Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Atodel 1 mg tablets.
Atodel 2 mg tablets.
Atodel 5 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Atodel 1 mg tablets: Orange, round, normal concave, scored tablets with Remedica’s logo on one side. The tablet can be divided into equal doses. Atodel 2 mg tablets: White, round, normal concave, scored tablets with Remedica’s logo on one side. The tablet can be divided into equal doses. Atodel 5 mg tablets: White, round, normal concave tablets. |
Atodel 1 mg tablets: Each tablet contains prazosin hydrochloride equivalent to 1 mg prazosin.
Atodel 2 mg tablets: Each tablet contains prazosin hydrochloride equivalent to 2 mg prazosin.
Atodel 5 mg tablets: Each tablet contains prazosin hydrochloride equivalent to 5 mg prazosin.
Excipient(s) with known effect:
Atodel 1 mg tablets: This product contains 81.2 mg lactose and 0.6 mg sunset yellow FCF E110.
Atodel 2 mg tablets: This product contains 113.7 mg lactose.
Atodel 5 mg tablets: This product contains 121.75 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Prazosin |
Prazosin causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. Prazosin has been found to successfully reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud’s disease. |
| List of Excipients |
|---|
|
Atodel 1 mg tablets: Microcrystalline cellulose Atodel 2 mg tablets and Atodel 5 mg tablets: Microcrystalline cellulose |
Atodel 1 mg tablets:
PVC/PVDC-Aluminium blisters. Pack sizes of 30 and 1000 tablets.
Atodel 2 mg tablets and Atodel 5 mg tablets:
PVC/PVDC-Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets.
Not all pack sizes may be marketed.
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Atodel 1 mg tablets: 9754
Atodel 2 mg tablets: 12649
Atodel 5 mg tablets: 12650
Atodel 1 mg tablets:
Date of first authorization: 09 February 1985
Date of latest renewal: 21 October 2011
Atodel 2 mg tablets:
Date of first authorization: 15 February 1990
Date of latest renewal: 21 October 2011
Atodel 5 mg tablets:
Date of first authorization: 15 February 1990
Date of latest renewal: 21 October 2011
| Drug | Countries | |
|---|---|---|
| ATODEL | Cyprus, Malta, Singapore |
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