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CHLORPHENAMINE 10MG/ML SOLUTION FOR INJECTION

Active substance(s): CHLORPHENAMINE MALEATE / CHLORPHENAMINE MALEATE / 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

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

The doctor may dilute Chlorphenamine
with sodium chloride 0.9% to make it
easier to measure and inject the small
amounts required for children.

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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.

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.

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

Symptoms of overdose include
sedation, seizures, stopping of
breathing (apnoea), convulsions,
abnormal and sustained muscle
contractions (dystonic reactions) and
heart failure (cardiovascular collapse).

Keep out of the sight and reach of
children.

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

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.

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.

Store below 25°C and protect from light.
Do not use after the date shown as
‘EXP’ on the carton.

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: 11/2016
LFT-CHL-GB-002

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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.

Expand Transcript

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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