Doxepin 25mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxepin hydrochloride

Available from:

Dexcel-Pharma Ltd

ATC code:

N06AA12

INN (International Name):

Doxepin hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5033847002147

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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 IS AND WHAT IT IS USED FOR
The name of this medicine is Doxepin 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 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
have
ever
had
an
allergic
reaction
to
tricyclic
antidepressants, doxepin, or any of the other ingredients of
Doxepin Capsules
• 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

Summary of Product characteristics

OBJECT 1
Doxepin 25mg Capsules
Summary of Product Characteristics Updated 15-Jun-2021 | Dexcel Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Doxepin 25 mg Capsules
2. Qualitative and quantitative composition
The capsules contain Doxepin hydrochloride equivalent to 25 mg
doxepin.
3. Pharmaceutical form
Capsules
Doxepin 25 mg: Blue cap and red body, size 3 hard gelatin capsules,
imprinted with “DP 25” on the body
in white.
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 reco