NORADRENALINE NORMON 0.5 mg/mL CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Noradrenaline Normon 0.5 mg/ml Concentrate for Solution for Infusion EFG

norepinephrine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Noradrenaline Normon and what is it used for
2. What you need to know before you use Noradrenaline Normon
3. How to use Noradrenaline Normon
4. Possible side effects
5. Storage of Noradrenaline Normon
6. Contents of the pack and further information

1. What is Noradrenaline Normon and what is it used for

Noradrenaline (norepinephrine) belongs to a group of medicines called "adrenergic and dopaminergic agents", which work by increasing blood pressure.

Noradrenaline is used to treat acute hypotension (low blood pressure).

2. What you need to know before you use Noradrenaline Normon

Do not useNoradrenalineNormon

• If you are allergic to noradrenaline bitartrate or any of the other ingredients of this medicine (listed in section 6).
• As the only therapy if you have low blood pressure due to a decrease in blood volume.
• If you are being given the anesthetic gases halothane or cyclopropane, as they may increase the risk of irregular heartbeats.

Warnings and precautions

Talk to your doctor before starting to use Noradrenaline Normon 0.5 mg/ml.

Inform your doctor of any allergy or medical problem you have or have had, especially if:

• you have diabetes
• you have liver or kidney failure
• you have high blood pressure
• you have hyperthyroidism
• you have low oxygen levels in the blood
• you have high carbon dioxide levels in the blood
• you have high pressure inside the skull (intracranial pressure)
• you have blood clots or blockages in the blood vessels that supply the heart, intestines, or other parts of the body
• you have post-myocardial infarction hypotension
• you have angina pectoris (chest pain), particularly Prinzmetal's angina
• you have significant left ventricular dysfunction
• you have recently had a myocardial infarction (heart attack)
• you have heart rhythm disorders (your heart beats too fast, too slow, or irregularly), you may need a reduced dose
• you are elderly

During the infusion of noradrenaline, your doctor will continuously monitor your blood pressure, heart rate, and infusion site.

Other medicines and Noradrenaline Normon

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

• medicines for treating depression called "monoamine oxidase inhibitors", if you are taking them now or have taken them in the last 14 days
• medicines for treating depression called "tricyclic antidepressants" (e.g., imipramine or desipramine)
• adrenergic-serotonergic medicines, e.g., used in the treatment of asthma and heart diseases
• linezolid (an antibiotic)
• anesthetics (especially anesthetic gases such as cyclopropane, halothane, chloroform, enflurane)
• medicines for treating high blood pressure (e.g., guanethidine, guanadrel, reserpine, methyldopa, alpha and beta blockers)
• medicines for treating heart rhythm disorders
• cardiac glycosides (for treating heart diseases)
• levodopa (for treating Parkinson's disease)
• thyroid hormones
• oxytocin (used to improve uterine contractions)
• antihistamines (for treating allergies)
• amphetamines
• doxapram (for respiratory disorders)
• mazindol (for treating obesity)
• medicines for treating migraine (ergot alkaloids)
• lithium (for treating certain mental disorders)
• vasopressin, desmopressin (antidiuretics, to reduce urine production)

The use of noradrenaline with propofol (an anesthetic) may cause propofol infusion syndrome (PRIS), a serious condition that affects patients undergoing sedation with propofol in intensive care units. In this case, the doctor may observe disorders in the body's metabolism from blood tests, which could lead to kidney failure, heart failure, and death.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine. Noradrenaline (norepinephrine) may harm the fetus. It is not known if this medicine is excreted in breast milk. Your doctor will decide if you should be given Noradrenaline (norepinephrine).

Driving and using machines

Do not drive or use machines if you are affected by the administration of this medicine.

Noradrenaline Normon0.5mg/ml concentrate for solution for infusion contains sodium metabisulfite (E-223) and sodium.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite (E-223).

This medicine contains 34.82 mg of sodium (main component of table salt/cooking salt) in each ampoule. This is equivalent to 1.74% of the maximum recommended daily intake of sodium for an adult.

3. How to use Noradrenaline Normon

Noradrenaline is administered intravenously.

This medicine will always be administered by healthcare personnel.

Your doctor will decide the dose and frequency at which you will be given the medicine.

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor again.

