify ...

Undesirable effects

The following have been observed: Immune System Disorders Allergic reactions and very few cases of anaphylaxis have been reported to occur with benzodiazepines. Angioedema may occur in rare cases. Endocrine ...

Overdose

As with other benzodiazepine drugs, overdosage should not present undue problems of management or threat to life. Patients have recovered from overdoses in excess of 60mg without special treatment. Severe ...

Pharmacodynamic properties

Pharmacotherapeutic group: Benzodiazepine derivatives ATC code: N03AE01 Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing ...

Pharmacokinetic properties

Absorption Clonazepam is quickly and completely absorbed after oral administration of Rivotril. Peak plasma concentrations are reached in most cases within 1 4 hours after an oral dose. Bioavailability ...

Preclinical safety data

Carcinogenicity Conventional studies of carcinogenic potential have not been conducted with clonazepam. No 2-year carcinogenicity studies have been conducted with clonazepam. However, in an 18-month chronic ...

List of excipients

Rivotril 0.5mg tablets: Lactose (monohydrate) Maize starch Pregelatinised potato starch Talc Magnesium stearate Deionised water Dye iron oxide red E172 Dye iron oxide yellow E172 Rivotril 2mg tablets: ...

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Store in the original container and in the outer carton, in order to protect from light.

Nature and contents of container

Rivotril 0.5mg Tablets: Amber glass bottles with polyethylene screw closures, containing 50, 100 or 150 tablets. Rivotril 2mg Tablets: Amber glass bottles with polyethylene screw closures, containing 30 ...

Special precautions for disposal and other handling

There are no special instructions. Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Marketing authorization number(s)

Rivotril 0.5mg Tablets: PL 00031/0076R Rivotril 2mg Tablets: PL 00031/0077R

Date of first authorization / renewal of the authorization

26 July 1983 / 27 May 2005

Date of revision of the text

11 October 2011