Prospect: information for the patient

Fenilefrina Aguettant 50 micrograms/ml sinjectable solution in preloaded syringe

(From now on“Fenilefrina injectable”)

Fenilefrina

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

• Keep this prospect, as you may need to read it again.
  If you have any questions, 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 injectableand for what it is used

2. What you need to know beforethey administerFenilefrina injectable

3. How to administerFenilefrina injectable

4. Possible adverse effects

5. Conservation ofFenilefrina injectable

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 injectable Fenilefrina:

• If you are allergic to hydrochloride of phenylephrine or to any of the other components of this medication (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 its withdrawal), used to treat depression (such as iproniazid, nialamida);
• If you have extremely overactive thyroid gland (hyperthyroidism).

Warnings and precautions

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

• If you are elderly;
• If you are diabetic;
• If you have high blood pressure;
• If you have an overactive thyroid gland (uncontrolled hyperthyroidism);
• If you have vascular disease, such as arteriosclerosis (hardening and thickening of blood vessel walls);
• If you have poor blood circulation in the brain;
• If you have 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 have a closed-angle glaucoma (a rare eye disease).

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

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

Use of injectable Fenilefrina 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, nialamida, moclobenida, toloxatona, imipramina, milnacipran or venlafaxina);
• Medications used to treat infections (linezolid);
• Some medications used to treat migraines (dihidroergotamina, ergotamina, metilergometrina, metisergida);
• Some medications used to treat Parkinson's disease (bromocriptina, lisurida, pergolida);
• Medication used to inhibit the production of a hormone responsible for lactation (cabergolina);
• Inhaled anesthesia(desflurano, enflurano, halotano, isoflurano, metoxiflurano, sevoflurano);
• Medications used as appetite suppressants (sibutramina);
• Medications used to treat high blood pressure (guanetidina);
• Medications used to treat heart failure and some arrhythmias (cardiac glycosides);
• Medications used to treat abnormal heart rhythms (quinidina);
• Medications used during delivery (oxitocina).

Pregnancy and breastfeeding

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

The use of this medication during breastfeeding is not recommended. However, breastfeeding is possible if administered only once during delivery.

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

Talk to your doctor if you want to drive or operate machinery after using this medication.

Fenilefrina injectable contains sodium

This medication contains 37.2 mg of sodium (main component of table salt/for cooking) in each syringe. This is equivalent to 1.9% of the maximum daily sodium intake recommended for an adult.

The administration will be performed by a qualified healthcare professional 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 Injectable than you should have:

You may experience the following symptoms: palpitations, cardiac rhythm disturbances (tachycardia, cardiac arrhythmias).

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 everyone 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);
• Hyperexcitability (excessive sensitivity of an organ or part of the body);
• Restlessness;
• Anxiety;
• Confusion;
• Headache;
• Nervousness;
• Insomnia (difficulty falling asleep or staying asleep);
• Tremors;
• Burning sensation of the skin;
• Itching of the skin;
• Itching or sensation of tingling of the skin (paresthesia);
• Slow or rapid heart rhythm;
• High blood pressure;
• Difficulty breathing;
• Fluids in the lungs;
• Nausea;
• Vomiting;
• Sweating;
• Pale skin (pale skin color);
• 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 that does not appear 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 about 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 packaging and on the syringe label after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation.

Conserve the blister in the outer packaging to protect it from light. Keep the syringe in the perfectly closed blister.

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

Any syringe, even if only partially used, must be discarded after use.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you do not need. In this way, you will help protect the environment.

Composition of Injectable Phenylephrine

The active ingredient is phenylephrine hydrochloride.

• Each milliliter of the injectable solution contains phenylephrine hydrochloride, equivalent to 50 micrograms of phenylephrine.
• Each pre-filled syringe of 10 milliliters contains phenylephrine hydrochloride, equivalent to 500 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 package

Phenylephrine injectable is a transparent, colorless solution, in a pre-filled syringe of polypropylene of 10 milliliters, individually packaged in a transparent blister.

Pre-filled syringes are available in boxes of 1 and 10 syringes.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Laboratoire AGUETTANT

1 rue Alexander Fleming, Parc Scientifique Tony Garnier

69007 Lyon- France

Laboratoire AGUETTANT

Lieu-Dit « Chantecaille »

07340 Champagne

France

Local Representative:

AGUETTANT IBERICA

C/Pau claris, 139, Pral. 2

08009, Barcelona-Spain

Date of the last review of this leaflet:September 2020

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

This information is intended solely for healthcare professionals:

Prepare the syringe carefully as indicated below

The pre-filled syringe is for a single patient. Dispose of the syringe after use.Do not reuse.

The contents of an unopened and undamaged blister are sterile and should not be opened until the time of use.

Inspect the product visually to check that there are no particles or color change before administration. Only use the solution when it is transparent, colorless, and free of particles or precipitates.

The product should not be used if the safety seal of the syringe is broken.

The exterior surface of the syringe is sterile until the blister is opened.

When used with an aseptic method,PhenylephrineAguettant50 micrograms/ml injectable solution in pre-filled syringecan be placed in a sterile field.

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

6) Connect the syringe to the intravenous access. Push the plunger slowly to inject the required volume.

7) The disposal of unused medication or waste materials should be carried out in accordance with local requirements..