TRANDATE™

Labetalol hydrochloride injection 5 mg/mL

What is in this leaflet

Please read this leaflet carefully before you are given TRANDATE.

This leaflet answers some common questions about TRANDATE. It does not
contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the expected
benefits of you receiving TRANDATE against the risks this medicine could have
for you.

If you have any concerns about being given TRANDATE, ask your doctor or
pharmacist.

Keep this leaflet. You may need to read it again.

What TRANDATE is used for

TRANDATE contains the active ingredient labetalol.

TRANDATE is used for:

• Rapidly lowering very high blood pressure (also called severe
  hypertension).
• Lowering blood pressure during an operation requiring certain types of
  anaesthetics (drugs used to put you to sleep during the operation).
• Quickly lowering high blood pressure if necessary after a heart attack.

Your doctor may have prescribed TRANDATE for another purpose.

Blood pressure is a measurement of the force exerted by the blood circulating
in your arteries. It is shown as two values. The first measures blood pressure
while the heart muscle is contracting to squeeze out blood (systolic pressure).
This is the higher figure. The second measures blood pressure when the heart
muscle relaxes between contractions (diastolic pressure). This is the lower
figure.

Blood pressure varies from one person to the next, but usually increases as
we get older. If you have blood pressure, which is higher than normal when
measured on three separate occasions, your doctor may diagnose hypertension.
High blood pressure does not necessarily cause symptoms. However, if it is
severely raised, you may get headaches and palpitations, and feel quite unwell.
It is important to reduce high blood pressure because it can cause stroke, heart
attack, heart failure and damage to other body organs, especially the kidneys.

TRANDATE belongs to a group of medicines called antihypertensives. Within
this group it belongs to a class of medicines called beta-blockers. TRANDATE
decreases high blood pressure by reducing the rate and force of the heartbeat
and by widening arteries and helping blood flow.

Ask your doctor if you have any questions about why TRANDATE has been
prescribed for you.

TRANDATE is available only with a doctor's prescription, and is given as an
injection by a doctor or nurse in hospital.

Before you are given TRANDATE

When you must not be given it

You should not be given TRANDATE if:

• You have had an allergic reaction before to labetalol or any of the other
  ingredients in TRANDATE injection listed at the end of this leaflet.
• The packaging or ampoule containing TRANDATE is torn, broken or shows
  signs of interference, or if the TRANDATE solution is discoloured or cloudy.
• If the ampoule containing your TRANDATE injection has been open for more
  than 24 hours.
• The expiry date on the packaging has passed. If you are given this
  medicine after the expiry date has passed, it may not work as well.
• If you have second or third degree heart block, cardiogenic shock, 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.
• You have asthma or another ongoing lung problem causing breathing
  difficulties.

Tell your doctor if:

• You are pregnant or plan to become pregnant.

TRANDATE is sometimes used to control pre-eclampsia (high blood pressure
brought on by pregnancy). As with all medicines used to lower high blood
pressure, TRANDATE may have unwanted effects in an unborn or new-born baby.
Your doctor will weigh up the benefits of you receiving TRANDATE against the
risks to your baby.

If you are trying to get pregnant and need a TRANDATE injection for another
condition, please tell your doctor.

• You are breastfeeding or plan to breastfeed.

The active ingredient in TRANDATE, labetalol, passes into breast milk. No
problems have been found in babies breastfed by mothers who have received
TRANDATE.

Do not breastfeed after receiving a TRANDATE injection until you doctor
says it is all right to do so.

• You are allergic to any other medicines, insect stings, foods, dyes or
  preservatives.

This is particularly important if you have had a sudden severe
(anaphylactic) reaction to anything in the past.

• You have liver damage or liver disease.
• You have heart disease or a blood disorder.
• You are about to have an operation which will require anaesthesia (a
  medicine that will put you to sleep during the operation)

If you have not told your doctor about any of the above, please do so before
being given TRANDATE.

Taking other medicines

Some medicines may affect the way others work.

Tell your doctor if you are taking any other medicines, including the oral
contraceptive pill or medicines you buy without a prescription from a pharmacy,
supermarket or health food shop.

