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LABETALOL TABLETS BP 100MG

Active substance(s): LABETALOL HYDROCHLORIDE

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labetalol
#100 mg
tablets

labetalol
#100 mg
tablets

Glue Area

PEEL HERE BUT DO NOT REMOVE

BASE LABEL

100
mg

Labetalol 100 mg
Film-coated Tablets

100
mg

56 film-coated tablets
Each film-coated tablet contains labetalol hydrochloride
100 mg. Contains sucrose. For Oral use as directed by a
doctor. Read the package leaflet before use.
Keep out of the sight and reach of children.
WARNING: Do not take this medicine if you have
wheezing or asthma.
Store in a dry place below 25 °C. Store in the original
package in order to protect from light.
PL 04569/0052 POM
LL0425AF 639608
Mylan, Potters Bar, Hertfordshire
EN6 1TL, United Kingdom

56 film-coated tablets
Each film-coated tablet contains labetalol hydrochloride
100 mg. Contains sucrose. For Oral use as directed by a
doctor. Read the package leaflet before use.
Keep out of the sight and reach of children.
WARNING: Do not take this medicine if you have
wheezing or asthma.
Store in a dry place below 25 °C. Store in the original
package in order to protect from light.
PL 04569/0052 POM
LL0425AF 639608
Mylan, Potters Bar, Hertfordshire
EN6 1TL, United Kingdom

Leave Blank.
Glue Area.

121 22221

- If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

Do not use this medicine after the expiry date which is
stated after EXP on the carton. The expiry date refers to the last
day of that month.

1. What Labetalol is and what it is used for

- The active substance is labetalol hydrochloride. Each tablet
contains 100 mg, 200 mg or 400 mg of the active substance
- The other ingredients are cellulose, microcrystalline, starch,
pregelatinised, sucrose (see section 2, ‘Labetalol contains
sucrose’), sodium starch glycolate, silica, colloidal anhydrous,

coughing or worsening of their symptoms.
Rare (may affect up to 1 in 1,000 people):
• a very slow heart beat
Very rare (may affect up to 1 in 10,000 people):
• shaking (in pregnant women)
• worsening of blood circulation problems
Not known (frequency cannot be estimated from the available
data):
• or dry eyes
• changes in behaviour, mood changes, feeling depressed or
confused, hallucinations
• sleep problems, nightmares
• headache, feeling tired or weak
• a blocked nose
• sweating

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme, at www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

6. Contents of the pack and other information
What Labetalol contains

3

5. How to store Labetalol
Store in a dry place below 25oC. Store in the original package in
order to protect from light.

Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturers:
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, UK
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.

Your medicine comes as round, orange film-coated tablets.
The 100 mg tablets are marked “LL 100” on one side and blank
on the other, the 200 mg tablets are marked “LL 200” on one
side and blank on the other and the 400 mg tablets are marked
“LL 400” on one side and blank on the other.

This leaflet was last revised in: 10/2013

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Do not take Labetalol if you
• are allergic to labetalol hydrochloride or any of the other
ingredients of this medicine (listed in section 6)
• suffer from a slow heart beat (known as bradycardia) or low
blood pressure
• suffer from heart failure which has not improved with
treatment e.g. digoxin
• suffer from missed heart beats (heart block) or a severe
heart condition called cardiogenic shock
• have a heart condition called sick sinus syndrome and do
not have a pacemaker
• have severe blood circulation problems
• have a history of asthma, wheezing or lung disease
• are not eating properly

High blood pressure often causes no obvious symptoms but if
it is not treated it can damage blood vessels in the long-term.
This can lead to heart attacks, kidney failure, stroke or blindness.
This is why it is important not to stop taking this medicine
without talking to your doctor.

Other medicines and Labetalol
Do not take Labetalol if you are already taking any of the
following:
• medicines if given by injection to treat an abnormal heart
rhythm e.g. verapamil, diltiazem, quinidine, amiodarone,

your condition may worsen. If you need to stop taking
Labetalol, your doctor will reduce the dose slowly over 1 or 2
weeks.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Very common (may affect more than 1 in 10 people):
• a positive anti-nuclear antibody blood test

Not known (frequency cannot be estimated from the available
data):
• cough or breathing problems that may indicate
inflammation of the lungs (interstitial lung disease)

Uncommon (may affect up to 1 in 100 people):
Patients with a history of asthma may suffer from wheezing,

If you take more Labetalol than you should

Labetalol with alcohol

If you take too many tablets, tell your doctor immediately or
contact you nearest hospital emergency department. Take
the container and any remaining tablets with you. Overdose
can lead to a drop in blood pressure and slowing of the heart,
difficulty breathing or a drop in blood sugar, which can cause
sweating or confusion.

