Labetalol S.A.L.F. 5 mg/ml solution for injection and infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Labetalol S.A.L.F. 5 mg/ml injection and infusion solution EFG

labetalol hydrochloride

Read the entire leaflet carefully before you start taking this medicine. 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 serious adverse effects or any adverse effect not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Labetalol S.A.L.F. is and what it is used for
2. What you need to know before you are administered Labetalol S.A.L.F.
3. How Labetalol S.A.L.F. is administered
4. Possible side effects
5. How to store Labetalol S.A.L.F.
6. Contents of the pack and other information

1. What Labetalol S.A.L.F. is and what it is used for

Labetalol S.A.L.F. contains the active substance labetalol. It is used to treat severe hypertension (high blood pressure), including severe pregnancy-induced hypertension (high blood pressure caused by pregnancy), when rapid control of blood pressure is required. Labetalol may also be used to control blood pressure during anaesthesia.

Labetalol belongs to a group of medicines known as alpha and beta blocking agents. These medicines reduce blood pressure by blocking receptors in the cardiovascular system, resulting in a decrease in blood pressure in blood vessels distant from the heart.

2. What you need to know before Labetalol S.A.L.F. is administered to you

Do not take Labetalol S.A.L.F.

• if you are allergic to labetalol or to any of the other ingredients of this medicine (listed in section 6);
• if you have certain heart conditions, for example, heart block or sick sinus syndrome (unless you have a pacemaker), cardiogenic shock, or uncontrolled heart failure;
• if you have persistently low blood pressure;
• if you have a very slow heart rate (severe bradycardia);
• if you have a condition known as Prinzmetal's angina;
• if you have asthma or a similar lung disease (obstructive airway disease);
• if you have a particular type of adrenal gland tumour (pheochromocytoma), not treated with appropriate pharmacological therapy (see section "Warnings and precautions")

Warnings and precautions

Talk to your doctor or pharmacist before starting Labetalol S.A.L.F.:

• if you have reduced liver function or liver damage;
• if you have reduced kidney function;
• if you have peripheral vascular disease, for example, Raynaud's syndrome, intermittent claudication;
• if you have diabetes mellitus (type 1 or type 2);
• if you have an overactive thyroid (thyrotoxicosis, hyperthyroidism);
• if you have previously had a severe allergic reaction (anaphylaxis) to any substance;
• if you have heart failure or other heart problems (e.g., impaired left ventricular systolic function, first-degree atrioventricular block);
• if you know you are going to undergo surgery;
• if you have metabolic acidosis (when the body produces too much acid or the kidneys do not remove enough acid from the body) and pheochromocytoma;
• if you have a condition known as ischemic heart disease;
• if you have any lung or respiratory system problems.

If you develop a slow heart rate (bradycardia) as a result of receiving Labetalol S.A.L.F., your doctor may reduce the dose.

If you develop skin rashes and/or dry eyes, or any type of allergic reaction while receiving Labetalol S.A.L.F., inform your doctor, as they may reduce or stop treatment.

Surgery

If you are undergoing surgery requiring general anaesthesia, you must inform your surgeon, prior to surgery, that you are taking labetalol, as labetalol may mask the effects of sudden blood loss.

Labetalol may affect your pupils during cataract surgery. Inform your ophthalmic surgeon, prior to surgery, that you are taking this medicine. Do not stop taking labetalol before surgery unless instructed by your surgeon.

Tests

This medicine may interfere with certain medical/laboratory tests and possibly cause false test results. Make sure laboratory staff and all your doctors know that you are taking this medicine.

Children and adolescents

This medicine must not be given to children or adolescents under 18 years of age.

