TRANDATE 5 MG / ML SOLUTION FOR INJECTION, LABETALOL HYDROCHLORIDE 5 MG / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

3. How you will be given Labetalol Injection

Labetalol Injection is usually only given to patients in hospital by a doctor or anaesthetist. It may be given as an injection into a vein, or by a slow drip, depending on how quickly your blood pressure needs to be reduced.

IMPORTANT: Your doctor will decide how the Labetalol

Injection will be given to you and the correct dose for you.

Remember: You should only be given this drug if you are lying down.

You should avoid sitting upright for three hours after being given Labetalol Injection as you may feel very dizzy and lightheaded.

While you are having Labetalol Injection your doctor may check your heart rate, blood pressure and breathing, to check your medicine is working properly.

Adults:

Injection into a vein (to reduce blood pressure very quickly)

• A dose of 50mg of Labetalol Injection will be given into your vein over a period of one minute.
• If necessary this dose can be repeated every five minutes up to three times until your blood pressure has been lowered.

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• The amount of the solution you will be given will depend on why your blood pressure needs to be lowered:

• 1. To lower high blood pressure in pregnancy

• 20mg of Labetalol Injection will be given over one hour.
• The dose may then be doubled every 30 minutes until your blood pressure has been reduced or the dose has reached 160mg per hour.
• Your doctor may occasionally need to use a higher dose.

• 2. To lower high blood pressure after a heart attack

• 15mg of Labetalol Injection will be given over one hour.
• The dose may then be gradually increased up to a maximum of 120mg per hour if needed.

• 3. To lower high blood pressure for other reasons

• 2mg of Labetalol Injection will be given per minute.
• When your blood pressure is low enough, the doctor will stop your drip.
• Your doctor may change the rate at which the drip goes in depending on how well you are responding to the medicine.
• The total dose given is usually between 50mg and 200mg, but occasionally higher doses may be needed.

To lower blood pressure during an operation

• Whilst you are under anaesthetic, 10–20mg Labetalol Injection (depending on your age and health) will be injected into your vein.
• If after five minutes your blood pressure has not been reduced, a dose of 5–10mg can be given every five minutes until your blood pressure is low enough.

Maintaining your blood pressure

• After you have had Labetalol Injection your doctor may suggest you take labetalol tablets to keep your blood pressure low.
• If this applies to you, your doctor or pharmacist will tell you exactly how many tablets to take and when to take them.

People with liver or kidney problems:

If you have problems with your liver or kidneys, your doctor may give you a lower dose of Labetalol Injection.

The elderly (65 years and over):

Your doctor may start you on a lower dose than the usual adult dose to make sure that the medicine is working properly.

Children:

Labetalol Injection is not recommended for use in children.

If you are given more Labetalol Injection than you should

If you think you may have been given too much Labetalol Injection, tell your doctor immediately.

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

4. possible side effects

Like all medicines Labetalol Injection can cause side effects, although not everybody gets them.

Remember:

You should avoid sitting upright for three hours after being given Labetalol Injection as you may feel very dizzy and lightheaded.

Stop using Labetalol Injection and seek immediate medical help if you have an allergic reaction. This includes any of the following symptoms:

• Difficulty in breathing
• Swelling of your eyelids, face or lips
• Rash or itching

Most of the side effects related to Labetalol Injection will wear off after the first few weeks. These include:

• headaches, tiredness or dizziness
• depression or exhaustion (lethargy)
• tingling of the scalp, or a blocked nose
• swollen ankles or sweating
• difficulty passing urine or not being able to pass urine
• not being able to ejaculate
• stomach pain, feeling sick or being sick
• the shakes after taking labetalol when pregnant
• dizziness when standing up
• low blood pressure (hypotension)
• poor circulation in the hands, cold or blue extremities, numbness or tingling of the extremities
• increase of existing leg pain on walking
• mental disturbances such as delusions and altered thought patterns, hallucinations or confusion
• sleep disturbances including nightmares
• diarrhoea
• wheezing or shortness of breath (in patients with asthma)
• the symptoms of an overactive thyroid (increased heart rate) or low blood sugar (as seen in blood test results) may be hidden
• high blood potassium levels (hyperkalaemia) especially if you have reduced kidney function
• hair loss; this may grow back after stopping treatment
• worsening of psoriasis
• heart failure causing shortness of breath with swelling of the feet and ankles
• poor blood circulation leading to nipple pain, cold or blue extremities with numbness or tingling in your fingers and toes

If any of these side effects occur, speak to your doctor immediately:

• problems with the immune system (e.g. systemic lupus erythematosus) causing shortness of breath, joint pain, or a rash on the cheeks and arms that worsen with sun exposure
• thrombocytopenia causing nosebleeds or bleeding in the mouth or bruising because your blood does not clot as it should
• drug fever making you feel hot and flu-like
• muscle disease (toxic myopathy) causing weakness and wasting of the muscles in the arms and legs
• flat topped bumps on your skin that join up into scaly patches (lichenoid rash)
• blurred vision or dry eyes
• cramps
• liver problems or jaundice causing discomfort and tenderness in the upper abdomen, yellowing of the skin and whites of the eyes
• slowing of the heart and heart block (where the heart signals are delayed causing your heartbeat to slow to 20–40 beats per minute)
• cough or breathing problems that may indicate inflammation of the lungs (interstitial lung disease)

Rare side effects on your baby

If you are being treated for high blood pressure during pregnancy, your baby may suffer the following effects for a few days after birth:

• low blood pressure
• slow heartbeat
• shallow or slow breathing
• low blood sugar
• feeling cold

Reporting of side effects

If you get 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 Yellow Card Scheme

Website: , or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store labetalol injection

Keep out of the sight and reach of children.

Do not use Labetalol Injection after the expiry date which is stated on the carton and the ampoule label. The expiry date refers to the last day of that month.

Store below 30°C.

Keep the ampoules in the original packaging in order to protect from light.

For single use only. Once opened use immediately. Discard any unused material.

Medicines should not be disposed of via wastewater or household waste.

Return any medicine you no longer need to your pharmacist.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6. Further information

What Labetalol Injection contains

• – The active ingredient is labetalol hydrochloride. Each 1ml of liquid contains 5mg of the active ingredient.

• – The other ingredients are dilute hydrochloric acid (E507), sodium hydroxide (E524), for pH adjustment, and water for injections.