Phenylephrine hydrochloride Altan 10 mg/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Phenylephrine Hydrochloride Altan 10 mg/ml Injection Solution

Read the entire leaflet carefully before you start using this medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may be harmful to them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents

1. What Phenylephrine Hydrochloride Altan is and what it is used for
2. What you need to know before using Phenylephrine Hydrochloride Altan
3. How to use Phenylephrine Hydrochloride Altan
4. Possible side effects
5. How to store Phenylephrine Hydrochloride Altan
6. Contents of the pack and other information

1. What Hidrocloruro de Fenilefrina Altan 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 (hypotension) that may occur during different types of anesthesia.

2. What you need to know before starting to use Phenylephrine Hydrochloride Altan

Do not use Phenylephrine Hydrochloride Altan

• If you are allergic (hypersensitive) to phenylephrine or to any of the other components of this medicine (listed in section 6.1).
• If you are being treated with any medicines known as monoamine oxidase inhibitors, or if less than 14 days have passed since you stopped taking such medicines.
• If you have high blood pressure.
• If you have excessive activity of the gland called the thyroid.

Warnings and precautions

Caution is required when administering Phenylephrine Hydrochloride Altan to patients with:

• pre-existing cardiovascular disease
• diabetes mellitus
• arterial hypertension
• ischemic heart disease
• arrhythmia
• bradycardia
• incomplete heart block
• tachycardia
• occlusive peripheral vascular 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 it to patients with atherosclerosis, elderly patients, and patients with compromised cerebral or coronary circulation.

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

Particular care should be taken during phenylephrine injection to prevent extravasation, as this may cause tissue necrosis.

Other Medicines and Phenylephrine Hydrochloride Altan

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Phenylephrine Hydrochloride Altan may interact with the following medicines:

• Contraindicated combinations (see section 4.3)

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

Paroxysmal hypertension, possibly leading to fatal hyperthermia. Due to the long duration of MAO inhibition, this interaction may still occur up to 15 days after discontinuation of the MAO inhibitor.

• Combinations not recommended

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

Risk of vasoconstriction and/or hypertensive crisis.

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

Risk of vasoconstriction and/or hypertensive crisis.

Tricyclic antidepressants (e.g., imipramine):

Paroxysmal hypertension with possible arrhythmia (due to inhibition of adrenaline or noradrenaline uptake into sympathetic nerve fibers).

Noradrenergic-serotonergic antidepressants (milnacipran, venlafaxine):

Paroxysmal hypertension with possible arrhythmia (due to inhibition of adrenaline or noradrenaline uptake into sympathetic nerve fibers).

Selective monoamine oxidase (MAO) type A inhibitors (moclobemide, toloxatone):

Risk of vasoconstriction and/or episodes of hypertension.

Linezolid:

Risk of vasoconstriction and/or hypertensive crisis.

Guanethidine and related products:

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

Cardiac glycosides, quinidine:

Increased risk of arrhythmias.

Sibutramine:

Paroxysmal hypertension with possible arrhythmias (due to inhibition of adrenaline or noradrenaline uptake into sympathetic nerve fibers).

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

Risk of hypertensive crises and perioperative arrhythmias.

• Combinations requiring precautions during use:

Antihypertensive agents, including α- and β-receptor blockers.

Phenylephrine may increase blood pressure and thereby counteract the effect of many antihypertensive agents. The interaction between phenylephrine and α- and β-receptor blockers may be complex. Medications acting on alpha-1 adrenergic receptors may either potentiate the effect of phenylephrine (e.g., granisetron) or reduce it (e.g., doxazosin or buspirone).

Oxytocic agents:

The effect of presynaptic sympathomimetic amines may be enhanced. Therefore, some oxytocic agents may cause severe persistent hypertension, and cerebrovascular accidents may occur in the postpartum period.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

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

Pregnancy

Phenylephrine hydrochloride Altan administered during late stages of pregnancy or during childbirth may cause harm to the fetus.

Breastfeeding

Small amounts of phenylephrine hydrochloride are excreted in breast milk.

Driving and operating machinery

There are no data available on how Phenylephrine Hydrochloride Altan affects the ability to drive or operate machinery.

3. How to use Phenylephrine Hydrochloride Altan

Follow exactly the administration instructions for Phenylephrine Hydrochloride Altan provided by your doctor. Consult your doctor or pharmacist if you have any questions.

Phenylephrine Hydrochloride Altan must always be administered by a healthcare professional and never by yourself (see section 6).

The normal dose is:

Adults:

• Subcutaneous or intramuscular injection: 2 to 5 mg, with additional doses of 1 to 10 mg if necessary, depending on the response.

• Slow intravenous injection: 100 to 500 micrograms as a 0.1% solution, repeated if necessary after a minimum of 15 minutes has elapsed.

