Patient Leaflet Updated 08-Feb-2018 | Kyowa Kirin Ltd
Chlorphenamine injection
Chlorphenamine 10 mg/ml Solution for Injection
(Chlorphenamine Maleate)
1. What Chlorphenamine is and what it is used for
2. What you need to know before Chlorphenamine is given
3. How Chlorphenamine is given
4. Possible side effects
5. How to store Chlorphenamine
6. Contents of the pack and other information
Chlorphenamine 10 mg/ml Solution for Injection contains the active ingredient chlorphenamine maleate which is an antihistamine.
Chlorphenamine is indicated in adults and children (aged 1 month to 18 years) for the treatment of acute allergic reactions.
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.
Talk to your doctor or nurse before you are given this medicine if you:
Children and the elderly are more likely to experience certain side effects (see section 4).
Tell your doctor if you are taking, have recently taken or might take any other medicines.
The following affect the way Chlorphenamine works:
Chlorphenamine may increase the effects of the following:
Do not consume alcohol whilst being treated with Chlorphenamine. It may cause the effects of the medicine to be increased, making you more drowsy. It may also cause the effect of the alcohol to be increased.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Chlorphenamine must not be given during pregnancy or breastfeeding unless your doctor believes it is essential.
Chlorphenamine may cause drowsiness and make you sleepy. Do not drive or operate machinery until you know how this product affects you.
This medicine contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially 'sodium-free'.
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, into a muscle, or directly into a vein.
Adults: the usual dose is 10 mg – 20 mg (1 or 2 ampoules), up to a maximum of 40 mg (4 ampoules) in 24 hours.
Children: the dose will be calculated by the doctor, according to the child’s age or body weight:
Dose: Age 1 month to 1 year, 0.25 mg/kg Age 1 year to 5 years, 2.5 mg to 5 mg or 0.20 mg/kg Age 6 to 12 years, 5 mg to 10 mg or 0.20 mg/kg Age 12 to 18 years, 10 mg to 20 mg or 0.20 mg/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 (giddiness).
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 nurse.
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:
Frequency Not Known (cannot be estimated from the available data)
Children and the elderly are more likely to experience the side effects which relate to the nervous system (these may affect the mind, nerves, muscles, and the senses). Elderly people may become confused and children may become agitated or excitable.
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 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.
Keep this medicine out of the sight and reach of children.
Store below 25ºC. Keep the ampoules in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the ampoule label and carton after ‘EXP’.
Once opened this medicine should be used immediately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is: chlorphenamine maleate (also known as chlorpheniramine maleate). Each 1 ml ampoule contains 10 mg of chlorphenamine maleate.
The other ingredients are: sodium chloride and water for injections (see end of section 2).
Chlorphenamine is a clear, colourless, sterile solution for injection supplied in glass ampoules.
Contents: 5 or 100 glass ampoules per box. Not all pack sizes may be marketed.
This leaflet was last revised: 12/2017
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