If you use more Noradrenaline Normon than you should:

In case of overdose or accidental ingestion, contact the Toxicological Information Service (telephone: 91 562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

It is unlikely that this will happen, as your doctor will determine your daily doses. However, if you receive more noradrenaline than you should, this could cause:

A severe increase in blood pressure with intense headache, rejection of light, acute pain behind the sternum (in the chest), pain in the pharynx, paleness, and intense sweating and vomiting.

If this happens, your doctor must immediately stop the treatment and, depending on the severity of the situation, administer:

• adequate fluid and electrolyte replacement therapy
• a medicine by intravenous route that decreases blood pressure (antihypertensive), if necessary, for the effects of the increase in blood pressure.

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

4. Possible side effects

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

The frequency of the side effects mentioned is not known (cannot be estimated from the available data).

Tell your doctor or nurse immediatelyif you experience:

• sudden pruritic rash (urticaria), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), feeling of fainting,
• pain or swelling at the injection site.

Tell your doctor or nurse as soon as possible if you experience:

• anxiety, insomnia, confusion, weakness, psychotic state
• headaches, tremors
• increased ocular pressure (acute glaucoma)
• decreased or increased heart rate
• abnormal heart rhythm
• electrocardiogram changes
• a potentially fatal type of circulatory failure called "cardiogenic shock"
• weakness of the heart muscle due to intense physical or emotional stress, palpitations, increased contractility of the heart muscle, acute heart failure
• high blood pressure, decreased oxygen supply to an organ (hypoxia)
• poor blood flow to hands and feet (may cause coldness, paleness, and/or pain in the extremities)
• gangrene (tissue death)
• reduction of plasma blood volume
• difficulty breathing
• paleness, skin scarification, bluish skin color, hot flashes or skin redness, skin rash, urticaria, or itching
• nausea, vomiting
• urine retention
• irritation and necrosis (cellular damage that causes cell death in tissue) at the injection site

Your doctor will monitor your blood pressure and blood volume.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Noradrenaline Normon 0.5 mg/ml concentrate for solution for infusion

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

Do not store above 25°C. Store in the original packaging.

Do not use this medicine after the expiry date which is stated on the packaging (after EXP). The expiry date is the last day of the month stated.

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

6. Contents of the pack and further information

What Noradrenaline Normon contains

The active substance is norepinephrine bitartrate. Each ml of solution contains 1 mg of norepinephrine bitartrate (10 mg per 10 ml ampoule), equivalent to 0.5 mg of norepinephrine base.

The other ingredients (excipients) are: sodium chloride, sodium metabisulfite (E-223), hydrochloric acid or sodium hydroxide, and water for injection.

Appearance of the product and pack contents

The solution contained in the ampoules of Noradrenaline Normon 0.5 mg/ml is clear, colorless, or practically colorless. The packs contain 10 ampoules.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was approved in June 2018.

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

This information is intended only for healthcare professionals:

Noradrenaline Normon 0.5 mg/ml concentrate for solution for infusion should be administered intravenously:

the initial dose is administered at a rate of 8 to 12 micrograms (0.008 to 0.012 mg) (base) per minute, adjusting the administration rate to establish and maintain the desired blood pressure.

For maintenance, the rate is adjusted to 2 to 4 micrograms (0.002 to 0.004 mg) (base) per minute, titrating the dosage according to the patient's response.

In case of septic shock, the doses should be adjusted to around 0.5 µg/kg/min (up to a maximum of 1.0 µg/kg/min) to achieve the desired mean blood pressure. It is recommended to administer it together with doses of 2-2.5 µg/kg/min of dopamine, which counteract vasoconstriction, ensuring good renal and splanchnic circulation.

To prepare the solution for intravenous infusion of noradrenaline, add 4 mg of noradrenaline (base) to 1 liter of 5% glucose solution. The resulting solution will contain 4 micrograms (0.004 mg) of noradrenaline (base) per ml. It should be taken into account that 1 mg of noradrenaline bitartrate is equivalent to 0.5 mg of noradrenaline base.

Noradrenaline Normon 0.5 mg/ml concentrate for solution for infusion can be used as an emergency measure to maintain coronary and cerebral perfusion until the end of volume replacement therapy.

Duration of treatment

The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without treatment. The infusion of noradrenaline should be gradually reduced, avoiding abrupt interruption. In some cases described of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.

Usual pediatric dose

Intravenous infusion, 0.1 microgram (base) per kg per minute, gradually adjusting the administration rate to achieve the desired blood pressure, up to 1 microgram (base) per kg per minute.

When added to local anesthetics, these solutions contain a concentration of noradrenaline of around 1:200,000 (5 µg/ml).