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Package leaflet: information for the user

Ephedrine Hydrochloride 3mg per ml Solution for Injection
Ephedrine Hydrochloride


(Referred to as “Ephedrine Injection” in this leaflet)
Ephedrine Injection must not be used with drugs used to treat
Read all of this leaflet carefully before you are given this
severe depression, such as phenelzine or moclobemide, or if
medicine because it contains important information for
you are within 2 weeks of discontinuing them. These drugs
are known as monoamine oxidase inhibitors (MAOIs).
• Keep this leaflet. You may need to read it again.
Other medicines which may interact with Ephedrine Injection
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• methylphenidate, used to treat “attention deficit
• If you get any of the side effects, talk to your doctor,
hyperactivity disorder (ADHD)”;
pharmacist or nurse. This includes any possible side

stimulators of the sympathetic nervous system such
effects not listed in this leaflet. See section 4.
as phenylpropanolamine or pseudoephedrine (medicines
used in nasal decongestant), phenylephrine (a medicine
What is in this leaflet:
used to treat hypotension);
1. What Ephedrine Injection is and what it is used for
• direct stimulators of alpha receptors of the sympathetic
2. What you need to know before you are given Ephedrine
nervous system (oral and/or nasal use) that are used to treat
hypotension or nasal congestion, among others;
3. How Ephedrine Injection is given
• anaesthetics that are inhaled, such as halothane;
4. Possible side effects
• medicines used to treat depression;
5. How to store Ephedrine Injection
• Sibutramine, a medicine used as an appetite suppressant
6. Contents of the pack and other information
• linezolid, used to treat infections;
• medicines used to treat asthma such as theophylline
• corticosteroids, a type of medicine used to relieve swelling
1. What Ephedrine Injection is and what it is
in a variety of different conditions;
used for
• medicines for epilepsy;
• doxapram, medicines used to treat breathing problems;
Ephedrine belongs to a group of medicines called
• oxytocin, a medicine used during labour;
sympathomimetics. Sympathomimetic drugs affect the part of
• reserpine and methyldopa and related medicines, used to
your nervous system that works automatically.
treat high blood pressure;
• guanethidine and related medicines, used to treat high
Ephedrine Injection is used to relieve low blood pressure
blood pressure;
during spinal or epidural anaesthesia. It raises blood pressure
• Ergot alkaloids, a type of medicines used as vasoconstrictors
by temporarily reducing the blood supply to small blood
(narrowing blood vessels) or for their dopaminergic action
(increasing the dopamine-related activity in the brain).

2. What you need to know before you are given
Ephedrine Injection
You should not be given Ephedrine Injection if:
• you are allergic to ephedrine hydrochloride or to any of the
other ingredients of this medicine (listed in section 6).
• you are taking another indirect sympathomimetic
agent such as phenylpropanolamine, phenylephrine,
pseudoephedrine (medicines used to relieve blocked nose)
or methylphenidate (medicine used to treat “attention
deficit hyperactivity disorder (ADHD)”),
• you are taking an alpha sympathomimetic agent (medicines
used to treat low blood pressure),
• you are taking or have taken in the last 14 days a nonselective monoamine oxidase inhibitor (medicines used to
treat depression).
Warnings and precautions
Talk to your doctor before using Ephedrine Injection if:
• you suffer from diabetes;
• you suffer from heart disease or any other heart conditions,
including angina;
• you suffer from weakness in a blood vessel wall leading
to a bulge developing (aneurysm);
• you have high blood pressure;
• you have a narrowing and/or blockage of blood vessels
(occlusive vascular disorders)
• you have an overactive thyroid gland (hyperthyroidism);
• you know or suspect that you suffer from glaucoma
(increased pressure in your eyes) or prostatic hypertrophy
(enlarged prostate gland);
• you are about to have an operation which requires that you
are given an anaesthetic
• you are currently taking or have taken within the last 14 days
any monoamine oxidase inhibitor medicine used to treat
Other medicines and Ephedrine Injection
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor,
pharmacist or nurse for advice before being given this
Laboratory Testing
This medicinal product contains an active ingredient that can
induce positive results in anti- doping controls.
Ephedrine Injection contains sodium
This medicinal product contains 2.36 mg (0.102 mmol) of
sodium per ml of injection (a total of 23.6 mg or 1.02 mmol
sodium in 10 ml syringe). This amount must be taken into
consideration by patients on a salt-restricted diet.

4. Possible side effects

6. Contents of the pack and other Information

Like all medicines this medicine can cause side effects,
although not everybody gets them.
Possible side effects include:
If you get any of the following side effects, stop taking this
medicine and seek urgent medical advice straight away:
• difficulty in breathing
• abnormal heart rhythm;
• palpitations, high blood pressure, fast heartbeat, or
• pain over the heart, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest);
• bleeding in the brain;
• build-up of a fluid within the lungs (pulmonary oedema);
• increased pressure in the eye (glaucoma)
• difficulty in passing urine

What Ephedrine Injection contains.
The active ingredient is Ephedrine Hydrochloride 0.3% w/v,
equivalent to 3mg ephedrine hydrochloride in 1ml or 30mg
ephedrine in 10ml.
The other ingredients are Sodium Chloride, Water for
Injections and Hydrochloric Acid, Nitrogen PF9
What Ephedrine Injection looks like and contents of the
Ephedrine Injection is a clear, colourless solution for injection.
The injection is supplied in 10ml glass ampoules. Each pack
contains 10 ampoules.

Other side effects that you may experience while taking this
medicine are:

Marketing Authorisation Holder: Aurum Pharmaceuticals
Ltd, T/A Martindale Pharma, Bampton Road, Harold Hill,
Romford, RM3 8UG

Common (may affect up to 1 in 10 people):
• confusion, feeling worried, depression;
• nervousness, irritability, restlessness, weakness, sleeping
problems, headache, sweating
• shortness of breath;
• nausea, vomiting.

MaCarthys Laboratories Ltd, Bampton Road, Harold Hill,
Romford, Essex, RM3 8UG, United Kingdom
Federa SA, Avenue Jean Jaureslaan 71, Brussels B-1030,

Not known (frequency cannot be estimated from the
available data):
• affects blood clotting;
• allergy (hypersensitivity);
• changes in your personality or the way you feel/think, fear
• tremor, excessive saliva production
• reduced appetite
• a decrease in blood potassium levels and changes in blood
sugar levels

Product Licence Number: PL 12064/0032
This leaflet was last revised in: December 2016

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: By reporting side
effects you can help provide more information on the safety of
this medicine.

5. How to store Ephedrine Injection
Keep out of the sight and reach of children.
You should not be given this medicine if it has passed the
expiry date shown on the carton and ampoule label.
Your doctor or nurse will check this. Do not store above 25°C.
Keep in the outer carton.
This medicine will only be used for your treatment. Your doctor
will dispose of any leftover medicine.

3. How Ephedrine Injection is given
This medicine is an injection that will be given to you by your
doctor or nurse, into a vein (intravenously). Your doctor will
decide the correct dosage for you and when and how the
injection should be administered.
The recommended doses are:
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.
Patients with kidney or liver disease:
There are no dose adjustments recommended for patients
with kidney or liver disease.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.
If you think you have been given too much Ephedrine
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.
If you have any further questions on the use of this product,
ask your doctor or nurse.

Continued overleaf



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