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fACKAGE LEAFLET: INFORMATION FORTHE USER

Ephedrine Hydrochloride Injection 3mg/ml

Read all this leaflet carefully before you are given Ephedrine Injection

•    Keep this leaflet. You may need to read it again

•    If you have any further questions, please askyour doctor or nurse

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse

In this leaflet:

1.    What Ephedrine Injection is and what it is used for

2.    Before Ephedrine Injection is given

3.    Elow Ephedrine Injection is given 1. Possible side effects

5. How to store Ephedrine Injection 5. Further information

This leaflet contains a summary of the information available for this medicine. You should askyour doctor or pharmacist if you are unsure about any aspect of this medicine.

1.    What Ephedrine Injection is and what it is used for

Ephedrine belongs to a group of medicines called sympathomimetics. These affect the part of your nervous system that work automatically. Ephedrine may be used to treat low blood pressure during spinal anaesthesia. It does this by temporarily reducing the blood supply to small blood vessels.

2.    Before Ephedrine Injection is given

You should not be given Ephedrine Injection if:

•    you are allergic (hypersensitive) to ephedrine or any of the other ingredients of this medicine, listed in section 6 of this leaflet

•    you have an overactive thyroid gland which can cause increased appetite, weight loss or sweating

•    you have prostate gland enlargement

•    you have heart disease or any other heart conditions, including any narrowing of the arteries and irregular heartbeats

•    you have high blood pressure

•    you are breast-feeding.

f any of the above applies to you, please tell your doctor.

This medicine should not be given to children under 12 years of age.

Take special care with Ephedrine Injection if:

•    you suffer from diabetes

•    you suffer from increased pressure in the eye (glaucoma)

•    you are about to have an operation which requires that you be given an anaesthetic

f you taking corticosteroids (medicines used to relieve swelling n a variety of conditions), aminophylline (a medicine used to treat serious lung problems) and other similar medicines, or medicines that make you pass more urine than usual (diuretics) you may beat risk from developing low levels of potassium in /our body. If you are taking any of these medicines you should tell your doctor before being given Ephedrine Injection.

Taking other medicines

³lease tell your doctor or nurse if you are taking, or have ecently taken, any other medicines including medicines obtained without a prescription.

Ephedrine Injection must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them. These drugs are cnown as Monoamine Oxidase Inhibitors(MAOI's).

Other medicines which may interact with Ephedrine Injection are:

•    any other medicines used to treat depression (trycyclic antidepressants)

•    medicines used to control epileptic fits (e.g. phenobarbitol and primidone)

•    cough and cold remedies

•    doxapram, a drug used to treat breathing problems

•    oxytocin, a drug used during labour

•    medicines used to treat heart problems (e.g. propranolol, cardiac glycosides)

•    medicines used to treat breathing problems (e.g. salbutamol)

•    medicines used to treat high blood pressure such as propranolol and doxazosin

Injection in this leaflet)

•    medicines used to suppress appetite such as fenfluramine and dexfenfluramine

•    corticosteroids, a type of medicine used to relieve swelling in a variety of different conditions

•    medicines used to treat serious lung problems (xanthines) such as aminophylline and theophylline

•    medicines that make you pass more urine than usual (diuretics)

•    anaesthetics that are inhaled, such as halothane.

Pregnancy and breast-feeding

Tell you doctor if you are pregnant or trying to become pregnant before you are given this medicine. You should not be given this medicine if you are breast-feeding.

Driving and using machines

Ephedrine Injection is not thought to have any affect on driving or using machines however if you feel at all unwell after being given this medicine you should consult your doctor before you begin driving or using machines again.

3.    How Ephedrine Injection is given

This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you require.

Adults, elderly and children over 12 years:

You will be given a slow injection into a vein over several minutes of 3 to 6mg (maximum 9mg) which may be repeated if necessary every 3 to 4 minutes to a maximum of 30mg. Children under 12 years:

Not recommended.

If you thinkyou have been given too much Ephedrine Injection

This medicine is given to you by your doctor so it is unlikely you will receive too much. You doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment, please talk to your doctor.

fyou have any further questions on the use of this product, askyour doctor or nurse.

4.    Possible side effects

Like all medicines Ephedrine Injection can cause side effects, although not everybody gets them Possible side effects include:

•    dizziness, headaches, feeling worried

•    restlessness, problems sleeping

•    feeling or being sick

•    sweating

•    muscular weakness or shaking

•    fast, slow or irregular heartbeat, or pain over the heart heightened sense of your heart beating (palpitations)

•    difficulty in passing urine

•    fear, confusion, irritability

•    changes in your personality or the way you feel/think

•    reduced appetite

•    changes in blood pressure, fainting, flushing

•    narrowing of the blood vessels which in severe cases may lead to gangrene in the fingers and toes

•    strokes

•    a fall in blood potassium levels and changes in blood sugar levels

•    heart failure (cardiac arrest)

•    breathing problems

•    excessive saliva production

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Continued overleaf