Labetalol 5 mg

Labetalol 5 mg/mL RBC belongs to a group of medicines called beta blockers. Labetalol 5 mg/mL RBC decreases high blood pressure by reducing the rate and force of the heartbeat and by widening arteries and helping blood flow. Labetalol 5 mg/mL RBC is given in the hospital. Labetalol 5 mg/mL RBC is used when a person’s blood pressure needs to be reduced very quickly. It can be used to lower very high blood pressure in pregnant women. Labetalol 5 mg/mL RBC is sometimes used by anaesthetists to keep your blood pressure down during operations. If you are not sure why you have been given this injection, ask your doctor.

Labetalol 5 mg/mL RBC should not be given to you if:

• you are hypersensitive (allergic) to labetalol or any of the other ingredients of Labetalol 5 mg/mL RBC (listed in section 6).
• you have a second or third-degree heart block, or a condition where your heart suddenly can’t pump enough blood (cardiogenic shock), chest pain caused by reduced blood flow to the heart (angina) or any other heart problem causing very low blood pressure or a slow heartbeat.
• you have low cardiac output (where not enough blood is being squeezed out of the heart with each beat) after a heart attack.
• your heart cannot maintain adequate circulation of blood (cardiogenic shock).
• you have heart failure that is out of control or not responding to treatment with digitalis.
• you have a heart defect (heart block) that leads to a decreased function of the heart.
• your heart has difficulty pumping the proper amount of blood to the body’s tissues.
• you have a problem that is common in the elderly, related to poor control of the working of your heart (sick sinus syndrome).
• you suffer from angina (chest pains) when at rest.
• you suffer from wheezing, obstructive airways disease or asthma – taking Labetalol 5 mg/mL RBC can make your breathing worse.
• you have a weak heart or a very slow heartbeat (less than 45 or 50 beats per minute).
• you are breastfeeding.
• you have a tumour near your kidneys (phaeochromocytoma)
• you have increased acid levels in the blood (metabolic acidosis)
• you have low blood pressure (hypotension)
• you have very bad circulation, especially in your hands and feet.

Labetalol 5 mg/mL RBC is not suitable for children.

Labetalol 5 mg/mL RBC is given in hospital as an injection into a vein by a person who is qualified to do so. You will never be expected to give yourself Labetalol 5 mg/mL RBC. You should only be given this medicine if you are lying down. You should not start to sit upright within three hours of starting a Labetalol 5 mg/mL RBC infusion; otherwise, your blood pressure could drop down too far, making you feel very dizzy and faint. Your doctor will calculate your dose, depending on the reason why your blood pressure needs to be lowered and how quickly this needs to happen. If you have the impression that the effect of Labetalol 5 mg/mL RBC is too strong or too weak, tell your doctor or pharmacist. Your doctor will do regular blood tests to make sure Labetalol 5 mg/mL RBC is working for you.

Like all medicines, Labetalol 5 mg/mL RBC can cause side effects, although not everybody gets them. If side effects occur, they usually do so while you are asleep. Your doctor will monitor these effects during your operation. Not all side effects reported for Labetalol 5 mg/mL RBC are included in this leaflet. Should your general health worsen while receiving Labetalol 5 mg/mL RBC, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happens, stop receiving Labetalol 5 mg/mL RBC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• severe skin rash, itching or hives
• swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Labetalol 5 mg/mL RBC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• jaundice (yellowing of your skin), liver problems (hepatitis)
• Labetalol 5 mg/mL RBC can cause bradycardia (slow heart rate) and heart block (slow irregular heartbeats). Your doctor or nurse will monitor you carefully for signs of these side effects
• heart failure causing shortness of breath with swelling of the feet and ankles. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• faintness or dizziness in the first few hours after being given Labetalol 5 mg/mL RBC
• rashes
• mental disturbances such as confusion or disorientation,
• heart pain or heart attack
• decreased blood pressure
• stuffiness in your nose
• evidence of liver or kidney damage
• raised liver functional tests
• muscle spasm
• not being able to ejaculate

Less frequent side effects:

• high body temperature
• high potassium levels in the body
• sleep disturbances
• nightmares
• mood depression
• imaginings
• headache,
• tiredness,
• dizziness,
• tremor
• impaired vision
• eyes are feeling dry
• decreased heart rate
• heart block
• abnormal liver functions
• sweating
• worsening of Raynaud’s syndrome
• difficulty breathing because the airways have narrowed
• swelling (fluid accumulation)
• decreased sugar levels

If you notice any side effects not mentioned in the leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or health care professional. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of Labetalol 5 mg/mL RBC.

Storage will be handled by healthcare professionals. Store at or below 25 º C. Keep the vials in the carton until required for use. Do not use it after the expiry date on the label and carton. Do not throw medicines in drains or sewerage systems (e.g., toilets). Keep all medicines out of reach and sight of children.