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ATENOLOL 50MG FILM-COATED TABLETS

Active substance(s): ATENOLOL / ATENOLOL / ATENOLOL

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Package leaflet: Information for the user
Totamol 25mg Tablets
Totamol 50mg Film-Coated Tablets
Totamol 100mg Film-Coated Tablets
Atenolol (Referred to as Totamol Tablets in this leaflet)
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.
− 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.
What is in this leaflet
1. What Totamol Tablets are and what they
are used for
2. What you need to know before you take
Totamol Tablets
3. How to take Totamol Tablets
4. Possible side effects
5. How to store Totamol Tablets
6. Contents of the pack and other
information
1. What
Totamol
Tablets are
and what
they are
used for

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Totamol Tablets
contain a
medicine called atenolol. This belongs to a
group of medicines called beta-blockers.
Totamol Tablets are used to:
• Treat high blood pressure (hypertension)
• Treat uneven heart beats (arrhythmias).
• Help prevent chest pain (angina).
• Protect the heart in the early treatment
after a heart attack (myocardial
infarction).
They work by making your heart beat more
slowly and with less force.

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2. What you need to know before you
take Totamol Tablets
Do not take Totamol Tablets:
• If you are allergic to atenolol or any of the
other ingredients of this medicine (listed
in section 6)
• If you have ever had any of the following
heart problems:
• heart failure which is not under control
(this usually makes you breathless and
causes your ankles to swell)
• second- or third-degree heart block (a
condition which may be treated by a
pacemaker)
• very slow or very uneven heart beats,
very low blood pressure or very poor
circulation.
• If you have a tumour called
phaeochromocytoma that is not being
treated. This is usually near your kidney
and can cause high blood pressure. If
you are being treated for
phaeochromocytoma, your doctor will
give you another medicine, called an
alpha-blocker, to take as well as Totamol
Tablets.
• If you have been told that you have
higher than normal levels of acid in your
blood (metabolic acidosis).
Do not take Totamol Tablets if any of the
above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking
Totamol Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Totamol Tablets:
• If you have asthma, wheezing or any
other similar breathing problems, or
you get allergic reactions, for example
to insect stings. If you have ever had
asthma or wheezing, do not take this
medicine without first checking with
your doctor.
• If you have a type of chest pain (angina)
called Prinzmetal's angina.
• If you have poor blood circulation or
controlled heart failure.
• If you have first-degree heart block.
• If you have diabetes. Your medicine may
change how you respond to having low
blood sugar. You may feel your heart
beating faster.
• If you have thyrotoxicosis (a condition

caused by an overactive thyroid gland).
Your medicine may hide the symptoms of
thyrotoxicosis.
• If you have problems with your kidneys.
You may need to have some check-ups
during your treatment.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Totamol Tablets.
Other medicines and Totamol Tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. This includes
medicines that you buy without a
prescription and herbal medicines.
This is because Totamol Tablets can affect
the way some other medicines work and
some medicines can have an effect on
Totamol Tablets.
In particular, tell your doctor if you are
taking any of the following medicines:
• Clonidine (for high blood pressure or
migraine). If you are taking clonidine and
Totamol Tablets 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.
• Verapamil, diltiazem and nifedipine (for
high blood pressure or chest pain).
• Disopyramide, quinidine or amiodarone
(for an uneven heart beat).
• Digoxin (for heart problems).
• Adrenaline, also known as epinephrine (a
medicine that stimulates the heart).
• Ibuprofen or indometacin (for pain and
inflammation).
• Insulin or medicines that you take by
mouth for diabetes.
• Medicines to treat nose or sinus
congestion or other cold remedies
(including those you can buy in the
pharmacy).
Operations
If you go into hospital to have an operation,
tell the anaesthetist or medical staff that
you are taking Totamol Tablets. This is
because you can get low blood pressure
(hypotension) if you are given certain
anaesthetics while you are taking Totamol
Tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Driving and using machines
• Your medicine is not likely to affect you
being able to drive or use any tools or
machines. However, it is best to wait to
see how your medicine affects you before
trying these activities.
• If you feel dizzy or tired when taking this
medicine, do not drive or use any tools or
machines.
3. How to take Totamol Tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
• Your doctor will tell you how many tablets
to take each day and when to take them.
Read the label on the carton to remind
you what the doctor said.
• Swallow your Totamol tablet whole with a
drink of water.
• Try to take your tablet at the same time
each day.
Adults
• High blood pressure (hypertension):
the recommended dose is 50 mg to 100
mg a day.
• Chest pain (angina): the recommended
dose is 100 mg a day or 50 mg twice a
day.
• Uneven heart beats (arrhythmias): the
recommended dose is 50 mg to 100 mg a
day.
• The early treatment of a heart attack
(myocardial infarction): the recommended
dose is 50 mg to 100 mg a day.
Older people
If you are an older person, your doctor may
decide to give you a lower dose, particularly
if you have problems with your kidneys.

