Phenylephrine Aguettant

Package leaflet: Information for the patient

Phenylephrine Aguettant 50 micrograms/ml injectable solution in pre-filled syringe

(referred to as "injectable Phenylephrine" in this leaflet)
Phenylephrine
Read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What injectable Phenylephrine is and what it is used for
2. What you need to know before using injectable Phenylephrine
3. How to use injectable Phenylephrine
4. Possible side effects
5. How to store injectable Phenylephrine
6. Contents of the pack and other information

1. What Fenilefrina injectable is and what it is used for

This medicinal product belongs to the group of adrenergic and dopaminergic agents.
It is used to treat episodes of low blood pressure during anaesthesia.

2. What you need to know before using Injectable Phenylephrine

Injectable Phenylephrine will not be administered to you:

• if you are allergic to phenylephrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe high blood pressure or peripheral vascular disease (poor blood circulation);
• if you are taking a monoamine oxidase inhibitor (MAO inhibitor) (or within 2 weeks of stopping them), used to treat depression (such as iproniazide, nialamide);
• if you have severe overactivity of the thyroid gland (hyperthyroidism).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given
Injectable Phenylephrine:

• if you are elderly;
• if you have diabetes;
• if you have high blood pressure;
• if you have overactivity of the thyroid gland (uncontrolled hyperthyroidism);
• if you have a blood vessel disease, such as arteriosclerosis (hardening and thickening of the blood vessel walls);
• if you have poor cerebral blood circulation;
• if you have heart disease, including chronic heart disease, peripheral vascular insufficiency, heart rhythm disorders, tachycardia (high heart rate), bradycardia (low heart rate), partial heart block, angina pectoris;
• if you have closed-angle glaucoma (a rare eye disease).

In patients with severe heart failure, phenylephrine may worsen heart failure as a result of blood vessel constriction.
During treatment, your arterial blood pressure will be monitored. If you have heart disease, additional monitoring of vital functions will be performed.
Children
This medicine is not recommended for use in children due to insufficient data on efficacy, safety, and dosage recommendations.
Other medicines and Injectable Phenylephrine
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including:

• certain antidepressants (iproniazide, nialamide, moclobemide, toloxatone, imipramine, milnacipran, or venlafaxine);
• a medicine used to treat infections (linezolid);
• certain medicines used to treat migraine (dihydroergotamine, ergotamine, methylergometrine, methysergide);
• certain medicines used to treat Parkinson’s disease (bromocriptine, lisuride, pergolide);
• a medicine used to inhibit the production of a hormone responsible for lactation (cabergoline);
• inhaled anaesthetics (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane);
• a medicine used as an appetite suppressant (sibutramine);
• a medicine used to treat high blood pressure (guanethidine);
• medicines used to treat heart failure and certain types of irregular heartbeat (cardiac glycosides);
• a medicine used to treat heart rhythm disorders (quinidine);
• a medicine used during labour (oxytocin).

Pregnancy and breastfeeding
The safety of this medicine during pregnancy and breastfeeding has not been established,
but the use of Injectable Phenylephrine during pregnancy is possible if necessary.
The use of this medicine during breastfeeding is not recommended. However,
breastfeeding may be possible following a single administration during childbirth.
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor, pharmacist, or nurse for advice before this medicine is administered to you.
Driving and using machines
Talk to your doctor if you intend to drive and/or operate machinery after receiving this medicine.
Injectable Phenylephrine contains sodium
This medicine contains 3.68 mg (0.160 mmol) of sodium per ml (for a total of 36.8 mg or 1.60 mmol of sodium in a 10 ml pre-filled syringe). This amount should be taken into consideration by patients on a low-sodium diet.