If you are taking any of the following types of medicines, please let your
doctor know before you are given TRANDATE:

• Class I anti-arrhythmic agents for irregular heart rhythms or medicines
  known as calcium channel blockers, which are used for high blood pressure,
  coronary artery disease (affecting blood vessels in the heart), and irregular
  heart rhythms.
• Non-steroidal anti-inflammatory medicines for relieving pain, stiffness
  and inflammation.

Your doctor or pharmacist will be able to tell you the trade names of the
above types of medicines, and about what to do when you are given TRANDATE while
taking other medicines.

How TRANDATE is given

How much you will be given

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 your blood pressure needs to be lowered urgently, you may be given a bolus
(concentrated dose) injection containing 50mg TRANDATE over one minute, followed
by up to four more injections every five minutes until your blood pressure comes
down.

If you have pre-eclampsia (high blood pressure caused by pregnancy), very
high blood pressure after a heart attack or from some other cause, or if there
is a need to lower your blood pressure when you are put to sleep for an
operation, you may be given a much slower continuous infusion (by a drip in a
vein) for up to several hours. The amount of TRANDATE you are given will depend
on the reason why your blood pressure needs to be lowered.

You should always start to sit upright within three hours of starting a
TRANDATE infusion, otherwise your blood pressure could drop down too far, making
you feel very dizzy and faint.

Your doctor will do regular blood tests to make sure TRANDATE is working for
you.

How TRANDATE is given

TRANDATE is given in hospital as an injection into a muscle by a doctor or
nurse while you are lying down.

In case of an overdose

If you think that you or anyone else has been given too much TRANDATE tell
your doctor or nurse immediately. Do this even if there are no signs of
discomfort or poisoning. You may need urgent medical attention.

An overdose of TRANDATE can cause extremely low blood pressure, a slow
heartbeat, difficulty breathing and, rarely, kidney damage.

Side effects

TRANDATE is usually well tolerated. However, like all medicines, TRANDATE can
have unwanted side effects. Sometimes they may be serious, but often they are
not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Be sure that your doctor or nurse knows as soon as possible if you do not
feel well when you are being given TRANDATE.

If you think TRANDATE is causing you to have an allergic (hypersensitivity)
reaction, TELL YOUR DOCTOR IMMEDIATELY. Symptoms include:

• Severe skin rash, itching or hives.
• Swelling of the face, lips, mouth or throat.
• Difficulty breathing or swallowing.

Tell your doctor or nurse if you notice any of the following:

• Faintness or dizziness in the first few hours after being given a bolus
  injection, or after starting a slow infusion.
• Stuffiness in your nose.
• Jaundice (yellowing of your skin), liver problems (hepatitis)

Tell your doctor if you notice anything else that is making you feel unwell,
even if it is not mentioned here.

Very occasionally, normal doses of TRANDATE can cause bradycardia (slow heart
rate) and heart block (slow irregular heartbeats). Your doctor or nurse will be
watching you carefully for signs of these.

Ask your doctor or pharmacist if you do not understand anything about the
possible side effects of TRANDATE mentioned here.

After TRANDATE has been given

Storage

TRANDATE is stored in a hospital ward or pharmacy in a dry place where the
temperature stays below 30°C.

Disposal

Hospital staff will dispose of any TRANDATE solution left over after your
injection or infusion is finished.

Product description

What TRANDATE looks like

TRANDATE is a clear colourless liquid supplied in a glass ampoule holding
20ml of solution, equivalent to labetalol 100mg.

Ingredients

Injection

Labetalol

Dilute hydrochloric acid or sodium hydroxide

Water

Infusion

When TRANDATE is to be given as an infusion, the ingredients listed above for
the injection are diluted with a very weak solution of one of the following
fluids:

• Sodium chloride
• Sodium chloride and dextrose
• Potassium chloride and dextrose
• Compound sodium lactate

Further information

Your doctor is the best person to give you advice on the treatment of your
condition. You may also be able to find general information about its treatment
from other sources, for example, books in public libraries and on the Internet.