Other medicines and Labetalol S.A.L.F.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines before receiving labetalol. This is especially important for the following medicines:

• NSAIDs (non-steroidal anti-inflammatory drugs), for example: sulindac or indomethacin, used to treat pain and inflammation;
• digoxin (a heart medicine);
• adrenaline, which may be used to treat severe allergic (anaphylactic) reactions;
• medicines for heart disorders (class I antiarrhythmics, for example, disopyramide and quinidine) and (class II antiarrhythmics, for example, amiodarone);
• other medicines that lower blood pressure (calcium channel blockers such as verapamil);
• general anaesthetics (used in surgery for narcosis);
• tricyclic antidepressants, for example, imipramine (used to treat depression);
• oral antidiabetics, for example, biguanides (e.g., metformin), sulfonylureas (e.g., glimepiride), meglitinides (e.g., repaglinide), and alpha-glucosidase inhibitors (e.g., acarbose), used to reduce blood glucose levels;
• ergotamine derivatives, for example, ergotamine or dihydroergotamine, used to treat migraine;
• cholinesterase inhibitors, for example, donepezil, galantamine or rivastigmine, used to treat mild cognitive impairment, Alzheimer's disease, and Parkinson's disease;
• nitrates, antipsychotics (e.g., phenothiazine derivatives, chlorpromazine) and other antipsychotics, antidepressants;
• clonidine, used to treat high blood pressure.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving labetalol. The foetus may be affected, but labetalol may be used when rapid blood pressure control is needed during pregnancy.

Labetalol is excreted in breast milk in small amounts. If you are breastfeeding, consult your doctor before receiving labetalol.

Cases of nipple pain and Raynaud's phenomenon of the nipple have been reported (see section 4).

Driving and use of machines

Not applicable.

Labetalol S.A.L.F. contains monohydrate glucose and sodium

1 ml contains 49.5 mg of monohydrate glucose. This should be taken into account in patients with diabetes mellitus.

This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml vial; hence, it is essentially "sodium-free".

However, it may be diluted in 9 mg/ml (0.9%) sodium chloride solution for infusion. This should be taken into account for patients on a sodium-controlled diet (see section INFORMATION FOR HEALTHCARE PROFESSIONALS).

3. How Labetalol S.A.L.F. is administered

Labetalol must always be used according to your doctor's instructions. Labetalol is intended for intravenous use in hospitalized patients and must be administered by healthcare personnel.

It is important that you remain lying down when the injection is given. You will be asked to remain lying down for three hours after receiving labetalol, as you may feel dizzy (due to low blood pressure) if you stand up before this time. Labetalol may be administered as an intravenous bolus injection (when the medicine is injected directly into a vein) or as an intravenous infusion (when the medicine is delivered directly into a vein over a longer period of time). Your doctor will decide how labetalol should be administered and what dose of labetalol you should receive.

If you are given more Labetalol S.A.L.F. than you should

Symptoms of labetalol overdose include severe dizziness when standing up (sitting or standing) and, sometimes, slow heart rate felt as a slow pulse (bradycardia).

Contact your doctor or nurse if you think you have been given too much of this medicine.

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

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 of Labetalol S.A.L.F. ingested. Specific treatment options are available.

4. Possible adverse effects

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

Frequent: may affect up to 1 in 10 people

• Congestive heart failure
• Dizziness due to low blood pressure when moving too quickly from lying down to sitting or from sitting to standing (postural hypotension). This may occur within three hours after injection of labetalol and is usually temporary, occurring during the first weeks of treatment.
• Nasal congestion, which is usually temporary and occurs during the first weeks of treatment
• Elevated liver function tests. This is usually reversible upon discontinuation of the medicine.
• Erectile dysfunction (impotence)
• Allergic reactions (hypersensitivity) may also include skin rash (of varying severity), itching, difficulty breathing, and very rarely, fever or rapid swelling of the skin.

Uncommon: may affect up to 1 in 100 people

• Narrowing of the lower airways (bronchospasm)

Rare: may affect up to 1 in 1,000 people

• Slow heart rate, which may be perceived as a weak pulse (bradycardia)

Very rare: may affect up to 1 in 10,000 people

• Interruption of the electrical impulses controlling the heartbeat (heart block)
• Worsening of symptoms of Raynaud's syndrome (cold fingers due to poor blood circulation)
• Inflammation of the liver (hepatitis), which is usually reversible when labetalol treatment is stopped
• Hepatocellular jaundice (yellowing of the skin and whites of the eyes), cholestatic jaundice (symptoms include fatigue and nausea, followed by itching, dark urine and jaundice, and may include skin rash or fever), and hepatic necrosis (damaged liver tissue). These symptoms are usually reversible when labetalol treatment is stopped.

