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XEPIN 5% W/W CREAM

Active substance(s): DOXEPIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Xepin 5% w/w Cream
doxepin hydrochloride
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.
• Tell your doctor if you are taking a medicine called Cimetidine before using Xepin 5% w/w
Cream.
Do not stop taking your medicine unless your doctor has told you to.
Tell your doctor, pharmacist or dentist that you are using Xepin 5% w/w Cream before having
general or local anaesthesia.
Pregnancy and breast-feeding
Do not use Xepin 5% w/w Cream if you are pregnant, think that you may be pregnant or if you are
breast-feeding. Please ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive if you feel drowsy after using Xepin 5% w/w Cream.
Do not use any tools or machines if you feel drowsy after using Xepin 5% w/w Cream.
Important information about some of the ingredients of Xepin 5% w/w Cream
Xepin 5% w/w Cream contains cetyl alcohol which can cause local skin reactions such as contact
dermatitis.

3. HOW TO USE XEPIN 5% w/w CREAM
Always use Xepin 5% w/w Cream exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Xepin 5% w/w Cream should not be used on children under the age of 12 years.
Usual Dose
Apply a thin film of cream only to the affected areas of the skin, 3 to 4 times a day or as directed by
your doctor.
Do not cover the cream with a bandage or with tight clothing, unless your doctor has told you to do
this. Do not apply near the eyes.
Do not apply the cream to more than 10% of the surface area of the body as it will increase the
likelihood of drowsiness and dryness in the mouth. The diagram below shows how to estimate 10% of
the surface area of the body. A total area equivalent to 10% of the body surface area is approximately:
one whole arm (1) the front or back of a leg (2) half the torso (3 and 4)
However this 10% can be made up of several smaller patches (for example knees, face and
hands).
If you use more Xepin 5% w/w Cream than you should
If you use more Xepin 5% w/w Cream than you should, wash it off
immediately. If you are at all worried, contact your doctor.

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If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Xepin 5% w/w Cream can cause side effects,
although not everybody gets them.
Xepin 5% w/w Cream can cause drowsiness or sleepiness,
especially during the first few days of treatment.
Other possible side effects include:
• Skin reactions such as burning, stinging, irritation, tingling and rash.

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4

2

More rare side effects include:
• dry mouth
• changes in taste
• dry eyes
• blurred vision • difficulty passing urine • headaches
• fever
• dizziness
• nausea
• indigestion
• vomiting
• diarrhoea or constipation
• depression, suicidal thoughts
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE XEPIN 5% w/w CREAM
Keep out of the sight and reach of children.
Do not store above 25ºC.
Do not use Xepin 5% w/w Cream after the expiry date that is stated on the tube and the carton after
EXP. The expiry date refers to the last day of the month.
If your doctor tells you to stop using Xepin 5% w/w Cream, take the tube back to the pharmacist for
safe disposal. Medicines should not be disposed of via household waste. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Xepin 5% w/w Cream contains
- The active substance is doxepin hydrochloride, 5% w/w
- The other ingredients are sorbitol solution 70%, cetyl alcohol, isopropyl myristate, PEG 100
stearate, glyceryl stearate, white soft paraffin, benzyl alcohol, titanium dioxide and purified water.
What Xepin 5% w/w Cream looks like and contents of the pack
Xepin 5% w/w Cream comes in aluminium tubes containing 30g, 60g or 120g Xepin 5% w/w Cream.
Not all pack sizes may be available.
Marketing Authorisation Holder: Cambridge Healthcare Supplies Ltd, Chestnut Drive,
Wymondham, Norfolk NR18 9SB, UK
Manufacturer: Bioglan AB, PO Box 50310, Borrgatan 31, S – 202 13, Malmö, Sweden.
Date of revision: March 2015.

910623
Printed in Sweden BERGSTENS, HBG 150413

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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