VELORIN Film-coated tablet Ref.[28201] Active ingredients: Atenolol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Velorin 25 mg film-coated tablets.

Velorin 50 mg film-coated tablets.

Velorin 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Velorin 25 mg film-coated tablets: White, round, film-coated tablets.

Velorin 50 mg film-coated tablets: White, round, film-coated tablets.

Velorin 100 mg film-coated tablets: Orange, round, scored, film-coated tablets.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Velorin 25 mg film-coated tablets

Each film-coated tablet contains 25 mg atenolol.

Excipient(s) with known effect:

This product contains 32.5 mg lactose.

Velorin 50 mg film-coated tablets

Each film-coated tablet contains 50 mg atenolol.

Excipient(s) with known effect:

This product contains 65 mg lactose.

Velorin 100 mg film-coated tablets

Each film-coated tablet contains 100 mg atenolol.

Excipient(s) with known effect:

This product contains 65 mg lactose, 0.09 mg ponceau 4R E124 and 0.94 sunset yellow E110.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Atenolol

Atenolol is a beta-blocker which is beta1-selective, (i.e. acts preferentially on beta1-adrenergic receptors in the heart). Atenolol is without intrinsic sympathomimetic and membrane-stabilising activities and as with other beta-blockers, has negative inotropic effects.

List of Excipients

Velorin 25 mg and 50 mg film-coated tablets

Core:

Lactose
Povidone
Magnesium stearate
Pregelatinised starch
Talc
Maize starch
Microcrystalline cellulose
Colloidal silicon dioxide
Sodium lauryl sulfate
Croscarmellose sodium

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Talc

Velorin 100 mg film-coated tablets

Core:

Lactose
Povidone
Magnesium stearate
Pregelatinised starch
Talc
Maize starch
Microcrystalline cellulose
Colloidal silicon dioxide
Sodium lauryl sulfate
Croscarmellose sodium

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Sunset Yellow FCF E110
Ponceau 4R E124
Talc

Pack sizes and marketing

Velorin 25 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 30 and 1000 film-coated tablets.

PP containers with PE closures. Pack-size of 1000 film-coated tablets.

Velorin 50 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 30, 100 and 1000 film-coated tablets.

PP containers with PE closures. Pack-size of 1000 film-coated tablets.

Velorin 100 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 14, 30,100 and 1000 film-coated tablets.

PP containers with PE closures. Pack-sizes of 100 and 1000 film-coated 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

Velorin 25 mg film-coated tablets: 19697
Velorin 50 mg film-coated tablets: 12371
Velorin 100 mg film-coated tablets: 10379

Velorin 25 mg film-coated tablets:

Date of first authorization: 18 July 2005
Date of latest renewal: 03 October 2012

Velorin 50 mg film-coated tablets:

Date of first authorization: 06 July 1989
Date of latest renewal: 29 October 2012

Velorin 100 mg film-coated tablets:

Date of first authorization: 08 March 1986
Date of latest renewal: 03 October 2012

Drugs

Drug Countries
VELORIN Albania, Cyprus, Malta, Singapore

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