PHENYLEPHRINE 100 micrograms/ml Solution

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Phenylephrine Aguettant, 100 micrograms/ml, solution for injection/infusion
   1. Table of contents of the leaflet
3. What is Phenylephrine Aguettant and what is it used for
4. Important information before using Phenylephrine Aguettant
   1. When not to use Phenylephrine Aguettant:
   2. Warnings and precautions
   3. Children
   4. Phenylephrine Aguettant and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Phenylephrine Aguettant contains sodium
5. How to use Phenylephrine Aguettant
   1. Recommended doses are as follows:
   2. Use in adults
   3. Use in the elderly
   4. Use in children
   5. Overdose of Phenylephrine Aguettant
6. Possible side effects
   1. Reporting side effects
7. How to store Phenylephrine Aguettant
8. Package contents and other information
   1. What Phenylephrine Aguettant contains
   2. What Phenylephrine Aguettant looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet: 2021-11-23

Leaflet included in the packaging: patient information

Phenylephrine Aguettant, 100 micrograms/ml, solution for injection/infusion

Phenylephrine
Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Phenylephrine Aguettant and what is it used for
• 2. Important information before using Phenylephrine Aguettant
• 3. How to use Phenylephrine Aguettant
• 4. Possible side effects
• 5. How to store Phenylephrine Aguettant
• 6. Package contents and other information

1. What is Phenylephrine Aguettant and what is it used for

This medicine belongs to a group of drugs that stimulate adrenergic and dopaminergic receptors.
It is used to treat low blood pressure during anesthesia.

2. Important information before using Phenylephrine Aguettant

When not to use Phenylephrine Aguettant:

• if the patient is allergic to phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe hypertension or peripheral vascular disease (poor blood circulation);
• if the patient is taking monoamine oxidase inhibitors (MAOIs) (or within 2 weeks of stopping them), used to treat depression (e.g., iproniazid, nialamide);
• if the patient has severe hyperthyroidism.

Warnings and precautions

Before starting treatment with Phenylephrine Aguettant, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient is elderly;
• if the patient has diabetes;
• if the patient has hypertension;
• if the patient has hyperthyroidism (uncontrolled hyperthyroidism);
• if the patient has vascular disease, such as atherosclerosis (hardening and thickening of blood vessel walls);
• if the patient has a condition that may lead to poor blood circulation in the brain;
• if the patient has an aneurysm;
• if the patient has heart disease, including chronic heart disease, non-severe peripheral vascular disease, arrhythmias, tachycardia (rapid heart rate), bradycardia (slow heart rate), partial heart block, angina pectoris;
• if the patient has glaucoma (a rare eye disease).

In patients with severe heart failure, phenylephrine may worsen heart failure due to vasoconstriction.
During treatment, the patient's blood pressure will be monitored. In patients with heart disease, additional monitoring of vital signs will be performed.

Children

The use of this medicine is not recommended in children due to insufficient data on efficacy, safety, and dosing.

Phenylephrine Aguettant and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, such as:

• certain antidepressants (iproniazid, nialamide, moclobemide, toloxatone, imipramine, minaprine, or venlafaxine);
• medicines used to treat infections (linezolid);
• certain medicines used to treat migraines (dihydroergotamine, ergotamine, methylergometrine, methysergide);
• certain medicines used to treat Parkinson's disease (bromocriptine, lisuride, pergolide);
• a medicine used to inhibit the secretion of the hormone responsible for lactation (cabergoline);
• inhalation anesthetics (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane);
• a medicine used to reduce appetite (sibutramine);
• a medicine used to treat high blood pressure (guanethidine);
• medicines used to treat heart failure and certain arrhythmias (digitalis glycosides);
• a medicine used to treat arrhythmias (quinidine);
• a medicine used during childbirth (oxytocin).

Pregnancy and breastfeeding

The safety of using this medicine during pregnancy and breastfeeding has not been established, but if necessary, Phenylephrine Aguettant can be administered during pregnancy.
The use of this medicine is not recommended during breastfeeding. However, in the case of a single administration during childbirth, breastfeeding is possible.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor, pharmacist, or nurse before using this medicine.

Driving and using machines

The patient should discuss with their doctor whether they can drive or use machines after receiving this medicine.

Phenylephrine Aguettant contains sodium

This medicine contains 78 mg of sodium (the main component of common salt) in each 20 ml vial. This is equivalent to 4% of the recommended maximum daily intake of sodium for an adult.

3. How to use Phenylephrine Aguettant

The medicine is administered exclusively by medical personnel after proper training and with sufficient supervision, who will determine the appropriate dose for the patient, the time, and the method of injection.

Recommended doses are as follows:

Use in adults

The doctor will determine the dose to be administered. The dose may be repeated or adjusted until the desired effect is achieved.
Use in patients with renal impairment(abnormal kidney function)
In patients with renal impairment, it may be necessary to use smaller doses of phenylephrine.
Use in patients with hepatic impairment(abnormal liver function)
In patients with liver cirrhosis, it may be necessary to use larger doses of phenylephrine.

Use in the elderly

Care should be taken when treating elderly patients.

Use in children

The use of this medicine is not recommended in children due to insufficient data on efficacy, safety, and dosing.

Overdose of Phenylephrine Aguettant

The following symptoms may occur: palpitations, arrhythmias (tachycardia, arrhythmias), headaches, nausea, vomiting, hallucinations, paranoid psychosis.
In case of any further doubts related to the use of this medicine, the patient should consult their 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 (frequency not known). The patient should immediately inform their doctor if they experience any of the following side effects:

• chest pain or angina pectoris,
• irregular heart rhythm,
• palpitations in the chest,
• bleeding in the brain (speech disorders, dizziness, paralysis of one side of the body),
• psychosis (loss of contact with reality).

Other side effects may include (frequency not known):

• allergic reaction (hypersensitivity),
• excessive dilation of the pupils,
• increased eye pressure (worsening of glaucoma),
• irritability (increased sensitivity of the organ or body part),
• agitation (restlessness),
• fatigue,
• disorientation,
• headache,
• nervousness,
• insomnia (difficulty falling asleep or sleeping),
• shivering,
• tingling or numbness of the skin (paresthesia),
• slow or rapid heart rate,
• high blood pressure,
• difficulty breathing,
• fluid in the lungs;
• nausea,
• vomiting,
• sweating,
• pallor,
• thickening of the skin,
• tissue damage at the injection site,
• muscle weakness,
• difficulty urinating or urinary retention.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Phenylephrine Aguettant

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month stated.
The doctor or nurse will check the expiry date.
There are no special requirements for storage temperature.
The vial should be stored in the outer packaging to protect it from light.
Do not use this medicine if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Phenylephrine Aguettant contains

The active substance is phenylephrine hydrochloride.

• One ml of the solution for injection contains phenylephrine hydrochloride equivalent to 100 micrograms (0.1 mg) of phenylephrine.
• Each 20 ml vial contains phenylephrine hydrochloride equivalent to 2000 micrograms (2 mg) of phenylephrine.
• The other ingredients are sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide, and water for injections.

What Phenylephrine Aguettant looks like and what the pack contains

Phenylephrine Aguettant is a clear, colorless solution for injection, in a 20 ml clear glass type II vial closed with a chlorobutyl rubber stopper and an aluminum cap.
The vials are available in packs of 1 and 10.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Date of last revision of the leaflet: 2021-11-23

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.