3 mg/ml solution for injection in a pre-filled syringe of
ephedrine hydrochloride
What Ephedrine Aguettant is and what it is used for
Ephedrine Aguettant is used to treat low blood pressure that can occur during various types of anesthesia. The product may only be used by or under the supervision of an anesthetist.
2. What you need to know before you are given Ephedrine Aguettant
You can not be given Ephedrine Aguettant if:
- you are allergic to ephedrine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
You should tell your doctor about:
- you have high blood pressure
- you suffer from heart disease or any other heart condition
- you have diabetes
- you have an overactive thyroid gland
- you have an enlarged prostate
- you know or suspect you are suffering from glaucoma (increased pressure in the eye)
- You are currently taking or within the last 14 days, you have taken a medicine called monoamine oxidase inhibitor (MAOI) which is used to treat depression.
Other medicines and Ephedrine Aguettant
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
It is especially important to tell your doctor if you are taking the following medicines:
- Antidepressants such as tricyclic antidepressants (eg imipramine) or serotoninerganoradrenergic drugs (eg milnacipran, venlafaxine ), or any monoamine oxidase inhibitors (eg moclobemide, toloxatone)
- Medicines used to lower blood pressure (eg guanethidine, clonidine )
- Theophylline, a drug used for respiratory diseases such as asthma
- Corticosteroids, which are drugs that reduce inflammation and the consequences of allergic reactions
- Sibutramine, an appetite suppressant administered orally for the treatment of obesity
- Linezolid, an antibiotic used to treat serious infections you
- Oxytocin, a drug used during childbirth
- Some other anesthetics and in particular cyclopropane and halothane
- Some medicines for coughs and colds that can raise your blood pressure(phenylpropanolamine, pseudoephedrine, phenylephrine )
- Methylphenidate, a drug used to treat ADHD
- Some medicines used to treat heart failure and/or irregular heartbeats (cardiac glycosides, quinidine )
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ephedrine Aguettant can be used during cesarean section.
You should stop breastfeeding for a few days after receiving this medicine.
Ephedrine Aguettant contains sodium
This medicine contains 3.32 mg (0.144 mmol) sodium per ml injection (total 33.2 mg or 1.44 mmol sodium in a 10 ml syringe ). This should be considered by patients on a low-salt diet.
3. How Ephedrine Aguettant is given
A doctor or nurse will give you Ephedrine Aguettant in a vein ( intravenous administration ). The doctor will determine the right dose for you and when and how the injection should be given.
If you have been given too much Ephedrine Aguettant
Getting too much Ephedrine Aguettant can lead to symptoms such as nausea, vomiting, fever, paranoid psychosis, irregular heartbeat, high blood pressure, decreased respiratory rate, seizure,s, and coma. If these symptoms occur, you may need intensive supportive care.
If you have any further questions on the use of this product, ask your doctor.
For practical information on handling or administering the medicinal product, please refer to the section for healthcare and healthcare professionals at the end of this leaflet.
4. Possible side effects
Like all medicines, Ephedrine Aguettant can cause side effects, although not everybody gets them.
Common (affects up to 1 in 10 people) :
- confusion, anxiety, depression
- nervousness, irritability, restlessness, weakness, difficulty sleeping (insomnia), headache, sweating
- palpitations, high blood pressure ( hypertension ), increased heart rate ( tachycardia )
- strained breathing ( dyspnoea )
- nausea, vomiting
Rare (affects up to 1 in 1,000 people) :
- irregular heartbeat ( cardiac arrhythmias )
- inability to urinate ( acute urinary retention )
No known frequency (cannot be calculated from the available data):
- allergic reactions (hypersensitivity)
- psychotic states, fear
- shaking ( tremor ), increased salivation (hypersecretion)
- episodes of narrow-angle glaucoma (a disease in which the optic nerve is damaged)
- chest pain, slow heartbeat (reflex bradycardia), cardiac arrest, low blood pressure( hypotension )
- cerebral hemorrhage (cerebral hemorrhage)
- fluid accumulation in the lungs ( pulmonary edema )
- decreased appetite
- low potassium levels in the blood ( hypokalaemia ), which can cause muscle weakness, jerky or abnormal heart rhythm, altered blood glucose levels
5. How to store Ephedrine Aguettant
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP and on the syringe label after EXP. The doctor or nurse checks this.
Store the blister in the outer carton. Sensitive to light.
The pre-filled syringe is for single use only.
After opening the product, it must be used immediately.
Any unused product or waste material should be disposed of by local requirements.
6. Contents of the packaging and other information
Content declaration
- The active substance is ephedrine hydrochloride. One milliliter solution for injection contains 3 mg of ephedrine hydrochloride. One pre-filled 10 ml syringe contains 30 mg of ephedrine hydrochloride.
- The other ingredients are sodium chloride, citric acid monohydrate, sodium citrate, water for injections, hydrochloric acid, d, or sodium hydroxide (for adjustment).
One milliliter of solution for injection contains 3.32 mg of sodium corresponding to 0.144 mmol.
What the medicine looks like and the contents of the pack
Ephedrine Aguettant is a clear and colorless solution. It is delivered in a pre-filled 10 ml syringe of polypropylene with a cap of polypropylene and a safety seal and is individually packed in a transparent blister pack.
The pre-filled syringes are delivered in cartons of 10 or 12 syringes.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 Lyon
France
Manufacturer:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON CEDEX
France
or
AGUETTANT LABORATORY
Lieu-dit “Chantecaille”
07340 CHAMPAGNE
France