Doxepin 10mg capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Doxepin hydrochloride

Inapatikana kutoka:

Morningside Healthcare Ltd

ATC kanuni:

N06AA12

INN (Jina la Kimataifa):

Doxepin hydrochloride

Kipimo:

10mg

Dawa fomu:

Oral capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04030100; GTIN: 5055132717604

Taarifa za kipeperushi

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Doxepin
10 mg, 25 mg and 50 mg Capsules
Doxepin hydrochloride
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•
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 only.
Do not pass it on to others. It may harm them
even if their signs of illness 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.
What is in this leaflet:
1. What Doxepin Capsules are and what they are
used for
2. What you need to know before you take
Doxepin Capsules
3. How to take Doxepin Capsules
4. Possible side effects
5. How to store Doxepin Capsules
6. Contents of the pack and other information
1. What Doxepin Capsules are and what they
are used for
The name of this medicine is Doxepin 10 mg,
25 mg and 50 mg
Capsules. The active ingredient
is doxepin hydrochloride. Doxepin 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, Doxepin Capsules 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. What you need to know before you take
Doxepin Capsules
Do not take Doxepin Capsules:
•
If you are allergic to tricyclic antidepressants,
doxepin, or any of the other ingredients of this
medicine (listed in section 6).
•
If you have serious liver problems.
•
If you have glaucoma (increased eye pressure).
•
If you suffer from difficulty in passing urine.
•
If you are breast-feeding.
•
If you are taking, or have taken in the last
two weeks, any medicines

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxepin 10 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains doxepin hydrochloride equivalent to 10 mg
doxepin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Red opaque cap and body size ‘4’ hard gelatin capsule, printed
with white ink
‘Doxepin’ on cap and ’10 mg’ on body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptoms
of
depressive
illness
in
adults,
especially
where
sedation
is
required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 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.
_PAEDIATRIC POPULATION _
The safety and efficacy in children under 18 ye