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CHLORPHENAMINE 10MG/ML SOLUTION FOR INJECTION

Active substance(s): CHLORPHENAMINE MALEATE

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Package leaflet: Information for the user
Chlorphenamine 10mg/ml Solution for Injection
(Chlorphenamine Maleate Ph. Eur.)

In this leaflet:
1. What Chlorphenamine is and what it is
used for
2. Before Chlorphenamine is given
3. How Chlorphenamine is given
4. Possible side effects
5. How to store Chlorphenamine
6. Further information
1. What Chlorphenamine is
and what it is used for
Chlorphenamine 10mg/ml Solution for
Injection contains the active ingredient
chlorphenamine maleate which is an
antihistamine. These medicines inhibit the
release of histamine into the body that occurs
during an allergic reaction. This product
relieves some of the main symptoms of a
severe allergic reaction.
This injection is usually given to you by your
doctor or someone else trained to give it to
you.
2. Before Chlorphenamine is
Given

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You MUST NOT be given
Chlorphenamine if you:
• are allergic to any of the ingredients
in the product (see section 6: Further
information)
• are in a pre-coma state
• have had monoamine oxidase inhibitor
(MAOI) antidepressive treatment
within the past 14 days.
Take special care with Chlorphenamine
You should tell your doctor before you are
given this product if you:
• are being treated for an overactive
thyroid or enlarged prostate gland
• have epilepsy, glaucoma, very high
blood pressure, heart, liver, asthma or
chest diseases.
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.

The following affect the way
Chlorphenamine works:
• MAOIs – these must not be given with
Chlorphenamine.
Chlorphenamine may increase the effects of
the following:
• drugs that treat anxiety or help you to
sleep
• alcohol
• psychotropic drugs (that change
perception or behaviour)
• atropine
• phenytoin, for epilepsy.
Pregnancy and breast-feeding
Tell your doctor before using any medicine.
Chlorphenamine must not be given during
pregnancy or breastfeeding unless your
doctor believes it is essential.
Driving and using machines
Chlorphenamine may cause drowsiness and
make you sleepy. Do not drive or operate
machinery until you know how this product
affects you.
Important information about some of the
ingredients
This medicinal product contains less than
1mmol sodium (23mg) per 1ml (essentially
“sodium-free”).
3. How Chlorphenamine is
Given
This injection is usually given to you by your
doctor or someone else trained to give it to
you. You will be given the injection beneath
your skin, or into a muscle, or directly into
a vein.
Adults: the usual dose is 10mg - 20mg
(1 or 2 vials), up to a maximum of 40mg
(4 vials) in 24 hours.
Children: the dose will be calculated by the
doctor, according to the child’s age or body
weight:
Age
1 month
to 1 year
1 to 5
years
6 to 12
years
12 to 18
years

Dose

2.5mg to
5mg
5mg to
10mg
10mg to
20mg

OR
OR
OR

0.25mg
/kg
0.20mg
/kg
0.20mg
/kg
0.20mg
/kg

The doctor may dilute Chlorphenamine
with sodium chloride 0.9% to make it easier

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Read all of this leaflet carefully before you
start taking this medicine.
− Please keep this leaflet. You may need to
read it again.
− If you have any further questions, ask
your doctor or pharmacist.
− If you suffer from any side effect that gets
serious, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist.

When administered into a vein, the injection
should be given slowly over a period of one
minute to avoid a fall in blood pressure
(hypotension) or central nervous system
stimulation.
If you are given more Chlorphenamine
than you should
This product will be given to you under
medical supervision. It is therefore unlikely
that you will be given too much. However,
if you feel unwell, you should tell your doctor
immediately.
Symptoms of overdose include sedation,
seizures, stopping of breathing (apnoea),
convulsions, abnormal and sustained muscle
contractions (dystonic reactions) and heart
failure (cardiovascular collapse).
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Chlorphenamine can
cause side effects, although not everybody
gets them.
The most common side effect is sedation,
which can range from slight drowsiness to
deep sleep.

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The following side effects have been reported:
• a stinging or burning feeling at the site of
injection
• giddiness or drowsiness if the drug is
injected too quickly into a vein (this
usually passes)
• nausea, vomiting, or diarrhoea
• feeling dizzy, weak, tired, unable to
concentrate
• rapid or irregular heart beat, chest
tightness, fall in blood pressure
• dryness of the mouth, headache,
anorexia, indigestion, abdominal pain,
liver problems including jaundice,
difficulty passing urine
• muscular incoordination, ringing in
the ears, blurred vision, irritability,
depression, nightmares
• allergic reactions (skin reactions, itching
of raised bumps on the skin, sensitivity to
light)
• blood abnormalities.
Elderly people may become confused and
children may become excitable.
If any of these side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor.

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.
Website: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide
more information on the safety of this
medicine.
5. How to store
Chlorphenamine
Keep out of the sight and reach of children.
Store below 25ºC and protect from light.
Do not use after the date shown as ‘EXP’ on
the carton.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Further Information
What Chlorphenamine contains
The active substance is: chlorphenamine
maleate (also known as chlorpheniramine
maleate).
The other ingredients are: sodium chloride
and water (see end of section 2).
What Chlorphenamine looks like and
contents of the pack
Chlorphenamine is supplied in glass
vials. Each 1ml vial contains 10mg
chlorphenamine maleate (clear, colourless
sterile solution). Contents: 5 glass vials
per box.
Marketing Authorisation Holder
Archimedes Pharma UK Ltd.
Galabank Business Park, Galashiels,
TD1 1QH, United Kingdom
(send all enquiries to this address).
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner, Landstrasse 18,
31028 Gronau, Germany
PL 12406/0013
This leaflet was last revised: 04/2015
LFT-CHL-GB-001

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to measure and inject the small amounts
required for children.

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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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