Do not drink alcohol whilst taking Labetalol as the effects of the
alcohol and Labetalol may be increased.

Unless it is almost time for your next dose, take it as soon as you
remember.
Do not take a double dose to make up for a forgotten dose,
simply take the next dose as planned.
If you stop taking Labetalol

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Very rare (may affect up to 1 in 10,000 people):
• liver problems which may be severe, and may cause your
skin or whites of your eyes to turn yellow (jaundice), dark
urine and pale stools.
• SLE (lupus), a severe skin reaction causing joint pain, skin
rashes and fever
• muscle pain and wasting

Common (may affect up to 1 in 10 people):
• difficulty passing urine
• ejaculation problems, difficulty obtaining or maintaining an
erection
• dizziness
• flu-like symptoms and fever
• tingling in the scalp may occur but wear off in the first few
weeks of treatment.
• raised liver enzymes in the blood

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If you forget to take Labetalol

If any of the following happen, stop taking Labetalol and
tell you doctor immediately or go to the nearest hospital
emergency department:
Common (may affect up to 1 in 10 people):
• allergic reactions causing itchy skin or a rash, shortness of
breath, feeling wheezy, or swelling of the face, mouth or throat











cramps
scaly skin patches
stomach pain, feeling or being sick, diarrhoea
cold or blue fingers and toes, numbness or tingling of hands
and feet
sensitivity to sunlight, worsening of psoriasis
hair loss. This may grow back after stopping treatment
high potassium levels in the blood
low blood platelet count which may cause nose bleeds or
bruising
low blood pressure

Feeling dizzy on standing is an uncommon side effect, but
more likely in patients on high doses or in cases when a dose is
increased too quickly.
Labetalol may mask the symptoms of an overactive thyroid or

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• heart failure, causing breathlessness and swollen ankles,
missed heart beats

Other side effects include:

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• cimetidine, to treat heartburn or ulcers
• anti-inflammatory painkillers e.g. ibuprofen, aspirin,
other medicines used to treat pain, or corticosteroids e.g.
prednisolone
• antimalarial medicines e.g. mefloquine or quinine
• medicines to treat migraine e.g. ergotamine
• alprostadil to treat impotence
• moxisylyte to treat Raynaud’s disease, a condition that
affects the blood circulation to the fingers and toes
• aldesleukin for the treatment of secondary cancer of the
kidney
• hormones such as oestrogen and progesterone used as
contraceptives or for hormone replacement therapy
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.

2
2. What you need to know before you take Labetalol

This helps to lower the pressure of the blood as it travels around
the body. Labetalol is used:
• to treat high blood pressure (hypertension), including high
blood pressure in pregnancy.
• to treat angina (pain in the chest, arms, shoulders or neck
caused by effort, stress or cold weather) in patients with
high blood pressure.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

4 5

previously taken a medicine called tamsulosin
• have diabetes as the symptoms of low blood sugar
(hypoglycaemia) such as shaking and a racing heartbeat,
may be masked by beta-blockers
• experience severe allergic reactions of any kind, as this
medicine may increase the likelihood of such reactions or
affect your response to treatment
• need a urine test, as Labetalol may affect the results of
some tests or you are receiving a procedure called MIBG
scintigraphy (often used to detect certain tumours).

• have liver or kidney problems
• have poor blood circulation e.g. Raynauds disease, as
beta-blockers may worsen the symptoms
• have ever had the skin condition psoriasis (red scaly
patches on the skin)
• need to have surgery and will be given an anaesthetic; tell
your doctor, dentist or hospital staff
• need to have cataract surgery and are taking or have

Labetalol is available in plastic bottles and blister packs of 5, 7,
10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168,
180, 250 and 500 tablets.
Not all pack sizes may be marketed.

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Keep this medicine out of the sight and reach of children.

