Doxepin 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxepin hydrochloride

Available from:

Zentiva Pharma UK Ltd

ATC code:

N06AA12

INN (International Name):

Doxepin hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 08594739235182

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Doxepin 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 is and what it is used for
2. What you need to know before you take Doxepin
3. How to take Doxepin
4. Possible side effects
5. How to store Doxepin
6. Contents of the pack and other information
1. What Doxepin is and what it is used for
The active ingredient of Doxepin is doxepin hydrochloride.
Doxepin is an antidepressant used in adults. It is one
of a group of medicines 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 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
Do not take Doxepin Capsules:
•
if you are allergic to doxepin, tricyclic antidepressants, 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 called monoamine oxidase inhibitors (MAOIs for
short);
•
if you suffer from a type of mood disorder called

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxepin 50 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains doxepin hydrochloride equivalent to 50 mg of
doxepin.
Excipient: 71 mg lactose monohydrate per capsule
-
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Size “2” hard gelatin capsule filled with white to off-white
granular powder
having
“AMNEAL” printed on yellow opaque cap and “DOXEPIN 50 MG”
printed
on yellow opaque body with black ink.
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 25-300
mg
daily. Doses up to 100 mg daily may be given on a divided or once
daily
schedule. Should doses over 100 mg daily be required, they should be
administered in three divided doses daily. 100 mg 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 75 mg
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 300 mg 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 50 mg 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 o