País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Doxepin hydrochloride
DE Pharmaceuticals
N06AA12
Doxepin hydrochloride
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100
C M Y CM MY CY CMY K PACKAGE LEAFLET: INFORMATION FOR THE USER SINEPIN (DOXEPIN) 25MG AND 50MG CAPSULES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR MEDICINE. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. IF YOU HAVE ANY FURTHER QUESTIONS, PLEASE 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 ANY OF THE SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST. IN THIS LEAFLET: 1. What Sinepin is and what it is used for 2. Before you take Sinepin 3. How to take Sinepin 4. Possible side effects 5. How to store Sinepin 6. Further information 1. WHAT SINEPIN IS AND WHAT IT IS USED FOR The name of this medicine is Sinepin. The active ingredient is doxepin hydrochloride. Sinepin is an antidepressant. It is one of a group called tricyclic antidepressants. Your doctor has decided that this medicine is suitable for treating your depression. Depression is a clinical illness. If you have been feeling sad, tearful or unable to enjoy life as you used to, Sinepin may help you to feel better. It may also help if you have difficulty sleeping because of your depression. If you are not sure why you are on these capsules, ask your doctor. 2. BEFORE YOU TAKE SINEPIN DO NOT TAKE SINEPIN CAPSULES IF: • You have ever had an allergic reaction to tricyclic antidepressants,doxepin, or any of the inactive ingredients of Sinepin Capsules (see ‘Further information’ section) • You have serious liver problems • You have glaucoma (increased eye pressure) • You suffer from difficulty in passing urine • You are breast-feeding • You are taking, or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs for short) • You suffer from a type of mood disorder called mania, where you experience an abnormally elevated mood state. • The patient is under 12 years of age If you suffer from an Llegiu el document complet
1. TRADE NAME OF MEDICINAL PRODUCT SINEPIN Capsules 25mg Doxepin 25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: Doxepin Hydrochloride BP The capsules contain Doxepin Hydrochloride BP equivalent to 25mg doxepin. 3 PHARMACEUTICAL FORM Capsules for oral administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptoms of depressive illness, especially where sedation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The optimum oral dose depends on the severity of the condition and the individual patient’s response. The dose required may vary from 25-300mg daily. Doses up to 100mg daily may be given on a divided or once daily schedule. Should doses over 100mg daily be required, they should be administered in three divided doses daily. 100mg is the maximum dose recommended at any one time. This dose may be given at bedtime. For the majority of patients with moderate or severe symptoms, it is recommended that treatment commences with an initial dose of 75mg daily. Many of these patients will respond satisfactorily at this dose level. For patients who do not, the dosage may be adjusted according to individual response. In more severely ill patients, it may be necessary to administer a dose of up to 300mg in divided doses daily, to obtain a clinical response. In patients where insomnia is a troublesome symptom, it is recommended that the total daily dose be divided so that a higher proportion is given for the evening dose; similarly, if drowsiness is experienced as a side effect of treatment, Doxepin 25mg Capsules may be administered by this regimen or the dosage may be reduced. It is often possible, having once obtained a satisfactory therapeutic response, to reduce the dose for maintenance therapy. The optimal anti-depressant effect may not be evident for two to three weeks. _USE IN CHILDREN_ The use of Doxepin 25mg Capsules in children under 12 years is not recommended because safe conditions for its use have not been established. _USE IN THE ELDERLY_ In general, dose sele Llegiu el document complet