Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Teofarma S.R.L., Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy
Prothiaden 25 mg Hard capsules.
| Pharmaceutical Form |
|---|
|
Capsule, hard. A red/brown hard gelatin capsule containing a white to off-white powder. The identifying code “P25” is printed on the capsule. |
Each capsule contains 25 mg dosulepin hydrochloride.
Excipients with known effect: Lactose monohydrate 106 mg per hard capsule; soya lecithin.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dosulepin |
Dosulepin is a tricyclic antidepressant which acts by inhibiting the re-uptake of monoamine neurotransmitters into presynaptic neurone at central nervous system, so producing a clinical antidepressant effect. Dosulepin, in common with other tricyclics, inhibits the reuptake of noradrenaline and 5-hydroxytryptamine, with a significantly greater action on the uptake of noradrenaline. |
| List of Excipients |
|---|
|
Capsules contents: Lactose monohydrate Capsule shell: Capsule cap: Red iron oxide (E172) Capsule body: Red iron oxide (E172) Printing ink: Opacode S-I-7305 HV white containing: |
An amber-coloured glass bottle containing 100, 500 or capsules
Or
A high density polyethylene bottle with a cap and aluminium-faced pulpboard liner. The caps for packs which contain 100 units or less will be clic-loc cap, for those containing more than 100 units per pack; the cap will be a standard polypropylene cap.
Not all pack sizes may be marketed.
Teofarma S.R.L., Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy
PA1235/005/001
Date of first authorisation: 12 January 1977
Date of last renewal: 12 January 2007
| Drug | Countries | |
|---|---|---|
| PROTHIADEN | France, Ireland, Japan, Netherlands, United Kingdom, South Africa |
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