3. How to use Injectable Phenylephrine

Administration will be performed by a healthcare professional with appropriate training and experience, who will determine the correct dosage for you and the timing and method of administration.
Recommended doses are:
Use in adults
The physician will determine the dose to be administered and may repeat or adjust it until the desired effect is achieved.
Use in patients with reduced renal function (impaired kidney function)
Lower doses of phenylephrine may be required in patients with reduced renal function.
Use in patients with reduced hepatic function (impaired liver function)
Higher doses of phenylephrine may be required in patients with hepatic cirrhosis.
Use in the elderly
Treatment in elderly patients should be carried out with caution.
Use in children
This medicinal product is not recommended for use in children due to insufficient data on efficacy, safety, and dosage recommendations.
If you have been given more Injectable Phenylephrine than you should have received:
You may experience the following symptoms: palpitations, cardiac rhythm disturbances (tachycardia, cardiac arrhythmias).
If you have any doubts about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious (frequencies are not known). Inform your doctor immediately
if any of the following occur:

• chest pain or pain due to angina;
• irregular heartbeat;
• awareness of heartbeat in the chest (palpitations);
• cerebral haemorrhage (speech disturbances, dizziness, paralysis on one side of the body);
• psychosis (loss of contact with reality).

Other side effects may include (frequencies are not known):

• hypersensitivity reaction (allergy);
• excessive dilation of the pupils;
• increased eye pressure (worsening of glaucoma);
• excitability (excessive sensitivity of an organ or body part);
• agitation (restlessness);
• anxiety;
• confusion;
• headache;
• nervousness;
• insomnia (difficulty falling asleep or staying asleep);
• tremor;
• skin burning;
• skin tingling;
• itching or tingling of the skin (paraesthesia);
• low or high heart rate;
• high blood pressure;
• breathing difficulty;
• fluid in the lung;
• nausea;
• vomiting;
• sweating;
• pallor or whitening of the skin (pale skin colour);
• goosebumps;
• tissue damage at the injection site;
• muscle weakness;
• difficulty in urination or urinary retention.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Injectable Phenylephrine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the syringe label. The expiry date refers to the last day of that month. Your doctor or nurse will check this for you.
Store the blister in the outer packaging to protect the medicine from light. Keep the syringe in its sealed blister until use.
Do not use this medicine if you notice any visible signs of deterioration.
Each syringe, even if partially used, must be properly disposed of after use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fenilefrina injectable contains
The active substance is phenylephrine hydrochloride.

• Each ml of injectable solution contains phenylephrine hydrochloride equivalent to 50 micrograms of phenylephrine.
• Each 10 ml pre-filled syringe contains phenylephrine hydrochloride equivalent to 500 micrograms of phenylephrine.
• The other components are sodium chloride, disodium citrate dihydrate, citric acid monohydrate, sodium hydroxide and water for injections.

Description of the appearance of Fenilefrina injectable and package contents
Fenilefrina injectable is a clear, colourless solution in a 10 ml pre-filled syringe made of
polypropylene, individually packaged in a transparent blister.
Pre-filled syringes are available in packs of 1 and 10 syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratoire Aguettant
1 Rue Alexander Fleming
69007 Lyon
France

Manufacturer:
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON
France

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).

The following information is intended exclusively for healthcare professionals:
Prepare the syringe carefully as follows
The pre-filled syringe is intended for single patient use only. Dispose of the syringe after use. Do not reuse.
The contents of an unopened and undamaged blister are sterile and must not be opened until the time of use.
The solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear, colourless solutions without particles or precipitates should be used.
The product must not be used if the tamper-evident seal on the syringe is broken.
The outer surface of the syringe is sterile until the blister is opened.
When handled using an aseptic technique, Fenilefrina Aguettant 50 micrograms/ml, solution for injection in pre-filled syringe, may be placed on a sterile surface.

1. Remove the pre-filled syringe from the sterile blister.

2. Push the plunger to dislodge the stopper. The sterilisation process may have caused the stopper to adhere to the syringe barrel.

3. Rotate the terminal cap to break the seal. Do not touch the exposed Luer connection to avoid contamination.

4. Check that the seal at the tip of the syringe has been completely removed. If not, replace the cap and rotate again.

5. Expel air by gently pressing the plunger.
6. Connect the syringe to the IV access. Slowly depress the plunger to inject the required volume.
7. Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.