Phenylephrine Aguettant 100 micrograms/ml solution for injection and infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

PhenylephrineAguettant 100 micrograms/ml solution for injection and infusion

(Hereinafter referred to as "PhenylephrineAguettant")

phenylephrine

Read the entire leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What PhenylephrineAguettant is and what it is used for
2. What you need to know before you are given PhenylephrineAguettant
3. How PhenylephrineAguettant is administered
4. Possible adverse effects
5. How to store PhenylephrineAguettant
6. Contents of the pack and other information

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

This medicine belongs to a group of adrenergic and dopaminergic agents.

It is used to treat low blood pressure during anesthesia.

2. What you need to know before Fenylephrine Aguettant is administered to you

Fenylephrine Aguettant must not be given:

• If you are allergic to phenylephrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• If you have extremely high blood pressure or peripheral vascular disease (poor circulation);
• If you are taking a monoamine oxidase inhibitor (MAOI) (or within 2 weeks of stopping it), which is used to treat depression (such as iproniazid, nialamide);
• If you have an overactive thyroid gland (hyperthyroidism).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Fenylephrine Aguettant:

• If you are elderly;
• If you have diabetes;
• If you have high blood pressure;
• If you have an overactive 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 blood circulation in the brain;
• If you have an aneurysm;
• If you have heart disease, including chronic heart disease, peripheral vascular insufficiency, heart rhythm disorders, tachycardia (fast heartbeat), bradycardia (slow heartbeat), partial heart block, angina pectoris;
• If you have closed-angle glaucoma (a rare eye condition).

In patients with severe heart failure, phenylephrine may worsen heart failure due to constriction of blood vessels.

Your blood pressure will be monitored during treatment. If you have heart disease, additional monitoring of your vital functions will be performed.

Children

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

Using Fenylephrine Aguettant with other medicines

Tell your doctor if you are using, have recently used, or might need to use any other medicines, such as:

• certain antidepressants (iproniazid, nialamide, moclobemide, toloxatone, imipramine, milnacipran, or venlafaxine);
• medicines used to treat infections (linezolid);
• certain medicines used to treat migraines (dihydroergotamine, ergotamine, methylergonovine, 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);
• medicines used as appetite suppressants (sibutramine);
• medicines used to treat high blood pressure (guanethidine);
• medicines used to treat heart failure and certain arrhythmias (cardiac glycosides);
• medicines used to treat abnormal heart rhythms (quinidine);
• medicines used during childbirth (oxytocin).

Pregnancy and breastfeeding

The safety of this medicine during pregnancy and breastfeeding has not been established, but the use of Fenylephrine Aguettant during pregnancy may be considered if necessary.

The use of this medicine during breastfeeding is not recommended. However, breastfeeding may be possible if a single dose is administered during childbirth.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Driving and using machines

Talk to your doctor if you wish to drive or operate machinery after using this medicine.

Fenylephrine Aguettant contains sodium

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

3. How Fenylephrine Aguettant is administered

Administration will be performed by a healthcare professional with appropriate training and experience, who will determine the correct dose for you and decide when and how the injection should be given.

Recommended doses are:

Use in adults

Your doctor will determine the dose to be administered and may repeat or adjust it until the desired effect is achieved.

Use in patients with renal insufficiency (kidneys not functioning properly)

Lower doses of phenylephrine may be necessary in patients with renal insufficiency.

Use in patients with hepatic insufficiency (liver not functioning properly)

Patients with liver cirrhosis may require higher doses of phenylephrine.

Use in elderly patients

Treatment in elderly individuals should be carried out with caution.

Use in children

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

If you have been given more Fenylephrine Aguettant than you should have:

You may experience the following symptoms: palpitations, cardiac rhythm disorders (tachycardia, cardiac arrhythmias), headache, nausea, vomiting, hallucinations, paranoid psychosis.

For further information about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious (frequency not known). Inform your doctor immediately if you experience any of the following symptoms:

• chest pain or pain due to angina;
• irregular heartbeat;
• sensation of the heart pounding or beating out of the chest;
• cerebral hemorrhage (speech disturbance, dizziness, paralysis on one side of the body);
• psychosis (loss of contact with reality);

Other adverse effects may include (frequency not known):

• hypersensitivity reaction (allergy);
• excessive dilation of the pupils;
• increased intraocular pressure (worsening of glaucoma);
• excitability (excessive sensitivity of an organ or part of the body);
• agitation (restlessness);
• anxiety;
• confusion;
• headache;
• nervousness;
• insomnia (difficulty falling asleep or staying asleep);
• tremors;
• itching or tingling sensation of the skin (paresthesia);
• slow or fast heartbeat;
• high blood pressure;
• breathing difficulty;
• fluid in the lungs;
• nausea;
• vomiting;
• sweating;
• paleness of the skin (pale skin color);
• goosebumps;
• tissue damage at the injection site;
• muscle weakness;
• difficulty urinating or urinary retention.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label after EXP. The expiry date is the last day of the month indicated. Your doctor or nurse will verify this.

This medicine does not require any special storage temperature.

Keep the vial in the outer packaging to protect it from light.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Phenylephrine Aguettant

• The active substance is phenylephrine hydrochloride.

• Each ml of the injectable solution 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 components are sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide, and water for injections.

Appearance of the medicinal product and contents of the container

This medicine is a clear, colourless injectable solution, contained in a 20 ml transparent type II glass vial, closed with a rubber stopper and an aluminium cap.

Vials are available in cartons containing 1 or 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

LABORATOIRE AGUETTANT
1 rue Alexander Fleming
69007 Lyon
France

Local representative:
Aguettant Ibérica S.L.
Parc Científic de Barcelona
Baldiri Reixac, 4-8 (Torre I)
08028 Barcelona
Spain

Date of the most recent revision of this leaflet: December 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/