Source: Medicines Authority (MT) Revision Year: 2021 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Arketis 10 mg, tablets.
Arketis 20 mg, tablets.
Arketis 30 mg, tablets.
Arketis 40 mg, tablets.
| Pharmaceutical Form |
|---|
|
Tablet. 10 mg: biconvex off white round tablet inscribed 10 on one side. 20 mg: flat faced bevel edged off white round tablet inscribed 20 on one side with a score line. The tablet can be divided into equal doses. 30 mg: flat faced bevel edged off white round tablet with a score line. The tablet can be divided into equal doses. 40 mg: capsule shaped off white tablet with a score line. The tablet can be divided into equal doses. |
Arketis 10 mg: Each tablet contains 10 mg paroxetine (as paroxetine hydrochloride anhydrate).
Arketis 20 mg: Each tablet contains 20 mg paroxetine (as paroxetine hydrochloride anhydrate).
Arketis 30 mg: Each tablet contains 30 mg paroxetine (as paroxetine hydrochloride anhydrate).
Arketis 40 mg: Each tablet contains 40 mg paroxetine (as paroxetine hydrochloride anhydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Paroxetine |
Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) uptake and its antidepressant action and effectiveness in the treatment of OCD, Social Anxiety disorder/Social Phobia, General Anxiety Disorder, Post-Traumatic Stress Disorder and Panic Disorder is thought to be related to its specific inhibition of 5-HT uptake in brain neurones. |
| List of Excipients |
|---|
|
Cellulose microcrystalline (E460) |
Polyvinylchloride foil – aluminium foil blisters: packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 120, 180, or 500 tablets are available.
Not all pack sizes may be marketed.
Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
MA032/06601
MA032/06602
MA032/06603
MA032/06604
Date of first authorisation: 4th January 2008
Date of latest renewal: 19th January 2012
| Drug | Countries | |
|---|---|---|
| ARKETIS | Cyprus, Estonia, Lithuania, Malta, Poland, Romania |
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