Leaflet: information for the user

Noradrenalina Normon 0.5 mg/ml concentrate for infusion solution EFG

norepinephrine

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• 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 only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Noradrenalina Normon

3. How to use Noradrenalina Normon

4. Possible side effects

5. Storage of Noradrenalina Normon

6. Contents of the pack and additional information

Noradrenalina (norepinephrine) belongs to a group of medications called “adrenergic and dopaminergic agents”, which act by increasing blood pressure.

Noradrenalina is used for the treatment of acute drops in blood pressure (acute hypotension).

No useNNoradrenalinaNormon

• If you are allergic to noradrenalina bitartrate or any of the other components of this medication (listed in section 6).
• As the sole therapy if you have low blood pressure due to a decrease in blood volume.
• If you are being administered halotano or ciclopropano anesthetics, as they may increase the risk of irregular heartbeats.

Warnings and precautions

Consult your doctor before starting to use Noradrenalina Normon 0.5 mg/ml.

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

• You have diabetes.
• You have liver or kidney insufficiency.
• You suffer from hypertension.
• You have hyperthyroidism.
• You have low oxygen levels in your blood.
• You have high carbon dioxide levels in your blood.
• You have elevated intracranial pressure.
• You have blood clots or obstructions in the blood vessels that supply the heart, intestines, or other parts of the body.
• You have hypotension following a heart attack.
• 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 cardiac rhythm disorders (your heart beats too quickly, too slowly, or irregularly), you will need a reduced dose.
• You are an elderly person.

During noradrenalina perfusion, the doctor will continuously monitor your blood pressure, heart rate, and perfusion site.

Other medications and Noradrenalina Normon

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

• Medications for treating depression known as "monoamine oxidase inhibitors," if you are currently taking them or have taken them in the last 14 days.
• Medications for treating depression known as "tricyclic antidepressants" (e.g., imipramine or desipramine).
• Adrenergic-serotoninergic medications, for example, used in the treatment of asthma and heart disease.
• Linezolid (an antibiotic).
• Anesthetics (especially gases such as ciclopropano, halotano, chloroform, enflurano).
• Medications for treating hypertension (e.g., guanetidina, guanadrel, reserpine, metildopa, alpha and beta blockers).
• Medications for treating cardiac 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).
• Medications for treating migraine (ergot alkaloids).
• Lithium (for treating certain mental disorders).
• Vasopressin, desmopressin (diuretics, to reduce urine production).

The use of noradrenalina with propofol (an anesthetic) may cause the propofol infusion syndrome (SIP), a serious condition that affects patients undergoing sedation with propofol in intensive care units. In this case, the doctor may observe metabolic disorders from blood tests, which may cause renal insufficiency, heart failure, and death.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before receiving this medication. Noradrenalina (Norepinefrina) may harm the fetus. It is unknown whether this medication is excreted in breast milk. The doctor will decide whether you should receive Noradrenalina (Norepinefrina).

Driving and operating machinery

You should not drive or operate machinery if you are affected by the administration of this medication.

Noradrenalina Normon 0.5 mg/ml concentrated solution for perfusion contains metabisulfito de sodio (E-223) and sodium.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains metabisulfito de sodio (E-223).

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

Noradrenalina is administered intravenously.

This medication will always be administered by a healthcare professional.

Your doctor will decide the dose and frequency at which the medication will be administered to you.

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

If you use more Noradrenalina Normon than you should:

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

This is unlikely to happen, as your doctor will determine your daily doses. However, if you receive more noradrenalina than you should, this could cause:

A severe increase in blood pressure with intense headache, photophobia, sharp chest pain, throat pain, pallor, intense sweating, and vomiting.

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

- an appropriate fluid and electrolyte replacement therapy

- an intravenous medication to lower blood pressure (antihypertensive), if necessary, to counteract the effects of the increased blood pressure.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The frequency of the mentioned adverse effects is unknown (cannot be estimated from the available data).

Inform your doctor or nurse immediately if you experience:

• pruritic sudden exanthema (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.

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

• anxiety, insomnia, confusion, weakness, psychotic state
• headaches, tremors
• acute glaucoma
• decrease or increase in heart rate
• abnormal heart rhythm
• electrocardiogram alterations
• a potentially fatal type of circulatory insufficiency called "cardiogenic shock"
• cardiac muscle weakness due to intense physical or emotional stress, palpitations, increased cardiac muscle contractility, acute heart failure
• hypertension, decreased oxygen supply to an organ (hypoxia)
• insufficient blood flow to hands and feet (may cause coldness, paleness, and/or pain in the extremities)
• gangrene (tissue death)
• reduction in plasma blood volume
• difficulty breathing
• pallor, skin scarring, blue discoloration of the skin, hot flashes or skin redness, skin rash, urticaria, or itching
• nausea, vomiting
• urine retention
• irritation and necrosis (cellular injury leading to cell death in the tissue) at the injection site

Your doctor will monitor your blood pressure and volemia.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nursing staff, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use this medicationafter the expiration datethat appearson the packaging (after CAD). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

What Noradrenalina Normon contains

The active ingredient 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 components (excipients) are:sodium chloride, sodium metabisulphite (E-223), hydrochloric acid or sodium hydroxide and water for injection.

Appearance of the product and contents of the pack

The solution contained in the Noradrenalina Normon0,5mg/ml ampoules is transparent, colourless or practically colourless. The packs contain 10 ampoules.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

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

This leaflet was approved in June 2018.

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

This information is intended solely for healthcare professionals:

Noradrenalina Normon0,5mg/ml concentrated solution for perfusion should be administered intravenously:

The initial dose is administered at a rate of8 to12micrograms(of0.008 to0.0012 mg) (base) per minute, adjusting the administration rate to establish and maintain the desired blood pressure.

For maintenance, the rate is adjusted to2 to4micrograms(of0.002 to0.004 mg) (base) per minute, titrating the dosage according to the patient's response.

In the case of septic shock, the doses should be adjusted 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 along with doses of 2-2.5 µg/kg/min of dopamine, which counteract vasoconstriction, ensuring good renal and splenic circulation.

To prepare the intravenous infusion solution of noradrenaline, add 4 mg of noradrenaline (base) to1 literof 5% glucose solution. The resulting solution will contain 4micrograms(0.004 mg) of noradrenaline (base) per ml. It should be noted that 1 mg of noradrenaline bitartrate is equivalent to 0.5 mg of noradrenaline base.

NoradrenalinaNormon0,5mg/ml concentrated solution for perfusioncan be used as an emergency measure to maintain coronary and cerebral perfusion until the volume replacement therapy is completed.

Treatment duration

The infusion should be continued until the desired blood pressure and tissue perfusion are maintained without treatment. The noradrenaline infusion 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, 0.1microgramper kg per minute, adjusting the administration rate gradually to achieve the desired blood pressure, up to 1microgramper kg per minute.

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