PERAZODIN Coated tablet Ref.[28192] Active ingredients: Dipyridamole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Perazodin 25 mg coated tablets.

Perazodin 75 mg coated tablets.

Perazodin 100 mg coated tablets.

Pharmaceutical Form

Coated Tablet.

Perazodin 25 mg coated tablets: Light orange, round, sugar-coated tablets.

Perazodin 75 mg coated tablets: Orange, round, sugar-coated tablets.

Perazodin 100 mg coated tablets: White, round, sugar-coated tablets.

Qualitative and quantitative composition

Perazodin 25 mg coated tablets: Each coated tablet contains 25 mg dipyridamole.

Perazodin 75 mg coated tablets: Each coated tablet contains 75 mg dipyridamole.

Perazodin 100 mg coated tablets: Each coated tablet contains 100 mg dipyridamole.

Excipient(s) with known effect:

Perazodin 25 mg coated tablets: This product contains 13.4 mg lactose monohydrate, 37.282 mg sucrose, 0.041 mg sunset yellow E110 and 0.004 mg ponceau 4R E124.

Perazodin 75 mg coated tablets: This product contains 40.2 mg lactose monohydrate, 71.331 mg sucrose and 0.106 mg ponceau 4R E124.

Perazodin 100 mg coated tablets: This product contains 53.6 mg lactose monohydrate and 95.099 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dipyridamole

Dipyridamole is an antithrombotic agent with antiplatelet activity. Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which are factors associated with the initiation of thrombus formation.

List of Excipients

Perazodin 25 mg coated tablets

Core:

Lactose monohydrate
Povidone
Microcrystalline cellulose
Sodium starch glycolate
Colloidal silicon dioxide
Magnesium stearate
Talc

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Talc
Gelatin
Polyethylene glycol 6000
Povidone
Sucrose
Calcium carbonate
Sunset yellow FCF E110
Ponceau 4R E124

Perazodin 75 mg coated tablets

Core:

Lactose monohydrate
Povidone
Microcrystalline cellulose
Sodium starch glycolate
Colloidal silicon dioxide
Magnesium stearate
Talc

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Talc
Gelatin
Polyethylene glycol 6000
Povidone
Sucrose
Calcium carbonate
Ponceau 4R E124
Quinoline yellow E104

Perazodin 100 mg coated tablets

Core:

Lactose monohydrate
Povidone
Microcrystalline cellulose
Sodium starch glycolate
Colloidal silicon dioxide
Magnesium stearate
Talc

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Talc
Gelatin
Polyethylene glycol 6000
Sucrose
Calcium carbonate
Povidone

Pack sizes and marketing

Perazodin 25 mg coated tablets:

PVC/Aluminium blisters. Pack sizes of 100 and 1000 coated tablets.

PP containers with PE closure. Pack size of 1000 coated tablets

Perazodin 75 mg coated tablets:

PVC/Aluminium blisters. Pack sizes of 20, 30, 100 and 1000 coated tablets.

Perazodin 100 mg coated tablets:

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

Marketing authorization holder

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

Marketing authorization dates and numbers

Perazodin 25 mg coated tablets: 8551
Perazodin 75 mg coated tablets: 8552
Perazodin 100 mg coated tablets: 10438

Perazodin 25 mg coated tablets:

Date of first authorization: 20 November 1982
Date of latest renewal: 01 September 2010

Perazodin 75 mg coated tablets:

Date of first authorization: 20 November 1982
Date of latest renewal: 19 April 2013

Perazodin 100 mg coated tablets:

Date of first authorization: 28 April 1986
Date of latest renewal: 19 April 2013

Drugs

Drug Countries
PERAZODIN Cyprus, Hong Kong, Malta, Singapore

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