Prospect: information for the patient

Fenilefrina Altan 0.1 mg/ml injectable solution and for perfusion

Fenilefrina

Read this prospect carefully before starting to use this 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 it isFenilefrina Altan 0.1 mg/mland for what it is used

2. What you need to know before starting to useFenilefrina Altan 0.1 mg/ml

3. How to useFenilefrina Altan 0.1 mg/ml

4. Possible adverse effects

5. Conservation ofFenilefrina Altan 0.1 mg/ml

6. Contents of the package and additional information.

This medicationbelongs to a group called adrenergic or dopaminergic agents.

Fenilefrina Altan 0.1 mg/mlis used to treat low blood pressure (hypotension) that may occur during different types of anesthesia.

Do not administer Fenilefrina Altan 0.1 mg/ml

- If you are allergic (hypersensitive) to phenylephrine or any of the other components of this medication (listed in section 6).

- If you are being treated with a medication known as a monoamine oxidase inhibitor or have stopped treatment with this type of medication in the last 14 days.

- If you have high blood pressure.

- If you have peripheral vascular disease (poor blood circulation).

- If you have excessive activity of the thyroid gland.

Warnings and precautions

Caution is required when administering Fenilefrina Altan 0.08 mg/ml in patients with:

- Pre-existing cardiovascular disease

- Diabetes mellitus

- Hypertension

- Coronary heart disease

- Arrhythmia

- Bradycardia

- Incomplete heart block

- Tachycardia

- Peripheral vascular occlusive disease, including arteriosclerosis

- Aneurysm

- In patients with angina pectoris, phenylephrine may precipitate or exacerbate angina.

- Closed-angle glaucoma.

Phenylephrine may induce a reduction in cardiac output. Therefore, caution is required when administering to patients with atherosclerosis, the elderly, and patients with compromised cerebral or coronary circulation.

In patients with severe heart failure or cardiogenic shock, phenylephrine may worsen heart failure as a result of induced vasoconstriction and increased afterload.

Special attention should be paid to the injection of phenylephrine to prevent extravasation, as this may cause tissue necrosis.

Use of Fenilefrina Altan 0.1 mg/ml with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

Fenilefrina Altan 0.1 mg/ml may interact with the following medications:

Contraindicated combinations (see section 4.3)

Non-selective monoamine oxidase inhibitors (MAO) (phenelzine, tranylcypromine)

Hypertensive crisis, possibly fatal hyperthermia. Due to the long duration of MAO inhibition, this interaction is still possible 15 days after stopping the MAO inhibitor.

Non-recommended combinations

Dopaminergic alkaloids (bromocriptine, cabergoline, lisuride, pergolide):

Risk of vasoconstriction and/or hypertensive crisis.

Vasoconstrictive alkaloids (dihydroergotamine, ergotamine, methylergometrine, methysergide):

Risk of vasoconstriction and/or hypertensive crisis.

Tricyclic antidepressants (e.g., imipramine):

Hypertensive crisis with a possibility of arrhythmia (inhibition of adrenaline or noradrenaline entry into sympathetic fibers).

SNRI antidepressants (milnacipran, venlafaxine):

Hypertensive crisis with a possibility of arrhythmia (inhibition of adrenaline or noradrenaline entry into sympathetic fibers).

MAO-A selective inhibitors (moclobemide, toloxatone)

Risk of vasoconstriction and/or hypertensive episodes.

Linezolid:

Risk of vasoconstriction and/or hypertensive crisis.

Guanethidine and related products:

Substantial increase in blood pressure (related to reduced sympathetic tone and/or inhibition of adrenaline or noradrenaline entry into sympathetic fibers). If the combination cannot be avoided, use lower doses of sympathomimetic agents with caution.

Cardiac glycosides, quinidine:

Increased risk of arrhythmias.

Sibutramine

Hypertensive crisis with a possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry into sympathetic fibers).

Halogenated volatile anesthetics (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane):

Risk of hypertensive crises and perioperative arrhythmias.

Combinations requiring caution:

Antihypertensives, including alpha and beta blockers.

Phenylephrine may elevate blood pressure and, therefore, reverse the action of many antihypertensive agents. The interaction between phenylephrine and alpha and beta blockers may be complex. Medications acting on alpha-1 adrenoreceptors may potentiate the action of phenylephrine (e.g., granisetron) or reduce it (e.g., doxazosin or buspirone).

Oxytocic agents:

The effect of presynaptic amines is potentiated. Therefore, some oxytocic agents may cause persistent severe hypertension and may occur cerebrovascular accidents during the postpartum period.

Children

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

Pregnancy, lactation, and fertility

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

Pregnancy

When administered in the later stages of pregnancy or during delivery, Fenilefrina Altan 0.1 mg/ml may harm the fetus. Phenylephrine injectable may be used during pregnancy according to indications.

Lactation

The amount of phenylephrine that passes into breast milk appears to be small.

Driving and operating machinery

There is no information on how Fenilefrina Altan 0.1 mg/ml affects your ability to drive and operate machinery.

Fenilefrina Altan 0.1 mg/ml contains sodium

This medication contains 366.2 mg of sodium (main component of table salt/for cooking) in each 100 ml. This is equivalent to 18.3% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Fenilefrina Altan 0.1 mg/ml must always be administered by a healthcare professional and never by the patient (see section 6).

The recommended dose is:

1. Intravenous bolus injection:

The normal dose is 50 to 100 micrograms, which can be repeated until the desired effect is obtained. A bolus dose should not exceed 100 micrograms.

