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 is indicated for the management of depression and associated anxiety.
For oral administration.
ฮคhe usual total daily dose is 75 mg to 150 mg in divided doses or as a single night-time dose. Treatment should be initiated at the lower dose. In certain circumstances, e.g. in hospital use, dosages up to 225 mg daily have been used.
Suggested regimens: 25 or 50mg three times daily or, alternatively, 75 or 150 mg as a single dose at night. Should the regimen of 150 mg as a single night-time dose be adopted, it is better to give a smaller dose for the first few days.
50 to 75 mg daily initially. As with any antidepressant, the initial dose should be increased with caution under close supervision. Half the normal adult dose may be sufficient to produce a satisfactory clinical response.
Not recommended.
Symptoms of overdosage may include dryness of the mouth, excitement, ataxia, drowsiness, loss of consciousness, muscle twitching, convulsions, widely dilated pupils, hyperreflexia, sinus tachycardia, cardiac arrhythmias, hypotension, hypothermia, depression of respiration, visual hallucinations, delirium, urinary retention, paralytic ileus, and respiratory or metabolic alkalosis.
Treatment should consist of gastric lavage. When the patient is unconscious or the cough reflex depressed, the lungs should be protected by a cuffed endotracheal tube. Repeated gastric/intestinal aspiration or repeated administration of activated charcoal may remove the drug and metabolites excreted into the gut via the bile. Continuous ECG monitoring is advisable. Abnormalities of cardiac rhythm and epileptic convulsions may occur and should be treated accordingly. Forced diuresis is not recommended. Bedrest is advisable, even after recovery.
3 years.
Do not store above 25ยฐC. Keep the container tightly closed in order to protect from moisture. Store in the original package in order to protect from light.
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.
No special requirements.
ยฉ All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
