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ATENOLOL 5MG/ML ORAL SOLUTION

Active substance(s): ATENOLOL

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Package leaflet: Information for the user

Atenolol 5mg/ml Oral Solution
Read alll of this leafflet
carefully before you
u start
taking tthis medicine
cause it conttains importa
ant
bec
ormation forr you.
info
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 pharmacis
st. This
includes any possible side effects
not listed in this leaflet. See
section 4.







e name of the medicine is Atenolol
The
ution but will be
g/ml Oral Solu
5mg
enolol through
erred to as Ate
hout this
refe
leafflet.
hat is in this leaflet:
Wh
What Aten
nolol is and w
what it is
1.
used for
What you need
n
to know
w before
2.
you take Atenolol
A
How to tak
ke Atenolol
3.
Possible siide effects
4.
How to sto
ore Atenolol
5.
Contents of
o the pack and other
6.
informatio
on
1.

enolol is and what it
What Ate
or
is used fo

s the active su
ubstance
Atenolol contains
nolol. This bellongs to a gro
oup of
aten
dicines called beta-blockers
s. Atenolol
med
is used to:
Treat high blood pressure
e

(hypertensio
on).
Treat uneve
en heart beats
s

(arrhythmia
as).
Help prevent chest pain ((angina).

Protect the heart in the e
early

treatment a
attack
after a heart a
(myocardiall infarction).
It works by making your heartt beat
ce.
morre slowly and with less forc

2. What you need to kn
now

before you take Aten
nolol





Do not ta
ake Atenololl if:
You are allerg
gic to Atenololl or any of
the other ingrredients of Ate
enolol
(listed in Secttion 6).
You have ever had any of tthe
following heart problems:
- heart failure which is no
ot under
control (this usually ma
akes you
breathless and causes y
your
ankles to swell).
- second- or third-degree
e heart
block (a condition which may be
treated by
y a pacemaker).
- very slow or very uneve
en heart
beats, verry low blood p
pressure or
very poor circulation.

PIL/UK/MFG105/04/v1





You have a tu
umour called
phaeochromo
ocytoma that iis not
being treated. This is usually near
your kidney and can cause high
blood pressure. If you are being
omocytoma,
treated for phaeochro
octor will give you another
your do
alpha-blocker, to
ne, called an a
medicin
olol.
take as well as Ateno
ve been told that you have
You hav
evels of acid in
higher tthan normal le
ood (metabolic acidosis).
your blo

e Atenolol if any of the above
Do not take
k to
ou. If you are not sure, talk
apply to yo
your doctorr or pharmacist before taking
Atenolol.
Warnings and precauttions
Talk to your doctor or pharmacist befo
ore
taking Aten
nolol if:
have asthma
 You h
a, wheezing or
o
other similar
any o
r breathing
probllems, or you get allergic
ect
reacttions, for exa
ample to inse
stings. If you hav
ve ever had
ma or wheez
asthm
zing, do not
take tthis medicin
ne without firrst
king with your doctor.
check
 You have a type of chest pain
na) called Prin
(angin
nzmetal’s
a.
angina
 You have poor bloo
od circulation or
o
olled heart failure.
contro
 You have first-degr
ree heart block.
ne
 You have diabetes. Your medicin
o
change how yo
may c
ou respond to
y
g low blood su
having
ugar. You may
our heart beating faster.
feel yo
cosis (a
 You have thyrotoxic
ve
y an overactiv
condittion caused by
ur medicine may
thyroiid gland). You
s of
hide tthe symptoms
thyrottoxicosis.
s with your
 You have problems
to have
ys. You may need
n
kidney
uring your
some check-ups du
ment.
treatm
e
y of the above
If you are not
n sure if any
ur doctor or
ou, talk to you
apply to yo
g Atenolol.
pharmacistt before taking
cines and
Other medic
Atenolol
A
a
octor or pharmacist if you are
Tell your do
have recently taken, any
taking, or h
nes
cludes medicin
other medicines. This inc
nd
uy without a prescription an
that you bu
s because
dicines. This is
herbal med
er
Atenolol can affect the way some othe
c
medicines work and some medicines can
have an efffect on Atenolol.
octor or
ar, tell your do
In particula
he
pharmacistt if you are taking any of th
following medicines:
 Clonidine (for high blood pressurre
or migraine). If you are taking
clonidine and Atenolol together, do
not sttop taking clonidine unless
your doctor tells yo
ou to do so. If
e,
you have to stop taking clonidine
your doctor will give you careful
instructions about how to do it.
 Verapamil, diltiazem and nifedipine
ssure or chestt
(for high blood pres
pain).










Disopy
yramide, quin
nidine or
amiod
darone (for an
n uneven hearrt
beat)..
Digoxin (for heart problems).
Adrenaline, also known as
hat
epinephrine (a medicine th
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).

