FENILEFRINE AGUETTANT 50 micrograms/mL Injectable Solution in Pre-filled Syringe

2. What you need to know before you are given Fenilefrina injectable

Fenilefrina injectable will not be administered to you:

• If you are allergic to phenylephrine hydrochloride or any of the other ingredients of this medicine (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 overactive thyroid gland (hyperthyroidism).

Warnings and precautions

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

• 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 a blood vessel disease, such as arteriosclerosis (hardening and thickening of the walls of the blood vessels);
• If you have poor blood circulation in the brain;
• if you have heart disease, including chronic heart disease, peripheral vascular insufficiency, cardiac rhythm disorders, tachycardia (rapid heart rate), bradycardia (slow heart rate), partial heart block, angina pectoris;
• If you have a rare eye disease (angle-closure glaucoma).

In patients with severe heart failure, phenylephrine could 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 medicine is not recommended in children due to insufficient data on its efficacy, safety, and dosage recommendations.

Using Fenilefrina injectable with other medicines

Tell your doctor if you are using, have recently used, or might 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);
• inhalation anesthesia (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 Fenilefrina injectable is possible during pregnancy if necessary.

The use of this medicine is not recommended during breastfeeding. However, breastfeeding is possible if it is administered once during childbirth.

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

Driving and using machines

Talk to your doctor if you want to drive or use machines after using this medicine.

Fenilefrina injectable contains sodium

This medicine contains 37.2 mg of sodium (a major component of table/cooking salt) per syringe. This is equivalent to 1.9% of the maximum recommended daily sodium intake for an adult.

3. How Fenilefrina injectable is administered

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

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(poor kidney function)

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

Use in patients with hepatic insufficiency(poor liver function)

Patients with liver cirrhosis may require higher doses of phenylephrine.

Use in elderly patients

Treatment in elderly patients 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 dosage recommendations.

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

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

For more information about the use of this medicine, consult your 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). Tell your doctor immediately if you experience any of these symptoms:

• Chest pain or pain due to angina;
• Irregular heartbeat;
• Feeling of the heart beating out of the chest;
• Cerebral hemorrhage (speech disorder, dizziness, paralysis of one side of the body);
• Psychosis (loss of contact with reality);

Other side effects may include (frequency not known):

• Hypersensitivity reaction (allergy);
• Excessive pupil dilation;
• Increased eye pressure (worsening of glaucoma);
• Excitability (excessive sensitivity of an organ or body part);
• Agitation (restlessness);
• Anxiety;
• Confusion;
• Headache;
• Nervousness;
• Insomnia (difficulty falling asleep or staying asleep);
• Tremors;
• Skin burning sensation;
• Skin itching;
• Itching or tingling sensation of the skin (paresthesia);
• Slow or rapid heartbeat;
• High blood pressure;
• Breathing difficulties;
• Fluid in the lungs;
• Nausea;
• Vomiting;
• Sweating;
• Pale skin color (pale skin);
• Goosebumps;
• Tissue damage at the injection site;
• Muscle weakness;
• Difficulty urinating or urinary retention.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenilefrina injectable

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

Do not use this medicine after the expiry date stated on the packaging and on the label of the syringe after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fenilefrina injectable

The active substance is phenylephrine hydrochloride.

• Each ml of the solution for injection contains phenylephrine hydrochloride, equivalent to 50 micrograms of phenylephrine.
• Each pre-filled syringe of 10 ml contains phenylephrine hydrochloride, equivalent to 500 micrograms of phenylephrine.

• The other ingredients are sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide, and water for injections.

Appearance and packaging of the product

Fenilefrina injectable is a clear, colorless solution in a 10 ml pre-filled polypropylene syringe, packaged individually in a transparent blister pack.

The pre-filled syringes are available in packs of 1 and 10 syringes.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

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 last revision of this leaflet:September 2020

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

This information is intended only for healthcare professionals:

Prepare the syringe carefully as follows

The pre-filled syringe is for single patient use. Discard the syringe after use. Do not reuse it.

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

The product should be visually inspected to check for particles or color change before administration. The solution should only be used if it is clear, colorless, and free of particles or precipitates.

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

The outer surface of the syringe is sterile until the blister pack is opened.

When used with an aseptic method, Fenilefrina Aguettant 50 micrograms/ml solution for injection in pre-filled syringe can be placed in a sterile field.

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

1. Connect the syringe to the intravenous access. Slowly push the plunger to inject the necessary volume.
2. Disposal of unused medicine or waste materials should be carried out in accordance with local requirements.