Doxepin 50mg capsules

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Doxepin hydrochloride

Disponível em:

Alliance Healthcare (Distribution) Ltd

Código ATC:

N06AA12

DCI (Denominação Comum Internacional):

Doxepin hydrochloride

Dosagem:

50mg

Forma farmacêutica:

Oral capsule

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04030100

Folheto informativo - Bula

PACKAGE LEAFLET:
INFORMATION FOR THE USER
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:
for
2
4. Possible side effects
1. WHAT DOXEPIN CAPSULES ARE AND
WHAT THEY ARE USED FOR
is doxepin hydrochloride.
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.
s a clinical illness. If you have been feeling
etter. 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 DOXEPIN CAPSULES
DO NOT TAKE DOXEPIN CAPSULES IF:
•
You have ever had an allergic reaction to tricyclic
antidepressants, doxepin, or any of the inactive
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
•
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 any of the above, speak to your doctor
TAKE SPECIAL CARE WITH DOXEPIN CAPSULES IF:
•
You are pregnant or trying to become pregnant
•
You have any heart problems
•
You have had a heart attack recently
•
You have kidney problems
•
You suffer from epilepsy (fits)
•
You have suicidal thoughts or have attempted suicide
in the past
If you answer YES to any of the above questions

Características técnicas

1.
TRADE NAME OF MEDICINAL PRODUCT
SINEPIN Capsules 50mg
Doxepin 50mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Doxepin Hydrochloride BP
The capsules contain Doxepin Hydrochloride BP equivalent to 50mg
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 50mg 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 50mg 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, do