Active ingredient
- labetalol hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 36301/0053.
Labetalol Hydrochloride 5mg/ml Solution for Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Labetalol Hydrochloride 5mg/ml Solution for Injection
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Labetalol Injection is for
2. Before you are given Labetalol Injection
3. How you will be given Labetalol Injection
4. Possible side effects
5. How to store Labetalol Injection
6. Further information
1.What Labetalol Injection is for
Labetalol Injection belongs to a group of medicines called beta blockers.
Labetalol Injection works by causing the heart to beat more slowly and with less force. It also widens the arteries in the body. This helps to lower the pressure of the blood as it travels around the body. The result is a rapid lowering of a person’s blood pressure.
Labetalol Injection is given in hospital and can be used to:
It is very important that the doctor treats your high blood pressure, because left untreated it can cause damage to your blood vessels in the long-term. This could lead to heart attacks, kidney failure, stroke or blindness.
2. Before you are given Labetalol Injection
Do not use Labetalol Injection if:
This medicine is not suitable for children.
If any of the above applies to you, talk to your doctor.
Check with your doctor before you are given Labetalol Injection if:
Tell your doctor if you are taking any of the following medicines:
Taking Labetalol Injection, at the same time as the drugs mentioned for treating your heart or blood pressure, can lead to a severe drop in blood pressure, reduced heart rate, heart failure or heart block. It is important to tell your doctor if you are taking these or any of the other drugs listed above.
The results of blood or urine tests may be affected by taking labetalol. If you need to have a blood or urine test, tell your doctor that you have been given Labetalol Injection.
Pregnancy and breast-feeding
Labetalol Injection should only be used during the first three months of pregnancy if it is absolutely necessary. Therefore, tell your doctor if you are pregnant or trying to become pregnant.
Labetalol Injection is not recommended whilst breast-feeding.
Driving and using machines
You may feel dizzy or tired when taking Labetalol Injection. If this happens to you, do not drive or operate machinery.
Important information about some of the other ingredients in Labetalol Injection
This medicinal product contains less than 1mmol (23mg) of sodium (salt) per 20ml vial, i.e. essentially sodium (salt) free.
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)
Slow drip into a vein (to reduce blood pressure more slowly)
1. To lower high blood pressure in pregnancy
2. To lower high blood pressure after a heart attack
3. To lower high blood pressure for other reasons
To lower blood pressure during an operation
Maintaining your blood pressure
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.
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:
Most of the side effects related to Labetalol Injection will wear off after the first few weeks. These include:
If any of these side effects occur, speak to your doctor immediately:
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:
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
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
What Labetalol Injection looks like
Labetalol Hydrochloride 5mg/ml Solution for Injection is a clear colourless solution.
Labetalol Injection comes in 20ml glass ampoules, with five ampoules in each pack.
Marketing Authorisation Holder
Manufacturer
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
This leaflet was last revised 06/2020
RMI6000877.00
Lagervagen 7, Jordbro, Sweden
+44 (0)845 023 0467
+44 207 862 1716
+44(0)845 023 0467
+44(0)845 023 0467