Prospect: information for the patient

FenilefrinaAguettant100 micrograms/ml sinjection solution and for perfusion

(From now on“FenilefrinaAguettant”)

fenilefrina

Read this prospect carefully beforethey administerthis medication, because it contains important information for you.

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

1. What isFenilefrina Aguettantand for what it is used

2. What you need to know beforethey administerFenilefrina Aguettant

3. How to administerFenilefrina Aguettant

4. Possible adverse effects

5. Conservation ofFenilefrina Aguettant

6. Contents of the package and additional information

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

It is used to treat low blood pressure during anesthesia

Do not administer Fenilefrina Aguettant:

• If you are allergic to hydrochloride of phenylephrine or to any of the other components of this medication (listed in section 6);
• If you suffer from extremely high blood pressure or peripheral vascular disease (poor circulation);
• If you are taking a monoamine oxidase inhibitor (MAOI) (or in the 2 weeks following its withdrawal), used to treat depression (such as iproniazid, nialamide);
• If you have an extremely overactive thyroid gland (hyperthyroidism).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Fenilefrina Aguettant:

• If you are elderly;
• If you are diabetic;
• If you suffer from 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 walls of blood vessels);
• If you suffer from poor blood circulation in the brain;
• If you suffer from an aneurysm;
• If you suffer from heart disease, including chronic heart disease, peripheral vascular insufficiency, cardiac arrhythmias, tachycardia (elevated heart rate), bradycardia (low heart rate), partial heart block, angina pectoris;
• If you suffer from a closed-angle glaucoma (a rare eye disease).

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

This medication is not recommended for use in children due to insufficient data on its efficacy, safety, and dosage recommendations.

Use of Fenilefrina Aguettant with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication, such as:

• Some antidepressants (iproniazid, nialamide, moclobemide, toloxatone, imipramine, milnacipran, or venlafaxine);
• Medications used to treat infections (linezolid);
• Some medications used to treat migraines (dihydroergotamine, ergotamine, methylergometrine, methisergide);
• Some medications used to treat Parkinson's disease (bromocriptine, lisuride, pergolide);
• Medication used to inhibit the production of a hormone responsible for lactation (cabergoline);
• Inhaled anesthesia (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane);
• Medications used as appetite suppressants (sibutramine);
• Medications used to treat high blood pressure (guanetidine);
• Medications used to treat heart failure and some arrhythmias (cardiac glycosides);
• Medications used to treat abnormal heart rhythms (quinidine);
• Medications used during childbirth (oxytocin).

Pregnancy and lactation

The safety of this medication during pregnancy and lactation has not been established, but the use of Fenilefrina Aguettant may be possible during pregnancy if necessary.

This medication is not recommended for use during lactation. However, lactation is possible if administered only once during childbirth.

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

Driving and operating machinery

Discuss with your doctor if you wish to drive or operate machinery after using this medication.

Fenilefrina Aguettant contains sodium

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

The administration will be carried out by a healthcare professional with the necessary training and experience, who will decide on the correct dose for you and when and how the injection should be administered.

The 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 do not function well)

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

Use in patients with hepatic insufficiency(liver does not function well)

Patients with liver cirrhosis may require higher doses of fenilefrina.

Use in elderly patients

Treatment in elderly patients should be carried out with caution.

Use in children

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

If you have been administered more Fenilefrina Aguettant than you should have:

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

For more information about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Some adverse effects may be severe (unknown frequency). Inform your doctor immediately if you experience any of the following symptoms:

• Chest pain or angina pain;
• Irregular heart rhythm;
• Feeling like your heart is pounding out of your chest;
• Cerebral hemorrhage (speech disorder, dizziness, paralysis of one side of the body);
• Psychosis (loss of contact with reality);

Other adverse effects may include (unknown frequency):

• 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);
• Restlessness;
• Anxiety;
• Confusion;
• Headache;
• Nervousness;
• Insomnia (difficulty falling asleep or staying asleep);
• Tremors;
• Itching or sensation of pins and needles (paresthesia);
• Slow or rapid heart rhythm;
• High blood pressure;
• Difficulty breathing;
• Pulmonary edema;
• Nausea;
• Vomiting;
• Sweating;
• Pallor (pale skin);
• Goosebumps;
• Tissue damage at the injection site;
• Muscle weakness;
• Difficulty urinating or urinary retention.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated. Your doctor or nurse will verify this.

This medication does not require any special temperature for conservation.

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

Do not use this medication if you observe visible signs of its deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Phenylephrine Aguettant

• The active principle is hydrochloride of phenylephrine.

• Each milliliter of the injectable solution contains hydrochloride of phenylephrine, equivalent to 100 micrograms (0.1 mg) of phenylephrine.
• Each vial of 20 ml contains hydrochloride of phenylephrine, equivalent to 2000 (2 mg) micrograms of phenylephrine.

• The other components are sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the packaging

This medicine is a transparent and colorless injectable solution, in a transparent type II glass vial of 20 ml, closed with a rubber stopper and an aluminum cap.

The vials are available in boxes of 1 and 10 vials.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

LABORATOIRE AGUETTANT

1 rue Alexander Fleming

69007 Lyon

France

Local representative:

Aguettant Ibérica S.L.

Parc Científic de Barcelona

Baldiri Reixac, 4-8 (Tower I)

08028 Barcelona

Last review date of this leaflet: December 2019

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