• Intravenous infusion: Dilute one 10 mg vial in 500 ml of 5% glucose solution for injection or 0.9% sodium chloride solution and administer by intravenous infusion, initially at a maximum rate of 180 micrograms per minute, reducing to 30–60 micrograms per minute according to response.

Children:

100 micrograms per kilogram of body weight administered subcutaneously or intramuscularly.

Elderly:

Dose adjustment is not required in the elderly.

If you use more Phenylephrine Hydrochloride Altan than you should

Symptoms of overdose include headache, vomiting, elevated blood pressure, and reflex bradycardia.

Treatment should consist of symptomatic and supportive measures. Hypertensive effects (high blood pressure) may be treated with medications known as α-adrenergic receptor blockers, such as phentolamine, 5–60 mg administered intravenously over 10–30 minutes, repeated if necessary.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Phenylephrine Hydrochloride Altan

Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Phenylephrine Hydrochloride Altan may cause adverse effects, although not everyone experiences them.

The frequency of occurrence of adverse effects is defined according to the following classification:

Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (cannot be estimated from the available data)

The most frequently reported adverse effects of phenylephrine are bradycardia, hypertensive episodes, nausea and vomiting, with hypertension being more common at higher doses.

The most frequently reported cardiovascular adverse effect appears to be bradycardia, likely due to vagal stimulation mediated by baroreceptors, consistent with the pharmacological action of phenylephrine.

The following adverse effects have been reported during the use of phenylephrine, with a frequency classified as not known:

Cardiac disorders:
Not known: reflex bradycardia (slow heart rate), reflex tachycardia (fast heart rate), cardiac arrhythmia (irregular heart rhythm), anginal pain, palpitations, cardiac arrest.

Vascular disorders:
Not known: hypotension (low blood pressure), flushing (reddening of the skin).

Nervous system disorders:
Not known: headache, dizziness, fainting, lethargy (mental or physical inactivity), insomnia, paresthesia (abnormal skin sensation), tremor (involuntary shaking of the body or limbs).

Respiratory, thoracic and mediastinal disorders:
Not known: dyspnea (difficulty breathing), pulmonary edema (lung inflammation).

Gastrointestinal disorders:
Not known: nausea, vomiting, hypersalivation.

Renal and urinary disorders:
Not known: difficulty urinating, urinary retention.

Skin and subcutaneous tissue disorders:
Not known: sweating, temporary tingling, skin cooling, pallor or paleness of the skin, piloerection, skin necrosis with extravasation.

Metabolism and nutrition disorders:
Not known: disturbances in glucose metabolism.

General disorders and administration site conditions:
Not known: extravasation of phenylephrine may cause tissue necrosis (tissue death).

Immune system disorders:
Not known: hypersensitivity.

Psychiatric disorders:
Not known: anxiety, excitability, agitation, psychotic states, confusion.

Eye disorders:
Not known: mydriasis, worsening of pre-existing closed-angle glaucoma.

Musculoskeletal and connective tissue disorders:
Not known: muscle weakness.

Other special populations

Elderly: the risk of phenylephrine toxicity increases in elderly patients.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Phenylephrine Hydrochloride Altan

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Phenylephrine Hydrochloride Altan after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Phenylephrine Hydrochloride Altan

The active substance is phenylephrine (hydrochloride). Each ampoule contains 10 mg of phenylephrine (hydrochloride).

The other components are: hydrochloric acid, sodium hydroxide, and water for injections.

Appearance of the product and contents of the container

Phenylephrine Hydrochloride Altan is presented as a colourless, clear injectable solution.

Each pack contains 10 ampoules of 1 ml.

Marketing Authorization Holder and 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

Manufacturer

Avda. de la Constitución, 198-199,
Polígono Industrial Monte Boyal,
Casarrubios del Monte, 45950 Toledo
Spain

Altan Pharmaceuticals, S.A.
Polígono Industrial de Bernedo s/n
01118 (Álava)
Spain

Date of the most recent revision of this summary: 10/2025

This information is intended only for physicians or healthcare professionals:

Dosage and method of administration:

Administer by subcutaneous, intramuscular, slow intravenous injection, or intravenous infusion.

Adults:

Phenylephrine Hydrochloride Altan may be administered subcutaneously or intramuscularly at doses of 2 to 5 mg, with additional doses of 1 to 10 mg if necessary, depending on response; or 100 to 500 μg by slow intravenous injection as a 0.1% solution, repeatable if necessary after a minimum interval of 15 minutes.

Alternatively, dilute one 10 mg ampoule in 500 ml of 5% glucose injection solution or 0.9% sodium chloride injection solution and administer by intravenous infusion, initially at a maximum rate of 180 μg per minute, then reducing according to response to 30–60 μg per minute.

Children:

100 μg/kg by subcutaneous or intramuscular route.

Elderly:

Dose reduction is not required in the elderly.