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Totamol 25, 50 & 100mg Tablets (Atenolol) - 28 Tabs
Wockhardt UK
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CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • New regulatory text

Non-Regulatory

Very rare (may affect up to 1 in 10,000
people)
• Changes to some of the cells or other
parts of your blood. Your doctor may take
blood samples every so often to check
whether Totamol has had any effect on
your blood.
Not known (frequency cannot be
estimated from the available data)
• Lupus-like syndrome (a disease where
the immune system produces antibodies
that attacks mainly skin and joints).
Conditions that may get worse
If you have any of the following conditions,
they may get worse when you start to take
your medicine. This happens rarely
affecting less than 1 in 1,000 people.
• Psoriasis (a skin condition).
• Being short of breath or having swollen

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Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.

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What Totamol Tablets looks like and
contents of the pack
Totamol Tablets are supplied in blister
packs of 28 tablets or in polypropylene or
polyethylene containers of 500 tablets.

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Rare (may affect up to 1 in 1,000 people)
• Heart block (which can cause dizziness,
abnormal heart beat, tiredness or
fainting).
• Numbness and spasm in your fingers
which is followed by warmth and pain
(Raynaud’s disease).
• Mood changes.
• Nightmares.
• Feeling confused.
• Changes in personality (psychoses) or
hallucinations.
• Headache.
• Dizziness (particularly when standing up).
• Tingling of your hands.
• Being unable to get an erection
(impotence).
• Dry mouth.
• Dry eyes.
• Disturbances of vision.
• Thinning of your hair.
• Skin rash.
• Reduced numbers of platelets in your
blood (this may make you bruise more
easily).
• Purplish marks on your skin.
• Jaundice (causing yellowing of your skin
or the whites of your eyes).

What Totamol Tablets contains
The active substance is: atenolol 25mg,
50mg or 100mg.
The other ingredients are: maize starch,
heavy magnesium carbonate, povidone
K30, sodium starch glycollate and
magnesium stearate.
Totamol 50mg and 100mg Tablets also
contain: purified water, opadry orange
OY-3455.

Manufacturer:
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following
information:
Product name

Reference
number

Totamol 25mg Tablets

PL 29831/0020

Totamol 50mg
Film-Coated Tablets

PL 29831/0018

Totamol 100mg
Film-Coated Tablets

PL 29831/0019

This is a service provided by the Royal
National Institute of Blind People.

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Uncommon (may affect up to 1 in 100
people)
• Disturbed sleep.

6. Contents of the pack and other
information

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Other possible side effects:
Common (may affect up to 1 in 10
people)
• You may notice that your pulse rate
becomes slower while you are taking the
tablets. This is normal, but if you are
concerned please tell your doctor about it.
• Cold hands and feet.
• Diarrhoea.
• Feeling sick (nausea).
• Feeling tired.

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Allergic reactions:
If you have an allergic reaction, see a
doctor straight away. The signs may include
raised lumps on your skin (weals), or
swelling of your face, lips, mouth, tongue or
throat.

• Keep this medicine out the sight and
reach of children.
• Do not store above 25°C. Store in the
original container to protect from
moisture; do
not transfer
your tablets to
another
container.
• Do not use
this medicine
after the
expiry date
which is stated
on the carton.
The expiry date refers to the last day of
that month.
• 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 protect the environment.

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

5. How to store Totamol Tablets

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4. Possible side effects

By reporting side effects you can help
provide more information on the safety of
this medicine.

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If you stop taking Totamol Tablets
Do not stop taking Totamol Tablets without
talking to your doctor. In some cases, you
may need to stop taking it gradually.

Malta:
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal

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If you forget to take Totamol Tablets
If you forget to take a dose, take it as soon
as you remember. However, if it is almost
time for the next dose, skip the missed
dose. Do not take a double dose to make
up for a forgotten dose.

United Kingdom:
Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.

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If you take more Totamol Tablets than
you should
If you take more Totamol Tablets than
prescribed by your doctor, talk to a doctor
or go to a hospital straight away. Take the
medicine pack with you so that the tablets
can be identified.

Reporting of side effects
If you get any side effects, talk to your
doctor, or pharmacist or nurse. This
includes any possible side effects not listed
in this leaflet. You can also report side
effects directly via the national reporting
systems listed below:

This leaflet was last revised in
December 2016

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Use in Children
This medicine must not be given to
children.

ankles (if you have heart failure).
• Asthma or breathing problems.
• Poor circulation.

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People with severe kidney problems
If you have severe kidney problems your
doctor may decide to give you a lower
dose.

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Expand Transcript

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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