Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dosulepin hydrochloride
Viatris UK Healthcare Ltd
N06AA16
Dosulepin hydrochloride
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5016695300467
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, Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DOSULEPIN CAPSULES 25 MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dosulepin Hydrochloride BP (Dosulepin) 25 mg 3 PHARMACEUTICAL FORM Capsules 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 Dosulepin Capsules 25mg are for oral administration. _ADULTS _ Initially 25 mg three times daily, gradually increasing the dosage to 50mg three times daily, if necessary, or 75 - 150mg as a single night-time dose. In certain circumstances, e.g. in hospital use for severely depressed patients, dosages up to 225 mg daily have been used. _ELDERLY _ 50 - 75 mg daily initially. Half the normal adult maintenance dose may be sufficient to produce a satisfactory clinical response. 4.3 CONTRAINDICATIONS Recent Myocardial Infarction. Any degree of heart block of other cardiac arrhythmias. Mania. Severe Liver Disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE TOXICITY IN OVERDOSE Dosulepin is associated with high mortality in overdose. There is a low margin of safety between the (maximum) therapeutic dose and potentially fatal doses. Onset of toxicity occurs within 4-6 hours. - A limited number of capsules should be prescribed to reduce the risk from overdose for all patients and especially for patients at risk of suicide. - A maximum prescription equivalent to two weeks supply of 75mg/day should be considered in patients with increased risk factors for suicide at initiation of treatment, during any dosage adjustment and until improvement occurs. - Avoid concomitant medications which may increase the risk Baca dokumen lengkap