Doxepin 25mg capsules

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Doxepin hydrochloride

Boleh didapati daripada:

DE Pharmaceuticals

Kod ATC:

N06AA12

INN (Nama Antarabangsa):

Doxepin hydrochloride

Dos:

25mg

Borang farmaseutikal:

Oral capsule

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 04030100

Risalah maklumat

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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

Ciri produk

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