PHENYLEPHRINE 50 MICROGRAMS / ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

1. What Phenylephrine Injection 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 phenylephrine injection

You will not receive Phenylephrine Injection:

• – if you are allergic to phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);

• – if you suffer from severe high blood pressure, or peripheral vascular disease (poor blood circulation);

• – if you are taking a Monoamine Oxydase inhibitor (MAO) (or within 2 weeks of their withdrawal), that is used to treat depression (such as iproniazide, nialamide);

• – if you suffer from severe overactive thyroid gland (hyperthyroidism).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Phenylephrine Injection:

• – if you are elderly;

• – if you are diabetic;

• – if you suffer from arterial hypertension;

• – if you have an overactive thyroid gland (uncontrolled hyperthyroidism);

• – if you have 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 suffer from heart disease including chronic heart conditions, peripheral vascular insufficiency, heart rhythm disorders, tachycardia (high heart rate), bradycardia (low heart rate), partial heart block, angina pectoris;

• – if you suffer from a closed angle glaucoma (a rare eye disease).

In patients with serious heart failure, phenylephrine may worsen the heart failure as a consequence of blood vessel constriction.

The blood pressure in your arteries will be monitored during treatment. If you have heart disease, additional monitoring of vital functions will be performed.

Children

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

Other medicines and Phenylephrine Injection

Tell your doctor if you are using, have recently used or might use any other medicines, such as:

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious (frequencies are not known). Tell your doctor straight away if you get any of the following:

• – chest pain or pain due to angina,

• – irregular heartbeat,

• – feeling the heart pumping in the chest,

• – bleeding in the brain (speech disorder, dizziness, paralysis of one side of the body),

• – psychosis (losing contact with reality).

Other side effects may include (frequencies are not known):

• – reaction of hypersensitivity (allergy),

• – excessive dilation of the pupils,

• – increased pressure in the eye (aggravation of glaucoma),

• – excitability (excessive sensitivity of an organ or body part),

• – agitation (restlessness),

• – anxiety,

• – confusion,

• – headache,

• – nervousness,

• – insomnia (difficulty falling or staying asleep),

• – shaking (tremor),

• – burning of the skin,

• – prickling of the skin,

• – itching or tingling skin sensation (paraesthesia), – slow or high heart rate,

• – high blood pressure,

• – difficulty in breathing,

• – fluids in the lung,

• – nausea,

• – vomiting,

• – sweating,

• – pallor or skin blanching (pale colour of the skin),

• – goose bump,

• – tissue damage at the site of the injection, – muscle weakness,

• – difficulty in passing urine or urine retention.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store phenylephrine injection

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

You should not be given this medicine after the expiry date which is stated on the carton and syringe label. The expiry date refers to the last day of that month. Your doctor or nurse will check this.

This medicine does not require any special temperature storage conditions.

Keep the blister in the outer carton in order to protect from light. Keep the syringe in its unopened blister until use.

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

Any syringe, even partially used, should be discarded appropriately after use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Phenylephrine Injection contains

The active ingredient is phenylephrine hydrochloride.

• – Each ml of solution for injection contains phenylephrine hydrochloride, equivalent to 50 micrograms phenylephrine.

• – Each 10 ml pre-filled syringe contains phenylephrine hydrochloride, equivalent to 500 micrograms phenylephrine.

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

What Phenylephrine Injection looks like and contents of the pack

Phenylephrine Injection is a clear colourless solution, in a 10 ml polypropylene pre-filled syringe, individually packaged in a transparent blister pack.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratoire AGUETTANT

1, rue Alexander Fleming

69007 LYON

France

Manufacturer

Laboratoire AGUETTANT

Lieu-dit “Chantecaille”

07340 CHAMPAGNE

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AGUETTANT Ltd

N°1, Farleigh House – Flax Bourton

BRISTOL – BS48 1UR

United Kingdom

This leaflet was last revised in 07/2020.

Detailed information on this medicinal product

is available on the website of the Medicines and Healthcare Products Regulatory Agency (MHRA).

TECHNICAL LEAFLET

Phenylephrine 50 micrograms/ml, Solution for injection in pre-filled syringe

The following information is intended for medical and healthcare professionals only:

This is an extract from the Summary of Product Characteristics to assist in the administration of PHENYLEPHRINE 50 micrograms/ml, solution for injection in pre-filled syringe. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the product.

Qualitative and quantitative composition:

Each ml of solution for injection contains phenylephrine hydrochloride equivalent to 50 micrograms (0.05 mg) phenylephrine.

Each 10 ml pre-filled syringe contains phenylephrine hydrochloride equivalent to 500 micrograms (0.5 mg) phenylephrine.

Excipients with known effect: sodium.

Each ml of solution for injection contains 3.72 mg equivalent to 0.162 mmol of sodium.

Each 10 ml pre-filled syringe contains 37.2 mg equivalent to 1.62 mmol of sodium.

Other excipients: Sodium citrate, Citric acid monohydrate, Sodium hydroxide, water for injections.

Description of solution:

Clear colorless solution.

pH: 4.7 – 5.3

Osmolality: 270–300 mOsm/Kg

Posology and method of administration

Posology

Adults

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

Renal impairment

Lower doses of phenylephrine may be needed in patients with impaired renal function.

Hepatic Impairment

Higher doses of phenylephrine may be needed in patients with cirrhosis of the liver.

Elderly

Treatment of the elderly should be carried out with care.

Paediatric population

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

Method of administration:

Intravenous bolus injection.

Phenylephrine, 50 micrograms/ml, solution for injection should only be administered by healthcare professionals with appropriate training and relevant experience.

The pre-filled syringe is not suitable for use in a syringe driver.

Contraindications

Phenylephrine should not be used:

• – in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1;

• – in patients with severe hypertension or peripheral vascular disease due to the risk of ischemic gangrene or vascular thrombosis;

• – in combination with non-selective monoamine oxidase inhibitors (MAOs) (or within 2 weeks of their withdrawal) due to risk of paroxysmal hypertension and possibly fatal hyperthermia (see section 4.5);

• – in patients with severe hyperthyroidism.

Special warning and precautions for use

The arterial blood pressure should be monitored during treatment.

Phenylephrine should be administered with care to patients with:

• – diabetes mellitus,

• – arterial hypertension,

• – uncontrolled hyperthyroidism,

• – coronary heart disease and chronic heart conditions,

• – non-severe peripheral vascular insufficiency,

• – bradycardia,

• – partial heart block,

• – tachycardia,

• – arrhythmias,

• – angina pectoris (phenylephrine can precipitate or exacerbate angina in patients with coronary artery disease and history of angina),

• – aneurysm,

• – closed angle glaucoma.