Warnings and precautions
Talk to your your doctor before taking Labetalol if you

Package leaflet: Information for the patient
Labetalol 100 mg Film-coated Tablets
Labetalol 200 mg Film-coated Tablets
Labetalol 400 mg Film-coated Tablets
(labetalol hydrochloride)

What Labetalol look like and contents of the pack

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• have abnormal levels of acid in your blood (called
metabolic acidosis) sometimes seen in diabetics
• have a rare tumour called a phaeochromocytoma that is
not being treated
• have Prinzmetal’s angina (chest pain while resting).

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the symptoms of low blood sugar (hypoglycaemia) in diabetic
patients.

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help to protect the
environment.

silica, colloidal hydrated and magnesium stearate. The
tablet coating contains hypromellose, macrogol, titanium
dioxide (E171), erythrosine (E127), quinoline yellow (E104)
and carnauba wax.

Marketing Authorisation Holder:

121 22221

1

In this leaflet:
1. What Labetalol is and what it is used for
2. What you need to know before you take Labetalol
3. How to take Labetalol
4. Possible side effects
5. How to store Labetalol
6. Contents of the pack and other information.
Labetalol belongs to a family of medicines known as betablockers. Labetalol works by causing the heart to beat slower
and with less force. It also widens the arteries in the body.

Labetalol 100 mg
Film-coated Tablets

TOP VARNISH AREA

If you stop taking your medicine without telling your doctor,

3. How to take Labetalol

If you are pregnant think you may be pregnant or are planning
to have a baby ask your doctor for advice before taking this
medicine. Labetalol should only be used during the first few
months of pregnancy if the benefits to the mother are likely to
outweigh any possible risk to the unborn baby.
Do not breast-feed your baby unless you have spoken to your
doctor first as Labetalol can pass into your breast milk.

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
• Swallow the tablets whole with food.
• Labetalol is usually taken twice a day; in the morning and
evening.
The recommended doses are:

Driving and using machines
Do not drive or operate machines if you feel dizzy or tired whilst

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Date: 18 May 2015
Description Labetalol Hydrochloride 100mg 56
Component Type Label Leaflet
Affiliate Item Code 639608
Superceded Affiliate Item Code 488278
TrackWise PR No. 639608
MA No. 04569/0052
Packing Site/Printer N/A
Supplier Code LL0425AF
Sign-offs

Pharma Code 669
SAP No. N/A
Vendor Job No. 234299
Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info 5016695640082

No. of colours

11

Adults
Hypertension with or without angina: the starting dose is 100 mg

Page Count

Colours

Black

PMS
1215

PMS
3405

Non-Print
Colours

Braille

Varnish
Free

Keyline

1/1

PMS
306

Equate CMYK
with
Main Font Myriad Pro
Dimensions 52 x 101mm

twice daily, increased every 2 weeks by 100 mg twice a day until
your blood pressure is controlled. In some cases, a daily dose
of up to 2400 mg may be required, divided into three or four
doses per day.
Hypertension in pregnancy: the starting dose is 100 mg twice
daily which may be increased, if necessary at weekly intervals
by 100 mg twice daily. As the pregnancy progresses, the dose
may be further increased to between 100 mg and 400 mg three
times a day. The maximum daily dose is 2400 mg a day.
Use in children: Labetalol should not be given to children.
Elderly: The recommended starting dose is 50 mg twice daily.
If you have liver or kidney problems your doctor may give you
a lower dose.

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Time: 13:55

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Tell your doctor if you are already taking any of the following as
they may interact with your medicine:
• antidepressants e.g. amitriptyline
• barbiturates e.g. phenobarbital, to help you sleep
• other medicines to lower blood pressure e.g. hydralazine,
nifedipine
• medicine given by injection which contains adrenaline
• antidiabetic drugs, including insulin
• other beta-blockers
• medicine for mental illness such as chlorpromazine

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taking Labetalol. Alcohol can make these side effects worse.
Labetalol contains sucrose
If you have been told by your doctor that you have an
intolerance to some sugars, such as sucrose, contact your
doctor before taking this medicine.

Pregnancy and breast-feeding

disopyramide, digoxin or digitoxin
• Clonidine, to treat high blood pressure (hypertension);
if starting Labetalol treatment, your clonidine should be
stopped slowly.
• a medicine to treat mental illness called a MAOI
(Monoamine Oxidase Inhibitor) e.g. phenelzine.

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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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