REMEDIUM Tablet Ref.[51162] Active ingredients: Diazepam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Remedium 5 mg tablets.

Pharmaceutical Form

Tablet.

Yellow, round, flat, scored tablets.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 5 mg of diazepam.

Excipient(s) with known effect: Each Remedium 5 mg tablet contains 113.6 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Diazepam

Diazepam is a psychotropic substance from the class of 1,4-benzodiazepines with marked properties of suppression of tension, agitation and anxiety as well as sedative and hypnotic effects. In addition, diazepam demonstrates muscle relaxant and anticonvulsive properties. It is used in the short-term treatment of anxiety and tension states, as a sedative and premedicant, in the control of muscle spasm and in the management of alcohol withdrawal symptoms.

List of Excipients

Cellulose, microcrystalline
Lactose monohydrate
Sodium starch glycolate (Type A)
Silica, colloidal anhydrous
Magnesium stearate
Talc
Maize starch
Povidone
Quinoline yellow aluminium lake E104

Pack sizes and marketing

Cardboard box containing Aluminium-PVC blisters of 10 tablets.

Pack sizes of 40, 100 and 1000 tablets.

Polypropylene container with a polyethylene security closure.

Pack size of 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

7750

Date of first authorization: 02 February 1981
Date of latest renewal: 04 September 2012

Drugs

Drug Countries
REMEDIUM Cyprus, Malta

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