Xepin 5% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxepin hydrochloride

Available from:

Cambridge Healthcare Supplies Ltd

ATC code:

D04AX01

INN (International Name):

Doxepin hydrochloride

Dosage:

50mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13030000; GTIN: 5037336000133

Patient Information leaflet

Xepin 5% w/w Cream
doxepin hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
- 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. 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 GETS SERIOUS, OR IF YOU NOTICE ANY SIDE
EFFECTS NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
In this leaflet:
1.
What Xepin 5% w/w Cream is and what it is used for
2.
Before you use Xepin 5% w/w Cream
3.
How to use Xepin 5% w/w Cream
4.
Possible side effects
5.
How to store Xepin 5% w/w Cream
6.
Further information
1. WHAT XEPIN 5% W/W CREAM IS AND WHAT IT IS USED FOR
Xepin 5% w/w Cream is a white moisturising cream for application to
the skin. Xepin 5% w/w
Cream is applied to relieve itching associated with eczematous
dermatitis.
2. BEFORE YOU USE XEPIN 5% W/W CREAM
DO NOT USE XEPIN 5% W/W CREAM IF YOU
•
are allergic (hypersensitive) to doxepin hydrochloride or any of the
other ingredients of Xepin
5% w/w Cream (see section 6).
TAKE SPECIAL CARE WITH XEPIN 5% W/W CREAM
Before treatment with Xepin 5% w/w Cream if you have any of the
following please talk to your
doctor before using the cream
•
glaucoma
•
a tendency to retain urine
•
severe liver disease
•
depression
•
severe heart disease including disorders of the rhythm of the
heartbeat.
Xepin 5% w/w Cream can cause drowsiness or sleepiness. You should not
drink alcohol while you
are using Xepin 5% w/w Cream, as this can make the drowsiness worse.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained without a prescription.
• If you are taking medication for depression called
monoamine-oxidase inhibitors, you should
have stopped taking this medicine before starting to use Xepin 5% w/w
Cream.
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Xepin 5% w/w Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxepin hydrochloride 5% w/w
3.
PHARMACEUTICAL FORM
Cream for topical application to the skin.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of pruritus associated with eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND CHILDREN OVER 12 YEARS _
A thin film of Xepin should be applied three to four times daily, to
the affected
area only. Clinical experience has shown that drowsiness is
significantly more
common in patients applying cream to more than 10% of the body surface
area, therefore, the maximum coverage should be less than 10% of body
surface area. For an average sized patient, this would equate to 3g of
Xepin
per application and not more than 12g of Xepin per day. If excessive
drowsiness does occur, it may be necessary to reduce the number of
applications, the amount of cream applied and/or the percentage of
body
surface area treated.
Occlusive dressings or clothing may increase the absorption of any
topically
applied drug, including Xepin; therefore, caution must be exercised
when
utilising occlusive dressings.
_CHILDREN UNDER 12 YEARS _
There are insufficient data to enable dosage recommendations to be
made for
children.
_ELDERLY _
There are no specific dosage recommendations for elderly patients.
4.3.
CONTRAINDICATIONS
Xepin is contra-indicated in individuals who have shown previous
hypersensitivity to
any of its components.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Drowsiness may occur with the use of Xepin. Clinical trial data
demonstrate
that drowsiness is observed principally in patients receiving
treatment to
greater than 10% of body surface area and that drowsiness is
transient, usually
remitting after the first few days of treatment.
Patients should, therefore be warned of this possibility and cautioned
against
driving or operating machinery if they become drowsy while being
treated
with Xepin.
Patients should also be warned that the