Prospect: Patient Information

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

labetalol hydrochloride

Read this prospect carefully before starting to take this medicine. It contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, ask your doctor, pharmacist, or nurse.
• If you experience severe adverse effects or any adverse effect not mentioned in this prospect, inform your doctor or pharmacist. See section 4.

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

Labetalol belongs to a group of medications called alpha and beta blockers.These medicationsreduce blood pressure by blocking cardiovascular system receptors (circulatory), resulting in a decrease inblood pressure in blood vessels away from the heart.

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 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 an extremely slow heart rate (severe bradycardia);
• if you have a condition known as Prinzmetal's angina;
• if you have asthma or a similar respiratory disease (chronic obstructive pulmonary disease);
• if you have a particular type of adrenal gland tumour (phaeochromocytoma),not treated with appropriate pharmacological therapy (see section «Warnings and precautions»)

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 had a severe allergic reaction (anaphylaxis) to any substance in the past;
• if you have heart failure or other heart problems (for example, left ventricular systolic dysfunction, first-degree atrioventricular block);
• if you know you are going to have an operation;
• 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 phaeochromocytoma;
• if you have a condition known as ischaemic heart disease;
• if you have any respiratory or respiratory system problems.

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

Surgery

If you are going to have surgery that requires general anaesthesia, you must inform 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. Inform your eye surgeon before the surgery that you are using this medicine. Do not stop taking labetalol unless your eye surgeon tells you to.

Tests

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

Children and adolescents

This medicine should not be given to children or adolescents under 18 years

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

Inform your doctor if you are taking, have taken recently or may have to take any other medicine before they give you labetalol. This is especially important in the case of the following medicines:

• NSAIDs (non-steroidal anti-inflammatory drugs), for example: sulindac or indometacin, used to treat pain and inflammation;
• digoxin (heart medicine)
• adrenaline, which may be used to treat severe allergic reactions (anaphylaxis);
• heart medicines (class I anti-arrhythmic agents, for example, disopyramide and quinidine) and (class II anti-arrhythmic agents, for example, amiodarone);
• other medicines that lower blood pressure (calcium channel blockers, for example, verapamil);
• general anaesthetics (used in surgery for narcosis);
• tricyclic antidepressants, for example; imipramine (used to treat depression);
• oral antidiabetic medicines, for example, biguanides (for example, metformin), sulphonylureas (for example, glimepiride), meglitinides (for example, repaglinide) and alpha-glucosidase inhibitors (for example, 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 (for example, 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 become pregnant, consult your doctor before they give you labetalol. It is possible that the foetus may be affected, but labetalol may be used when rapid control of blood pressure is necessary during pregnancy.

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

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

Driving and operating machinery

No information available.

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

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

This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml ampoule; this is essentially “sodium-free”. However, it may be diluted in 9 mg/ml sodium chloride solution (0.9%) for infusion. This should be taken into account for patients on a controlled sodium diet (see section INFORMATION FOR HEALTHCARE PROFESSIONALS).

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

It is essential that you are lying down when the injection is administered. 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 can be administered as an intravenous bolus injection (when the medication is injected directly into a vein) or as an intravenous infusion (when the medication is injected 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 administered more Labetalol S.A.L.F. than you should

The symptoms of a labetalol overdose include extreme dizziness when standing up (sitting or standing) and, sometimes, a low heart rate that you may feel as a slow pulse (bradycardia).

Contact your doctor or nurse if you think you have been administered too much of this medication.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent: may affect up to 1 in 10 people

• Heart failure
• Dizziness due to low blood pressure if it passes too quickly from a lying to a sitting or from a sitting to a standing position (postural hypotension). This can occur within three hours after the injection of labetalol, 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. It is usually reversible upon discontinuing the medication.
• Erectile dysfunction (impotence)
• Allergic reactions (hypersensitivity) may also include skin rash (of variable severity), itching, difficulty breathing, and, very rarely, fever or rapid skin swelling.

Possibly frequent: may affect up to 1 in 100 people

• Narrowing of the lower airways (bronchospasm)

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

• Low heart rate, which may be perceived as a slow pulse (bradycardia)

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

• Disruption of the electrical impulses that control heartbeats (cardiac block)
• Worsening of symptoms of Raynaud's syndrome (cold fingers due to poor blood circulation)
• Inflammation of the liver (hepatitis) that is usually reversible when treatment with labetalol is discontinued.
• Hepatocellular jaundice (the skin and white of the eyes turn yellow), cholestatic jaundice (symptoms include fatigue and nausea, followed by pruritus, dark urine, and jaundice, and may include skin rash or fever) and hepatic necrosis (damaged liver tissue). These symptoms are usually reversible when treatment with labetalol is discontinued.

Unknown (cannot be estimated from available data)

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

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse. Even if they are possible side effects that do not appear in this prospectus. You can also report them directly through the national notification system:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the ampoule and on the carton after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe signs of deterioration.

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

From a microbiological point of view, the product must be used immediately. If it is not used immediately, storage times and previous use conditions are the responsibility of the user and are normally not greater than 24 hours at a temperature of between 2 and 8°C.

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

What Labetalol S.A.L.F contains

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

Appearance of Labetalol S.A.L.F. and contents of the package

• Clear and colorless solution in transparent glass ampoules. Each package contains 5 ampoules of 20 ml. Each ampoule contains 100 mg of hydrochloride of labetalol (5 mg/ml).

Holder of the marketing authorization and responsible for manufacturing

S.A.L.F. S.p.A. Pharmaceutical Laboratory

via Marconi, 2

24069 Cenate Sotto (BG)

Italy

Tel. +39 035 940097

Local representative

Stragen España

Calle Serrano, 90, 6º

28006 Madrid

Spain

Last review date of this leaflet: July 2024

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

INFORMATION FOR HEALTH PROFESSIONALS

This information is intended solely for healthcare professionals:

Administration:

Labetalol S.A.L.F. is intended for intravenous administration in hospitalized patients and should be administered by healthcare professionals. Patients should receive the medication always in a supine or left lateral position. Avoid lifting the patient before 3 hours of labetalol administration via intravenous, as excessive postural hypotension may occur. It is desirable to control 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 can be controlled by injecting atropine 1 to 2 mg intravenously. Observe respiratory function, 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 hypotensive agents, including beta-blockers, without adverse effects.

Maintenance oral treatment:

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

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

• Adults:

• Pediatric population:

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

Compatibility:

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

Labetalol injectable is compatible with the following intravenous infusion liquids:

• 5% Dextrosa BP.
• 0.18% Sodium Chloride and 4% Dextrosa BP.
• 0.3% Potassium Chloride and 5% Dextrosa BP.
• Sodium Lactate BP compound (Lactate Ringer).
• 0.9% Sodium Chloride.

Incompatibilities:

It has been demonstrated that labetalol injectable is incompatible with 4.2% Sodium Bicarbonate BP 4.2% P/V.

Overdose:

Symptoms and signs:

Deep cardiovascular effects can be expected, for example, excessive postural hypotension and, sometimes, bradycardia. A case of oliguric renal failure has been reported after a 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 a supine position with legs elevated. Adrenergic/anticholinergic therapy should be administered as needed to improve circulation.

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