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PINDOLOL TABLETS 5MG

Active substance(s): PINDOLOL

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BASE LABEL

101.00 mm

81.00 mm
26.00 mm

Superceded Affiliate Item Code 10002986
TrackWise PR No. 457773
MA No. 04569/0118
Packing Site/Printer Gerard
Supplier Code LL0430AE

Pharma Code TBC
SAP No. N/A
Vendor Job No. N/A
Proof No. 3
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Colours
Non-Print
Colours

4

1/1

Page Count
Black

383

Process
Blue

Varnish
Free

Braille

Keyline

306

Equate CMYK
with
Main Font Humanist

Body Text Size

9 pt

GLUE AREA

Dimensions 101 x 52 mm

12.00 mm

65.00 mm

24.00 mm

20.00 mm

pindolol
#5 mg
tablets

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PEEL HERE BUT DO NOT REMOVE

FRONT FACE
5
mg

REVERSE

Pindolol 5 mg
Tablets

5
mg

100 Tablets

21122222

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Manufacturer
Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13,
Ireland.

pharmacist how to throw away
medicines you no longer use. These
measures will help to protect the
environment.

4. Possible side effects
5. How to store Pindolol
6. Contents of the pack and other
information

6. Contents of the pack and other
information

1. What Pindolol is and what it is used
for

What Pindolol contains
The active substance is pindolol. Each tablet
contains 5 mg pindolol.The other
ingredients are cellulose, microcrystalline
; starch, pregelatinised; magnesium
stearate and colloidal silicon dioxide.

Pindolol belongs to a class of medicines
called beta-blockers, which help slow the
heartbeat and relax blood vessels. This
reduces blood pressure and the heart’s
demand for oxygen.
Pindolol is used to treat the following

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

(listed in section 6)
• if you have a history of breathing
difficulties or wheezing, asthma or
other lung disorders
• if you have heart problems such as
uncontrolled heart failure, unstable
angina (Prinzmetal’s angina), heart
block, a slow heart rate (less than
45-50 beats per minute) or irregular
heart beat, low blood pressure or bad
circulation
• if you have a type of tumour called a
phaeochromocytoma that is not
being treated

You can also report side effects directly
via the Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the safety
of this medicine.

• seeing, feeling or hearing things that
are not there (hallucinations),
• depression (feeling sad)
• diarrhoea, nausea (feeling sick) and
being sick
• insomnia (difficulty sleeping), sleep
disturbance, nightmares
• headaches
• epigastric pain (pain in the abdomen)
• fatigue
• dizziness, confusion
• impaired vision, dry eyes
• slow or irregular heartbeat
• hypotension (low blood pressure)

If you think you may have any of the
following side effects, contact your
doctor or go to your nearest hospital
emergency room immediately. The
frequency of these side effects is not
known (frequency cannot be estimated
from the available data:
• allergic skin reactions

Chest pain (angina pectoris): The
recommended dose is 2.5 mg or 5 mg up
to three times a day.

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PINDOLOL 5 mg TABLETS

Use in children and adolescents
Pindolol is not recommended for use in
children or adolescents.
If you take more Pindolol than you
should
If you have taken more tablets than you
should, you must seek medical help
immediately. In case of an overdose you
may experience a slow heartbeat.

Driving and using machines
Pindolol are unlikely to have a serious
effect on your ability to drive or use
machinery. On rare occasions though
you may feel a bit dizzy or more tired
than usual. If this happens, do not drive
or operate machinery.
3. How to take Pindolol
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

doctor tells you to, as this could make
your condition worse (see section 4
‘Possible side effects’)
• if you have allergies as beta-blockers
may increase allergies and the
seriousness of an allergic reaction
• if you suffer from heart conditions
such as heart failure, a slow heart rate
(50-55 beats per minute), heart block
(due to abnormal heart function) or
not enough blood supply to your
heart (ischaemic heart disease)
• if you have recently suffered a
myocardial infarction (heart attack)

• if you have an overactive thyroid
gland, as Pindolol can hide some of
the symptoms associated with this
condition.
if you need any form of surgery Pindolol
may react with certain anaesthetics used
in operations (e.g. halothane,
cyclopropane, trichloroethylene, ether,
chloroform); therefore you should tell the
medical staff at the hospital or dentist
that you are taking Pindolol.
Beta-blockers can cause skin rashes
and/or dry eyes. If you have these
symptoms do not stop taking your

• calcium channel blockers for high
blood pressure or chest pains (angina)
such as verapamil or diltiazem Do not
take Pindolol at the same time as
these medicines
• medicines for depression, such as
moclobemide (MAO inhibitors),
tricyclic antidepressants
• barbiturates, used for epilepsy or to
help you sleep
• medicines for feeling sick (nausea) or
mental problems, such as chlorpromazine
(phenothiazines)
• reserpine (used for mental problems

heartbeat such as quinidine,
disopyramide, amiodarone
• medicines for heart failure, such as
digoxin (digitalis glycosides),
adrenaline, ephedrine, dopamine
(sympathomimetic amines)
• xanthines (used for asthma, e.g.
theophylline)
• cimetidine (for stomach ulcers and
indigestion) medicines to relieve pain
and inflammation, such as ibuprofen,
indomethacin, naproxen, diclofenac
(non-steroidal anti-inflammatory
drugs − NSAIDs)

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What is in this leaflet:
1. What Pindolol is and what it is used for
2. What you need to know before you
take Pindolol
3. How to take Pindolol

conditions:
• high blood pressure (hypertension)
• chest pain (angina): Pindolol helps
prevent or reduce chest pains which
may occur when your heart cannot
get enough oxygen, such as when
doing exercise.
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2. What you need to know before you
take Pindolol
Do not take Pindolol:
• if you are allergic to pindolol or any of
the other ingredients of this medicine

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• if you have severe kidney failure
• if you are fasting for a long time
• if you have metabolic acidosis (when
your blood becomes too acid)
• if you are also taking a type of
medicine called a calcium channel
blocker (e.g. verapamil).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Pindolol:
• if you have asthma or chronic
obstructive lung disease. Pindolol
should not be taken unless your

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This page is intetionally blank

What Pindolol looks like and contents of
the pack
Pindolol Tablets are white, flat bevelled
edged tablets, marked 'PL' breakline '5'
on one side of the tablet and “G” on the
reverse.

