Document: leaflet MAH GENERIC_PL 29831-0585 change

• leaflet MAH GENERIC_PL 12406-0013
• leaflet MAH GENERIC_PL 29831-0585

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PACKAGE LEAFLET: INFORMATION FOR THE USER Chlorphenamine lOmg/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. WHATYOUNEEDTOKNOWBEFOREYOUARE 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

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Chlorphenamine lOmg/ml Solution for Injection

Please refer to the Summary of Product Characteristics (SmPC) for further details on this product.

Qualitative and Quantitative Composition

Each 1ml of solution contains 10mg of chlorphenamine maleate.

•    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 1 mmol sodium (23mg) per dose of up to 4ml, i.e. it is essentially "sodium-ffee".

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	Dose
1 month to 1 year			0.25mg/kg
1 to 5 years	2.5mg to 5mg	OR	0.20mg/kg
6 to 12 years	5mgto 10mg	OR	0.20mg/kg
12 to 18 years	10mgto 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.

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drowsiness, giddiness or hypotension which may follow is usually transitory.

In the event of a blood transfusion reaction, a dose of 10mg to 20mg of chlorphenamine injection should be given by the subcutaneous route. This can be repeated to a total of 40mg within a 24-hour period, or oral forms of chlorphenamine may be given until the symptoms subside.

Excipient with known effect:

Each 1ml of solution contains 0.13mmol (3.1 mg) of sodium.

Pharmaceutical Form

Solution for injection

Clear, colourless sterile solution for injection.

The pH of the solution is 4.0 - 5.2 and the osmolality is 261 -319m0sm/Kg.

Therapeutic Indications

Chlorphenamine injection is indicated for acute urticaria, control of allergic reactions to insect bites and stings, angioneurotic oedema, drug and serum reactions, desensitisation reactions, hayfever, vasomotor rhinitis, severe pruritus of non-specific origin.

Posology and method of administration

Adults:

The usual dose of chlorphenamine injection for adults is 10mg to 20mg, but not more than 40mg should be given within a 24-hour period. The injection may be given by the subcutaneous, intramuscular or intravenous route.

When a rapid effect is desired, as in anaphylactic reactions, the intravenous route is recommended in addition to emergency therapy with adrenaline (epinephrine), corticosteroids, oxygen and supportive therapy as required. In this case chlorphenamine injection should be injected slowly over a period of one minute, using the smallest adequate syringe. Any

Chlorphenamine injection may be helpful in the prevention of delayed reactions to penicillin and other drugs when given separately by intramuscular injection immediately prior to administration of the other drug. The usual dose islOmg.

Chlorphenamine injection cannot, however, be relied on to prevent anaphylactic reactions in patients known to be allergic to a particular drug.

Paediatric population:

The dose for children should be calculated, based on either the child's age or their body weight, using the following table:

Age	Dose
1 month to 1 year			0.25mg/kg
1 to 5 years	2.5mg to 5mg	OR	0.20mg/kg
6 to 12 years	5mgto10mg	OR	0.20mg/kg
12 to 18 years	10mgto20mg	OR	0.20mg/kg

Extra care should be taken when preparing the injection for children under 1 year due to the small volumes that are required. Dilution of chlorphenamine injection with sodium chloride intravenous infusion (0.9% w/v) should facilitate preparation. For example, diluting 0.2ml chlorphenamine injection to 2ml with sodium chloride 0.9% injection produces a solution containing chlorphenamine 1 mg/ml.

For instruction on dilution of the product before administration, see "Special precautions for disposal".

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