Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Amirol 10 mg film-coated tablets.
Amirol 25 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Amirol 10 mg film-coated tablets: Light blue, round, film-coated tablets. Amirol 25 mg film-coated tablets: Yellow, round, film-coated tablets. |
Amirol 10 mg film-coated tablets: Each film-coated tablet contains Amitriptyline Hydrochloride 10 mg.
Amirol 25 mg film-coated tablets: Each film-coated tablet contains Amitriptyline Hydrochloride 25 mg.
Excipient with known effect:
Amirol 10 mg film-coated tablets: Each film-coated tablet contains 58,4 mg of lactose monohydrate.
Amirol 25 mg film-coated tablets: Each film-coated tablet contains 96,6 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Amitriptyline |
Amitriptyline is a tricyclic antidepressant and an analgesic. It prevents the re-uptake, and hence the inactivation of noradrenaline and serotonin at nerve terminals. Reuptake prevention of these monoamine neurotransmitters potentiate their action in the brain. This appears to be associated with the antidepressant activity. |
| List of Excipients |
|---|
|
Core: Sodium starch glycolate (type A) Coating: Hypromellose Additional excipient for Amirol 10 mg film-coated tablets: Brilliant Blue FCF Aluminium Lake E133. Additional excipient for Amirol 25 mg film-coated tablets: Quinoline Yellow E104. |
Amirol 10 mg film-coated tablets:
PVC/Aluminium blisters. Pack-size of 30 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100, 500 and 1000 film-coated tablets.
Amirol 25 mg film-coated tablets:
PVC-PE-PVDC/Aluminium blisters. Pack-sizes of 30, 50, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-size of 1000 film-coated tablets.
Not all pack-sizes may be marketed.
Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Amirol 10 mg film-coated tablets: 7749
Amirol 25 mg film-coated tablets: 7748
Amirol 10 mg film-coated tablets:
Date of first authorization: 02 February 1981
Date of latest renewal: 16 January 2012
Amirol 25 mg film-coated tablets:
Date of first authorization: 02 February 1981
Date of latest renewal: 24 August 2011
| Drug | Countries | |
|---|---|---|
| AMIROL | Cyprus, Malta, New Zealand |
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