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LABETALOL TABLETS BP 400MG

Active substance(s): LABETALOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Labetalol Tablets 100 mg, 200 mg and 400 mg
(Labetalol Hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may want to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Labetalol Tablets are and what they are used for
2. Before you take Labetalol Tablets
3. How to take Labetalol Tablets
4. Possible side effects
5. How to store Labetalol Tablets
6. Further Information

1

What Labetalol Tablets are and what they are
used for

The active ingredient of these tablets, labetalol, belongs to a group of
medicines known as adrenergic blocking agents which are used for
the treatment of hypertension (high blood pressure) and angina (chest
pain).
Labetalol Tablets are used to treat high blood pressure. They are also
used to treat angina in patients who also have high blood pressure.

2

Before you take Labetalol Tablets

Do not take Labetalol Tablets if any of the following applies to
you:
• An allergy to labetalol or any of the other ingredients in this
medicine (see section 6 ‘Further information’).
• Heart shock (cardiogenic shock); your heart is unable to supply
enough blood to your body.
• Uncontrolled heart failure.
• Heart block (your blood pressure is very low for a long time or your
heart beats very slowly e.g. second or third degree heart block).
• Chest pain (angina), either at rest or after vigorous action/effort.
• Wheezing, obstructive airways disease or asthma.
• A tumour of the adrenal gland (phaeochromocytoma); your doctor
will tell you if you have this.
• Metabolic acidosis, a condition where there are more acid waste
products than normal in your blood.
• Slow heart beat (less than 45 or 50 beats a minute).
• Low blood pressure (hypotension).
• Poor circulation.
Take special care with Labetalol Tablets
Tell your doctor if any of the following applies to you:
• Heart problems, e.g. a weak heart, poor blood supply to the heart,
digitalis-resistant heart failure or atrio-ventricular block.
• You are about to have an anaesthetic; you must always tell the
anaesthetist or doctor before you have an anaesthetic.
• A circulatory problem (such as Raynaud’s disease).
• Jaundice (yellowing of the skin and whites of the eyes) or liver
problems.
• Kidney problems.
• A history of psoriasis.
• A history of severe allergic reactions.
• You are elderly.
• You are receiving a procedure called MIBG scintigraphy (often used
to detect certain tumors).
Treatment should NOT be suddenly discontinued, especially if you
have a disease of the heart caused by a failure in the blood supply
(ischaemic heart disease).
Labetalol can affect the results of blood tests to check your liver
function. If you are going to have such a test tell your hospital or
surgery that you are taking labetalol.

In particular, tell your doctor if you are taking:
• Medicines for your heart or blood pressure e.g. digitalis, clonidine,
hydralazine, disopyramide, quinidine, amiodarone, calcium
antagonists such as verapamil, diltiazem, nifedipine.
• Drugs for depression such as monoamine oxidase inhibitors and
tricyclic antidepressants, barbiturates and phenothiazines.
• Pain killers such as aspirin.
• Drugs which stimulate the activity of the sympathetic nervous
system such as salbutamol.
• Cimetidine, a drug for stomach ulcers.
• Insulin or oral antidiabetic drugs.
• Prostaglandin synthetase inhibiting drugs - your doctor will tell you
if you are taking these.
Please tell the hospital doctor, anaesthetist or dentist, that you are
taking labetalol. This is important if you are going to have an operation
involving a general anaesthetic.
Taking Labetalol Tablets with food and drink
These tablets should be taken with food.
Do not drink alcohol whilst taking labetalol as it can interfere with the
usual effect of the medicine.
Pregnancy and Breast-feeding
Labetalol should only be taken in the first three months of pregnancy
if considered essential by your doctor.
Labetalol passes into breast milk. Breast-feeding whilst taking
labetalol is not recommended. Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Labetalol may make you feel sleepy and/or dizzy. If affected, do not
drive or operate any tools or machines whilst taking this medicine.
Important information about some of the ingredients of Labetalol
Tablets
• This medicine contains Lactose. If you have been told by your
doctor you have an intolerance to lactose or some sugars contact
your doctor before taking Labetalol Tablets.
• This medicine also contains propyl hydroxybenzoate (E216) and
methyl hydroxybenzoate (E218) which may cause allergic
reactions (possibly delayed).

3

How to take Labetalol Tablets

These tablets should be taken with food. The normal dose of Labetalol
Tablets is as follows:
Adults: When you are prescribed these tablets for the first time, your
doctor will prescribe one 100 mg tablet twice a day (every 12 hours).
Depending upon your response your doctor may increase your
dosage, usually every 2 weeks, although this may be more frequently
if you are in hospital, until your condition has stabilised.
A total daily dose of 800mg may be taken (in very severe cases doses
as high as 2,400mg may be given in which case you will probably be
told to take your tablets 3 or 4 times a day).

Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including those obtained without a prescription.
Continued on the next page >>

You may be given other medicines along with labetalol to help control
your blood pressure, and these, together with the labetalol, will have a
combined effect.
Elderly Patients: An initial dose of 50mg twice daily is
recommended.
Children: Not recommended.
You should always follow your doctor's instructions on taking your
medicine.
Your doctor will tell you how long your treatment with Labetalol Tablets
will last. Do not stop treatment early (see section below on If you stop
taking Labetalol Tablets).
If you have the impression that the effect of labetalol is too strong or
too weak, talk to your doctor or pharmacist.
If you take more Labetalol Tablets than you should
If you have taken more tablets than you should, talk to your doctor or
local hospital accident and emergency department.
If you forget to take Labetalol Tablets
Do not take a double dose to make up for forgotten individual doses. If
you have forgotten to take your medicine, take it as soon as you
remember. If your next dose is due within 2 hours, take the dose now
and skip the next one.
If you stop taking Labetalol Tablets
DO NOT stop taking the tablets until the doctor has told you to. It can
be dangerous to suddenly stop taking them, especially if you have
ischaemic heart disease. The dosage should gradually be reduced,
over 1-2 weeks, if necessary at the same time starting replacement
treatment to prevent a worsening of chest pain (angina pectoris). In
addition, high blood pressure and changes in the rhythm of the heart
beat may develop.
If you have any furter questions on the use of this product, ask your
doctor or pharmacist.

4

Possible side effects











increase of existing leg pain on walking
hallucinations
mental disturbances
confusion
sleep disturbances
nightmares
diarrhoea
wheezing or shortness of breath (in patients with asthma)
masking of the symptoms of high thyroid hormone or low blood
sugar level.

Reports of other effects, which may be related to drugs like labetalol
include:
• blurred vision
• dry eyes
• cramps
Tell your doctor if you experience any of these effects.
Pregnancy
• Tremor has been reported in pregnant women after taking Labetalol
Tablets.
Tell your doctor if you experience this effect.
Taking labetalol during pregnancy may cause problems to your baby
when it is born. The following effects have been reported:
• slow heart rate
• low blood pressure
• breathing problems
• low blood sugar level
• low body temperature
These effects are rare and the baby will usually respond quickly to
treatment.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5

How to store Labetalol Tablets

Keep out of the reach and sight of children.
Keep this medicine in a cool dry place and protect from light.

Like all medicines Labetalol Tablets can have side effects, although
not everybody gets them.

Do not use Labetalol Tablets after the expiry date which is stated on
the blister or carton. The expiry date refers to the last day of that month.

The following side effects have been reported rarely:
• Allergic reactions (rash, itching, swelling, difficulty breathing).
• Problems with the normal function of the body’s immune system.
• Slowing of the heart and heart block (where the heart signals are
delayed).
• Other rashes.
• Liver problems, including jaundice.

Do not use Labetalol Tablets if you notice any defects such as chips or
discolouration, take them to your pharmacist for advice.

The following side effects have been reported very rarely:
• Drug fever (you may feel hot and flu-like).
• Muscle disease (toxic myopathy); you may experience muscle
cramps, stiffness, and/or spasm.
Tell your doctor immediately or go to the casualty department at
your nearest hospital if you notice any of the above effects.
Tell your doctor if you experience any of the following side effects,
which should wear off in the first few weeks:
• headache
• tiredness
• depression
• lethargy
• dizziness
• sweating
• blocked nose
• swollen ankles
• tingling of the scalp
• feeling faint or dizzy on standing up
• difficulty in passing urine
• ejaculatory problems
• stomach pain
• feeling sick
• being sick
Other possible side effects include:
• heart failure
• cold or blue extremities
• poor circulation in the hands (Raynaud’s disease)
• a numbness/tingling sensation in the fingers and toes (paraesthesia)

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6

Further information

What Labetalol Tablets contains
The active substance is labetalol hydrochloride. Each tablet contains
100 mg, 200 mg or 400 mg of labetalol hydrochloride.
Other ingredients include: lactose, maize starch, magnesium stearate,
hydroxypropyl methylcellulose, colour containing titanium dioxide
(E171) and sunset yellow (E110), methyl hydroxybenzoate (E218),
propyl hydroxybenzoate (E216).
What Labetalol Tablets look like
Labetalol Tablets 100mg are orange, circular, biconvex, film-coated
tablets engraved with ‘100 LAB’ on one side and plain on the other.
Labetalol Tablets 200mg are orange, circular, biconvex, film-coated
tablets engraved with ‘200 LAB’ on one side and plain on the other.
Labetalol Tablets 400mg are orange, circular, biconvex, film-coated
tablets engraved with ‘400 LAB’ on one side and plain on the other.
Labetalol Tablets are supplied in blister pack sizes of 56 tablets.
Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, UK.
This leaflet was last approved in 09/2010 (tbaaa).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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