Phenylephrine aguettant

Package leaflet: Information for the patient

Phenylephrine Aguettant, 50 micrograms/ml, solution for injection in pre-filled syringe
Phenylephrinum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Phenylephrine Aguettant is and what it is 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. Contents of the pack and other information

1. What Phenylephrine Aguettant is and what it is used for
This medicine belongs to a group of agents that stimulate adrenergic and dopaminergic receptors.
It is used in the treatment of low blood pressure during anaesthesia.

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 (MAO inhibitors) (or within 2 weeks of stopping them), used in the treatment of depression (e.g. iproniazid, nialamide);
• if the patient has severe hyperthyroidism.

Warnings and precautions
Before using Phenylephrine Aguettant, discuss with your 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 diseases such as atherosclerosis (hardening and thickening of blood vessel walls);
• if the patient has poor cerebral circulation;
• if the patient has heart diseases, including chronic heart disease, peripheral circulatory failure, cardiac arrhythmias, tachycardia (abnormally fast heart rate), bradycardia (abnormally slow heart rate), partial heart block, angina pectoris;
• if the patient has closed-angle glaucoma (a rare eye condition).

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 parameters will be performed.
Children
This medicine is not recommended for use in children due to insufficient data on efficacy, safety and dosing.
Phenylephrine Aguettant and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, such as:

• certain antidepressants (iproniazid, nialamide, moclobemide, toloxatone, imipramine, mianserin or venlafaxine);
• medicines 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 secretion of the hormone responsible for lactation (cabergoline);
• inhaled anaesthetics (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 cardiac arrhythmias (cardiac glycosides);
• a medicine used to treat cardiac arrhythmia (quinidine);
• a medicine used during childbirth (oxytocin).

Pregnancy and breastfeeding
The safety of this medicine during pregnancy and breastfeeding has not been established. However, if necessary, Phenylephrine Aguettant may be administered during pregnancy.
Use of this medicine is not recommended during breastfeeding. However, after a single dose administered during childbirth, breastfeeding is possible.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor, pharmacist or nurse before using this medicine.
Driving and operating machinery
Please consult your doctor if the patient plans to drive or operate machinery after receiving this medicine.
Phenylephrine Aguettant contains sodium
This medicine contains 37.2 mg of sodium (the main component of table salt) per pre-filled syringe.
This corresponds to 1.9% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Phenylephrine Aguettant

The medicine is administered exclusively by trained medical personnel with appropriate training and sufficient experience, who will determine the correct dose, timing, and method of injection.
Recommended doses are as follows:
Use in adults
The physician 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 (impaired kidney function)
In patients with impaired renal function, lower doses of phenylephrine may be required.
Use in patients with hepatic impairment (impaired liver function)
In patients with liver cirrhosis, higher doses of phenylephrine may be required.
Use in elderly patients
Caution should be exercised when treating elderly patients.
Use in children
Use of this medicine in children is not recommended due to insufficient data on efficacy, safety, and dosing recommendations.
Administration of a higher than recommended dose of Phenylephrine Aguettant
The following symptoms may occur: palpitations, cardiac arrhythmias (tachycardia, arrhythmia).
If you have any further doubts regarding the use of this medicine, consult a physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious (frequency unknown). You must immediately
inform a doctor if any of the following adverse reactions occur:

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

Other possible adverse reactions include (frequency unknown):

• hypersensitivity reaction (allergy),
• excessive pupil dilation,
• increased intraocular pressure (worsening of glaucoma),
• irritability (excessive sensitivity of an organ or body part),
• restlessness,
• anxiety,
• disorientation,
• headache,
• nervousness,
• insomnia (difficulty falling asleep or staying asleep),
• tremor,
• skin burning,
• pricking sensation,
• skin itching or tingling (paresthesia),
• slow or fast heartbeat,
• high blood pressure,
• breathing difficulties,
• presence of fluid in the lungs,
• nausea,
• vomiting,
• sweating,
• pallor or skin blanching,
• goosebumps,
• tissue damage at the injection site,
• muscle weakness,
• difficulty urinating or urinary retention.

Reporting of adverse reactions
If any adverse symptoms occur in the patient, including any possible adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Phenylephrine Aguettant

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 the syringe label.
The expiry date refers to the last day of the stated month. The doctor or nurse will check the expiry date.
No special temperature requirements for storage.
Store the blister pack in the outer packaging to protect it from light.
Keep the syringe in its unopened blister until ready to use.
Do not use this medicine if visible signs of deterioration are observed.
Each syringe, even if partially used, must be properly disposed of after single use.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Phenylephrine Aguettant contains
The active substance is phenylephrine hydrochloride.

• Each ml of injection 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 ingredients are sodium chloride, disodium citrate dihydrate, citric acid monohydrate, sodium hydroxide, and water for injections.

What Phenylephrine Aguettant looks like and contents of the pack
Phenylephrine Aguettant is a clear, colourless solution in a 10 ml polypropylene pre-filled syringe, individually packed 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
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France
Laboratoire Aguettant
Lieu-Dit Chantecaille
07340 Champagne
France

For further information about this medicinal product, contact the local representative:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. +48 22 364 61 01

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

The following information is intended exclusively for healthcare professionals:

The syringe should be prepared carefully as follows:
The pre-filled syringe is intended for single patient use only. The syringe must be discarded after use. It must not be reused.
The contents of the unopened and undamaged blister are sterile and must not be opened before use. Prior to administration, visually inspect the solution for particles and discoloration. Only use a clear, colourless solution free from particles or precipitates.
Do not use the product if the tamper-evident seal on the syringe tip cap is broken or missing.
The outer surface of the syringe is sterile until the blister is opened.
When using aseptic technique, Phenylephrine Aguettant 50 micrograms/ml injection solution may be placed on a sterile field.

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

2. Press the plunger to release the rubber plunger. The sterilisation process may have caused the rubber plunger to adhere to the syringe barrel.

3. Unscrew the tip cap to break the tamper-evident seal. Do not touch the exposed Luer connection to avoid contamination.

4. Check whether the syringe tip protection has been completely removed. If not, reattach the cap and twist again.

5. Gently expel air by pressing the plunger.
6. Attach the syringe to the intravenous access. Slowly depress the plunger to inject the required volume.
7. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.