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EPHEDRINE 30 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION

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Package leaflet: Information for the user

Ephedrine 30 mg/ml Concentrate for
solution for injection
Ephedrine hydrochloride
(Referred to as Ephedrine Injection in this leaflet)
Read all of this leaflet carefully before you are given 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 nurse.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Ephedrine Injection is and what it is used for
2. What you need to know before Ephedrine Injection is given
3. How Ephedrine Injection is given
4. Possible side effects
5. How to store Ephedrine Injection
6. Contents of the pack and other information

1. What Ephedrine Injection is and what it
is used for
Ephedrine belongs to a group of medicines called sympathomimetics. Sympathomimetic drugs affect the part of your nervous
system that works automatically.
Ephedrine Injection is used to relieve low blood pressure during spinal anaesthesia. It raises blood pressure by temporarily
reducing the blood supply to small blood vessels.

2. What you need to know before
Ephedrine Injection is given
You should not be given Ephedrine Injection if:
- you are allergic (hypersensitive) to ephedrine hydrochloride
or to any of the other ingredients in this medicine (listed in
section 6),
- you suffer from overactive thyroid gland which can cause
increased appetite, weight loss or sweating
- you suffer from prostate gland enlargement
- you suffer from any heart disease
- you suffer from increased pressure in the eye (glaucoma)
- you suffer from diabetes
- you suffer from blood clots
- you suffer from low blood pressure
- you are taking monoamine oxidase inhibitors or MAOIs (see
other medicines and Ephedrine Injection)
- you have high blood pressure.
If any of the above applies to you, please tell your doctor.

Other medicines which may interact with Ephedrine Injection
are:
- a type of anti-depressant known as monoamine oxidase
inhibitors (MAOIs). Tell your doctor or nurse even if you have
stopped taking them in the past 2 weeks.
- cough and cold remedies,
- anaesthetics that are inhaled such as halothane,
- medicines used to treat depression,
- sibutramine, a medicine used as an appetite suppressant,
- linezolid, used to treat infections,
- medicines used to treat asthma such as theophylline,
- corticosteroids, a type of medicine used to relieve swelling
in a variety of different conditions,
- medicines for epilepsy,
- doxapram, a drug used to treat breathing problems,
- oxytocin, a drug used during labour,
- medicines used to treat high blood pressure such as guanethidine.
Pregnancy and breast-feeding
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.
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 you should
consult your doctor before you begin driving or using machines
again.
Laboratory Testing
This medicinal product contains an active ingredient that can
induce positive results in anti-doping controls.

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 and the elderly:
The usual starting dose is 3-7.5mg given slowly into a vein.
Your dose may be repeated until the maximum amount of medicine (30mg) is given.
Patients with renal or hepatic impairment
There are no specific dosage recommendations for patients
with renal or hepatic impairment.
Children:
Ephedrine Injection is not recommended for use in children
due to insufficient data on efficacy, safety and dosage recommendations.

Other medicines and Ephedrine Injection
Please tell your doctor or nurse if you are taking, or have recently taken, any other medicine including medicines obtained
without prescription.

If you think you 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. Your doctor has information on how to

The following information is intended for healthcare professionals only:

For intravenous injection.

This is an extract from the Summary of Product Characteristics
to assist in the administration of Ephedrine Injection. When
determining appropriateness of use in a particular patient, the
prescriber should be familiar with the Summary of Product
Characteristics of the product.
Drug name:

Ephedrine 30 mg/ml Concentrate for
solution for injection
Safety information:
Ephedrine Injection must be used solely by or under the supervision of the anaesthetist.

PB Ephedrin Carino UK 30mg-ml.indd 1

Incompatibility:
In the absence of compatibility studies, this medicinal product
must not be mixed with other medicinal products.
Administration:
The ampoules contain a concentrate for solution for injection
containing 30 mg ephedrine hydrochloride in each ml of solution. This medicine should be administered immediately after
dilution with sterile isotonic sodium chloride in a ratio of 1:10.
Adult and the elderly
Up to 30 mg in increments of 3 to 7.5 mg.
After the development of hypotension, by slow intravenous
administration.

25.02.13 07:23

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.

4. Possible side effects

Like all medicines Ephedrine Injection can cause side effects,
although not everybody gets them.

