MEDOLIN Tablet Ref.[28250] Active ingredients: Salbutamol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medolin 2 mg tablets.

Pharmaceutical Form

Tablet.

Pink, round, flat, scored, tablets with diameter 7 mm.

Qualitative and quantitative composition

Each tablet contains Salbutamol sulphate equivalent to salbutamol 2 mg.

Excipient with known effect: lactose monohydrate. Each tablet contains 118.1 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Salbutamol

Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle. Salbutamol is administered for the symptomatic relief of bronchospasm associated with chronic or acute asthma, bronchitis or other obstructive pulmonary diseases.

List of Excipients

The excipients are:

Lactose monohydrate
Microcrystalline cellulose
Sodium starch glycollate
Colloidal anhydrous silica
Magnesium stearate
Red lake (E123)

Pack sizes and marketing

Primary packaging: PVC – Aluminium foil blisters.

Secondary packaging: Cast coated Carton boxes with information leaflet.

Pack sizes available: Boxes of 50, 100, 1000 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

19931

20/12/2005 (date of authorisation)

Drugs

Drug Countries
MEDOLIN Cyprus, Hong Kong

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