2. Continuous perfusion:

The initial dose is 25 to 50 micrograms/min. Doses can be increased or decreased to maintain systolic blood pressure near the normal value. Doses between 25 and 100 micrograms/min have been found to be effective.

Pediatric population

The safety and efficacy of fenilefrina have not been established in children under 18 years. No data are available.

Renal insufficiency

It may be necessary to use lower doses of fenilefrina in patients with renal insufficiency.

Liver insufficiency

It may be necessary to use higher doses of fenilefrina in patients with liver cirrhosis.

Advanced age

Treatment in elderly individuals should be carried out with caution.

If you use more Fenilefrina Altan 0.1 mg/ml than you should

The symptoms of overdose include headache, nausea, vomiting, paranoid psychosis, hallucinations, increased blood pressure, reflex bradycardia, and irregular heart rhythm. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Treatment should consist of symptomatic and supportive measures. Hypertensive effects (elevated blood pressure) can be treated with medications known as α-adrenergic blockers, such as fentolamine, 5-60 mg intravenously over 10-30 minutes, repeated as necessary.

If you forgot to useFenilefrina Altan 0.1 mg/ml

Do not use a double dose to compensate for a missed dose. If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Fenilefrina Altan 0.1 mg/ml contains sodium

This medication contains 366.2 mg of sodium (main component of table salt/for cooking) in each 100 ml. This is equivalent to 18.3% of the maximum daily sodium intake recommended for an adult.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects can be classified by frequency in the following way: Very common: (may affect more than 1 in 10 people),Common (may affect up to 1 in 10 people),Uncommon (may affectup to 1 in 100 people),Rare (may affect up to1 in 1,000 people),Very rare (may affect up to1 in 10,000 people) andUnknown (the frequency cannot be estimated with the available data)

The most common side effects of phenylephrine are bradycardia, hypertensive episodes, nausea, and vomiting. Hypertension is more common with high doses.

The most commonly reported cardiovascular side effect appears to be bradycardia, probably due to vagal stimulation mediated by baroreceptors and consistent with the pharmacological effect of phenylephrine.

The following adverse reactions have been reported during the use of phenylephrine, although their frequency has not been clearly established:

Immune system disorders:

hypersensitivity

Mental and behavioral disorders:

anxiety, excitability, agitation, psychotic states, confusion.

Nervous system disorders:

headache, cerebral hemorrhage, vertigo, syncope, lethargy (mental or physical inactivity), insomnia, paresthesia (abnormal skin sensation), tremor (involuntary shaking of the body or limbs).

Eye disorders:

mydriasis, worsening of pre-existing angle-closure glaucoma.

Cardiac disorders:

reflex bradycardia (slow heart rate), reflex tachycardia (rapid heart rate), cardiac arrhythmia (irregular heart rate), angina pectoris, palpitations, cardiac arrest.

Vascular disorders

hypertension (high blood pressure), hypotension (low blood pressure), flushing, hypertensive crisis.

Respiratory, thoracic, and mediastinal disorders:

shortness of breath (respiratory difficulties), pulmonary edema(lung inflammation).

Gastrointestinal disorders:

nausea, vomiting, hypersalivation.

Skin and subcutaneous tissue disorders:

sweating, temporary tingling, skin cooling, pallor or pallor of the skin, piloerection

Renal and urinary disorders:

difficulty urinating, urinary retention.

Metabolism and nutrition disorders:

alterations in glucose metabolism.

General disorders and administration site conditions:

the extravasation of phenylephrine may cause tissue necrosis (tissue death).

If you experience any side effect, talk to your doctor or pharmacist. This includes possible side effects that do not appear in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special temperature for conservation for polypropylene bags.

Do not store at a temperature above 30°C for polyolefin bags without PVC.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not freeze

Your doctor will store this medication for you.

From a microbiological point of view, the product must be used immediately after the first opening.

Phenylephrine Altan 0.1 mg/ml should not be used if there are visible particles in it.

Medications should not be thrown away through drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

Composition of Fenilefrina Altan 0.1 mg/ml

- The active ingredient is phenylephrine hydrochloride. Each bag contains 10 mg of phenylephrine hydrochloride equivalent to 8 mg of phenylephrine base.

- The other components are sodium chloride, sodium citrate, citric acid, and water for injection.

Appearance of the product and contents of the package

Fenilefrina Altan 0.1 mg/ml is a transparent and colorless solution. Each bag ofpolypropyleneorpolyolefin PVC-freecontains 100 ml of solution.

Package sizes

Polypropylene bag: 10 x 100 ml

Polyolefin PVC-free bag: 10 x 100 ml

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Altan Pharmaceuticals S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F.

Edificio Prisma, Las Rozas, 28230 Madrid – Spain

Responsible manufacturer

Altan Pharmaceuticals, S.A.

Industrial Park of Bernedo, s/n,

01118 Bernedo, Álava.- Spain

Last review date of this leaflet:January 2021

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

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This information is intended solely for healthcare professionals:

Fenilefrina Altan 0.1 mg/ml injectable and infusion solution

Dosage and administration:

Parenteral administration or intravenous infusion. Fenilefrina Altan 0.1 mg/ml injectable and infusion solution should only be administered by healthcare professionals with adequate training and experience.

1. Intravenous bolus injection:

The usual dose is 50 to 100 micrograms, which may be repeated until the desired effect is achieved. A bolus dose should not exceed 100 micrograms.

2. Continuous infusion:

The initial dose is 25 to 50 micrograms/min. Doses may be increased or decreased to maintain systolic blood pressure near normal values. Doses between 25 and 100 micrograms/min have been evaluated as effective.

Older patients:

Treatment of older patients should be carried out with caution.