Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dosulepin hydrochloride
A A H Pharmaceuticals Ltd
N06AA16
Dosulepin hydrochloride
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5025903002994
DOSULEPIN CAPSULES 25 MG READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE DOSULEPIN 3. HOW TO TAKE DOSULEPIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DOSULEPIN 6. FURTHER INFORMATION WHAT DOSULEPIN IS AND WHAT IT IS USED FOR Dosulepin belongs to a group of medicines called antidepressants. Dosulepin is used to treat depression and can also help reduce feelings of anxiety. This medicine will only be used when other medicines have been found to be unsuitable. Please ask your doctor or pharmacist if you need more information. BEFORE YOU TAKE DOSULEPIN DO NOT TAKE DOSULEPIN CAPSULES AND SPEAK TO YOUR DOCTOR IF: - you know that you are allergic (hypersensitive) to dosulepin or any of the other ingredients (listed in section 6 of this leaflet) in Dosulepin capsules - you have an irregular heart beat or any other heart problems - you have liver problems - you have an eye condition known as glaucoma - you are a man that has prostate problems (difficulty in passing water) - you have been diagnosed as having mania (feeling over-excited with unusual behaviour) - you have fits (epilepsy). Dosulepin should not be given to children. TAKE SPECIAL CARE WITH DOSULEPIN IF: - you are going to have general or dental surgery, tell your surgeon you are taking Dosulepin. It may affect the anaesthetic used. THOUGHTS OF SUICIDE AND WORSENING OF YOUR DEPRESSION OR ANXIETY DISORDER If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dosulepin 25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains dosulepin hydrochloride 25 mg. Excipient(s) with known effect Each capsule contains 153 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Size 4 orange/caramel capsules marked ‘MP75’ and ‘25mg’ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dosulepin is indicated in the treatment of symptoms of depressive illness especially where an anti-anxiety effect is required. Due to its toxicity in overdose, Dosulepin should only be used in patients intolerant of or unresponsive to alternative treatment options (see sections 4.4 and 4.9). Initiation of treatment for patients who have not previously received Dosulepin should be restricted to specialist care prescribers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Initially 75 mg/day in divided doses or as a single dose at night, increasing to 150 mg/day. In certain circumstances, e.g. in hospital use, dosages up to 225 mg daily have been used. Suggested regimens: 25 or 50 mg 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. _Use in the elderly: _ 50-75 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. It has been found that, in certain cases of depression, the daily dose of dosulepin given as a single night-time dose is more effective and even better tolerated than the conventional divided day-time dosage. There is evidence that this single bed-time dose improves the sleep pattern of the depressed patient. There may be a latent period of up to two to four weeks from the start of treatment, before any improvement in the patient’s d Read the complete document