Not known (cannot be estimated from available data)

• Nipple pain
• Intermittent reduction in blood flow to the nipples, which may cause numbness, paleness, and pain (Raynaud's phenomenon)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system: www.notificaRAM.es.

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

5. Storage of Labetalol S.A.L.F.

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the ampoule and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if signs of deterioration are observed.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C, 30 °C, and 40 °C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature between 2 and 8 °C.

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

6. Contents of the pack and other information

What Labetalol S.A.L.F. contains

• The active substance is labetalol hydrochloride. One ml of solution contains 5 mg of labetalol hydrochloride.
• The other components are monohydrate glucose, disodium edetate, and water for injection; sodium hydroxide and hydrochloric acid (to adjust pH).

Appearance of Labetalol Hydrochloride S.A.L.F. and contents of the pack

• Clear, colourless solution in clear glass ampoules. Each pack contains 5 ampoules of 20 ml. Each ampoule contains 100 mg of labetalol hydrochloride (5 mg/ml).

Marketing Authorization Holder and Manufacturer

S.A.L.F. S.p.A. Laboratorio Farmacológico
via Marconi, 2
24069 Cenate Sotto (BG)
Italy
Tel. +39 035 940097

Local representative

Stragen España
Calle Serrano, 90, 6º
28006 Madrid
Spain

Date of the most recent revision of this leaflet: July 2024

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.

INFORMATION FOR HEALTHCARE PROFESSIONALS

This information is intended exclusively for healthcare professionals:

Administration:

Labetalol S.A.L.F. is intended for intravenous treatment in hospitalized patients and must be administered by healthcare professionals. Patients should always receive the medication in the supine or left lateral position. Patients should not be raised from this position before 3 hours have elapsed after intravenous administration of labetalol, as excessive postural hypotension may occur. Blood pressure and heart rate should be monitored after injection and during infusion. In most patients, a slight decrease in heart rate occurs; severe bradycardia is unusual, but if it occurs, it may be treated by intravenous injection of 1 to 2 mg of atropine. Respiratory function should be monitored, particularly in patients with known respiratory impairment. Injectable labetalol may be administered as an intravenous bolus injection or as an intravenous infusion. Injectable labetalol has been administered to patients with uncontrolled hypertension who were already receiving other antihypertensive agents, including beta-blocking drugs, without adverse effects.

Oral maintenance treatment:

Once blood pressure has been adequately reduced by bolus injection or infusion, maintenance treatment should be continued with labetalol tablets, starting with an initial dose of 100 mg twice daily.

Dosage: Injectable Labetalol S.A.L.F.

• Adults:

• Paediatric population:

The safety and efficacy of labetalol in paediatric patients aged 0 to 18 years have not been established. No data are available.

Compatibility:

Labetalol must only be diluted with intravenous infusion fluids that are compatible, under aseptic conditions.

Injectable labetalol is compatible with the following intravenous infusion fluids:

• 5% Dextrose BP.
• 0.18% Sodium Chloride and 4% Dextrose BP.
• 0.3% Potassium Chloride and 5% Dextrose BP.
• Sodium Lactate BP Compound (Ringer's Lactate).
• 0.9% Sodium Chloride.

Incompatibilities:

Injectable labetalol has been shown to be incompatible with Sodium Bicarbonate BP 4.2% w/v injection.

Overdose:

Symptoms and signs:

Profound cardiovascular effects may be expected, for example, postural hypotension and, occasionally, bradycardia. Oliguric renal failure has been reported following massive oral overdose of labetalol. In one case, the use of dopamine to increase blood pressure may have worsened renal failure.

Treatment:

Patients should be placed in the supine position with legs elevated. Parenteral adrenergic/anticholinergic therapy should be administered as necessary to improve circulation.

Haemodialysis removes less than 1% of labetalol hydrochloride from the circulation.