LABETALOL S.A.L.F. 5 mg/mL Injectable Solution and Perfusion Solution

Introduction

Package Leaflet: Information for the Patient

Labetalol S.A.L.F. 5 mg/ml Solution for Injection and Infusion EFG

labetalol hydrochloride

Read all of this leaflet carefully before you start taking this medicine. 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, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Labetalol S.A.L.F. is and what it is used for
2. What you need to know before you are given Labetalol S.A.L.F.
3. How Labetalol S.A.L.F. is given
4. Possible side effects
5. Storage of Labetalol S.A.L.F.
6. Contents of the pack and further 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 hypertension in pregnancy (pregnancy-induced high blood pressure) when rapid blood pressure control is needed. Labetalol may also be used to control blood pressure during anesthesia.

Labetalol belongs to a group of medicines called alpha and beta blockers. These medicines lower blood pressure by blocking the receptors in the cardiovascular system (circulatory system), which causes a decrease in blood pressure in the blood vessels away from the heart.

2. What you need to know before you are given Labetalol S.A.L.F.

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

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Labetalol S.A.L.F.:

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

If you develop a low heart rate (bradycardia) as a result of being given 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 when you are being given Labetalol S.A.L.F., tell your doctor, as they may reduce or stop treatment.

Surgery

If you are going to have surgery that requires general anesthesia, you must tell your surgeon before the surgery that you are using labetalol, as labetalol may mask the effects of sudden blood loss.

Labetalol may affect your pupils during cataract surgery. Tell your eye surgeon before the surgery that you are using this medicine. Do not stop using labetalol before surgery unless your surgeon tells you to.

Tests

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

Children and adolescents

This medicine must not be given to children and 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 take any other medicines before you are given labetalol. This is especially important for the following medicines:

• NSAIDs (non-steroidal anti-inflammatory drugs), such as sulindac or indomethacin, used to treat pain and inflammation;
• digoxin (heart medicine)
• adrenaline, which may be used to treat severe allergic reactions (anaphylaxis);
• medicines for heart disorders (class I antiarrhythmic agents, such as disopyramide and quinidine) and (class II antiarrhythmic agents, such as amiodarone);
• other medicines that lower blood pressure (calcium channel blockers, such as verapamil);
• general anesthetics (used in surgery for narcosis);
• tricyclic antidepressants, such as imipramine (used to treat depression);
• oral antidiabetics, such as 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, such as ergotamine or dihydroergotamine, used to treat migraine;
• cholinesterase inhibitors, such as 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 are planning to have a baby, ask your doctor for advice before you are given labetalol. The fetus 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, ask your doctor for advice before you are given labetalol.

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

Driving and using machines

Not applicable.

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

1 ml contains 49.5 mg of glucose monohydrate. 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 ampoule; i.e., it is essentially "sodium-free".

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

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

Labetalol should always be used following the instructions of your doctor. Labetalol is intended for intravenous treatment in hospitalized patients and should be administered by healthcare personnel.

It is important that you are lying down when you are given the injection. 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 get up too quickly. Labetalol may be given as an intravenous bolus injection (when the medicine is injected directly into a vein) or as an intravenous infusion (when the medicine is injected directly into a vein over a longer period). Your doctor will decide how labetalol should be given and what dose of labetalol you should receive.

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

The symptoms of an overdose of labetalol include extreme dizziness when standing up (sitting or standing) and sometimes a slow heart rate that you may feel 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 on the use of this medicine, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount of Labetalol S.A.L.F. ingested. Specific treatment options are available.

4. Possible side effects

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

Common: may affect up to 1 in 10 people

• congestive heart failure
• dizziness due to low blood pressure if you get up too quickly from lying down to sitting or standing (postural hypotension). This may occur in the three hours following the injection of labetalol and is usually temporary and occurs in the first weeks of treatment.
• nasal congestion, which is usually temporary and occurs in the first weeks of treatment
• elevated liver function tests. This is usually reversible when the medicine is discontinued.
• 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 airways (bronchospasm)

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

• slow heart rate, which may feel like a slow pulse (bradycardia)

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

• disruption of the electrical impulses that control the heartbeat (heart block)
• worsening of the symptoms of Raynaud's syndrome (cold fingers due to poor blood circulation)
• inflammation of the liver (hepatitis) which is usually reversible when treatment with labetalol is discontinued.
• hepatocellular jaundice (the skin and whites of the eyes turn yellow), cholestatic jaundice (symptoms include fatigue and nausea, followed by itching, dark urine, and jaundice, and may include skin rash or fever) and liver necrosis (damaged liver tissue). These symptoms are usually reversible when treatment with labetalol is discontinued.

Not known (cannot be estimated from the available data)

• nipple pain
• intermittent reduction of blood flow to the nipples, which may cause numbness, paleness, and pain (Raynaud's phenomenon of the nipple)

Reporting of side effects

If you experience 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 the national reporting system: www.notificaRAM.es.

By reporting side 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 any special storage conditions.

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

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

Chemical and physical stability have been demonstrated for 24 hours at 25°C, 30°C, and 40°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at a temperature of 2-8°C.

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

6. Container Content and Additional Information

What Labetalol S.A.L.F contains

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

Appearance of Labetalol S.A.L.F and Container Content

• Transparent and colorless solution in transparent glass ampoules. Each package 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. Pharmacological Laboratory

via Marconi, 2

24069 Cenate Sotto (BG)

Italy

Tel. +39 035 940097

Local Representative

Stragen Spain

Calle Serrano, 90, 6th floor

28006 Madrid

Spain

Date of the Last Revision of this Prospectus: July 2024

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

INFORMATION FOR HEALTHCARE PROFESSIONALS

This information is intended only for healthcare professionals:

Administration:

Labetalol S.A.L.F is intended for intravenous treatment in hospitalized patients and should be administered by healthcare professionals. Patients should always receive the medication in a supine or left lateral position. It is recommended to avoid lifting the patient before 3 hours have passed since the administration of labetalol intravenously, as excessive postural hypotension may occur. It is desirable to monitor blood pressure and heart rate after injection and during infusion. In most patients, a small decrease in heart rate occurs; severe bradycardia is unusual, but it can be controlled by injecting 1 to 2 mg of atropine intravenously. Respiratory function should be observed, particularly in patients with any known alteration. Labetalol injectable can be administered as a bolus injection or intravenous infusion. Labetalol injectable has been administered to patients with uncontrolled hypertension who were already receiving other antihypertensive agents, including beta-blockers, without adverse effects.

Maintenance Oral Treatment:

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

Posology: Labetalol S.A.L.F Injectable

• Adults:

• Pediatric Population:

The safety and efficacy of labetalol have not been established in pediatric patients from 0 to 18 years. There are no available data.

Compatibility:

Labetalol should be diluted only with compatible intravenous infusion liquids under aseptic conditions.

Labetalol injectable is compatible with the following intravenous infusion liquids:

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

Incompatibilities:

Labetalol injectable has been shown to be incompatible with Sodium Bicarbonate BP 4.2% P/V injection.

Overdose:

Symptoms and Signs:

Deep cardiovascular effects can be expected, such as excessive postural hypotension and sometimes bradycardia. Oliguric renal failure has been reported after a massive overdose of labetalol orally. In one case, the use of dopamine to increase blood pressure may have worsened renal failure.

Treatment:

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

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