Phenylephrine Aguettant 50 micrograms/ml solution for injection in pre-filled syringe
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Fenilefrina Injectable is and what it is used for
- 2. What you need to know before you are given Injectable Phenylephrine
- 3. How Fenylephrine Injectable is Administered
- 4. Possible adverse effects
- 5. Storage of Injectable Phenylephrine
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Phenylephrine Aguettant 50 micrograms/ml injectable solution in pre-filled syringe
(Hereinafter referred to as "Injectable Phenylephrine")
Phenylephrine
Read the entire leaflet carefully before you are administered this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult 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
- What Injectable Phenylephrine is and what it is used for
- What you need to know before being administered Injectable Phenylephrine
- How Injectable Phenylephrine is administered
- Possible adverse effects
- How to store Injectable Phenylephrine
- Contents of the pack and other information
1. What Fenilefrina Injectable 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 anaesthesia.
2. What you need to know before you are given Injectable Phenylephrine
You must not be given Injectable Phenylephrine:
- 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), used to treat depression (such as iproniazide, nialamide);
- If you have an extremely overactive thyroid gland (hyperthyroidism).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you start using Injectable Phenylephrine:
- 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 atherosclerosis (hardening and thickening of the blood vessel walls);
- If you have poor blood circulation in the brain;
- If you have heart disease, including chronic heart conditions, 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 efficacy, safety, and dosage recommendations.
Use of Injectable Phenylephrine with other medicines
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, such as:
- Some antidepressants (iproniazide, nialamide, moclobemide, toloxatone, imipramine, milnacipran, or venlafaxine);
- Medicines used to treat infections (linezolid);
- Some medicines used to treat migraines (dihydroergotamine, ergotamine, methylergonovine, methysergide);
- Some medicines used to treat Parkinson’s disease (bromocriptine, lisuride, pergolide);
- A medicine used to inhibit the production of a hormone responsible for lactation (cabergoline);
- Inhalational 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 Injectable Phenylephrine may be considered during pregnancy 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 use of machinery
Talk to your doctor if you intend to drive or operate machinery after using this medicine.
Injectable Phenylephrine contains sodium
This medicine contains 37.2 mg of sodium (main component of table/cooking salt) per syringe. This corresponds to 1.9% of the maximum daily recommended sodium intake for an adult.
3. How Fenylephrine Injectable 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 required 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 dosage recommendations.
If you have been administered more injectable phenylephrine than you should have:
You may experience the following symptoms: palpitations, cardiac rhythm disorders (tachycardia, cardiac arrhythmias).
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;
- brain 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;
- skin burning;
- skin itching;
- skin itching or tingling sensation (paresthesia);
- slow or fast heartbeat;
- high blood pressure;
- breathing difficulty;
- fluid in the lungs;
- nausea;
- vomiting;
- sweating;
- skin pallor (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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Injectable Phenylephrine
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 refers to the last day of the month indicated.
This medicine does not require any special storage temperature.
Keep the blister in the outer packaging to protect it from light. Keep the syringe in its sealed blister.
Do not use this medicine if you notice any visible signs of deterioration.
Any syringe, even if only partially used, must be discarded after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Phenylephrine Injectable
The active substance is phenylephrine hydrochloride.
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Each ml of the injectable solution contains phenylephrine hydrochloride equivalent to 50 micrograms of phenylephrine.
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Each 10 ml pre-filled syringe contains phenylephrine hydrochloride equivalent to 500 micrograms of phenylephrine.
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The other components are sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide and water for injections.
Appearance of the product and contents of the container
Phenylephrine Injectable 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 cartons containing 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 the most recent review of this leaflet: September 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
Prepare the syringe carefully as indicated below
The pre-filled syringe is for single-patient use. Discard the syringe after use. Do not reuse.
The contents of an unopened and undamaged blister are sterile and should not be opened until immediately before use.
The product should be visually inspected before administration to check for the presence of particles or discoloration. The solution should only be used if it is clear, colourless and free from particles or precipitates.
The product must not be used if the syringe's security seal is broken.
The outer surface of the syringe is sterile until the blister is opened.
When handled using an aseptic technique, Phenylephrine Aguettant 50 micrograms/ml solution for injection in pre-filled syringe may be placed on a sterile field.
- Remove the pre-filled syringe from the sterile blister.
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- Connect the syringe to the intravenous access. Push the plunger slowly to inject the required volume.
- Disposal of unused medicine or waste materials must be carried out in accordance with local requirements.