The following categories are used for stating the frequency of
side effects:
Very common:

more than 1 in 10 patients treated

Common:

1 to 10 out of 100 patients treated

Uncommon:

1 to 10 out of 1,000 patients treated

Rare:

1 to 10 out of 10,000 patients treated

Very rare:

less than 1 in 10,000 patients treated

Not known:

cannot be estimated from the available data

Common:
- Confusion, feeling worried, depression
- Nervousness, irritability, restlessness, weakness, sleeping
problems, headache, sweating, anxiety
- Palpitations, high blood pressure, fast heartbeat
- Shortness of breath
- Nausea, vomiting
Rare:
- Irregular heartbeat
- Difficulty in passing urine
Other side effects (it is not known how often these occur):
- Affects blood clotting
- Allergy
- Change in your personality or the way you feel/think, fear
- Tremor, excessive saliva production
- Increased pressure in the eye (glaucoma)
- Pain over the heart, slow heartbeat, heart failure (cardiac
arrest), low blood pressure
- Bleeding in the brain
- Breathing problems
- Reduced appetite
- A fall in blood potassium levels, changes in blood glucose
levels
- Build up of a fluid within the lungs (pulmonary oedema)
If you are given too much of this medicine you may:
- see or hear things that aren’t there (hallucinations)
- believe in things that aren’t true (delusions)
- notice changes in your personality or the way you feel/think.
If you get any side effects, talk to your doctor or nurse. This
includes any side effects not listed in this leaflet.

5. How to store Ephedrine Injection

You should not be given this medicine if it has passed the expiry date which is stated on the label and the carton after “EXP”
respectively “Expiry Date”. The expiry date refers to the last
day of that month.
This medicinal product does not require any special storage
conditions.
Chemical and physical in-use stability has been demonstrated
for 24 hours at 25°C. 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
responsibilities of the user and would normally not be longer
than 24 hours at 2 to 8°C, unless dilution has taken place in
controlled and validated aseptic conditions.
You should not be given this medicine if a colouration or turbidity of the solution occurs.
Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Contents of the pack and other
information
What Ephedrine Injection contains
- The active substance is ephedrine hydrochloride. Each ml
of concentrate for solution for injection contains 30 mg of
ephedrine hydrochloride. Each ampoule contains 1 ml.
- The other ingredient is water for injection.
What Ephedrine Injection looks like and contents
of the pack
This medicine is a clear, colourless solution supplied to your
doctor or pharmacist in a pack of 10 clear and glass ampoules,
each containing 1 ml of medicine.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CARINOPHARM GmbH
Bahnhofstr. 18, D-31008 Elze
Tel.: 0049 (0)180 2 1234-01
Fax: 0049 (0)180 2 1234-02
E-mail: info@carinopharm.de
Manufacturer
Haupt Pharma Livron S.A.S.
1 rue comte de Sinard,
F-26250 Livron sur Drome
This medicinal product is authorised in the Member States
of the EEA under the following names:
Germany:
Ephedrin Carino 30 mg/ml Konzentrat zur
Herstellung einer Injektionslösung
United Kingdom: Ephedrine 30 mg/ml Concentrate for solution
for injection

Keep this medicine out of the sight and reach of children.

This leaflet was last revised in 02/2013.

Patients with renal or hepatic impairment
There are no specific dosage recommendations for patients
with renal or hepatic impairment.

Storage and Shelf-life:
Do not use this medicine after the expiry date which is stated
on the label and the carton. The expiry date refers to the last
day of that month.
This medicinal product does not require any special storage
conditions.
Chemical and physical in-use stability has been demonstrated
for 24 hours at 25°C. 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
responsibilities of the user and would normally not be longer
than 24 hours at 2 to 8°C, unless dilution has taken place in

Children
Ephedrine Injection is not recommended for use in children due
to insufficient data on efficacy, safety and dosage recommendations.
Overdose:
Symptoms as described in the section “Possible side effects”,
paranoid psychosis, delusions and hallucinations may occur.
Treatment: In severe overdosage Diazepam may be required
to control CNS stimulation and severe hypertension will require
specific therapy.

PB Ephedrin Carino UK 30mg-ml.indd 2

25.02.13 07:23

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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