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Chlorphenamine Maleate 10mg/ml Solution for Injection

Active Ingredient:
chlorphenamine maleate
Company:  
Wockhardt UK Ltd See contact details
ATC code: 
R06AB04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 29 Mar 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0585.

{printer} Print patient leaflet as text only

Chlorphenamine 10mg/ml Solution for Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorphenamine 10mg/ml Solution for Injection

Chlorphenamine maleate

(Referred to as Chlorphenamine throughout this leaflet)

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
  • 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 Chlorphenamine is and what it is used for
2. What you need to know before you are given Chlorphenamine
3. How Chlorphenamine is given
4. Possible side effects
5. How to store Chlorphenamine
6. Contents of the pack and other 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. What you need to know before you are given Chlorphenamine
You MUST NOT be given Chlorphenamine if you:
  • are allergic to chlorphenamine or any of the other ingredients of this medicine (listed in section 6)
  • are in a pre-coma state
  • have had monoamine oxidase inhibitor (MAOI) antidepressive treatment within the past 14 days.

Warnings and precautions

Talk to your doctor before you are given Chlorphenamine 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.

Other medicines and Chlorphenamine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

Chlorphenamine contains sodium

This medicinal product contains less than 1mmol sodium (23mg) per dose of up to 4ml, i.e. it is 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 ampoules), up to a maximum of 40mg (4 ampoules) in 24 hours.

Use in children and adolescents: the dose will be calculated by the doctor, according to the child’s age or body weight:

Age 1 month to 1 year: Dose 0.25mg/kg

Age 1 to 5 years: Dose 2.5mg to 5mg OR 0.20mg/kg

Age 6 to 12 years: Dose 5mg to 10mg OR 0.20mg/kg

Age 12 to 18 years: Dose 10mg to 20mg OR 0.20mg/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.

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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.

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.

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 national reporting system listed below:

United Kingdom:

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App store.

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
  • This medicinal product does not require any special storage conditions
  • This medicine should be used immediately after opening. Once opened, any unused contents should be discarded
  • After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 5°C in polypropylene syringes. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user
  • This medicine should not be used after the expiry date which is stated on the carton and inner label after ‘EXP’. The expiry date refers to the last day of that month
  • Medicines should not be thrown away via wastewater or household waste. Your doctor or nurse will dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information
What Chlorphenamine contains

The active substance is: chlorphenamine maleate (also known as chlorpheniramine maleate). Each 1ml of solution contains 10mg chlorphenamine 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 a clear, colourless sterile solution for injection, supplied in 1ml clear, neutral glass (Type I) ampoules. It is available in packs of five ampoules.

Marketing Authorisation Holder in UK:
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
United Kingdom

Manufacturer
CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
United Kingdom

Other sources of information

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only).

This medicinal product is authorised in the Member States of the EEA under the following name:

United Kingdom: Chlorphenamine 10mg/ml Solution for Injection

This leaflet was last revised 06/2022

107937/4

Wockhardt UK Ltd
Company image
Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
WWW
www.wockhardt.co.uk
Medical Information e-mail
[email protected]