Operrations
u go into hospital to have an
If you
ation, tell the anaesthetist or
opera
medical staff that you are taking
olol. This is because you can get
Ateno
low blood pressure (hypotension) if you
are given certain anaesthetics while you
aking Atenolol.
are ta
nolol with foo
od
Aten
olol should no
ot be taken witth the
Ateno
food.
Pregnancy and
breast-feed
ding
Talk tto your doctor before taking
olol if you are pregnant, ma
ay
Ateno
me pregnant or
o are breast--feeding.
becom
Driviing and using machines
our medicine is not likely to
o affect
Yo
ou being able to drive or us
se any
yo
ools or machin
to
nes. However,, it is
est to wait to see how yourr
be
medicine affectts you before trying
m
hese activities
th
s.
en taking

If you feel dizzy or tired whe
his medicine, do not drive o
or use
th
ny tools or ma
achines.
an


Atenolol contains:
c
cine contains methyl
This medic
e
parahydrroxybenzoate
(E21
18) and propyl
zoate (E216): May
parahydroxybenz
ctions (possibly
cause
e allergic reac
delay
yed).
sing)
non-crystallis
Sorb
bitol liquid (n
by your
(E42
20): If you have been told b
ance to
ave an intolera
docto
or that you ha
or before
some
e sugars, contact your docto
taking this medicinal product.
This medicinal product contains 2.43
er dose
mmol (or 55.89 mg) sodium pe
o be taken intto
(20ml Atenolol). To
controlled
consideration by patients on a c
sodiu
um diet.

3. How to take Atenolol
Alway
ys take Ateno
olol exactly as your
docto
or has told you. You should check
with y
your doctor or pharmacist if you
are n
not sure.
ow much
Your doctor will tell you ho

solution to take each day and when
to take it. Read the label on the
carton to remind you whatt the
doctor said.

Atenolol should be swallowed.
our medicine at the

Try to take yo
same time each day.
TURN OVER

Adults

High blood pressure
(hypertension): The usual initial
dose is 5ml (25mg) per day. The
usual maintenance dose is once
daily 10 to 20ml (50 to 100mg).

Chest pain (angina): The usual
dose is 10 to 20ml (50 to 100mg)
per day. The dose of 20ml
(100mg) per day can be divided
over two doses per day.

Uneven heart beats (arrhythmias):
the usual dose is 10ml (50mg) to
20ml (100mg) once daily.

The early treatment of a heart
attack (myocardial infarction): the
usual dose is 10ml (50mg) to 20ml
(100mg) a day.
Elderly people
If you are an elderly person, your doctor
may decide to give you a lower dose,
particularly if you have problems with
your kidneys.
People with kidney problems
If you have severe kidney problems
your doctor may decide to give you a
lower dose.
Children
Your medicine must not be given to
children.
Route and method of administration
This medicinal product must be taken
orally.
Use the double ended plastic spoon (as
shown below) to measure the required
dose. The smaller end measures 2.5ml
and larger end measures 5ml.

If you take more Atenolol than you
should
If you take more Atenolol 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 medicine can be identified.
If you forget to take Atenolol
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.
If you stop taking Atenolol
Do not stop taking Atenolol without
talking to your doctor. In some cases,
you may need to stop taking it
gradually.
4.

Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
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.
PIL/UK/MFG105/04/v1

See your doctor as soon as possible
if you get any of the following side
effects:



Jaundice (causing yellowing of your
skin or the whites of your eyes).
You may become more prone to
bruising or bleeding or have
purplish marks on your skin – this
could be a sign of changes to some
of the cells or other parts of your
blood and your doctor may want to
take blood samples every so often
to check this.

Other possible side effects:
Common (affects less than 1 in 10
people)

You may notice that your pulse
rate becomes slower while you are
taking the medicine. This is
normal, but if you are concerned
please tells your doctor about it.

Cold hands and feet.

Diarrhoea.

Feeling sick (nausea).

Feeling tired.
Uncommon (affects less than 1 in 100
people)

Disturbed sleep.
Rare (affects less than 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).

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.
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 ankles (if you have heart
failure).

Asthma or breathing problems.

Poor circulation.
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.
5.








How to store Atenolol

Keep out of the sight and reach of
children.
Do not use after the expiry date
which is stated on the carton or
bottle after ‘Exp’. The expiry date
refers to the last day of that month.
Do not store above 25°C.
For 100ml and 150ml: Discard 30
days after first opening.
For 300ml: Discard 60 days after
first opening.
Do not throw away any medicine via
waste water or household waste. Ask
your pharmacist how to dispose of
medicines you no longer use. These
measures will help to protect the
environment.
6.

Contents of the pack and
other information

What Atenolol contains
The active substance is Atenolol.
Each ml of oral solution contains 5mg
Atenolol.
The other ingredients are methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), citric acid
monohydrate (E330), sodium citrate
(E331), sorbitol liquid (non-crystallising)
(E420), saccharin sodium (E954),
orange flavor [containing propylene
glycol (E1520)] and purified water.
What Atenolol looks like and
contents of the pack
Atenolol is clear colourless oral solution
with orange flavour supplied in an
amber PET bottle with tamper-evident
child resistant plastic cap and a doubleended plastic spoon for measuring and
administering the dose.
Atenolol is supplied in bottles containing
100ml, 150ml and 300ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Syri Limited t/a Thame Laboratories
Unit 4, Bradfield Road,
Ruislip, Middlesex,
POM
HA4 0NU, UK
The medicinal product is authorised
in the Member states of the EEA
under the following names:
UK and IE: Atenolol 5mg/ml Oral Solution
This leaflet was last revised in 09/2015.

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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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