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PHENYLEPHRINE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): PHENYLEPHRINE HYDROCHLORIDE

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Package Leaflet: Information for the User

PHENYLEPHRINE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
(Referred to as Phenylephrine Injection in this leaflet)

Read all of this leaflet carefully before you
are given this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or nurse.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or nurse.
In this leaflet:
1.What Phenylephrine Injection is and what it
is used for
2.Before you are given Phenylephrine Injection
3.How Phenylephrine Injection will be given
4.Possible side effects
5.How to store Phenylephrine Injection
6.Further information
1. WHAT PHENYLEPHRINE INJECTION IS
AND WHAT IT IS USED FOR
Phenylephrine Injection contains
phenylephrine hydrochloride, which belongs to
a group of medicines known as adrenergic
cardiac stimulants. It raises blood pressure by
constricting blood vessels.
Phenylephrine Injection is used to treat low
blood pressure, which may be caused by
circulatory failure, spinal anaesthesia or
certain medicines.
2. BEFORE YOU ARE GIVEN
PHENYLEPHRINE INJECTION
You should NOT be given Phenylephrine
Injection if any of the following apply to you.
Tell your doctor if:
• you are allergic (hypersensitive) to
phenylephrine hydrochloride or any of the
other ingredients (listed in section 6)
• you suffer from high blood pressure
• you have an overactive thyroid
• you are taking Monoamine Oxidase
Inhibitors (MAOIs) used to treat depression,
or have taken them in the last 14 days.

Special care should be taken with
Phenylephrine Injection if any of the
following apply to you.
Tell your doctor if you have:
• any heart problems or disease, including
arrhythmias or angina
• a disease of your blood vessels, such as
arteriosclerosis or aneurysms
• diabetes mellitus
• closed-angle glaucoma (increased pressure
in the eye)
• you are pregnant or breast feeding.
Taking other medicines
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
In particular, tell your doctor or nurse if you are
taking any of the following:
• anaesthetics given as a gas that you inhale,
such as cyclopropane or halothane
• tricyclic antidepressants
• medicines used to treat heart conditions
including cardiac glycosides, or quinidine
• medicines used to treat high blood pressure
• medicines known as alpha blockers (used to
treat Reynaud’s syndrome or tumour of the
adrenal gland) or beta blockers (used to
treat heart conditions or reduce blood
pressure).
• ganisetron used to prevent nausea and
vomiting
• doxazosin used to treat high blood pressure or
symptoms of an enlarged prostate
• buspirone used to treat anxiety.
Pregnancy and breast-feeding
Tell your doctor or nurse if you are pregnant or
breast-feeding.
The safety of phenylephrine during pregnancy
and breast-feeding has not been established.
Giving phenylephrine in late pregnancy or labour
may reduce the foetal heart rate and oxygen
levels.
Continued overleaf.....

Package Leaflet: Information for the Healthcare Professional

PHENYLEPHRINE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
The following information is intended for medical or healthcare professionals only:
Qualitative and quantitative composition
Phenylephrine hydrochloride Ph Eur 1.0% w/v.
Each 1 ml ampoule contains 10 mg
phenylephrine.
Therapeutic indications
For the treatment of hypotensive states, e.g.
circulatory failure, during spinal anaesthesia or
drug-induced hypotension.
Posology and method of administration
For subcutaneous, intramuscular or slow
intravenous injection or by intravenous infusion.
Inspect visually for particulate matter and
discolouration prior to administration.

Adults:
Phenylephrine injection may be administered
subcutaneously or intramuscularly in a dosage of
2 to 5 mg with further doses of 1 to 10 mg if
necessary according to response, or in a dose of
100 to 500 micrograms by slow intravenous
injection as a 0.1% solution, repeated as
necessary after at least 15 minutes.
Alternatively, 10 mg in 500 ml of glucose 5%
injection or sodium chloride 0.9% injection may
be infused intravenously, initially at a rate of up to
180 micrograms per minute, reduced according
to response to 30-60 micrograms per minute.

3. HOW PHENYLEPHRINE INJECTION WILL
BE GIVEN
You will normally be given Phenylephrine
Injection in a hospital or clinic.
Phenylephrine Injection can be given by an
injection under the skin, into a muscle, or
diluted and given by slow injection or infusion
(drip) into a vein.
Dose for adults, including the elderly:
When given under the skin or into a muscle
the usual dose is 2 to 5 mg with further doses
of 1 to 10 mg if necessary.
When given as a diluted solution by slow
injection into a vein the dose is 100 to 500
micrograms, repeated as necessary after at
least 15 minutes.
Alternatively, it may be infused as a diluted
solution into a vein (drip), and the dose
adjusted according to the response.
Dose for children:
The usual dose is 100 micrograms/kg
bodyweight given as an injection under the
skin or into a muscle.
If you are given more Phenylephrine
Injection than you should
As you will be given Phenylephrine Injection in
a hospital or clinic by a qualified healthcare
professional, this will be unlikely.
If you have any further questions on the use of
this product, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Phenylephrine Injection can
cause side effects, although not everybody gets
them.
Tell your doctor or nurse if you have any of
the following side effects:
• a change in your heart rate (speeding up,
slowing down or cessation, palpitations)
• an irregular heart beat (arrhythmias)
• chest pain or pain due to angina
• an increase in blood pressure with headache
and vomiting, which may cause bleeding in
the brain or fluid on the lungs
• a decrease in blood pressure with dizziness
• difficulty in passing urine or urine retention
• fainting or flushing
• difficulty breathing
• excessive dilation of the pupil
• tissue damage at the site of the injection.

Other side effects
• sweating
• excessive production of saliva
• a feeling of fullness in the head
• tingling or coolness of the skin
• altered metabolism including glucose
metabolism.
Reporting of side effects
If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE PHENYLEPHRINE
INJECTION
Keep out of the reach and sight of children.
Store below 25ºC. Store in the original
package.
Do not use after the expiry date, which is stated
on the carton and ampoule.
6. FURTHER INFORMATION
What Phenylephrine Injection contains
• Each 1ml ampoule contains 10mg of the
active substance phenylephrine hydrochloride
• The other ingredients are sodium hydroxide,
hydrochloric acid and water for injections.
What Phenylephrine Injection looks like and
contents of the pack
Phenylephrine Injection is a clear, colourless,
sterile solution in a glass ampoule, available in
packs of 10 ampoules.
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd., Tunbridge Wells,
Kent TN1 1YG
Manufacturer
Biomendi S.A, Polígono Industrial de Bernedo
s/n, 01118 Bernedo (Álava), Spain.
This leaflet was last revised in 07/2015

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Children:
100 micrograms/kg bodyweight subcutaneously
or intramuscularly.

Incompatibilities
Phenylephrine Injection has been stated to be
incompatible with alkalis, ferric salts,
phenytoin sodium and oxidising agents.

Elderly:
There is no need for dosage reduction in the
elderly.

For full prescribing information please
refer to the Summary of Product
Characteristics

Pharmacokinetic properties
When injected subcutaneously or
intramuscularly, phenylephrine takes 10 to 15
minutes to act. Intravenous injections are
effective for up to about 20 minutes, whereas
subcutaneous injections are effective for up to
one hour and intramuscular injections for up to
two hours.

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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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