Phenylephrine Altan 0.1 mg/ml solution for injection and for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Phenylephrine Altan 0.1 mg/ml solution for injection and infusion

Phenylephrine

Read the entire leaflet carefully before you start using 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, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Phenylephrine Altan 0.1 mg/ml is and what it is used for
2. What you need to know before using Phenylephrine Altan 0.1 mg/ml
3. How to use Phenylephrine Altan 0.1 mg/ml
4. Possible side effects
5. How to store Phenylephrine Altan 0.1 mg/ml
6. Contents of the pack and other information

1. What Fenilefrina Altan 0.1 mg/ml is and what it is used for

This medicine belongs to a group of medicines called adrenergic or dopaminergic agents.

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

2. What you need to know before using Phenylephrine Altan 0.1 mg/ml

Do not administer Phenylephrine Altan 0.1 mg/ml

• If you are allergic (hypersensitive) to phenylephrine or any of the other components of this medicine (listed in section 6).
• If you are being treated with a medicine known as a monoamine oxidase inhibitor (MAOI), or if you have discontinued treatment with this type of medicine within the last 14 days.
• If you have high blood pressure.
• If you have peripheral vascular disease (poor blood circulation).
• If you have overactivity of the thyroid gland.

Warnings and precautions

Caution is required when administering Phenylephrine Altan 0.08 mg/ml 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 atherosclerosis
• 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 heart failure as a result of induced vasoconstriction and increased afterload.

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

Use of Phenylephrine Altan 0.1 mg/ml with other medicines

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

Phenylephrine Altan 0.1 mg/ml may interact with the following medicines:

Contraindicated combinations (see section 4.3)

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

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

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 (inhibition of adrenaline or noradrenaline uptake into sympathetic nerve fibers).

Noradrenergic-serotonergic antidepressants (milnacipran, venlafaxine):

Paroxysmal hypertension with possible arrhythmia (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 agents:

Substantial increase in blood pressure (hyperreactivity related 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 (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:

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

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

Oxytocic agents:

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

Children

Use of this medicine is not recommended in children due to insufficient data on efficacy, safety, and dosage recommendations.

Pregnancy, breastfeeding, 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 medicine.

Pregnancy

When administered in the late stages of pregnancy or during labor, Phenylephrine Altan 0.1 mg/ml may harm the fetus. Injectable phenylephrine may be used during pregnancy according to clinical indications.

Breastfeeding

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

Driving and using machines

There is no information available on how Phenylephrine Altan 0.1 mg/ml affects your ability to drive or use machines.

Phenylephrine Altan 0.1 mg/ml contains sodium

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

3. How to use Phenylephrine Altan 0.1 mg/ml

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Phenylephrine 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 usual dose is 50 to 100 micrograms, which may be repeated until the desired effect is achieved. A single bolus dose must 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 close to the normal value. Doses between 25 and 100 micrograms/min have been shown to be effective.

Paediatric population

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

Renal impairment

Lower doses of phenylephrine may be required in patients with renal impairment.

Hepatic impairment

Higher doses of phenylephrine may be required in patients with hepatic cirrhosis.

Elderly

Treatment in elderly patients should be carried out with caution.

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

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to use Phenylephrine Altan 0.1 mg/ml

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

Phenylephrine Altan 0.1 mg/ml contains sodium

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects can be classified by frequency as follows: 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), and Unknown (frequency cannot be estimated from the available data).

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

The most commonly reported cardiovascular adverse effect appears to be bradycardia, likely due to baroreceptor-mediated vagal stimulation, 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

Psychiatric disorders:

anxiety, excitability, agitation, psychotic states, confusion.

Nervous system disorders:

headache, cerebral haemorrhage, dizziness, fainting, lethargy (mental or physical inactivity), insomnia, paraesthesia (abnormal skin sensation), tremor (involuntary shaking of the body or limbs).

Eye disorders:

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

Cardiac disorders:

reflex bradycardia (slow heart rate), reflex tachycardia (fast heart rate), cardiac arrhythmia (irregular heart rhythm), anginal pain, palpitations, cardiac arrest.

Vascular disorders:

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

Respiratory, thoracic and mediastinal disorders:

dyspnoea (breathing difficulties), pulmonary oedema (lung inflammation).

Gastrointestinal disorders:

nausea, vomiting, hypersalivation.

Skin and subcutaneous tissue disorders:

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

Renal and urinary disorders:

difficulty urinating, urinary retention.

Metabolism and nutrition disorders:

glucose metabolism disturbances.

General disorders and administration site conditions:

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

If you experience any adverse effect, speak to your doctor or pharmacist. This includes possible adverse effects not listed in this leaflet.

Reporting of adverse effects

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

5. Storage of Phenylephrine Altan 0.1 mg/ml

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

This medicine does not require special storage temperature conditions for polypropylene bags.

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

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Do not freeze.

Your physician will store this medicine for you.

From a microbiological standpoint, the product should be used immediately after first opening.

Phenylephrine Altan 0.1 mg/ml should not be used if visible particles are present.

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

6. Contents of the pack and other information

Composition of Phenylephrine Altan 0.1 mg/ml

• The active substance 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 injections.

Appearance of the product and contents of the pack

Phenylephrine Altan 0.1 mg/ml is a clear, colourless solution. Each polypropylene or PVC-free polyolefin bag contains 100 ml of solution.

Pack sizes

Polypropylene bag: 10 x 100 ml
PVC-free polyolefin bag: 10 x 100 ml

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Altan Pharmaceuticals S.A.
C/ Cólquide, No. 6, Portal 2, 1st Floor, Office F
Edificio Prisma, Las Rozas, 28230 Madrid – Spain

Manufacturer

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

Date of the most recent revision of this summary: January 2021

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

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This information is intended for healthcare professionals only:

Phenylephrine Altan 0.1 mg/ml solution for injection and infusion

Dosage and method of administration:

Parenteral administration or intravenous infusion. Phenylephrine Altan 0.1 mg/ml solution for injection and infusion must only be administered by healthcare professionals with appropriate 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 as needed to maintain systolic blood pressure close to normal values. Doses between 25 and 100 micrograms/min have been shown to be effective.

Elderly patients:

Treatment of elderly patients should be carried out with caution.