5. How to store Pindolol
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date, which is stated on the label, carton
or foil after ‘EXP’. The expiry date refers to
the last day of that month.

• a cold or numb feeling in your fingers or
toes, which may also have a blue tint
(Raynaud’s syndrome) or worsening of
circulation problemspins and needles,
numbness or tingling of hands and feet
• muscle cramps
• shaking (tremor)
• inability to get or maintain an erection
(impotence)
• increase in antibodies in the blood
• beta-blockers may mask the symptoms
of high levels of thyroid hormones in
the blood (thyrotoxicosis) or low blood
sugar levels (hypoglycaemia).

medicine but tell your doctor or
pharmacist. Stopping this medicine must
be done gradually.

If you forget to take Pindolol
Take the next dose as soon as you
remember unless it is almost time for
your next dose. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Pindolol
Do not stop taking Pindolol unless your
doctor has told you to do so. Stopping
treatment with beta-blockers such as
Pindolol should always be gradual.

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If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Adults and the Elderly
High blood pressure (hypertension): The
recommended starting dose is one 5 mg
tablet taken 2 or 3 times per day (10 mg
to15 mg daily) or 3 tablets (15 mg) taken
once a day with breakfast. Your doctor
may gradually increase the dose
according to your response. The
maximum dose is
45 mg (9 tablets) daily.
If necessary your doctor may also
prescribe other antihypertensive
medicine to help reduce your blood
pressure.

• insulin and oral antidiabetic medicines
to treat diabetes, such as metformin.

Pregnancy and breast-feeding
Do not take this medicine if you are
pregnant. As small amounts of pindolol
may pass into the breast-milk, do not
take this medicine while you are
breast-feeding.

Pindolol with alcohol
Do not drink alcohol as it may increase the
effect of this medicine.

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Other side effects
Frequency not known (frequency cannot
be estimated from the available data):

and high blood pressure but only
available outside the UK market)
• clonidine (for high blood pressure or
migraine). If you are taking clonidine
and Pindolol together, do not stop
taking clonidine unless your doctor
tells you to do so. If you have to stop
taking clonidine, your doctor will give
you careful instructions about how to
do it
• other medicines for high blood
pressure or chest pains (angina)such
as nifedipine or hydralazine
• medicines for regulating the

Surgery
Pindolol may react with certain
anaesthetics used in operations (e.g.
halothane, cyclopropane,
trichloroethylene, ether, chloroform).
So in the event that you need any form of
surgery, you should tell the medical staff
at the hospital that you are taking Pindolol.

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Store below 25 ˚C. Store in the original
package in order to protect from light.
Do not throw any medicines via
wastewater or household waste. Ask your

• a severe mental condition in which the
person loses contact with reality and is
unable to think and judge clearly
(psychoses)
• disease of the heart with shortness of
breath and swelling of the feet or legs
due to fluid build-up (heart failure)
• difficulty in breathing or wheezing
(bronchospasm) in patients with
asthma or a history of asthma.

Children and adolescents
Pindolol is not recommended for use in
children or adolescents.

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Pindolol Tablets are available in
containers or blister packs of 5, 7, 10, 14,
15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100,
112, 120, 168, 180, 250, 500 and 1000
tablets.
Not all pack sizes may be marketed.

• if you have low blood sugar levels or
are using medicines for diabetes.
Pindolol may hide an increase in your
heart rate, which is one of the warning
signs of low blood sugar levels
• if you suffer from attacks of headache,
sweating, palpitations, flushing of the
face or pains in the chest or stomach
caused by a rare tumour called a
phaeochromocytoma
• if you have a history of a common skin
disorder known as psoriasis
• if you have kidney problems. You may
require a lower dose than stated

Other medicines and Pindolol
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. In particular tell
your doctor if you are taking any of the
following medicines:

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LL0430AE
457773

- 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.
- 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.

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

This leaflet was last revised in: 07/2013

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

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02

Each tablet contains: Pindolol 5 mg.
Also contains: microcrystalline cellulose. Dosage:
For oral use as directed by a doctor. Read the
attached leaflet. Do not take this medicine if you
have a history of wheezing or asthma. Keep
out of the sight and reach of children. Store below
25°C. Store in the original package in order to
protect from light.
PL 4569/0118 POM
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

(pindolol)
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.

4. Possible side effects

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LEAVE BLANK

01

LL0430AE
457773

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6
1TL. United Kingdom

30

Pindolol 5 mg
Tablets
100 Tablets

Each tablet contains: Pindolol 5 mg.
Also contains: microcrystalline cellulose. Dosage:
For oral use as directed by a doctor. Read the
attached leaflet. Do not take this medicine if you
have a history of wheezing or asthma. Keep
out of the sight and reach of children. Store below
25°C. Store in the original package in order to
protect from light.
PL 4569/0118 POM
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.

52.00 mm

Component Type Label Leflet
Affiliate Item Code 457773

No. of colours

52.00 mm

pindolol
#5 mg
tablets

Date: 28 JUL 2014
Description Pindalol 5 mg Tablets

5 0 1 6 6 9 5 160078

24.00 mm

TOP LABEL

If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
for advice before taking this medicine.

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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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